Bill Text: MN SF1484 | 2013-2014 | 88th Legislature | Engrossed
Bill Title: Omnibus health related licensing boards provisions
Sponsorship: Slight Partisan Bill (Democrat 8-3)
Status: (Engrossed - Dead) 2014-04-30 - Senate file first reading, referred to Health and Human Services Finance [SF1484 Detail]
Download: Minnesota-2013-SF1484-Engrossed.html
1.2relating to health; making changes to dental licensing provisions; authorizing
1.3the administration of influenza vaccine by qualified dentists under certain
1.4circumstances; providing penalties; modifying grounds for disciplinary
1.5action by the Board of Nursing; modifying the health professionals services
1.6program; modifying the compensation paid to the health-related licensing board
1.7members; making changes to the Minnesota prescription monitoring program;
1.8adding and modifying definitions; changing the requirements for pharmacist
1.9participation in immunizations; changing the powers and duties of the Board
1.10of Pharmacy; changing licensing requirements for businesses regulated by the
1.11Board of Pharmacy; clarifying requirements for compounding; allowing certain
1.12educational institutions to purchase legend drugs in limited circumstances;
1.13allowing certain entities to handle drugs in preparation for emergency use;
1.14clarifying the requirement that drug manufacturers report certain payments to the
1.15Board of Pharmacy; adding certain substances to the schedules for controlled
1.16substances; requiring a report; appropriating money;amending Minnesota
1.17Statutes 2012, sections 148.261, subdivisions 1, 4, by adding a subdivision;
1.18150A.01, subdivision 8a; 150A.06, subdivisions 1, 1a, 1c, 1d, 2, 2a, 2d, 3, 8;
1.19150A.091, subdivisions 3, 8, 16; 150A.10; 151.01; 151.06; 151.211; 151.26;
1.20151.34; 151.35; 151.361, subdivision 2; 151.37, as amended; 151.44; 151.58,
1.21subdivisions 2, 3, 5; 152.02, subdivision 8b; 152.126, as amended; 214.09,
1.22subdivision 3; 214.32, by adding a subdivision; 214.33, subdivision 3; Minnesota
1.23Statutes 2013 Supplement, sections 151.252, by adding a subdivision; 152.02,
1.24subdivision 2; 364.09; proposing coding for new law in Minnesota Statutes,
1.25chapters 150A; 151.
1.26BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF MINNESOTA:
1.29 Section 1. Minnesota Statutes 2012, section 148.261, subdivision 1, is amended to read:
1.30 Subdivision 1. Grounds listed. The board may deny, revoke, suspend, limit, or
1.31condition the license and registration of any person to practice professional, advanced
1.32practice registered, or practical nursing under sections148.171 to
148.285 , or to otherwise
2.1discipline a licensee or applicant as described in section148.262 . The following are
2.2grounds for disciplinary action:
2.3(1) Failure to demonstrate the qualifications or satisfy the requirements for a license
2.4contained in sections148.171 to
148.285 or rules of the board. In the case of a person
2.5applying for a license, the burden of proof is upon the applicant to demonstrate the
2.6qualifications or satisfaction of the requirements.
2.7(2) Employing fraud or deceit in procuring or attempting to procure a permit, license,
2.8or registration certificate to practice professional or practical nursing or attempting to
2.9subvert the licensing examination process. Conduct that subverts or attempts to subvert
2.10the licensing examination process includes, but is not limited to:
2.11(i) conduct that violates the security of the examination materials, such as removing
2.12examination materials from the examination room or having unauthorized possession of
2.13any portion of a future, current, or previously administered licensing examination;
2.14(ii) conduct that violates the standard of test administration, such as communicating
2.15with another examinee during administration of the examination, copying another
2.16examinee's answers, permitting another examinee to copy one's answers, or possessing
2.17unauthorized materials; or
2.18(iii) impersonating an examinee or permitting an impersonator to take the
2.19examination on one's own behalf.
2.20(3) Conviction of a felony or gross misdemeanor reasonably related to the practice
2.21of professional, advanced practice registered, or practical nursing. Conviction as used in
2.22this subdivision includes a conviction of an offense that if committed in this state would
2.23be considered a felony or gross misdemeanor without regard to its designation elsewhere,
2.24or a criminal proceeding where a finding or verdict of guilt is made or returned but the
2.25adjudication of guilt is either withheld or not entered.
2.26(4) Revocation, suspension, limitation, conditioning, or other disciplinary action
2.27against the person's professional or practical nursing license or advanced practice
2.28registered nursing credential, in another state, territory, or country; failure to report to the
2.29board that charges regarding the person's nursing license or other credential are pending in
2.30another state, territory, or country; or having been refused a license or other credential by
2.31another state, territory, or country.
2.32(5) Failure to or inability to perform professional or practical nursing as defined in
2.33section148.171, subdivision 14 or 15, with reasonable skill and safety, including failure
2.34of a registered nurse to supervise or a licensed practical nurse to monitor adequately the
2.35performance of acts by any person working at the nurse's direction.
3.1(6) Engaging in unprofessional conduct, including, but not limited to, a departure
3.2from or failure to conform to board rules of professional or practical nursing practice that
3.3interpret the statutory definition of professional or practical nursing as well as provide
3.4criteria for violations of the statutes, or, if no rule exists, to the minimal standards of
3.5acceptable and prevailing professional or practical nursing practice, or any nursing
3.6practice that may create unnecessary danger to a patient's life, health, or safety. Actual
3.7injury to a patient need not be established under this clause.
3.8(7) Failure of an advanced practice registered nurse to practice with reasonable
3.9skill and safety or departure from or failure to conform to standards of acceptable and
3.10prevailing advanced practice registered nursing.
3.11(8) Delegating or accepting the delegation of a nursing function or a prescribed
3.12health care function when the delegation or acceptance could reasonably be expected to
3.13result in unsafe or ineffective patient care.
3.14(9) Actual or potential inability to practice nursing with reasonable skill and safety
3.15to patients by reason of illness, use of alcohol, drugs, chemicals, or any other material, or
3.16as a result of any mental or physical condition.
3.17(10) Adjudication as mentally incompetent, mentally ill, a chemically dependent
3.18person, or a person dangerous to the public by a court of competent jurisdiction, within or
3.19without this state.
3.20(11) Engaging in any unethical conduct, including, but not limited to, conduct likely
3.21to deceive, defraud, or harm the public, or demonstrating a willful or careless disregard
3.22for the health, welfare, or safety of a patient. Actual injury need not be established under
3.23this clause.
3.24(12) Engaging in conduct with a patient that is sexual or may reasonably be
3.25interpreted by the patient as sexual, or in any verbal behavior that is seductive or sexually
3.26demeaning to a patient, or engaging in sexual exploitation of a patient or former patient.
3.27(13) Obtaining money, property, or services from a patient, other than reasonable
3.28fees for services provided to the patient, through the use of undue influence, harassment,
3.29duress, deception, or fraud.
3.30(14) Revealing a privileged communication from or relating to a patient except when
3.31otherwise required or permitted by law.
3.32(15) Engaging in abusive or fraudulent billing practices, including violations of
3.33federal Medicare and Medicaid laws or state medical assistance laws.
3.34(16) Improper management of patient records, including failure to maintain adequate
3.35patient records, to comply with a patient's request made pursuant to sections144.291 to
3.36144.298, or to furnish a patient record or report required by law.
4.1(17) Knowingly aiding, assisting, advising, or allowing an unlicensed person to
4.2engage in the unlawful practice of professional, advanced practice registered, or practical
4.3nursing.
4.4(18) Violating a rule adopted by the board, an order of the board, or a state or federal
4.5law relating to the practice of professional, advanced practice registered, or practical
4.6nursing, or a state or federal narcotics or controlled substance law.
4.7(19) Knowingly providing false or misleading information that is directly related
4.8to the care of that patient unless done for an accepted therapeutic purpose such as the
4.9administration of a placebo.
4.10(20) Aiding suicide or aiding attempted suicide in violation of section609.215 as
4.11established by any of the following:
4.12(i) a copy of the record of criminal conviction or plea of guilty for a felony in
4.13violation of section609.215, subdivision 1 or 2;
4.14(ii) a copy of the record of a judgment of contempt of court for violating an
4.15injunction issued under section609.215, subdivision 4 ;
4.16(iii) a copy of the record of a judgment assessing damages under section609.215,
4.17subdivision 5 ; or
4.18(iv) a finding by the board that the person violated section609.215, subdivision
4.191 or 2. The board shall investigate any complaint of a violation of section
609.215,
4.20subdivision 1 or 2.
4.21(21) Practicing outside the scope of practice authorized by section148.171,
4.22subdivision 5 , 10, 11, 13, 14, 15, or 21.
4.23(22) Practicing outside the specific field of nursing practice for which an advanced
4.24practice registered nurse is certified unless the practice is authorized under section148.284 .
4.25(23) Making a false statement or knowingly providing false information to the
4.26board, failing to make reports as required by section148.263 , or failing to cooperate with
4.27an investigation of the board as required by section148.265 .
4.28(24) Engaging in false, fraudulent, deceptive, or misleading advertising.
4.29(25) Failure to inform the board of the person's certification status as a nurse
4.30anesthetist, nurse-midwife, nurse practitioner, or clinical nurse specialist.
4.31(26) Engaging in clinical nurse specialist practice, nurse-midwife practice, nurse
4.32practitioner practice, or registered nurse anesthetist practice without current certification
4.33by a national nurse certification organization acceptable to the board, except during the
4.34period between completion of an advanced practice registered nurse course of study and
4.35certification, not to exceed six months or as authorized by the board.
4.36(27) Engaging in conduct that is prohibited under section145.412 .
5.1(28) Failing to report employment to the board as required by section148.211,
5.2subdivision 2a , or knowingly aiding, assisting, advising, or allowing a person to fail to
5.3report as required by section148.211, subdivision 2a .
5.4(29) Discharge from the health professionals services program as described in
5.5sections 214.31 to 214.37, or any other alternative monitoring or diversion program for
5.6reasons other than satisfactory completion of the program as set forth in the participation
5.7agreement.
5.8 Sec. 2. Minnesota Statutes 2012, section 148.261, is amended by adding a subdivision
5.9to read:
5.10 Subd. 1a. Conviction of a felony-level criminal sexual offense. (a) Except as
5.11provided in paragraph (e), the board may not grant or renew a license to practice nursing
5.12to any person who has been convicted on or after August 1, 2014, of any of the provisions
5.13of sections609.342, subdivision 1 ,
609.343, subdivision 1 ,
609.344 , subdivision 1,
5.14paragraphs (c) to (o), or609.345, subdivision 1 , paragraphs (c) to (o), or a similar statute
5.15in another jurisdiction.
5.16(b) A license to practice nursing is automatically revoked if the licensee is convicted
5.17of an offense listed in paragraph (a) of this section.
5.18(c) A license to practice nursing that has been denied or revoked under this
5.19subdivision is not subject to chapter 364.
5.20(d) For purposes of this subdivision, "conviction" means a plea of guilty, a verdict of
5.21guilty by a jury, or a finding of guilty by the court, unless the court stays imposition or
5.22execution of the sentence and final disposition of the case is accomplished at a nonfelony
5.23level.
5.24(e) The board may establish criteria whereby an individual convicted of an offense
5.25listed in paragraph (a) of this subdivision may become licensed provided that the criteria:
5.26(1) utilize a rebuttable presumption that the applicant is not suitable for licensing;
5.27(2) provide a standard for overcoming the presumption; and
5.28(3) require that a minimum of ten years has elapsed since the applicant's sentence
5.29was discharged.
5.30The board shall not consider an application under this paragraph if the board
5.31determines that the victim involved in the offense was a patient or a client of the applicant
5.32at the time of the offense.
5.33 Sec. 3. Minnesota Statutes 2012, section 148.261, subdivision 4, is amended to read:
6.1 Subd. 4. Evidence. In disciplinary actions alleging a violation of subdivision 1,
6.2clause (3) or (4), or subdivision 1a, a copy of the judgment or proceeding under the seal
6.3of the court administrator or of the administrative agency that entered the same shall be
6.4admissible into evidence without further authentication and shall constitute prima facie
6.5evidence of the violation concerned.
6.6 Sec. 4. Minnesota Statutes 2012, section 150A.01, subdivision 8a, is amended to read:
6.7 Subd. 8a. Resident dentist. "Resident dentist" means a person who is licensed to
6.8practice dentistry as an enrolled graduate student or student of an advanced education
6.9program accredited by theAmerican Dental Association Commission on Dental
6.10Accreditation.
6.11 Sec. 5. [150A.055] ADMINISTRATION OF INFLUENZA IMMUNIZATIONS.
6.12 Subdivision 1. Practice of dentistry. A person licensed to practice dentistry under
6.13sections 150A.01 to 150A.14 shall be deemed to be practicing dentistry while participating
6.14in the administration of an influenza vaccination.
6.15 Subd. 2. Qualified dentists. (a) The influenza immunization shall be administered
6.16only to patients 19 years of age and older and only by licensed dentists who:
6.17(1) have immediate access to emergency response equipment, including but not
6.18limited to oxygen administration equipment, epinephrine, and other allergic reaction
6.19response equipment; and
6.20(2) are trained in or have successfully completed a program approved by the
6.21Minnesota Board of Dentistry, specifically for the administration of immunizations. The
6.22training or program must include:
6.23(i) educational material on the disease of influenza and vaccination as prevention
6.24of the disease;
6.25(ii) contraindications and precautions;
6.26(iii) intramuscular administration;
6.27(iv) communication of risk and benefits of influenza vaccination and legal
6.28requirements involved;
6.29(v) reporting of adverse events;
6.30(vi) documentation required by federal law; and
6.31(vii) storage and handling of vaccines.
6.32(b) Any dentist giving influenza vaccinations under this section shall comply
6.33with guidelines established by the federal Advisory Committee on Immunization
6.34Practices relating to vaccines and immunizations, which includes, but is not limited to,
7.1vaccine storage and handling, vaccine administration and documentation, and vaccine
7.2contraindications and precautions.
7.3 Subd. 3. Coordination of care. After a dentist qualified under subdivision 2 has
7.4administered an influenza vaccine to a patient, the dentist shall report the administration of
7.5the immunization to the Minnesota Immunization Information Connection or otherwise
7.6notify the patient's primary physician or clinic of the administration of the immunization.
7.7EFFECTIVE DATE.This section is effective January 1, 2015, and applies to
7.8influenza immunizations performed on or after that date.
7.9 Sec. 6. Minnesota Statutes 2012, section 150A.06, subdivision 1, is amended to read:
7.10 Subdivision 1. Dentists. A person of good moral character who has graduated from
7.11a dental program accredited by the Commission on Dental Accreditationof the American
7.12Dental Association, having submitted an application and fee as prescribed by the board,
7.13may be examined by the board or by an agency pursuant to section150A.03, subdivision
7.141 , in a manner to test the applicant's fitness to practice dentistry. A graduate of a dental
7.15college in another country must not be disqualified from examination solely because of
7.16the applicant's foreign training if the board determines that the training is equivalent to or
7.17higher than that provided by a dental college accredited by the Commission on Dental
7.18Accreditationof the American Dental Association. In the case of examinations conducted
7.19pursuant to section150A.03, subdivision 1 , applicants shall take the examination prior to
7.20applying to the board for licensure. The examination shall include an examination of the
7.21applicant's knowledge of the laws of Minnesota relating to dentistry and the rules of the
7.22board. An applicant is ineligible to retake the clinical examination required by the board
7.23after failing it twice until further education and training are obtained as specified by the
7.24board by rule. A separate, nonrefundable fee may be charged for each time a person applies.
7.25An applicant who passes the examination in compliance with subdivision 2b, abides by
7.26professional ethical conduct requirements, and meets all other requirements of the board
7.27shall be licensed to practice dentistry and granted a general dentist license by the board.
7.28 Sec. 7. Minnesota Statutes 2012, section 150A.06, subdivision 1a, is amended to read:
7.29 Subd. 1a. Faculty dentists. (a) Faculty members of a school of dentistry must be
7.30licensed in order to practice dentistry as defined in section150A.05 . The board may
7.31issue to members of the faculty of a school of dentistry a license designated as either a
7.32"limited faculty license" or a "full faculty license" entitling the holder to practice dentistry
7.33within the terms described in paragraph (b) or (c). The dean of a school of dentistry and
7.34program directors of a Minnesota dental hygiene or dental assisting school accredited by
8.1the Commission on Dental Accreditationof the American Dental Association shall certify
8.2to the board those members of the school's faculty who practice dentistry but are not
8.3licensed to practice dentistry in Minnesota. A faculty member who practices dentistry as
8.4defined in section150A.05 , before beginning duties in a school of dentistry or a dental
8.5hygiene or dental assisting school, shall apply to the board for a limited or full faculty
8.6license. Pursuant to Minnesota Rules, chapter 3100, and at the discretion of the board,
8.7a limited faculty license must be renewed annually and a full faculty license must be
8.8renewed biennially. The faculty applicant shall pay a nonrefundable fee set by the board
8.9for issuing and renewing the faculty license. The faculty license is valid during the time
8.10the holder remains a member of the faculty of a school of dentistry or a dental hygiene or
8.11dental assisting school and subjects the holder to this chapter.
8.12(b) The board may issue to dentist members of the faculty of a Minnesota school
8.13of dentistry, dental hygiene, or dental assisting accredited by the Commission on Dental
8.14Accreditationof the American Dental Association, a license designated as a limited
8.15faculty license entitling the holder to practice dentistry within the school and its affiliated
8.16teaching facilities, but only for the purposes of teaching or conducting research. The
8.17practice of dentistry at a school facility for purposes other than teaching or research is not
8.18allowed unless the dentist was a faculty member on August 1, 1993.
8.19(c) The board may issue to dentist members of the faculty of a Minnesota school
8.20of dentistry, dental hygiene, or dental assisting accredited by the Commission on Dental
8.21Accreditationof the American Dental Association a license designated as a full faculty
8.22license entitling the holder to practice dentistry within the school and its affiliated teaching
8.23facilities and elsewhere if the holder of the license is employed 50 percent time or more by
8.24the school in the practice of teaching or research, and upon successful review by the board
8.25of the applicant's qualifications as described in subdivisions 1, 1c, and 4 and board rule.
8.26The board, at its discretion, may waive specific licensing prerequisites.
8.27 Sec. 8. Minnesota Statutes 2012, section 150A.06, subdivision 1c, is amended to read:
8.28 Subd. 1c. Specialty dentists. (a) The board may granta one or more specialty
8.29license licenses in the specialty areas of dentistry that are recognized by the American
8.30Dental Association Commission on Dental Accreditation.
8.31(b) An applicant for a specialty license shall:
8.32(1) have successfully completed a postdoctoral specialtyeducation program
8.33accredited by the Commission on Dental Accreditationof the American Dental
8.34Association, or have announced a limitation of practice before 1967;
9.1(2) have been certified by a specialtyexamining board approved by the Minnesota
9.2Board of Dentistry, or provide evidence of having passed a clinical examination for
9.3licensure required for practice in any state or Canadian province, or in the case of oral and
9.4maxillofacial surgeons only, have a Minnesota medical license in good standing;
9.5(3) have been in active practice or a postdoctoral specialty education program or
9.6United States government service at least 2,000 hours in the 36 months prior to applying
9.7for a specialty license;
9.8(4) if requested by the board, be interviewed by a committee of the board, which
9.9may include the assistance of specialists in the evaluation process, and satisfactorily
9.10respond to questions designed to determine the applicant's knowledge of dental subjects
9.11and ability to practice;
9.12(5) if requested by the board, present complete records on a sample of patients
9.13treated by the applicant. The sample must be drawn from patients treated by the applicant
9.14during the 36 months preceding the date of application. The number of records shall be
9.15established by the board. The records shall be reasonably representative of the treatment
9.16typically provided by the applicant for each specialty area;
9.17(6) at board discretion, pass a board-approved English proficiency test if English is
9.18not the applicant's primary language;
9.19(7) pass all components of the National Board Dental Examinations;
9.20(8) pass the Minnesota Board of Dentistry jurisprudence examination;
9.21(9) abide by professional ethical conduct requirements; and
9.22(10) meet all other requirements prescribed by the Board of Dentistry.
9.23(c) The application must include:
9.24(1) a completed application furnished by the board;
9.25(2) at least two character references from two different dentists for each specialty
9.26area, one of whom must be a dentist practicing in the same specialty area, and the other
9.27 from the director ofthe each specialty program attended;
9.28(3) a licensed physician's statement attesting to the applicant's physical and mental
9.29condition;
9.30(4) a statement from a licensed ophthalmologist or optometrist attesting to the
9.31applicant's visual acuity;
9.32(5) a nonrefundable fee; and
9.33(6) a notarized, unmounted passport-type photograph, three inches by three inches,
9.34taken not more than six months before the date of application.
9.35(d) A specialty dentist holdinga one or more specialty license licenses is limited to
9.36practicing in the dentist's designated specialty area or areas. The scope of practice must be
10.1defined by each national specialty board recognized by theAmerican Dental Association
10.2 Commission on Dental Accreditation.
10.3(e) A specialty dentist holding a generaldentist dental license is limited to practicing
10.4in the dentist's designated specialty area or areas if the dentist has announced a limitation
10.5of practice. The scope of practice must be defined by each national specialty board
10.6recognized by theAmerican Dental Association Commission on Dental Accreditation.
10.7(f) All specialty dentists who have fulfilled the specialty dentist requirements and
10.8who intend to limit their practice to a particular specialty area or areas may apply for
10.9a one or more specialty license licenses.
10.10 Sec. 9. Minnesota Statutes 2012, section 150A.06, subdivision 1d, is amended to read:
10.11 Subd. 1d. Dental therapists. A person of good moral character who has graduated
10.12with a baccalaureate degree or a master's degree from a dental therapy education program
10.13that has been approved by the board or accredited by theAmerican Dental Association
10.14 Commission on Dental Accreditation or another board-approved national accreditation
10.15organization may apply for licensure.
10.16The applicant must submit an application and fee as prescribed by the board and a
10.17diploma or certificate from a dental therapy education program. Prior to being licensed,
10.18the applicant must pass a comprehensive, competency-based clinical examination that is
10.19approved by the board and administered independently of an institution providing dental
10.20therapy education. The applicant must also pass an examination testing the applicant's
10.21knowledge of the Minnesota laws and rules relating to the practice of dentistry. An
10.22applicant who has failed the clinical examination twice is ineligible to retake the clinical
10.23examination until further education and training are obtained as specified by the board. A
10.24separate, nonrefundable fee may be charged for each time a person applies. An applicant
10.25who passes the examination in compliance with subdivision 2b, abides by professional
10.26ethical conduct requirements, and meets all the other requirements of the board shall
10.27be licensed as a dental therapist.
10.28 Sec. 10. Minnesota Statutes 2012, section 150A.06, subdivision 2, is amended to read:
10.29 Subd. 2. Dental hygienists. A person of good moral character, who has graduated
10.30from a dental hygiene program accredited by the Commission on Dental Accreditationof
10.31the American Dental Association and established in an institution accredited by an agency
10.32recognized by the United States Department of Education to offer college-level programs,
10.33may apply for licensure. The dental hygiene program must provide a minimum of two
10.34academic years of dental hygiene education. The applicant must submit an application and
11.1fee as prescribed by the board and a diploma or certificate of dental hygiene. Prior to being
11.2licensed, the applicant must pass the National Board of Dental Hygiene examination and a
11.3board approved examination designed to determine the applicant's clinical competency. In
11.4the case of examinations conducted pursuant to section150A.03, subdivision 1 , applicants
11.5shall take the examination before applying to the board for licensure. The applicant must
11.6also pass an examination testing the applicant's knowledge of the laws of Minnesota relating
11.7to the practice of dentistry and of the rules of the board. An applicant is ineligible to retake
11.8the clinical examination required by the board after failing it twice until further education
11.9and training are obtained as specified by board rule. A separate, nonrefundable fee may
11.10be charged for each time a person applies. An applicant who passes the examination in
11.11compliance with subdivision 2b, abides by professional ethical conduct requirements, and
11.12meets all the other requirements of the board shall be licensed as a dental hygienist.
11.13 Sec. 11. Minnesota Statutes 2012, section 150A.06, subdivision 2a, is amended to read:
11.14 Subd. 2a. Licensed dental assistant. A person of good moral character, who has
11.15graduated from a dental assisting program accredited by the Commission on Dental
11.16Accreditationof the American Dental Association, may apply for licensure. The applicant
11.17must submit an application and fee as prescribed by the board and the diploma or
11.18certificate of dental assisting. In the case of examinations conducted pursuant to section
11.19150A.03, subdivision 1
, applicants shall take the examination before applying to the board
11.20for licensure. The examination shall include an examination of the applicant's knowledge
11.21of the laws of Minnesota relating to dentistry and the rules of the board. An applicant is
11.22ineligible to retake the licensure examination required by the board after failing it twice
11.23until further education and training are obtained as specified by board rule. A separate,
11.24nonrefundable fee may be charged for each time a person applies. An applicant who
11.25passes the examination in compliance with subdivision 2b, abides by professional ethical
11.26conduct requirements, and meets all the other requirements of the board shall be licensed
11.27as a dental assistant.
11.28 Sec. 12. Minnesota Statutes 2012, section 150A.06, subdivision 2d, is amended to read:
11.29 Subd. 2d. Continuing education and professional development waiver. (a) The
11.30board shall grant a waiver to the continuing education requirements under this chapter for
11.31a licensed dentist, licensed dental therapist, licensed dental hygienist, or licensed dental
11.32assistant who documents to the satisfaction of the board that the dentist, dental therapist,
11.33dental hygienist, or licensed dental assistant has retired from active practice in the state
11.34and limits the provision of dental care services to those offered without compensation
12.1in a public health, community, or tribal clinic or a nonprofit organization that provides
12.2services to the indigent or to recipients of medical assistance, general assistance medical
12.3care, or MinnesotaCare programs.
12.4(b) The board may require written documentation from the volunteer and retired
12.5dentist, dental therapist, dental hygienist, or licensed dental assistant prior to granting
12.6this waiver.
12.7(c) The board shall require the volunteer and retired dentist, dental therapist, dental
12.8hygienist, or licensed dental assistant to meet the following requirements:
12.9(1) a licensee seeking a waiver under this subdivision must complete and document
12.10at least five hours of approved courses in infection control, medical emergencies, and
12.11medical management for the continuing education cycle; and
12.12(2) provide documentation of current CPR certification from completion of the
12.13American Heart Association healthcare provider course, or the American Red Cross
12.14professional rescuer course, or an equivalent entity.
12.15 Sec. 13. Minnesota Statutes 2012, section 150A.06, subdivision 3, is amended to read:
12.16 Subd. 3. Waiver of examination. (a) All or any part of the examination for
12.17dentists or dental hygienists, except that pertaining to the law of Minnesota relating to
12.18dentistry and the rules of the board, may, at the discretion of the board, be waived for an
12.19applicant who presents a certificate of having passed all components of the National Board
12.20Dental Examinations or evidence of having maintained an adequate scholastic standing
12.21as determined by the board, in dental school as to dentists, or dental hygiene school as
12.22to dental hygienists.
12.23(b) The board shall waive the clinical examination required for licensure for any
12.24dentist applicant who is a graduate of a dental school accredited by the Commission on
12.25Dental Accreditationof the American Dental Association, who has passed all components
12.26of the National Board Dental Examinations, and who has satisfactorily completed a
12.27Minnesota-based postdoctoral general dentistry residency program (GPR) or an advanced
12.28education in general dentistry (AEGD) program after January 1, 2004. The postdoctoral
12.29program must be accredited by the Commission on Dental Accreditationof the American
12.30Dental Association, be of at least one year's duration, and include an outcome assessment
12.31evaluation assessing the resident's competence to practice dentistry. The board may require
12.32the applicant to submit any information deemed necessary by the board to determine
12.33whether the waiver is applicable.The board may waive the clinical examination for an
12.34applicant who meets the requirements of this paragraph and has satisfactorily completed an
12.35accredited postdoctoral general dentistry residency program located outside of Minnesota.
13.1 Sec. 14. Minnesota Statutes 2012, section 150A.06, subdivision 8, is amended to read:
13.2 Subd. 8. Licensure by credentials. (a) Any dental assistant may, upon application
13.3and payment of a fee established by the board, apply for licensure based on an evaluation
13.4of the applicant's education, experience, and performance record in lieu of completing a
13.5board-approved dental assisting program for expanded functions as defined in rule, and
13.6may be interviewed by the board to determine if the applicant:
13.7(1) has graduated from an accredited dental assisting program accredited by the
13.8Commissionof on Dental Accreditation of the American Dental Association, or is
13.9currently certified by the Dental Assisting National Board;
13.10(2) is not subject to any pending or final disciplinary action in another state or
13.11Canadian province, or if not currently certified or registered, previously had a certification
13.12or registration in another state or Canadian province in good standing that was not subject
13.13to any final or pending disciplinary action at the time of surrender;
13.14(3) is of good moral character and abides by professional ethical conduct
13.15requirements;
13.16(4) at board discretion, has passed a board-approved English proficiency test if
13.17English is not the applicant's primary language; and
13.18(5) has met all expanded functions curriculum equivalency requirements of a
13.19Minnesota board-approved dental assisting program.
13.20(b) The board, at its discretion, may waive specific licensure requirements in
13.21paragraph (a).
13.22(c) An applicant who fulfills the conditions of this subdivision and demonstrates the
13.23minimum knowledge in dental subjects required for licensure under subdivision 2a must
13.24be licensed to practice the applicant's profession.
13.25(d) If the applicant does not demonstrate the minimum knowledge in dental subjects
13.26required for licensure under subdivision 2a, the application must be denied. If licensure is
13.27denied, the board may notify the applicant of any specific remedy that the applicant could
13.28take which, when passed, would qualify the applicant for licensure. A denial does not
13.29prohibit the applicant from applying for licensure under subdivision 2a.
13.30(e) A candidate whose application has been denied may appeal the decision to the
13.31board according to subdivision 4a.
13.32 Sec. 15. Minnesota Statutes 2012, section 150A.091, subdivision 3, is amended to read:
13.33 Subd. 3. Initial license or permit fees. Along with the application fee, each of the
13.34following applicants shall submit a separateprorated initial license or permit fee. The
13.35prorated initial fee shall be established by the board based on the number of months of the
14.1applicant's initial term as described in Minnesota Rules, part 3100.1700, subpart 1a, not to
14.2exceed the followingmonthly nonrefundable fee amounts:
14.3(1) dentist or full faculty dentist,$14 times the number of months of the initial
14.4term $168;
14.5(2) dental therapist,$10 times the number of months of the initial term $120;
14.6(3) dental hygienist,$5 times the number of months of the initial term $60;
14.7(4) licensed dental assistant,$3 times the number of months of the initial term
14.8 $36; and
14.9(5) dental assistant with a permit as described in Minnesota Rules, part 3100.8500,
14.10subpart 3,$1 times the number of months of the initial term $12.
14.11 Sec. 16. Minnesota Statutes 2012, section 150A.091, subdivision 8, is amended to read:
14.12 Subd. 8. Duplicate license or certificate fee. Each applicant shall submit, with
14.13a request for issuance of a duplicate of the original license, or of an annual or biennial
14.14renewal certificate for a license or permit, a fee in the following amounts:
14.15(1) original dentist, full faculty dentist, dental therapist, dental hygiene, or dental
14.16assistant license, $35;and
14.17(2) annual or biennial renewal certificates, $10.; and
14.18(3) wallet-sized license and renewal certificate, $15.
14.19 Sec. 17. Minnesota Statutes 2012, section 150A.091, subdivision 16, is amended to
14.20read:
14.21 Subd. 16. Failure of professional development portfolio audit.A licensee shall
14.22submit a fee as established by the board not to exceed the amount of $250 after failing two
14.23consecutive professional development portfolio audits and, thereafter, for each failed (a) If
14.24a licensee fails a professional development portfolio audit under Minnesota Rules, part
14.253100.5300, the board is authorized to take the following actions:
14.26(1) for the first failure, the board may issue a warning to the licensee;
14.27(2) for the second failure within ten years, the board may assess a penalty of not
14.28more than $250; and
14.29(3) for any additional failures within the ten year period, the board may assess a
14.30penalty of not more than $1000.
14.31(b) In addition to the penalty fee, the board may initiate the complaint process to
14.32address multiple failed audits.
15.1 Sec. 18. Minnesota Statutes 2012, section 150A.10, is amended to read:
15.2150A.10 ALLIED DENTAL PERSONNEL.
15.3 Subdivision 1. Dental hygienists. Any licensed dentist, licensed dental therapist,
15.4public institution, or school authority may obtain services from a licensed dental hygienist.
15.5The licensed dental hygienist may provide those services defined in section150A.05,
15.6subdivision 1a . The services provided shall not include the establishment of a final
15.7diagnosis or treatment plan for a dental patient. All services shall be provided under
15.8supervision of a licensed dentist. Any licensed dentist who shall permit any dental service
15.9by a dental hygienist other than those authorized by the Board of Dentistry, shall be deemed
15.10to be violating the provisions of sections150A.01 to
150A.12 , and any unauthorized dental
15.11service by a dental hygienist shall constitute a violation of sections150A.01 to
150A.12 .
15.12 Subd. 1a. Limited authorization for dental hygienists. (a) Notwithstanding
15.13subdivision 1, a dental hygienist licensed under this chapter may be employed or retained
15.14by a health care facility, program, or nonprofit organization to perform dental hygiene
15.15services described under paragraph (b) without the patient first being examined by a
15.16licensed dentist if the dental hygienist:
15.17(1) has been engaged in the active practice of clinical dental hygiene for not less than
15.182,400 hours in the past 18 months or a career total of 3,000 hours, including a minimum of
15.19200 hours of clinical practice in two of the past three years;
15.20(2) has entered into a collaborative agreement with a licensed dentist that designates
15.21authorization for the services provided by the dental hygienist;
15.22(3) has documented participation in courses in infection control and medical
15.23emergencies within each continuing education cycle; and
15.24(4) maintains current CPR certification from completion of the American Heart
15.25Association healthcare provider course, or the American Red Cross professional rescuer
15.26course, or an equivalent entity.
15.27(b) The dental hygiene services authorized to be performed by a dental hygienist
15.28under this subdivision are limited to:
15.29(1) oral health promotion and disease prevention education;
15.30(2) removal of deposits and stains from the surfaces of the teeth;
15.31(3) application of topical preventive or prophylactic agents, including fluoride
15.32varnishes and pit and fissure sealants;
15.33(4) polishing and smoothing restorations;
15.34(5) removal of marginal overhangs;
15.35(6) performance of preliminary charting;
15.36(7) taking of radiographs; and
16.1(8) performance of scaling and root planing.
16.2The dental hygienist may administer injections of local anesthetic agents or nitrous
16.3oxide inhalation analgesia as specifically delegated in the collaborative agreement with
16.4a licensed dentist. The dentist need not first examine the patient or be present. If the
16.5patient is considered medically compromised, the collaborative dentist shall review the
16.6patient record, including the medical history, prior to the provision of these services.
16.7Collaborating dental hygienists may work with unlicensed and licensed dental assistants
16.8who may only perform duties for which licensure is not required. The performance of
16.9dental hygiene services in a health care facility, program, or nonprofit organization as
16.10authorized under this subdivision is limited to patients, students, and residents of the
16.11facility, program, or organization.
16.12(c) A collaborating dentist must be licensed under this chapter and may enter into
16.13a collaborative agreement with no more than four dental hygienists unless otherwise
16.14authorized by the board. The board shall develop parameters and a process for obtaining
16.15authorization to collaborate with more than four dental hygienists. The collaborative
16.16agreement must include:
16.17(1) consideration for medically compromised patients and medical conditions for
16.18which a dental evaluation and treatment plan must occur prior to the provision of dental
16.19hygiene services;
16.20(2) age- and procedure-specific standard collaborative practice protocols, including
16.21recommended intervals for the performance of dental hygiene services and a period of
16.22time in which an examination by a dentist should occur;
16.23(3) copies of consent to treatment form provided to the patient by the dental hygienist;
16.24(4) specific protocols for the placement of pit and fissure sealants and requirements
16.25for follow-up care to assure the efficacy of the sealants after application; and
16.26(5) a procedure for creating and maintaining dental records for the patients that are
16.27treated by the dental hygienist. This procedure must specify where these records are
16.28to be located.
16.29The collaborative agreement must be signed and maintained by the dentist, the dental
16.30hygienist, and the facility, program, or organization; must be reviewed annually by the
16.31collaborating dentist and dental hygienist; and must be made available to the board
16.32upon request.
16.33(d) Before performing any services authorized under this subdivision, a dental
16.34hygienist must provide the patient with a consent to treatment form which must include a
16.35statement advising the patient that the dental hygiene services provided are not a substitute
16.36for a dental examination by a licensed dentist. If the dental hygienist makes any referrals
17.1to the patient for further dental procedures, the dental hygienist must fill out a referral form
17.2and provide a copy of the form to the collaborating dentist.
17.3(e) For the purposes of this subdivision, a "health care facility, program, or
17.4nonprofit organization" is limited to a hospital; nursing home; home health agency; group
17.5home serving the elderly, disabled, or juveniles; state-operated facility licensed by the
17.6commissioner of human services or the commissioner of corrections; and federal, state, or
17.7local public health facility, community clinic, tribal clinic, school authority, Head Start
17.8program, or nonprofit organization that serves individuals who are uninsured or who are
17.9Minnesota health care public program recipients.
17.10(f) For purposes of this subdivision, a "collaborative agreement" means a written
17.11agreement with a licensed dentist who authorizes and accepts responsibility for the
17.12services performed by the dental hygienist. The services authorized under this subdivision
17.13and the collaborative agreement may be performed without the presence of a licensed
17.14dentist and may be performed at a location other than the usual place of practice of the
17.15dentist or dental hygienist and without a dentist's diagnosis and treatment plan, unless
17.16specified in the collaborative agreement.
17.17 Subd. 2. Dental assistants. Every licensed dentist and dental therapist who uses the
17.18services of any unlicensed person for the purpose of assistance in the practice of dentistry
17.19or dental therapy shall be responsible for the acts of such unlicensed person while engaged
17.20in such assistance. The dentist or dental therapist shall permit the unlicensed assistant to
17.21perform only those acts which are authorized to be delegated to unlicensed assistants
17.22by the Board of Dentistry. The acts shall be performed under supervision of a licensed
17.23dentist or dental therapist. A licensed dental therapist shall not supervise more than four
17.24registered licensed or unlicensed dental assistants at any one practice setting. The board
17.25may permit differing levels of dental assistance based upon recognized educational
17.26standards, approved by the board, for the training of dental assistants. The board may also
17.27define by rule the scope of practice of licensed and unlicensed dental assistants. The
17.28board by rule may require continuing education for differing levels of dental assistants,
17.29as a condition to their license or authority to perform their authorized duties. Any
17.30licensed dentist or dental therapist who permits an unlicensed assistant to perform any
17.31dental service other than that authorized by the board shall be deemed to be enabling an
17.32unlicensed person to practice dentistry, and commission of such an act by an unlicensed
17.33assistant shall constitute a violation of sections150A.01 to
150A.12 .
17.34 Subd. 3. Dental technicians. Every licensed dentist and dental therapist who uses
17.35the services of any unlicensed person, other than under the dentist's or dental therapist's
17.36supervision and within the same practice setting, for the purpose of constructing, altering,
18.1repairing or duplicating any denture, partial denture, crown, bridge, splint, orthodontic,
18.2prosthetic or other dental appliance, shall be required to furnish such unlicensed person
18.3with a written work order in such form as shall be prescribed by the rules of the board. The
18.4work order shall be made in duplicate form, a duplicate copy to be retained in a permanent
18.5file of the dentist or dental therapist at the practice setting for a period of two years, and
18.6the original to be retained in a permanent file for a period of two years by the unlicensed
18.7person in that person's place of business. The permanent file of work orders to be kept
18.8by the dentist, dental therapist, or unlicensed person shall be open to inspection at any
18.9reasonable time by the board or its duly constituted agent.
18.10 Subd. 4. Restorative procedures. (a) Notwithstanding subdivisions 1, 1a, and
18.112, a licensed dental hygienist or licensed dental assistant may perform the following
18.12restorative procedures:
18.13(1) place, contour, and adjust amalgam restorations;
18.14(2) place, contour, and adjust glass ionomer;
18.15(3) adapt and cement stainless steel crowns;and
18.16(4) place, contour, and adjust class I and class V supragingival composite restorations
18.17where the margins are entirely within the enamel.; and
18.18(5) place, contour, and adjust class II and class V supragingival composite
18.19restorations on primary teeth.
18.20(b) The restorative procedures described in paragraph (a) may be performed only if:
18.21(1) the licensed dental hygienist or licensed dental assistant has completed a
18.22board-approved course on the specific procedures;
18.23(2) the board-approved course includes a component that sufficiently prepares the
18.24licensed dental hygienist or licensed dental assistant to adjust the occlusion on the newly
18.25placed restoration;
18.26(3) a licensed dentist or licensed advanced dental therapist has authorized the
18.27procedure to be performed; and
18.28(4) a licensed dentist or licensed advanced dental therapist is available in the clinic
18.29while the procedure is being performed.
18.30(c) The dental faculty who teaches the educators of the board-approved courses
18.31specified in paragraph (b) must have prior experience teaching these procedures in an
18.32accredited dental education program.
18.33 Sec. 19. Minnesota Statutes 2012, section 214.09, subdivision 3, is amended to read:
18.34 Subd. 3. Compensation. (a)Members of the boards may be compensated at the
18.35rate of $55 a day spent on board activities, when authorized by the board, plus expenses
19.1in Members of health-related licensing boards may be compensated at the rate of $75 a
19.2day spent on board activities and members of nonhealth-related licensing boards may be
19.3compensated at the rate of $55 a day spent on board activities when authorized by the
19.4board, plus expenses in the same manner and amount as authorized by the commissioner's
19.5plan adopted under section43A.18, subdivision 2 . Members who, as a result of time spent
19.6attending board meetings, incur child care expenses that would not otherwise have been
19.7incurred, may be reimbursed for those expenses upon board authorization.
19.8(b) Members who are state employees or employees of the political subdivisions
19.9of the state must not receive the daily payment for activities that occur during working
19.10hours for which they are also compensated by the state or political subdivision. However,
19.11a state or political subdivision employee may receive the daily payment if the employee
19.12uses vacation time or compensatory time accumulated in accordance with a collective
19.13bargaining agreement or compensation plan for board activity. Members who are state
19.14employees or employees of the political subdivisions of the state may receive the expenses
19.15provided for in this subdivision unless the expenses are reimbursed by another source.
19.16Members who are state employees or employees of political subdivisions of the state
19.17may be reimbursed for child care expenses only for time spent on board activities that
19.18are outside their working hours.
19.19(c) Each board must adopt internal standards prescribing what constitutes a day
19.20spent on board activities for purposes of making daily payments under this subdivision.
19.21 Sec. 20. Minnesota Statutes 2012, section 214.32, is amended by adding a subdivision
19.22to read:
19.23 Subd. 6. Duties of a participating board. Upon receiving a report from the program
19.24manager in accordance with section 214.33, subdivision 3, that a regulated person has been
19.25discharged from the program due to noncompliance based on allegations that the regulated
19.26person has engaged in conduct that might cause risk to the public, the participating board
19.27may temporarily suspend the regulated person's professional license until the completion of
19.28a disciplinary investigation. The board must complete the disciplinary investigation within
19.2960 days of receipt of the report from the program. If the investigation is not completed by
19.30the board within 60 days, the temporary suspension shall be lifted, unless the regulated
19.31person requests a delay in the disciplinary proceedings for any reason, upon which the
19.32temporary suspension shall remain in place until the completion of the investigation.
19.33 Sec. 21. Minnesota Statutes 2012, section 214.33, subdivision 3, is amended to read:
20.1 Subd. 3. Program manager. (a) The program manager shall report to the
20.2appropriate participating board a regulated person who:
20.3(1) does not meet program admission criteria,;
20.4(2) violates the terms of the program participation agreement, or;
20.5(3) leaves or is discharged from the program except upon fulfilling the terms for
20.6successful completion of the program as set forth in the participation agreement.;
20.7(4) is subject to the provisions of sections 214.17 to 214.25;
20.8(5) causes identifiable patient harm;
20.9(6) unlawfully substitutes or adulterates medications;
20.10(7) writes a prescription or causes a prescription to be dispensed in the name of a
20.11person, other than the prescriber, or veterinary patient for the personal use of the prescriber;
20.12(8) alters a prescription without the knowledge of the prescriber for the purpose of
20.13obtaining a drug for personal use;
20.14(9) unlawfully uses a controlled or mood-altering substance or uses alcohol while
20.15providing patient care or during the period of time in which the regulated person may be
20.16contacted to provide patient care or is otherwise on duty, if current use is the reason for
20.17participation in the program or the use occurs while the regulated person is participating
20.18in the program; or
20.19The program manager shall report to the appropriate participating board a regulated
20.20person who (10) is alleged to have committed violations of the person's practice act that
20.21are outside the authority of the health professionals services program as described in
20.22sections214.31 to
214.37 .
20.23(b) The program manager shall inform any reporting person of the disposition of the
20.24person's report to the program.
20.25EFFECTIVE DATE.This section is effective August 1, 2014, and applies to
20.26violations that occur after the effective date.
20.27 Sec. 22. Minnesota Statutes 2013 Supplement, section 364.09, is amended to read:
20.28364.09 EXCEPTIONS.
20.29(a) This chapter does not apply to the licensing process for peace officers; to law
20.30enforcement agencies as defined in section626.84, subdivision 1 , paragraph (f); to fire
20.31protection agencies; to eligibility for a private detective or protective agent license; to the
20.32licensing and background study process under chapters 245A and 245C; to eligibility
20.33for school bus driver endorsements; to eligibility for special transportation service
20.34endorsements; to eligibility for a commercial driver training instructor license, which is
21.1governed by section171.35 and rules adopted under that section; to emergency medical
21.2services personnel, or to the licensing by political subdivisions of taxicab drivers, if the
21.3applicant for the license has been discharged from sentence for a conviction within the ten
21.4years immediately preceding application of a violation of any of the following:
21.5(1) sections609.185 to
609.21 ,
609.221 to
609.223 ,
609.342 to
609.3451 , or
617.23 ,
21.6subdivision 2 or 3;
21.7(2) any provision of chapter 152 that is punishable by a maximum sentence of
21.815 years or more; or
21.9(3) a violation of chapter 169 or 169A involving driving under the influence, leaving
21.10the scene of an accident, or reckless or careless driving.
21.11This chapter also shall not apply to eligibility for juvenile corrections employment, where
21.12the offense involved child physical or sexual abuse or criminal sexual conduct.
21.13(b) This chapter does not apply to a school district or to eligibility for a license
21.14issued or renewed by the Board of Teaching or the commissioner of education.
21.15(c) Nothing in this section precludes the Minnesota Police and Peace Officers
21.16Training Board or the state fire marshal from recommending policies set forth in this
21.17chapter to the attorney general for adoption in the attorney general's discretion to apply to
21.18law enforcement or fire protection agencies.
21.19(d) This chapter does not apply to a license to practice medicine that has been denied
21.20or revoked by the Board of Medical Practice pursuant to section147.091, subdivision 1a .
21.21(e) This chapter does not apply to any person who has been denied a license to
21.22practice chiropractic or whose license to practice chiropractic has been revoked by the
21.23board in accordance with section148.10, subdivision 7 .
21.24(f) This chapter does not apply to any license, registration, or permit that has
21.25been denied or revoked by the Board of Nursing in accordance with section 148.261,
21.26subdivision 1a.
21.27(f) (g) This chapter does not supersede a requirement under law to conduct a
21.28criminal history background investigation or consider criminal history records in hiring
21.29for particular types of employment.
22.1This appropriation is from the state
22.2government special revenue fund for board
22.3member per diem payments and licensing
22.4activity.
22.6This appropriation is from the state
22.7government special revenue fund for board
22.8member per diem payments.
22.10This appropriation is from the state
22.11government special revenue fund for board
22.12member per diem payments.
22.14This appropriation is from the state
22.15government special revenue fund for board
22.16member per diem payments.
22.18This appropriation is from the state
22.19government special revenue fund for board
22.20member per diem payments and licensing
22.21activity.
22.23This appropriation is from the state
22.24government special revenue fund for board
22.25member per diem payments.
22.27This appropriation is from the state
22.28government special revenue fund for board
22.29member per diem payments and licensing
22.30activity.
23.1This appropriation is from the state
23.2government special revenue fund for board
23.3member per diem payments.
23.5This appropriation is from the state
23.6government special revenue fund for board
23.7member per diem payments.
23.9This appropriation is from the state
23.10government special revenue fund for board
23.11member per diem payments.
23.13This appropriation is from the state
23.14government special revenue fund for board
23.15member per diem payments.
23.17This appropriation is from the state
23.18government special revenue fund for board
23.19member per diem payments.
23.21This appropriation is from the state
23.22government special revenue fund for board
23.23member per diem payments.
23.25This appropriation is from the state
23.26government special revenue fund for board
23.27member per diem payments and licensing
23.28activity.
23.30This appropriation is from the state
23.31government special revenue fund for board
23.32member per diem payments.
24.3 Section 1. Minnesota Statutes 2012, section 151.01, is amended to read:
24.4151.01 DEFINITIONS.
24.5 Subdivision 1. Words, terms, and phrases. Unless the language or context clearly
24.6indicates that a different meaning is intended, the following words, terms, and phrases, for
24.7the purposes of this chapter, shall be given the meanings subjoined to them.
24.8 Subd. 2. Pharmacy. "Pharmacy" meansan established a place of business in
24.9whichprescriptions, prescription drugs, medicines, chemicals, and poisons are prepared,
24.10compounded, or dispensed, vended, or sold to or for the use of patients by or under
24.11the supervision of a pharmacist and from which related clinical pharmacy services are
24.12delivered.
24.13 Subd. 2a. Limited service pharmacy. "Limited service pharmacy" means a
24.14pharmacy that has been issued a restricted license by the board to perform a limited range
24.15of the activities that constitute the practice of pharmacy.
24.16 Subd. 3. Pharmacist. The term "pharmacist" means an individual with a currently
24.17valid license issued by the Board of Pharmacy to practice pharmacy.
24.18 Subd. 5. Drug. The term "drug" means all medicinal substances and preparations
24.19recognized by the United States Pharmacopoeia and National Formulary, or any revision
24.20thereof, vaccines and biologicals, and all substances and preparations intended for external
24.21and internal use in the diagnosis, cure, mitigation, treatment, or prevention of disease in
24.22humans or other animals, and all substances and preparations, other than food, intended to
24.23affect the structure or any function of the bodies of humans or other animals. The term drug
24.24shall also mean any compound, substance, or derivative that is not approved for human
24.25consumption by the United States Food and Drug Administration or specifically permitted
24.26for human consumption under Minnesota law and, when introduced into the body, induces
24.27an effect similar to that of a Schedule I or Schedule II controlled substance listed in
24.28section 152.02, subdivisions 2 and 3, or Minnesota Rules, parts 6800.4210 and 6800.4220,
24.29regardless of whether the substance is marketed for the purpose of human consumption.
24.30 Subd. 6. Medicine. The term "medicine" means any remedial agent that has the
24.31property of curing, preventing, treating, or mitigating diseases, or that is used for that
24.32purpose.
24.33 Subd. 7. Poisons. The term "poisons" means any substancewhich that, when
24.34introduced into the system, directly or by absorption, produces violent, morbid, or fatal
24.35changes, orwhich that destroys living tissue with which it comes in contact.
25.1 Subd. 8. Chemical. The term "chemical" means all medicinal or industrial
25.2substances, whether simple or compound, or obtained through the process of the science
25.3and art of chemistry, whether of organic or inorganic origin.
25.4 Subd. 9. Board orState Board of Pharmacy. The term "board" or "State Board of
25.5Pharmacy" means the MinnesotaState Board of Pharmacy.
25.6 Subd. 10. Director. The term "director" means the executive director of the
25.7MinnesotaState Board of Pharmacy.
25.8 Subd. 11. Person. The term "person" means an individual, firm, partnership,
25.9company, corporation, trustee, association, agency, or other public or private entity.
25.10 Subd. 12. Wholesale. The term "wholesale" means and includes any sale for the
25.11purpose of resale.
25.12 Subd. 13. Commercial purposes. The phrase "commercial purposes" means the
25.13ordinary purposes of trade, agriculture, industry, and commerce, exclusive of the practices
25.14of medicineand, pharmacy, and other health care professions.
25.15 Subd. 14. Manufacturing. The term "manufacturing"except in the case of bulk
25.16compounding, prepackaging or extemporaneous compounding within a pharmacy, means
25.17and includes the production, quality control and standardization by mechanical, physical,
25.18chemical, or pharmaceutical means, packing, repacking, tableting, encapsulating, labeling,
25.19relabeling, filling or by any other process, of all drugs, medicines, chemicals, or poisons,
25.20without exception, for medicinal purposes. preparation, propagation, conversion, or
25.21processing of a drug, either directly or indirectly, by extraction from substances of natural
25.22origin or independently by means of chemical or biological synthesis. Manufacturing
25.23includes the packaging or repackaging of a drug, or the labeling or relabeling of
25.24the container of a drug, for resale by pharmacies, practitioners, or other persons.
25.25Manufacturing does not include the prepackaging, extemporaneous compounding, or
25.26anticipatory compounding of a drug within a licensed pharmacy or by a practitioner,
25.27nor the labeling of a container within a pharmacy or by a practitioner for the purpose of
25.28dispensing a drug to a patient pursuant to a valid prescription.
25.29 Subd. 14a. Manufacturer. The term "manufacturer" means any person engaged
25.30in manufacturing.
25.31 Subd. 14b. Outsourcing facility. "Outsourcing facility" means a facility that is
25.32registered by the United States Food and Drug Administration pursuant to United States
25.33Code, title 21, section 353b.
25.34 Subd. 15. Pharmacist intern. The term "pharmacist intern" means (1) a natural
25.35person satisfactorily progressing toward the degree in pharmacy required for licensure, or
25.36(2) a graduate of the University of Minnesota College of Pharmacy, or other pharmacy
26.1college approved by the board, who is registered by theState Board of Pharmacy for the
26.2purpose of obtaining practical experience as a requirement for licensure as a pharmacist,
26.3or (3) a qualified applicant awaiting examination for licensure.
26.4 Subd. 15a. Pharmacy technician. The term "pharmacy technician" means a person
26.5not licensed as a pharmacist or a pharmacist intern, who assists the pharmacist in the
26.6preparation and dispensing of medications by performing computer entry of prescription
26.7data and other manipulative tasks. A pharmacy technician shall not perform tasks
26.8specifically reserved to a licensed pharmacist or requiring professional judgment.
26.9 Subd. 16. Prescription drug order. The term "prescription drug order" means a
26.10signed lawful written order, or an, oral, or electronic order reduced to writing, given by of
26.11 a practitionerlicensed to prescribe drugs for patients in the course of the practitioner's
26.12practice, issued for an individual patient and containing the following: the date of issue,
26.13name and address of the patient, name and quantity of the drug prescribed, directions
26.14for use, and the name and address of the prescriber. for a drug for a specific patient.
26.15Prescription drug orders for controlled substances must be prepared in accordance with the
26.16provisions of section 152.11 and the federal Controlled Substances Act and the regulations
26.17promulgated thereunder.
26.18 Subd. 16a. Prescription. The term "prescription" means a prescription drug order
26.19that is written or printed on paper, an oral order reduced to writing by a pharmacist, or an
26.20electronic order. To be valid, a prescription must be issued for an individual patient by
26.21a practitioner within the scope and usual course of the practitioner's practice, and must
26.22contain the date of issue, name and address of the patient, name and quantity of the drug
26.23prescribed, directions for use, the name and address of the practitioner, and a telephone
26.24number at which the practitioner can be reached. A prescription written or printed on
26.25paper that is given to the patient or an agent of the patient or that is transmitted by fax
26.26must contain the practitioner's manual signature. An electronic prescription must contain
26.27the practitioner's electronic signature.
26.28 Subd. 16b. Chart order. The term "chart order" means a prescription drug order for
26.29a drug that is to be dispensed by a pharmacist, or by a pharmacist intern under the direct
26.30supervision of a pharmacist, and administered by an authorized person only during the
26.31patient's stay in a hospital or long-term care facility. The chart order shall contain the name
26.32of the patient, another patient identifier such as birth date or medical record number, the
26.33drug ordered, and any directions that the practitioner may prescribe concerning strength,
26.34dosage, frequency, and route of administration. The manual or electronic signature of the
26.35practitioner must be affixed to the chart order at the time it is written or at a later date in
26.36the case of verbal chart orders.
27.1 Subd. 17. Legend drug. "Legend drug" means a drugwhich that is required by
27.2federal law tobear the following statement, "Caution: Federal law prohibits dispensing
27.3without prescription." be dispensed only pursuant to the prescription of a licensed
27.4practitioner.
27.5 Subd. 18. Label. "Label" means a display of written, printed, or graphic matter
27.6upon the immediate container of any drug or medicine; and a requirement made by or
27.7under authority of Laws 1969, chapter 933 that. Any word, statement, or other information
27.8appearing required by or under the authority of this chapter to appear on the label shall not
27.9be considered to be complied with unless such word, statement, or other information also
27.10appears appear on the outside container or wrapper, if any there be, of the retail package of
27.11such drug or medicine, oris be easily legible through the outside container or wrapper.
27.12 Subd. 19. Package. "Package" means any container or wrapping in which any
27.13drug or medicine is enclosed for use in the delivery or display of that article to retail
27.14purchasers, but does not include:
27.15(a) shipping containers or wrappings used solely for the transportation of any such
27.16article in bulk or in quantity to manufacturers, packers, processors, or wholesale or
27.17retail distributors;
27.18(b) shipping containers or outer wrappings used by retailers to ship or deliver any
27.19such article to retail customers if such containers and wrappings bear no printed matter
27.20pertaining to any particular drug or medicine.
27.21 Subd. 20. Labeling. "Labeling" means all labels and other written, printed, or
27.22graphic matter (a) upon a drug or medicine or any of its containers or wrappers, or (b)
27.23accompanying such article.
27.24 Subd. 21. Federal act. "Federal act" means the Federal Food, Drug, and Cosmetic
27.25Act, United States Code, title 21, section 301, et seq., as amended.
27.26 Subd. 22. Pharmacist in charge. "Pharmacist in charge" means a duly licensed
27.27pharmacist in the state of Minnesota who has been designated in accordance with the rules
27.28of theState Board of Pharmacy to assume professional responsibility for the operation
27.29of the pharmacy in compliance with the requirements and duties as established by the
27.30board in its rules.
27.31 Subd. 23. Practitioner. "Practitioner" means a licensed doctor of medicine, licensed
27.32doctor of osteopathy duly licensed to practice medicine, licensed doctor of dentistry,
27.33licensed doctor of optometry, licensed podiatrist, or licensed veterinarian. For purposes of
27.34sections151.15, subdivision 4 ; 151.252, subdivision 3;
151.37, subdivision 2 , paragraphs
27.35(b), (e), and (f); and151.461 , "practitioner" also means a physician assistant authorized to
27.36prescribe, dispense, and administer under chapter 147A, or an advanced practice nurse
28.1authorized to prescribe, dispense, and administer under section148.235 . For purposes of
28.2sections151.15, subdivision 4 ; 151.252, subdivision 3;
151.37, subdivision 2 , paragraph
28.3(b); and151.461 , "practitioner" also means a dental therapist authorized to dispense and
28.4administer under chapter 150A.
28.5 Subd. 24. Brand name. "Brand name" means the registered trademark name given
28.6to a drug product by its manufacturer, labeler or distributor.
28.7 Subd. 25. Generic name. "Generic name" means the established name or official
28.8name of a drug or drug product.
28.9 Subd. 26. Finished dosage form. "Finished dosage form" means that form of a
28.10drugwhich that is or is intended to be dispensed or administered to the patient and requires
28.11no further manufacturing or processing other than packaging, reconstitution, or labeling.
28.12 Subd. 27. Practice of pharmacy. "Practice of pharmacy" means:
28.13 (1) interpretation and evaluation of prescription drug orders;
28.14 (2) compounding, labeling, and dispensing drugs and devices (except labeling by
28.15a manufacturer or packager of nonprescription drugs or commercially packaged legend
28.16drugs and devices);
28.17 (3) participation in clinical interpretations and monitoring of drug therapy for
28.18assurance of safe and effective use of drugs, including the performance of laboratory tests
28.19that are waived under the federal Clinical Laboratory Improvement Act of 1988, United
28.20States Code, title 42, section 263a et seq., provided that a pharmacist may interpret the
28.21results of laboratory tests but may modify drug therapy only pursuant to a protocol or
28.22collaborative practice agreement;
28.23 (4) participation in drug and therapeutic device selection; drug administration for first
28.24dosage and medical emergencies; drug regimen reviews; and drug or drug-related research;
28.25 (5) participation in administration of influenza vaccines to all eligible individuals ten
28.26years of age and older and all other vaccines to patients 18 years of age and olderunder
28.27standing orders from a physician licensed under chapter 147 or by written protocol with a
28.28physician licensed under chapter 147, a physician assistant authorized to prescribe drugs
28.29under chapter 147A, or an advanced practice nurse authorized to prescribe drugs under
28.30section 148.235, provided that:
28.31(i) the protocol includes, at a minimum:
28.32(A) the name, dose, and route of each vaccine that may be given;
28.33(B) the patient population for whom the vaccine may be given;
28.34(C) contraindications and precautions to the vaccine;
28.35(D) the procedure for handling an adverse reaction;
29.1(E) the name, signature, and address of the physician, physician assistant, or
29.2advanced nurse practitioner;
29.3(F) a telephone number at which the physician, physician assistant, or advanced
29.4nurse practitioner can be contacted; and
29.5(G) the date and time period for which the protocol is valid;
29.6(i) (ii) the pharmacist is trained in has successfully completed a program approved
29.7by theAmerican Accreditation Council of Pharmaceutical for Pharmacy Education
29.8specifically for the administration of immunizations orgraduated from a college of
29.9pharmacy in 2001 or thereafter a program approved by the board; and
29.10(ii) (iii) the pharmacist reports the administration of the immunization to the patient's
29.11primary physician or clinic or to the Minnesota Immunization Information Connection; and
29.12(iv) the pharmacist complies with guidelines for vaccines and immunizations
29.13established by the federal Advisory Committee on Immunization Practices, except that a
29.14pharmacist does not need to comply with those portions of the guidelines that establish
29.15immunization schedules when administering a vaccine pursuant to a valid, patient-specific
29.16order issued by a physician licensed under chapter 147, a physician assistant authorized to
29.17prescribe drugs under chapter 147A, or an advanced practice nurse authorized to prescribe
29.18drugs under section 148.235, provided that the order is consistent with the United States
29.19Food and Drug Administration approved labeling of the vaccine;
29.20 (6) participation in thepractice of managing drug therapy and modifying initiation,
29.21management, modification, and discontinuation of drug therapy, according to section
29.22151.21, subdivision 1, according to a written protocol or collaborative practice agreement
29.23betweenthe specific pharmacist: (i) one or more pharmacists and the individual dentist,
29.24optometrist, physician, podiatrist, or veterinarian who is responsible for the patient's
29.25care and authorized to independently prescribe drugs one or more dentists, optometrists,
29.26physicians, podiatrists, or veterinarians; or (ii) one or more pharmacists and one or more
29.27physician assistants authorized to prescribe, dispense, and administer under chapter 147A,
29.28or advanced practice nurses authorized to prescribe, dispense, and administer under
29.29section 148.235. Anysignificant changes in drug therapy made pursuant to a protocol or
29.30collaborative practice agreement must bereported documented by the pharmacist to in
29.31 the patient's medical record or reported by the pharmacist to a practitioner responsible
29.32for the patient's care;
29.33 (7) participation in the storage of drugs and the maintenance of records;
29.34 (8)responsibility for participation in patient counseling on therapeutic values,
29.35content, hazards, and uses of drugs and devices; and
30.1 (9) offering or performing those acts, services, operations, or transactions necessary
30.2in the conduct, operation, management, and control of a pharmacy.
30.3 Subd. 27a. Protocol. "Protocol" means:
30.4(1) a specific written plan that describes the nature and scope of activities that a
30.5pharmacist may engage in when initiating, managing, modifying, or discontinuing drug
30.6therapy as allowed in subdivision 27, clause (6); or
30.7(2) a specific written plan that authorizes a pharmacist to administer vaccines and
30.8that complies with subdivision 27, clause (5).
30.9 Subd. 27b. Collaborative practice. "Collaborative practice" means patient care
30.10activities, consistent with subdivision 27, engaged in by one or more pharmacists who
30.11have agreed to work in collaboration with one or more practitioners to initiate, manage,
30.12and modify drug therapy under specified conditions mutually agreed to by the pharmacists
30.13and practitioners.
30.14 Subd. 27c. Collaborative practice agreement. "Collaborative practice agreement"
30.15means a written and signed agreement between one or more pharmacists and one or more
30.16practitioners that allows the pharmacist or pharmacists to engage in collaborative practice.
30.17 Subd. 28. Veterinary legend drug. "Veterinary legend drug" means a drug that is
30.18required by federal law tobear the following statement: "Caution: Federal law restricts
30.19this drug to use by or on the order of a licensed veterinarian." be dispensed only pursuant
30.20to the prescription of a licensed veterinarian.
30.21 Subd. 29. Legend medical gas. "Legend medical gas" means a liquid or gaseous
30.22substance used for medical purposes and that is required by federal law tobear the
30.23following statement: "Caution: Federal law prohibits dispensing without a prescription."
30.24 be dispensed only pursuant to the prescription of a licensed practitioner.
30.25 Subd. 30. Dispense or dispensing. "Dispense or dispensing" means thepreparation
30.26or delivery of a drug pursuant to a lawful order of a practitioner in a suitable container
30.27appropriately labeled for subsequent administration to or use by a patient or other individual
30.28entitled to receive the drug. interpretation, evaluation, and processing of a prescription
30.29drug order and includes those processes specified by the board in rule that are necessary
30.30for the preparation and provision of a drug to a patient or patient's agent in a suitable
30.31container appropriately labeled for subsequent administration to, or use by, a patient.
30.32 Subd. 31. Central service pharmacy. "Central service pharmacy" means a
30.33pharmacy that may provide dispensing functions, drug utilization review, packaging,
30.34labeling, or delivery of a prescription product to another pharmacy for the purpose of
30.35filling a prescription.
31.1 Subd. 32. Electronic signature. "Electronic signature" means an electronic sound,
31.2symbol, or process attached to or associated with a record and executed or adopted by a
31.3person with the intent to sign the record.
31.4 Subd. 33. Electronic transmission. "Electronic transmission" means transmission
31.5of information in electronic form.
31.6 Subd. 34. Health professional shortage area. "Health professional shortage area"
31.7means an area designated as such by the federal Secretary of Health and Human Services,
31.8as provided under Code of Federal Regulations, title 42, part 5, and United States Code,
31.9title 42, section 254E.
31.10 Subd. 35. Compounding. "Compounding" means preparing, mixing, assembling,
31.11packaging, and labeling a drug for an identified individual patient as a result of
31.12a practitioner's prescription drug order. Compounding also includes anticipatory
31.13compounding, as defined in this section, and the preparation of drugs in which all bulk
31.14drug substances and components are nonprescription substances. Compounding does
31.15not include mixing or reconstituting a drug according to the product's labeling or to the
31.16manufacturer's directions. Compounding does not include the preparation of a drug for the
31.17purpose of, or incident to, research, teaching, or chemical analysis, provided that the drug
31.18is not prepared for dispensing or administration to patients. All compounding, regardless
31.19of the type of product, must be done pursuant to a prescription drug order unless otherwise
31.20permitted in this chapter or by the rules of the board. Compounding does not include a
31.21minor deviation from such directions with regard to radioactivity, volume, or stability,
31.22which is made by or under the supervision of a licensed nuclear pharmacist or a physician,
31.23and which is necessary in order to accommodate circumstances not contemplated in the
31.24manufacturer's instructions, such as the rate of radioactive decay or geographical distance
31.25from the patient.
31.26 Subd. 36. Anticipatory compounding. "Anticipatory compounding" means the
31.27preparation by a pharmacy of a supply of a compounded drug product that is sufficient to
31.28meet the short-term anticipated need of the pharmacy for the filling of prescription drug
31.29orders. In the case of practitioners only, anticipatory compounding means the preparation
31.30of a supply of a compounded drug product that is sufficient to meet the practitioner's
31.31short-term anticipated need for dispensing or administering the drug to patients treated
31.32by the practitioner. Anticipatory compounding is not the preparation of a compounded
31.33drug product for wholesale distribution.
31.34 Subd. 37. Extemporaneous compounding. "Extemporaneous compounding"
31.35means the compounding of a drug product pursuant to a prescription drug order for a specific
32.1patient that is issued in advance of the compounding. Extemporaneous compounding is
32.2not the preparation of a compounded drug product for wholesale distribution.
32.3 Subd. 38. Compounded positron emission tomography drug. "Compounded
32.4positron emission tomography drug" means a drug that:
32.5(1) exhibits spontaneous disintegration of unstable nuclei by the emission of
32.6positrons and is used for the purpose of providing dual photon positron emission
32.7tomographic diagnostic images;
32.8(2) has been compounded by or on the order of a practitioner in accordance with the
32.9relevant parts of Minnesota Rules, chapters 4731 and 6800, for a patient or for research,
32.10teaching, or quality control; and
32.11(3) includes any nonradioactive reagent, reagent kit, ingredient, nuclide generator,
32.12accelerator, target material, electronic synthesizer, or other apparatus or computer program
32.13to be used in the preparation of such a drug.
32.14 Sec. 2. Minnesota Statutes 2012, section 151.06, is amended to read:
32.15151.06 POWERS AND DUTIES.
32.16 Subdivision 1. Generally; rules. (a) Powers and duties. The Board of Pharmacy
32.17shall have the power and it shall be its duty:
32.18 (1) to regulate the practice of pharmacy;
32.19 (2) to regulate the manufacture, wholesale, and retail sale of drugs within this state;
32.20 (3) to regulate the identity, labeling, purity, and quality of all drugs and medicines
32.21dispensed in this state, using the United States Pharmacopeia and the National Formulary,
32.22or any revisions thereof, or standards adopted under the federal act as the standard;
32.23 (4) to enter and inspect by its authorized representative any and all places where
32.24drugs, medicines, medical gases, or veterinary drugs or devices are sold, vended, given
32.25away, compounded, dispensed, manufactured, wholesaled, or held; it may secure samples
32.26or specimens of any drugs, medicines, medical gases, or veterinary drugs or devices
32.27after paying or offering to pay for such sample; it shall be entitled to inspect and make
32.28copies of any and all records of shipment, purchase, manufacture, quality control, and
32.29sale of these items provided, however, that such inspection shall not extend to financial
32.30data, sales data, or pricing data;
32.31 (5) to examine and license as pharmacists all applicants whom it shall deem qualified
32.32to be such;
32.33 (6) to license wholesale drug distributors;
32.34 (7) todeny, suspend, revoke, or refuse to renew take disciplinary action against any
32.35registration or license required under this chapter, to any applicant or registrant or licensee
33.1 upon any of thefollowing grounds: listed in section 151.071, and in accordance with
33.2the provisions of section 151.071;
33.3(i) fraud or deception in connection with the securing of such license or registration;
33.4(ii) in the case of a pharmacist, conviction in any court of a felony;
33.5(iii) in the case of a pharmacist, conviction in any court of an offense involving
33.6moral turpitude;
33.7(iv) habitual indulgence in the use of narcotics, stimulants, or depressant drugs;
33.8or habitual indulgence in intoxicating liquors in a manner which could cause conduct
33.9endangering public health;
33.10(v) unprofessional conduct or conduct endangering public health;
33.11(vi) gross immorality;
33.12(vii) employing, assisting, or enabling in any manner an unlicensed person to
33.13practice pharmacy;
33.14(viii) conviction of theft of drugs, or the unauthorized use, possession, or sale thereof;
33.15(ix) violation of any of the provisions of this chapter or any of the rules of the State
33.16Board of Pharmacy;
33.17(x) in the case of a pharmacy license, operation of such pharmacy without a
33.18pharmacist present and on duty;
33.19(xi) in the case of a pharmacist, physical or mental disability which could cause
33.20incompetency in the practice of pharmacy;
33.21(xii) in the case of a pharmacist, the suspension or revocation of a license to practice
33.22pharmacy in another state; or
33.23(xiii) in the case of a pharmacist, aiding suicide or aiding attempted suicide in
33.24violation of section
609.215 as established by any of the following:
33.25(A) a copy of the record of criminal conviction or plea of guilty for a felony in
33.26violation of section
609.215, subdivision 1 or 2;
33.27(B) a copy of the record of a judgment of contempt of court for violating an
33.28injunction issued under section
609.215, subdivision 4;
33.29(C) a copy of the record of a judgment assessing damages under section
609.215,
33.30subdivision 5
; or
33.31(D) a finding by the board that the person violated section
609.215, subdivision
33.321
or 2. The board shall investigate any complaint of a violation of section
609.215,
33.33subdivision 1
or 2;
33.34 (8) to employ necessary assistants and adopt rules for the conduct of its business;
33.35 (9) to register as pharmacy technicians all applicants who the board determines are
33.36qualified to carry out the duties of a pharmacy technician;and
34.1 (10) to perform such other duties and exercise such other powers as the provisions of
34.2the act may require.; and
34.3(11) to enter and inspect any business to which it issues a license or registration.
34.4(b) Temporary suspension. In addition to any other remedy provided by law, the board
34.5may, without a hearing, temporarily suspend a license for not more than 60 days if the board
34.6finds that a pharmacist has violated a statute or rule that the board is empowered to enforce
34.7and continued practice by the pharmacist would create an imminent risk of harm to others.
34.8The suspension shall take effect upon written notice to the pharmacist, specifying the
34.9statute or rule violated. At the time it issues the suspension notice, the board shall schedule
34.10a disciplinary hearing to be held under the Administrative Procedure Act. The pharmacist
34.11shall be provided with at least 20 days' notice of any hearing held under this subdivision.
34.12(c) (b) Rules. For the purposes aforesaid, it shall be the duty of the board to make
34.13and publish uniform rules not inconsistent herewith for carrying out and enforcing
34.14the provisions of this chapter. The board shall adopt rules regarding prospective drug
34.15utilization review and patient counseling by pharmacists. A pharmacist in the exercise of
34.16the pharmacist's professional judgment, upon the presentation of anew prescription by a
34.17patient or the patient's caregiver or agent, shall perform the prospective drug utilization
34.18review required by rules issued under this subdivision.
34.19(d) (c) Substitution; rules. If the United States Food and Drug Administration
34.20(FDA) determines that the substitution of drugs used for the treatment of epilepsy or
34.21seizures poses a health risk to patients, the board shall adopt rules in accordance with
34.22accompanying FDA interchangeability standards regarding the use of substitution for
34.23these drugs. If the board adopts a rule regarding the substitution of drugs used for the
34.24treatment of epilepsy or seizures that conflicts with the substitution requirements of
34.25section151.21, subdivision 3 , the rule shall supersede the conflicting statute. If the rule
34.26proposed by the board would increase state costs for state public health care programs,
34.27the board shall report to the chairs and ranking minority members of the senate Health
34.28and Human Services Budget Division and the house of representatives Health Care and
34.29Human Services Finance Division the proposed rule and the increased cost associated
34.30with the proposed rule before the board may adopt the rule.
34.31 Subd. 1a.Disciplinary action Cease and desist orders. It shall be grounds for
34.32disciplinary action by the Board of Pharmacy against the registration of the pharmacy if
34.33the Board of Pharmacy determines that any person with supervisory responsibilities at the
34.34pharmacy sets policies that prevent a licensed pharmacist from providing drug utilization
34.35review and patient counseling as required by rules adopted under subdivision 1. The
34.36Board of Pharmacy shall follow the requirements of chapter 14 in any disciplinary actions
35.1taken under this section. (a) Whenever it appears to the board that a person has engaged in
35.2an act or practice constituting a violation of a law, rule, or other order related to the duties
35.3and responsibilities entrusted to the board, the board may issue and cause to be served
35.4upon the person an order requiring the person to cease and desist from violations.
35.5(b) The cease and desist order must state the reasons for the issuance of the order
35.6and must give reasonable notice of the rights of the person to request a hearing before
35.7an administrative law judge. A hearing must be held not later than ten days after the
35.8request for the hearing is received by the board. After the completion of the hearing,
35.9the administrative law judge shall issue a report within ten days. Within 15 days after
35.10receiving the report of the administrative law judge, the board shall issue a further order
35.11vacating or making permanent the cease and desist order. The time periods provided in
35.12this provision may be waived by agreement of the executive director of the board and the
35.13person against whom the cease and desist order was issued. If the person to whom a cease
35.14and desist order is issued fails to appear at the hearing after being duly notified, the person
35.15is in default, and the proceeding may be determined against that person upon consideration
35.16of the cease and desist order, the allegations of which may be considered to be true. Unless
35.17otherwise provided, all hearings must be conducted according to chapter 14. The board
35.18may adopt rules of procedure concerning all proceedings conducted under this subdivision.
35.19(c) If no hearing is requested within 30 days of service of the order, the cease and
35.20desist order will become permanent.
35.21(d) A cease and desist order issued under this subdivision remains in effect until
35.22it is modified or vacated by the board. The administrative proceeding provided by this
35.23subdivision, and subsequent appellate judicial review of that administrative proceeding,
35.24constitutes the exclusive remedy for determining whether the board properly issued the
35.25cease and desist order and whether the cease and desist order should be vacated or made
35.26permanent.
35.27 Subd. 1b. Enforcement of violations of cease and desist orders. (a) Whenever
35.28the board under subdivision 1a seeks to enforce compliance with a cease and desist
35.29order that has been made permanent, the allegations of the cease and desist order are
35.30considered conclusively established for purposes of proceeding under subdivision 1a for
35.31permanent or temporary relief to enforce the cease and desist order. Whenever the board
35.32under subdivision 1a seeks to enforce compliance with a cease and desist order when a
35.33hearing or hearing request on the cease and desist order is pending, or the time has not
35.34yet expired to request a hearing on whether a cease and desist order should be vacated or
35.35made permanent, the allegations in the cease and desist order are considered conclusively
36.1established for the purposes of proceeding under subdivision 1a for temporary relief to
36.2enforce the cease and desist order.
36.3(b) Notwithstanding this subdivision or subdivision 1a, the person against whom
36.4the cease and desist order is issued and who has requested a hearing under subdivision 1a
36.5may, within 15 days after service of the cease and desist order, bring an action in Ramsey
36.6County District Court for issuance of an injunction to suspend enforcement of the cease
36.7and desist order pending a final decision of the board under subdivision 1a to vacate or
36.8make permanent the cease and desist order. The court shall determine whether to issue
36.9such an injunction based on traditional principles of temporary relief.
36.10 Subd. 2. Application. In the case of a facility licensed or registered by the board,
36.11the provisions of subdivision 1 shall apply to an individual owner or sole proprietor and
36.12shall also apply to the following:
36.13(1) In the case of a partnership, each partner thereof;
36.14(2) In the case of an association, each member thereof;
36.15(3) In the case of a corporation, each officer or director thereof and each shareholder
36.16owning 30 percent or more of the voting stock of such corporation.
36.17Subd. 3. Application of Administrative Procedure Act. The board shall comply
36.18with the provisions of chapter 14, before it fails to issue, renew, suspends, or revokes any
36.19license or registration issued under this chapter.
36.20Subd. 4. Reinstatement. Any license or registration which has been suspended
36.21or revoked may be reinstated by the board provided the holder thereof shall pay all costs
36.22of the proceedings resulting in the suspension or revocation, and, in addition thereto,
36.23pay a fee set by the board.
36.24Subd. 5. Costs; penalties. The board may impose a civil penalty not exceeding
36.25$10,000 for each separate violation, the amount of the civil penalty to be fixed so as
36.26to deprive a licensee or registrant of any economic advantage gained by reason of
36.27the violation, to discourage similar violations by the licensee or registrant or any other
36.28licensee or registrant, or to reimburse the board for the cost of the investigation and
36.29proceeding, including, but not limited to, fees paid for services provided by the Office of
36.30Administrative Hearings, legal and investigative services provided by the Office of the
36.31Attorney General, court reporters, witnesses, reproduction of records, board members'
36.32per diem compensation, board staff time, and travel costs and expenses incurred by board
36.33staff and board members.
36.34EFFECTIVE DATE.Subdivisions 1a and 1b are effective August 1, 2014, and
36.35apply to violations occurring on or after that date.
37.1 Sec. 3. [151.071] DISCIPLINARY ACTION.
37.2 Subdivision 1. Forms of disciplinary action. When the board finds that a licensee,
37.3registrant, or applicant has engaged in conduct prohibited under subdivision 2, it may
37.4do one or more of the following:
37.5(1) deny the issuance of a license or registration;
37.6(2) refuse to renew a license or registration;
37.7(3) revoke the license or registration;
37.8(4) suspend the license or registration;
37.9(5) impose limitations, conditions, or both on the license or registration, including
37.10but not limited to: the limitation of practice designated settings; the imposition of
37.11retraining or rehabilitation requirements; the requirement of practice under supervision;
37.12the requirement of participation in a diversion program such as that established pursuant to
37.13section 214.31 or the conditioning of continued practice on demonstration of knowledge
37.14or skills by appropriate examination or other review of skill and competence;
37.15(6) impose a civil penalty not exceeding $10,000 for each separate violation, the
37.16amount of the civil penalty to be fixed so as to deprive a licensee or registrant of any
37.17economic advantage gained by reason of the violation, to discourage similar violations
37.18by the licensee or registrant or any other licensee or registrant, or to reimburse the board
37.19for the cost of the investigation and proceeding, including but not limited to, fees paid
37.20for services provided by the Office of Administrative Hearings, legal and investigative
37.21services provided by the Office of the Attorney General, court reporters, witnesses,
37.22reproduction of records, board members' per diem compensation, board staff time, and
37.23travel costs and expenses incurred by board staff and board members; and
37.24(7) reprimand the licensee or registrant.
37.25 Subd. 2. Grounds for disciplinary action. The following conduct is prohibited and
37.26is grounds for disciplinary action:
37.27(1) failure to demonstrate the qualifications or satisfy the requirements for a license
37.28or registration contained in this chapter or the rules of the board. The burden of proof is on
37.29the applicant to demonstrate such qualifications or satisfaction of such requirements;
37.30(2) obtaining a license by fraud or by misleading the board in any way during
37.31the application process or obtaining a license by cheating, or attempting to subvert
37.32the licensing examination process. Conduct that subverts or attempts to subvert the
37.33licensing examination process includes, but is not limited to: (i) conduct that violates the
37.34security of the examination materials, such as removing examination materials from the
37.35examination room or having unauthorized possession of any portion of a future, current,
37.36or previously administered licensing examination; (ii) conduct that violates the standard of
38.1test administration, such as communicating with another examinee during administration
38.2of the examination, copying another examinee's answers, permitting another examinee
38.3to copy one's answers, or possessing unauthorized materials; or (iii) impersonating an
38.4examinee or permitting an impersonator to take the examination on one's own behalf;
38.5(3) for a pharmacist, pharmacy technician, pharmacist intern, applicant for a
38.6pharmacist or pharmacy license, or applicant for a pharmacy technician or pharmacist
38.7intern registration, conviction of a felony reasonably related to the practice of pharmacy.
38.8Conviction as used in this subdivision includes a conviction of an offense that if committed
38.9in this state would be deemed a felony without regard to its designation elsewhere, or
38.10a criminal proceeding where a finding or verdict of guilt is made or returned but the
38.11adjudication of guilt is either withheld or not entered thereon. The board may delay the
38.12issuance of a new license or registration if the applicant has been charged with a felony
38.13until the matter has been adjudicated;
38.14(4) for a facility, other than a pharmacy, licensed or registered by the board, if an
38.15owner or applicant is convicted of a felony reasonably related to the operation of the
38.16facility. The board may delay the issuance of a new license or registration if the owner or
38.17applicant has been charged with a felony until the matter has been adjudicated;
38.18(5) for a controlled substance researcher, conviction of a felony reasonably related
38.19to controlled substances or to the practice of the researcher's profession. The board may
38.20delay the issuance of a registration if the applicant has been charged with a felony until
38.21the matter has been adjudicated;
38.22(6) disciplinary action taken by another state or by one of this state's health licensing
38.23agencies:
38.24(i) revocation, suspension, restriction, limitation, or other disciplinary action against
38.25a license or registration in another state or jurisdiction, failure to report to the board that
38.26charges or allegations regarding the person's license or registration have been brought in
38.27another state or jurisdiction, or having been refused a license or registration by any other
38.28state or jurisdiction. The board may delay the issuance of a new license or registration if
38.29an investigation or disciplinary action is pending in another state or jurisdiction until the
38.30investigation or action has been dismissed or otherwise resolved; and
38.31(ii) revocation, suspension, restriction, limitation, or other disciplinary action against
38.32a license or registration issued by another of this state's health licensing agencies, failure
38.33to report to the board that charges regarding the person's license or registration have been
38.34brought by another of this state's health licensing agencies, or having been refused a
38.35license or registration by another of this state's health licensing agencies. The board may
38.36delay the issuance of a new license or registration if a disciplinary action is pending before
39.1another of this state's health licensing agencies until the action has been dismissed or
39.2otherwise resolved;
39.3(7) for a pharmacist, pharmacy, pharmacy technician, or pharmacist intern, violation
39.4of any order of the board, of any of the provisions of this chapter or any rules of the
39.5board or violation of any federal, state, or local law or rule reasonably pertaining to the
39.6practice of pharmacy;
39.7(8) for a facility, other than a pharmacy, licensed by the board, violations of any
39.8order of the board, of any of the provisions of this chapter or the rules of the board or
39.9violation of any federal, state, or local law relating to the operation of the facility;
39.10(9) engaging in any unethical conduct; conduct likely to deceive, defraud, or harm
39.11the public, or demonstrating a willful or careless disregard for the health, welfare, or safety
39.12of a patient; or pharmacy practice that is professionally incompetent, in that it may create
39.13unnecessary danger to any patient's life, health, or safety, in any of which cases, proof
39.14of actual injury need not be established;
39.15(10) aiding or abetting an unlicensed person in the practice of pharmacy, except
39.16that it is not a violation of this clause for a pharmacist to supervise a properly registered
39.17pharmacy technician or pharmacist intern if that person is performing duties allowed
39.18by this chapter or the rules of the board;
39.19(11) for an individual licensed or registered by the board, adjudication as mentally ill
39.20or developmentally disabled, or as a chemically dependent person, a person dangerous
39.21to the public, a sexually dangerous person, or a person who has a sexual psychopathic
39.22personality, by a court of competent jurisdiction, within or without this state. Such
39.23adjudication shall automatically suspend a license for the duration thereof unless the
39.24board orders otherwise;
39.25(12) for a pharmacist or pharmacy intern, engaging in unprofessional conduct as
39.26specified in the board's rules. In the case of a pharmacy technician, engaging in conduct
39.27specified in board rules that would be unprofessional if it were engaged in by a pharmacist
39.28or pharmacist intern or performing duties specifically reserved for pharmacists under this
39.29chapter or the rules of the board;
39.30(13) for a pharmacy, operation of the pharmacy without a pharmacist present and on
39.31duty except as allowed by a variance approved by the board;
39.32(14) for a pharmacist, the inability to practice pharmacy with reasonable skill and
39.33safety to patients by reason of illness, drunkenness, use of drugs, narcotics, chemicals, or
39.34any other type of material or as a result of any mental or physical condition, including
39.35deterioration through the aging process or loss of motor skills. In the case of registered
39.36pharmacy technicians, pharmacist interns, or controlled substance researchers, the
40.1inability to carry out duties allowed under this chapter or the rules of the board with
40.2reasonable skill and safety to patients by reason of illness, drunkenness, use of drugs,
40.3narcotics, chemicals, or any other type of material or as a result of any mental or physical
40.4condition, including deterioration through the aging process or loss of motor skills;
40.5(15) for a pharmacist, pharmacy, pharmacist intern, pharmacy technician, medical
40.6gas distributor, or controlled substance researcher, revealing a privileged communication
40.7from or relating to a patient except when otherwise required or permitted by law;
40.8(16) for a pharmacist or pharmacy, improper management of patient records,
40.9including failure to maintain adequate patient records, to comply with a patient's request
40.10made pursuant to sections 144.291 to 144.298, or to furnish a patient record or report
40.11required by law;
40.12(17) paying, offering to pay, receiving, or agreeing to receive, a commission, rebate,
40.13kickback, or other form of remuneration, directly or indirectly, for the referral of patients
40.14or the dispensing of drugs or devices;
40.15(18) engaging in abusive or fraudulent billing practices, including violations of the
40.16federal Medicare and Medicaid laws or state medical assistance laws or rules;
40.17(19) engaging in conduct with a patient that is sexual or may reasonably be
40.18interpreted by the patient as sexual, or in any verbal behavior that is seductive or sexually
40.19demeaning to a patient;
40.20(20) failure to make reports as required by section 151.072 or to cooperate with an
40.21investigation of the board as required by section 151.074;
40.22(21) knowingly providing false or misleading information that is directly related
40.23to the care of a patient unless done for an accepted therapeutic purpose such as the
40.24dispensing and administration of a placebo;
40.25(22) aiding suicide or aiding attempted suicide in violation of section 609.215 as
40.26established by any of the following:
40.27(i) a copy of the record of criminal conviction or plea of guilty for a felony in
40.28violation of section 609.215, subdivision 1 or 2;
40.29(ii) a copy of the record of a judgment of contempt of court for violating an
40.30injunction issued under section 609.215, subdivision 4;
40.31(iii) a copy of the record of a judgment assessing damages under section 609.215,
40.32subdivision 5; or
40.33(iv) a finding by the board that the person violated section 609.215, subdivision
40.341 or 2. The board shall investigate any complaint of a violation of section 609.215,
40.35subdivision 1 or 2;
41.1(23) for a pharmacist, practice of pharmacy under a lapsed or nonrenewed license.
41.2For a pharmacist intern, pharmacy technician, or controlled substance researcher,
41.3performing duties permitted to such individuals by this chapter or the rules of the board
41.4under a lapsed or nonrenewed registration. For a facility required to be licensed under this
41.5chapter, operation of the facility under a lapsed or nonrenewed license or registration; and
41.6(24) for a pharmacist, pharmacist intern, or pharmacy technician, termination
41.7or discharge from the health professional services program for reasons other than the
41.8satisfactory completion of the program.
41.9 Subd. 3. Automatic suspension. (a) A license or registration issued under this
41.10chapter to a pharmacist, pharmacist intern, pharmacy technician, or controlled substance
41.11researcher is automatically suspended if: (1) a guardian of a licensee or registrant is
41.12appointed by order of a court pursuant to sections 524.5-101 to 524.5-502, for reasons
41.13other than the minority of the licensee or registrant; or (2) the licensee or registrant is
41.14committed by order of a court pursuant to chapter 253B. The license or registration
41.15remains suspended until the licensee is restored to capacity by a court and, upon petition
41.16by the licensee or registrant, the suspension is terminated by the board after a hearing.
41.17(b) For a pharmacist, pharmacy intern, or pharmacy technician, upon notice to the
41.18board of a judgment of, or a plea of guilty to, a felony reasonably related to the practice
41.19of pharmacy, the license or registration of the regulated person may be automatically
41.20suspended by the board. The license or registration will remain suspended until, upon
41.21petition by the regulated individual and after a hearing, the suspension is terminated by
41.22the board. The board may indefinitely suspend or revoke the license or registration of the
41.23regulated individual if, after a hearing before the board, the board finds that the felonious
41.24conduct would cause a serious risk of harm to the public.
41.25(c) For a facility that is licensed or registered by the board, upon notice to the
41.26board that an owner of the facility is subject to a judgment of, or a plea of guilty to,
41.27a felony reasonably related to the operation of the facility, the license or registration of
41.28the facility may be automatically suspended by the board. The license or registration will
41.29remain suspended until, upon petition by the facility and after a hearing, the suspension
41.30is terminated by the board. The board may indefinitely suspend or revoke the license or
41.31registration of the facility if, after a hearing before the board, the board finds that the
41.32felonious conduct would cause a serious risk of harm to the public.
41.33(d) For licenses and registrations that have been suspended or revoked pursuant
41.34to paragraphs (a) and (b), the regulated individual may have a license or registration
41.35reinstated, either with or without restrictions, by demonstrating clear and convincing
41.36evidence of rehabilitation, as provided in section 364.03. If the regulated individual has
42.1the conviction subsequently overturned by court decision, the board shall conduct a
42.2hearing to review the suspension within 30 days after the receipt of the court decision.
42.3The regulated individual is not required to prove rehabilitation if the subsequent court
42.4decision overturns previous court findings of public risk.
42.5(e) For licenses and registrations that have been suspended or revoked pursuant to
42.6paragraph (c), the regulated facility may have a license or registration reinstated, either with
42.7or without restrictions, conditions, or limitations, by demonstrating clear and convincing
42.8evidence of rehabilitation of the convicted owner, as provided in section 364.03. If the
42.9convicted owner has the conviction subsequently overturned by court decision, the board
42.10shall conduct a hearing to review the suspension within 30 days after receipt of the court
42.11decision. The regulated facility is not required to prove rehabilitation of the convicted
42.12owner if the subsequent court decision overturns previous court findings of public risk.
42.13(f) The board may, upon majority vote of a quorum of its appointed members,
42.14suspend the license or registration of a regulated individual without a hearing if the
42.15regulated individual fails to maintain a current name and address with the board, as
42.16described in paragraphs (h) and (i), while the regulated individual is: (1) under board
42.17investigation, and a notice of conference has been issued by the board; (2) party to a
42.18contested case with the board; (3) party to an agreement for corrective action with the
42.19board; or (4) under a board order for disciplinary action. The suspension shall remain
42.20in effect until lifted by the board to the board's receipt of a petition from the regulated
42.21individual, along with the current name and address of the regulated individual.
42.22(g) The board may, upon majority vote of a quorum of its appointed members,
42.23suspend the license or registration of a regulated facility without a hearing if the regulated
42.24facility fails to maintain a current name and address of the owner of the facility with the
42.25board, as described in paragraphs (h) and (i), while the regulated facility is: (1) under
42.26board investigation, and a notice of conference has been issued by the board; (2) party
42.27to a contested case with the board; (3) party to an agreement for corrective action with
42.28the board; or (4) under a board order for disciplinary action. The suspension shall remain
42.29in effect until lifted by the board pursuant to the board's receipt of a petition from the
42.30regulated facility, along with the current name and address of the owner of the facility.
42.31(h) An individual licensed or registered by the board shall maintain a current name
42.32and home address with the board and shall notify the board in writing within 30 days of
42.33any change in name or home address. An individual regulated by the board shall also
42.34maintain a current business address with the board as required by section 214.073. For
42.35an individual, if a name change only is requested, the regulated individual must request
42.36a revised license or registration. The board may require the individual to substantiate
43.1the name change by submitting official documentation from a court of law or agency
43.2authorized under law to receive and officially record a name change. In the case of an
43.3individual, if an address change only is requested, no request for a revised license or
43.4registration is required. If the current license or registration of an individual has been lost,
43.5stolen, or destroyed, the individual shall provide a written explanation to the board.
43.6(i) A facility licensed or registered by the board shall maintain a current name and
43.7address with the board. A facility shall notify the board in writing within 30 days of any
43.8change in name. A facility licensed or registered by the board but located outside of the
43.9state must notify the board within 30 days of an address change. A facility licensed or
43.10registered by the board and located within the state must notify the board at least 60
43.11days in advance of a change of address that will result from the move of the facility to a
43.12different location and must pass an inspection at the new location as required by the board.
43.13If the current license or registration of a facility has been lost, stolen, or destroyed, the
43.14facility shall provide a written explanation to the board.
43.15 Subd. 4. Effective dates. A suspension, revocation, condition, limitation,
43.16qualification, or restriction of a license or registration shall be in effect pending
43.17determination of an appeal. A revocation of a license pursuant to subdivision 1 is not
43.18appealable and shall remain in effect indefinitely.
43.19 Subd. 5. Conditions on reissued license. In its discretion, the board may restore
43.20and reissue a license or registration issued under this chapter, but as a condition thereof
43.21may impose any disciplinary or corrective measure that it might originally have imposed.
43.22 Subd. 6. Temporary suspension of license for pharmacists. In addition to any
43.23other remedy provided by law, the board may, without a hearing, temporarily suspend the
43.24license of a pharmacist if the board finds that the pharmacist has violated a statute or rule
43.25that the board is empowered to enforce and continued practice by the pharmacist would
43.26create a serious risk of harm to the public. The suspension shall take effect upon written
43.27notice to the pharmacist, specifying the statute or rule violated. The suspension shall
43.28remain in effect until the board issues a final order in the matter after a hearing. At the
43.29time it issues the suspension notice, the board shall schedule a disciplinary hearing to be
43.30held pursuant to the Administrative Procedure Act. The pharmacist shall be provided with
43.31at least 20 days' notice of any hearing held pursuant to this subdivision. The hearing shall
43.32be scheduled to begin no later than 30 days after the issuance of the suspension order.
43.33 Subd. 7. Temporary suspension of license for pharmacist interns, pharmacy
43.34technicians, and controlled substance researchers. In addition to any other remedy
43.35provided by law, the board may, without a hearing, temporarily suspend the registration of
43.36a pharmacist intern, pharmacy technician, or controlled substance researcher if the board
44.1finds that the registrant has violated a statute or rule that the board is empowered to enforce
44.2and continued registration of the registrant would create a serious risk of harm to the
44.3public. The suspension shall take effect upon written notice to the registrant, specifying
44.4the statute or rule violated. The suspension shall remain in effect until the board issues a
44.5final order in the matter after a hearing. At the time it issues the suspension notice, the
44.6board shall schedule a disciplinary hearing to be held pursuant to the Administrative
44.7Procedure Act. The licensee or registrant shall be provided with at least 20 days' notice of
44.8any hearing held pursuant to this subdivision. The hearing shall be scheduled to begin no
44.9later than 30 days after the issuance of the suspension order.
44.10 Subd. 8. Temporary suspension of license for pharmacies, drug wholesalers,
44.11drug manufacturers, medical gas manufacturers, and medical gas distributors.
44.12In addition to any other remedy provided by law, the board may, without a hearing,
44.13temporarily suspend the license or registration of a pharmacy, drug wholesaler, drug
44.14manufacturer, medical gas manufacturer, or medical gas distributor if the board finds
44.15that the licensee or registrant has violated a statute or rule that the board is empowered
44.16to enforce and continued operation of the licensed facility would create a serious risk of
44.17harm to the public. The suspension shall take effect upon written notice to the licensee or
44.18registrant, specifying the statute or rule violated. The suspension shall remain in effect
44.19until the board issues a final order in the matter after a hearing. At the time it issues the
44.20suspension notice, the board shall schedule a disciplinary hearing to be held pursuant to
44.21the Administrative Procedure Act. The licensee or registrant shall be provided with at
44.22least 20 days' notice of any hearing held pursuant to this subdivision. The hearing shall be
44.23scheduled to begin no later than 30 days after the issuance of the suspension order.
44.24 Subd. 9. Evidence. In disciplinary actions alleging a violation of subdivision 2,
44.25clause (4), (5), (6), or (7), a copy of the judgment or proceeding under the seal of the court
44.26administrator or of the administrative agency that entered the same shall be admissible
44.27into evidence without further authentication and shall constitute prima facie evidence
44.28of the contents thereof.
44.29 Subd. 10. Mental examination; access to medical data. (a) If the board has
44.30probable cause to believe that an individual licensed or registered by the board falls under
44.31subdivision 2, clause (14), it may direct the individual to submit to a mental or physical
44.32examination. For the purpose of this subdivision, every licensed or registered individual is
44.33deemed to have consented to submit to a mental or physical examination when directed in
44.34writing by the board and further to have waived all objections to the admissibility of the
44.35examining practitioner's testimony or examination reports on the grounds that the same
44.36constitute a privileged communication. Failure of a licensed or registered individual to
45.1submit to an examination when directed constitutes an admission of the allegations against
45.2the individual, unless the failure was due to circumstances beyond the individual's control,
45.3in which case a default and final order may be entered without the taking of testimony or
45.4presentation of evidence. Pharmacists affected under this paragraph shall at reasonable
45.5intervals be given an opportunity to demonstrate that they can resume the competent
45.6practice of the profession of pharmacy with reasonable skill and safety to the public.
45.7Pharmacist interns, pharmacy technicians, or controlled substance researchers affected
45.8under this paragraph shall at reasonable intervals be given an opportunity to demonstrate
45.9that they can competently resume the duties that can be performed, under this chapter or
45.10the rules of the board, by similarly registered persons with reasonable skill and safety to
45.11the public. In any proceeding under this paragraph, neither the record of proceedings nor
45.12the orders entered by the board shall be used against a licensed or registered individual
45.13in any other proceeding.
45.14(b) In addition to ordering a physical or mental examination, the board may,
45.15notwithstanding section 13.384, 144.651, or any other law limiting access to medical or
45.16other health data, obtain medical data and health records relating to an individual licensed
45.17or registered by the board, or to an applicant for licensure or registration, without the
45.18individual's consent, if the board has probable cause to believe that the individual falls
45.19under subdivision 2, clause (14). The medical data may be requested from a provider,
45.20as defined in section 144.291, subdivision 2, paragraph (h), an insurance company, or a
45.21government agency, including the Department of Human Services. A provider, insurance
45.22company, or government agency shall comply with any written request of the board under
45.23this subdivision and is not liable in any action for damages for releasing the data requested
45.24by the board if the data are released pursuant to a written request under this subdivision,
45.25unless the information is false and the provider giving the information knew, or had reason
45.26to believe, the information was false. Information obtained under this subdivision is
45.27classified as private under sections 13.01 to 13.87.
45.28 Subd. 11. Tax clearance certificate. (a) In addition to the provisions of subdivision
45.291, the board may not issue or renew a license or registration if the commissioner of
45.30revenue notifies the board and the licensee or applicant for a license that the licensee or
45.31applicant owes the state delinquent taxes in the amount of $500 or more. The board may
45.32issue or renew the license or registration only if (1) the commissioner of revenue issues a
45.33tax clearance certificate, and (2) the commissioner of revenue or the licensee, registrant, or
45.34applicant forwards a copy of the clearance to the board. The commissioner of revenue
45.35may issue a clearance certificate only if the licensee, registrant, or applicant does not owe
45.36the state any uncontested delinquent taxes.
46.1(b) For purposes of this subdivision, the following terms have the meanings given.
46.2(1) "Taxes" are all taxes payable to the commissioner of revenue, including penalties
46.3and interest due on those taxes.
46.4(2) "Delinquent taxes" do not include a tax liability if (i) an administrative or court
46.5action that contests the amount or validity of the liability has been filed or served, (ii) the
46.6appeal period to contest the tax liability has not expired, or (iii) the licensee or applicant
46.7has entered into a payment agreement to pay the liability and is current with the payments.
46.8(c) In lieu of the notice and hearing requirements of subdivision 1, when a licensee,
46.9registrant, or applicant is required to obtain a clearance certificate under this subdivision,
46.10a contested case hearing must be held if the licensee or applicant requests a hearing in
46.11writing to the commissioner of revenue within 30 days of the date of the notice provided
46.12in paragraph (a). The hearing must be held within 45 days of the date the commissioner of
46.13revenue refers the case to the Office of Administrative Hearings. Notwithstanding any law
46.14to the contrary, the licensee or applicant must be served with 20 days' notice in writing
46.15specifying the time and place of the hearing and the allegations against the licensee or
46.16applicant. The notice may be served personally or by mail.
46.17(d) A licensee or applicant must provide the licensee's or applicant's Social Security
46.18number and Minnesota business identification number on all license applications. Upon
46.19request of the commissioner of revenue, the board must provide to the commissioner of
46.20revenue a list of all licensees and applicants that includes the licensee's or applicant's
46.21name, address, Social Security number, and business identification number. The
46.22commissioner of revenue may request a list of the licensees and applicants no more than
46.23once each calendar year.
46.24 Subd. 12. Limitation. No board proceeding against a regulated person or facility
46.25shall be instituted unless commenced within seven years from the date of the commission
46.26of some portion of the offense or misconduct complained of except for alleged violations
46.27of subdivision 2, clause (21).
46.28 Sec. 4. [151.072] REPORTING OBLIGATIONS.
46.29 Subdivision 1. Permission to report. A person who has knowledge of any conduct
46.30constituting grounds for discipline under the provisions of this chapter or the rules of the
46.31board may report the violation to the board.
46.32 Subd. 2. Pharmacies. A pharmacy located in this state must report to the board any
46.33discipline that is related to an incident involving conduct that would constitute grounds
46.34for discipline under the provisions of this chapter or the rules of the board, that is taken
46.35by the pharmacy or any of its administrators against a pharmacist, pharmacist intern, or
47.1pharmacy technician, including the termination of employment of the individual or the
47.2revocation, suspension, restriction, limitation, or conditioning of an individual's ability
47.3to practice or work at or on behalf of the pharmacy. The pharmacy shall also report the
47.4resignation of any pharmacist, pharmacist intern, or technician prior to the conclusion of
47.5any disciplinary proceeding, or prior to the commencement of formal charges but after the
47.6individual had knowledge that formal charges were contemplated or in preparation. Each
47.7report made under this subdivision must state the nature of the action taken and state in
47.8detail the reasons for the action. Failure to report violations as required by this subdivision
47.9is a basis for discipline pursuant to section 151.071, subdivision 2, clause (8).
47.10 Subd. 3. Licensees and registrants of the board. A licensee or registrant of
47.11the board shall report to the board personal knowledge of any conduct that the person
47.12reasonably believes constitutes grounds for disciplinary action under this chapter or
47.13the rules of the board by any pharmacist, pharmacist intern, pharmacy technician, or
47.14controlled substance researcher, including any conduct indicating that the person may be
47.15professionally incompetent, or may have engaged in unprofessional conduct or may be
47.16medically or physically unable to engage safely in the practice of pharmacy or to carry
47.17out the duties permitted to the person by this chapter or the rules of the board. Failure
47.18to report violations as required by this subdivision is a basis for discipline pursuant to
47.19section 151.071, subdivision 2, clause (20).
47.20 Subd. 4. Self-reporting. A licensee or registrant of the board shall report to the
47.21board any personal action that would require that a report be filed with the board pursuant
47.22to subdivision 2.
47.23 Subd. 5. Deadlines; forms. Reports required by subdivisions 2 to 4 must be
47.24submitted not later than 30 days after the occurrence of the reportable event or transaction.
47.25The board may provide forms for the submission of reports required by this section, may
47.26require that reports be submitted on the forms provided, and may adopt rules necessary
47.27to assure prompt and accurate reporting.
47.28 Subd. 6. Subpoenas. The board may issue subpoenas for the production of any
47.29reports required by subdivisions 2 to 4 or any related documents.
47.30 Sec. 5. [151.073] IMMUNITY.
47.31 Subdivision 1. Reporting. Any person, health care facility, business, or organization
47.32is immune from civil liability or criminal prosecution for submitting in good faith a report
47.33to the board under section 151.072 or for otherwise reporting in good faith to the board
47.34violations or alleged violations of this chapter or the rules of the board. All such reports
47.35are investigative data as defined in chapter 13.
48.1 Subd. 2. Investigation. (a) Members of the board and persons employed by the board
48.2or engaged on behalf of the board in the investigation of violations and in the preparation
48.3and management of charges or violations of this chapter of the rules of the board, or persons
48.4participating in the investigation or testifying regarding charges of violations, are immune
48.5from civil liability and criminal prosecution for any actions, transactions, or publications
48.6in the execution of, or relating to, their duties under this chapter or the rules of the board.
48.7(b) Members of the board and persons employed by the board or engaged in
48.8maintaining records and making reports regarding adverse health care events are immune
48.9from civil liability and criminal prosecution for any actions, transactions, or publications
48.10in the execution of, or relating to, their duties under section 151.301.
48.11 Sec. 6. [151.074] LICENSEE OR REGISTRANT COOPERATION.
48.12An individual who is licensed or registered by the board, who is the subject of an
48.13investigation by or on behalf of the board, shall cooperate fully with the investigation.
48.14An owner or employee of a facility that is licensed or registered by the board, when the
48.15facility is the subject of an investigation by or on behalf of the board, shall cooperate
48.16fully with the investigation. Cooperation includes responding fully and promptly to any
48.17question raised by, or on behalf of, the board relating to the subject of the investigation and
48.18providing copies of patient pharmacy records and other relevant records, as reasonably
48.19requested by the board, to assist the board in its investigation. The board shall maintain
48.20any records obtained pursuant to this section as investigative data pursuant to chapter 13.
48.21 Sec. 7. [151.075] DISCIPLINARY RECORD ON JUDICIAL REVIEW.
48.22Upon judicial review of any board disciplinary action taken under this chapter, the
48.23reviewing court shall seal the administrative record, except for the board's final decision,
48.24and shall not make the administrative record available to the public.
48.25 Sec. 8. Minnesota Statutes 2012, section 151.211, is amended to read:
48.26151.211 RECORDS OF PRESCRIPTIONS.
48.27 Subdivision 1. Retention of prescription drug orders. Allprescriptions dispensed
48.28 prescription drug orders shall be kept on file at the locationin from which such dispensing
48.29occurred of the ordered drug occurs for a period of at least two years. Prescription drug
48.30orders that are electronically prescribed must be kept on file in the format in which
48.31they were originally received. Written or printed prescription drug orders and verbal
48.32prescription drug orders reduced to writing, must be kept on file as received or transcribed,
48.33except that such orders may be kept in an electronic format as allowed by the board.
49.1Electronic systems used to process and store prescription drug orders must be compliant
49.2with the requirements of this chapter and the rules of the board. Prescription drug orders
49.3that are stored in an electronic format, as permitted by this subdivision, may be kept on
49.4file at a remote location provided that they are readily and securely accessible from the
49.5location at which dispensing of the ordered drug occurred.
49.6 Subd. 2. Refill requirements.No A prescription shall drug order may be refilled
49.7except only with the written, electronic, or verbal consent of the prescriber and in
49.8accordance with the requirements of this chapter, the rules of the board, and where
49.9applicable, section 152.11. The date of such refill must be recorded and initialed upon
49.10the original prescription drug order, or within the electronically maintained record of the
49.11original prescription drug order, by the pharmacist, pharmacist intern, or practitioner
49.12who refills the prescription.
49.13 Sec. 9. [151.251] COMPOUNDING.
49.14 Subdivision 1. Exemption from manufacturing licensure requirement. Section
49.15151.252 shall not apply to:
49.16(1) a practitioner engaged in extemporaneous compounding, anticipatory
49.17compounding, or compounding not done pursuant to a prescription drug order when
49.18permitted by this chapter or the rules of the board; and
49.19(2) a pharmacy in which a pharmacist is engaged in extemporaneous compounding,
49.20anticipatory compounding, or compounding not done pursuant to a prescription drug order
49.21when permitted by this chapter or the rules of the board.
49.22 Subd. 2. Compounded drug. A drug product may be compounded under this
49.23section if a pharmacist or practitioner:
49.24(a) compounds the drug product using bulk drug substances, as defined in the federal
49.25regulations published in Code of Federal Regulations, title 21, section 207.3(a)(4):
49.26(1) that:
49.27(i) comply with the standards of an applicable United States Pharmacopoeia
49.28or National Formulary monograph, if a monograph exists, and the United States
49.29Pharmacopoeia chapter on pharmacy compounding;
49.30(ii) if such a monograph does not exist, are drug substances that are components of
49.31drugs approved for use in this country by the United States Food and Drug Administration;
49.32or
49.33(iii) if such a monograph does not exist and the drug substance is not a component of
49.34a drug approved for use in this country by the United States Food and Drug Administration,
49.35that appear on a list developed by the United States Food and Drug Administration through
50.1regulations issued by the secretary of the federal Department of Health and Human
50.2Services pursuant to section 503a of the Food, Drug and Cosmetic Act under paragraph (d);
50.3(2) that are manufactured by an establishment that is registered under section 360
50.4of the federal Food, Drug and Cosmetic Act, including a foreign establishment that is
50.5registered under section 360(i) of that act; and
50.6(3) that are accompanied by valid certificates of analysis for each bulk drug substance;
50.7(b) compounds the drug product using ingredients, other than bulk drug substances,
50.8that comply with the standards of an applicable United States Pharmacopoeia or National
50.9Formulary monograph, if a monograph exists, and the United States Pharmacopoeia
50.10chapters on pharmacy compounding;
50.11(c) does not compound a drug product that appears on a list published by the secretary
50.12of the federal Department of Health and Human Services in the Federal Register of drug
50.13products that have been withdrawn or removed from the market because such drug products
50.14or components of such drug products have been found to be unsafe or not effective;
50.15(d) does not compound any drug products that are essentially copies of a
50.16commercially available drug product; and
50.17(e) does not compound any drug product that has been identified pursuant to
50.18United States Code, title 21, section 353a, as a drug product that presents demonstrable
50.19difficulties for compounding that reasonably demonstrate an adverse effect on the safety
50.20or effectiveness of that drug product.
50.21The term "essentially a copy of a commercially available drug product" does not
50.22include a drug product in which there is a change, made for an identified individual
50.23patient, that produces for that patient a significant difference, as determined by the
50.24prescribing practitioner, between the compounded drug and the comparable commercially
50.25available drug product.
50.26 Subd. 3. Exceptions. This section shall not apply to:
50.27(1) compounded positron emission tomography drugs as defined in section 151.01,
50.28subdivision 38; or
50.29(2) radiopharmaceuticals.
50.30 Sec. 10. Minnesota Statutes 2013 Supplement, section 151.252, is amended by adding
50.31a subdivision to read:
50.32 Subd. 1a. Outsourcing facility. (a) No person shall act as an outsourcing facility
50.33without first obtaining a license from the board and paying any applicable manufacturer
50.34licensing fee specified in section 151.065.
51.1(b) Application for an outsourcing facility license under this section shall be made
51.2in a manner specified by the board and may differ from the application required of other
51.3drug manufacturers.
51.4(c) No license shall be issued or renewed for an outsourcing facility unless the
51.5applicant agrees to operate in a manner prescribed for outsourcing facilities by federal and
51.6state law and according to Minnesota Rules.
51.7(d) No license shall be issued or renewed for an outsourcing facility unless the
51.8applicant supplies the board with proof of such registration by the United States Food and
51.9Drug Administration as required by United States Code, title 21, section 353b.
51.10(e) No license shall be issued or renewed for an outsourcing facility that is required
51.11to be licensed or registered by the state in which it is physically located unless the
51.12applicant supplies the board with proof of such licensure or registration. The board may
51.13establish, by rule, standards for the licensure of an outsourcing facility that is not required
51.14to be licensed or registered by the state in which it is physically located.
51.15(f) The board shall require a separate license for each outsourcing facility located
51.16within the state and for each outsourcing facility located outside of the state at which drugs
51.17that are shipped into the state are prepared.
51.18(g) The board shall not issue an initial or renewed license for an outsourcing facility
51.19unless the facility passes an inspection conducted by an authorized representative of the
51.20board. In the case of an outsourcing facility located outside of the state, the board may
51.21require the applicant to pay the cost of the inspection, in addition to the license fee in
51.22section 151.065, unless the applicant furnishes the board with a report, issued by the
51.23appropriate regulatory agency of the state in which the facility is located or by the United
51.24States Food and Drug Administration, of an inspection that has occurred within the 24
51.25months immediately preceding receipt of the license application by the board. The board
51.26may deny licensure unless the applicant submits documentation satisfactory to the board
51.27that any deficiencies noted in an inspection report have been corrected.
51.28 Sec. 11. Minnesota Statutes 2012, section 151.26, is amended to read:
51.29151.26 EXCEPTIONS.
51.30 Subdivision 1. Generally. Nothing in this chapter shall subject a person duly
51.31licensed in this state to practice medicine, dentistry, or veterinary medicine, to inspection
51.32by the State Board of Pharmacy, nor prevent the person from administering drugs,
51.33medicines, chemicals, or poisons in the person's practice, nor prevent a duly licensed
51.34practitioner from furnishing to a patient properly packaged and labeled drugs, medicines,
51.35chemicals, or poisons as may be considered appropriate in the treatment of such patient;
52.1unless the person is engaged in the dispensing, sale, or distribution of drugs and the board
52.2provides reasonable notice of an inspection.
52.3Except for the provisions of section151.37 , nothing in this chapter applies to or
52.4interferes with the dispensing, in its original package and at no charge to the patient, of
52.5a legend drug, other than a controlled substance, that was packaged by a manufacturer
52.6and provided to the dispenser fordistribution dispensing as a professional sample, so
52.7long as the sample is prepared and distributed pursuant to Code of Federal Regulations,
52.8title 21, section 203, subpart D.
52.9Nothing in this chapter shall prevent the sale of drugs, medicines, chemicals, or
52.10poisons at wholesale to licensed physicians, dentists and veterinarians for use in their
52.11practice, nor to hospitals for use therein.
52.12Nothing in this chapter shall prevent the sale of drugs, chemicals, or poisons either
52.13at wholesale or retail for use for commercial purposes, or in the arts, nor interfere with the
52.14sale of insecticides, as defined in Minnesota Statutes 1974, section24.069 , and nothing in
52.15this chapter shall prevent the sale of common household preparations and other drugs,
52.16chemicals, and poisons sold exclusively for use for nonmedicinal purposes.; provided
52.17that this exception does not apply to any compound, substance, or derivative that is not
52.18approved for human consumption by the United States Food and Drug Administration
52.19or specifically permitted for human consumption under Minnesota law and, when
52.20introduced into the body, induces an effect similar to that of a Schedule I or Schedule II
52.21controlled substance listed in section 152.02, subdivisions 2 and 3, or Minnesota Rules,
52.22parts 6800.4210 and 6800.4220, regardless of whether the substance is marketed for the
52.23purpose of human consumption.
52.24Nothing in this chapter shall apply to or interfere with the vending or retailing of
52.25any nonprescription medicine or drug not otherwise prohibited by statutewhich that is
52.26prepackaged, fully prepared by the manufacturer or producer for use by the consumer, and
52.27labeled in accordance with the requirements of the state or federal Food and Drug Act; nor
52.28to the manufacture, wholesaling, vending, or retailing of flavoring extracts, toilet articles,
52.29cosmetics, perfumes, spices, and other commonly used household articles of a chemical
52.30nature, for use for nonmedicinal purposes.; provided that this exception does not apply
52.31to any compound, substance, or derivative that is not approved for human consumption
52.32by the United States Food and Drug Administration or specifically permitted for human
52.33consumption under Minnesota law that, when introduced into the body, induces an effect
52.34similar to that of a Schedule I or Schedule II controlled substance listed in section 152.02,
52.35subdivisions 2 and 3, or Minnesota Rules, parts 6800.4210 and 6800.4220, regardless of
52.36whether the substance is marketed for the purpose of human consumption. Nothing in
53.1this chapter shall prevent the sale of drugs or medicines by licensed pharmacists at a
53.2discount to persons over 65 years of age.
53.3 Sec. 12. Minnesota Statutes 2012, section 151.34, is amended to read:
53.4151.34 PROHIBITED ACTS.
53.5It shall be unlawful to:
53.6(1) manufacture, sell or deliver, hold or offer for sale any drug that is adulterated
53.7or misbranded;
53.8(2) adulterate or misbrand any drug;
53.9(3) receive in commerce any drug that is adulterated or misbranded, and to deliver or
53.10proffer delivery thereof for pay or otherwise;
53.11(4) refuse to permit entry or inspection, or to permit the taking of a sample, or to
53.12permit access to or copying of any record as authorized by this chapter;
53.13(5) remove or dispose of a detained or embargoed article in violation of this chapter;
53.14(6) alter, mutilate, destroy, obliterate, or remove the whole or any part of the labeling
53.15of, or to do any other act with respect to a drug, if such act is done while such drug is held
53.16for sale and results in such drug being adulterated or misbranded;
53.17(7) use for a person's own advantage or to reveal other than to the board or its
53.18authorized representative or to the courts when required in any judicial proceeding under
53.19this chapter any information acquired under authority of this chapter concerning any
53.20method or processwhich that is a trade secret and entitled to protection;
53.21(8) use on the labeling of any drug any representation or suggestion that an
53.22application with respect to such drug is effective under the federal act or that such drug
53.23complies with such provisions;
53.24(9) in the case of a manufacturer, packer, or distributor offering legend drugs for sale
53.25within this state, fail to maintain for transmittal or to transmit, to any practitioner licensed
53.26by applicable law to administer such drug who makes written request for information as to
53.27such drug, true and correct copies of all printed matterwhich that is required to be included
53.28in any package in which that drug is distributed or sold, or such other printed matter as is
53.29approved under the federal act. Nothing in this paragraph shall be construed to exempt
53.30any person from any labeling requirement imposed by or under provisions of this chapter;
53.31(10) conduct a pharmacy without a pharmacist in charge;
53.32(11) dispense a legend drug without first obtaining a valid prescription for that drug;
53.33(12) conduct a pharmacy without proper registration with the board;
53.34(13) practice pharmacy without being licensed to do so by the board;or
54.1(14) sell at retail federally restricted medical gases without proper registration with
54.2the board except as provided in this chapter.; or
54.3(15) sell any compound, substance, or derivative that is not approved for human
54.4consumption by the United States Food and Drug Administration or specifically permitted
54.5for human consumption under Minnesota law and, when introduced into the body, induces
54.6an effect similar to that of a Schedule I or Schedule II controlled substance listed in
54.7section 152.02, subdivisions 2 and 3, or Minnesota Rules, parts 6800.4210 and 6800.4220,
54.8regardless of whether the substance is marketed for the purpose of human consumption.
54.9EFFECTIVE DATE.This section is effective August 1, 2014, and applies to sales
54.10on or after that date.
54.11 Sec. 13. Minnesota Statutes 2012, section 151.35, is amended to read:
54.12151.35 DRUGS, ADULTERATION.
54.13A drug shall be deemed to be adulterated:
54.14(1) if it consists in whole or in part of any filthy, putrid or decomposed substance; or
54.15if it has been produced, prepared, packed, or held under unsanitary conditions whereby it
54.16may have been rendered injurious to health, or whereby it may have been contaminated
54.17with filth; or if the methods used in, or the facilities or controls used for, its manufacture,
54.18processing, packing, or holding do not conform to or are not operated or administered
54.19in conformity with current good manufacturing practice as required under the federal
54.20act to assure that such drug is safe and has the identity, strength, quality, and purity
54.21characteristics, which it purports or is represented to possess; or the facility in which it
54.22was produced was not registered by the United States Food and Drug Administration or
54.23licensed by the board; or, its container is composed, in whole or in part, of any poisonous
54.24or deleterious substance which may render the contents injurious to health; or it bears
54.25or contains, for purposes of coloring only, a color additive which is unsafe within the
54.26meaning of the federal act, or it is a color additive, the intended use of which in or on drugs
54.27is for the purposes of coloring only, and is unsafe within the meaning of the federal act;
54.28(2) if it purports to be or is represented as a drug the name of which is recognized in
54.29the United States Pharmacopoeia or the National Formulary, and its strength differs from,
54.30or its quality or purity falls below, the standard set forth therein. Such determination as
54.31to strength, quality, or purity shall be made in accordance with the tests or methods of
54.32assay set forth in such compendium, or in the absence of or inadequacy of such tests or
54.33methods of assay, those prescribed under authority of the federal act. No drug defined
54.34in the United States Pharmacopoeia or the National Formulary shall be deemed to be
55.1adulterated under this paragraph because it differs from the standard of strength, quality,
55.2or purity therefor set forth in such compendium, if its difference in strength, quality, or
55.3purity from such standard is plainly stated on its label;
55.4(3) if it is not subject to the provisions of paragraph (2) of this section and its
55.5strength differs from, or its purity or quality differs from that which it purports or is
55.6represented to possess;
55.7(4) if any substance has been mixed or packed therewith so as to reduce its quality or
55.8strength, or substituted wholly or in part therefor.
55.9 Sec. 14. Minnesota Statutes 2012, section 151.361, subdivision 2, is amended to read:
55.10 Subd. 2. After January 1, 1983. (a) No legend drug in solid oral dosage form
55.11may be manufactured, packaged or distributed for sale in this state after January 1, 1983
55.12unless it is clearly marked or imprinted with a symbol, number, company name, words,
55.13letters, national drug code or other mark uniquely identifiable to that drug product. An
55.14identifying mark or imprint made as required by federal law or by the federal Food and
55.15Drug Administration shall be deemed to be in compliance with this section.
55.16(b) The Board of Pharmacy may grant exemptions from the requirements of this
55.17section on its own initiative or upon application of a manufacturer, packager, or distributor
55.18indicating size or other characteristicswhich that render the product impractical for the
55.19imprinting required by this section.
55.20(c) The provisions of clauses (a) and (b) shall not apply to any of the following:
55.21(1) Drugs purchased by a pharmacy, pharmacist, or licensed wholesaler prior to
55.22January 1, 1983, and held in stock for resale.
55.23(2) Drugs which are manufactured by or upon the order of a practitioner licensed by
55.24law to prescribe or administer drugs and which are to be used solely by the patient for
55.25whom prescribed.
55.26 Sec. 15. Minnesota Statutes 2012, section 151.37, as amended by Laws 2013, chapter
55.2743, section 30, Laws 2013, chapter 55, section 2, and Laws 2013, chapter 108, article
55.2810, section 5, is amended to read:
55.29151.37 LEGEND DRUGS, WHO MAY PRESCRIBE, POSSESS.
55.30 Subdivision 1. Prohibition. Except as otherwise provided in this chapter, it shall be
55.31unlawful for any person to have in possession, or to sell, give away, barter, exchange, or
55.32distribute a legend drug.
55.33 Subd. 2. Prescribing and filing. (a) A licensed practitioner in the course of
55.34professional practice only, may prescribe, administer, and dispense a legend drug, and
56.1may cause the same to be administered by a nurse, a physician assistant, or medical
56.2student or resident under the practitioner's direction and supervision, and may cause a
56.3person who is an appropriately certified, registered, or licensed health care professional
56.4to prescribe, dispense, and administer the same within the expressed legal scope of the
56.5person's practice as defined in Minnesota Statutes. A licensed practitioner may prescribe a
56.6legend drug, without reference to a specific patient, by directing a licensed dietitian or
56.7licensed nutritionist, pursuant to section148.634 ; a nurse, pursuant to section
148.235 ,
56.8subdivisions 8 and 9; physician assistant; medical student or resident; or pharmacist
56.9according to section 151.01, subdivision 27, to adhere to a particular practice guideline or
56.10protocol when treating patients whose condition falls within such guideline or protocol,
56.11and when such guideline or protocol specifies the circumstances under which the legend
56.12drug is to be prescribed and administered. An individual who verbally, electronically, or
56.13otherwise transmits a written, oral, or electronic order, as an agent of a prescriber, shall
56.14not be deemed to have prescribed the legend drug. This paragraph applies to a physician
56.15assistant only if the physician assistant meets the requirements of section147A.18 .
56.16(b) The commissioner of health, if a licensed practitioner, or a person designated
56.17by the commissioner who is a licensed practitioner, may prescribe a legend drug to an
56.18individual or by protocol for mass dispensing purposes where the commissioner finds that
56.19the conditions triggering section144.4197 or
144.4198, subdivision 2 , paragraph (b), exist.
56.20The commissioner, if a licensed practitioner, or a designated licensed practitioner, may
56.21prescribe, dispense, or administer a legend drug or other substance listed in subdivision 10
56.22to control tuberculosis and other communicable diseases. The commissioner may modify
56.23state drug labeling requirements, and medical screening criteria and documentation, where
56.24time is critical and limited labeling and screening are most likely to ensure legend drugs
56.25reach the maximum number of persons in a timely fashion so as to reduce morbidity
56.26and mortality.
56.27 (c) A licensed practitioner that dispenses for profit a legend drug that is to be
56.28administered orally, is ordinarily dispensed by a pharmacist, and is not a vaccine, must
56.29file with the practitioner's licensing board a statement indicating that the practitioner
56.30dispenses legend drugs for profit, the general circumstances under which the practitioner
56.31dispenses for profit, and the types of legend drugs generally dispensed. It is unlawful to
56.32dispense legend drugs for profit after July 31, 1990, unless the statement has been filed
56.33with the appropriate licensing board. For purposes of this paragraph, "profit" means (1)
56.34any amount received by the practitioner in excess of the acquisition cost of a legend drug
56.35for legend drugs that are purchased in prepackaged form, or (2) any amount received
56.36by the practitioner in excess of the acquisition cost of a legend drug plus the cost of
57.1making the drug available if the legend drug requires compounding, packaging, or other
57.2treatment. The statement filed under this paragraph is public data under section13.03 .
57.3This paragraph does not apply to a licensed doctor of veterinary medicine or a registered
57.4pharmacist. Any person other than a licensed practitioner with the authority to prescribe,
57.5dispense, and administer a legend drug under paragraph (a) shall not dispense for profit.
57.6To dispense for profit does not include dispensing by a community health clinic when the
57.7profit from dispensing is used to meet operating expenses.
57.8 (d) A prescriptionor drug order for the following drugs is not valid, unless it can
57.9be established that the prescriptionor drug order was based on a documented patient
57.10evaluation, including an examination, adequate to establish a diagnosis and identify
57.11underlying conditions and contraindications to treatment:
57.12 (1) controlled substance drugs listed in section152.02, subdivisions 3 to 5;
57.13 (2) drugs defined by the Board of Pharmacy as controlled substances under section
57.14152.02, subdivisions 7
, 8, and 12;
57.15 (3) muscle relaxants;
57.16 (4) centrally acting analgesics with opioid activity;
57.17 (5) drugs containing butalbital; or
57.18 (6) phoshodiesterase type 5 inhibitors when used to treat erectile dysfunction.
57.19 (e) For the purposes of paragraph (d), the requirement for an examination shall be
57.20met if an in-person examination has been completed in any of the following circumstances:
57.21 (1) the prescribing practitioner examines the patient at the time the prescription
57.22or drug order is issued;
57.23 (2) the prescribing practitioner has performed a prior examination of the patient;
57.24 (3) another prescribing practitioner practicing within the same group or clinic as the
57.25prescribing practitioner has examined the patient;
57.26 (4) a consulting practitioner to whom the prescribing practitioner has referred the
57.27patient has examined the patient; or
57.28 (5) the referring practitioner has performed an examination in the case of a
57.29consultant practitioner issuing a prescription or drug order when providing services by
57.30means of telemedicine.
57.31 (f) Nothing in paragraph (d) or (e) prohibits a licensed practitioner from prescribing
57.32a drug through the use of a guideline or protocol pursuant to paragraph (a).
57.33 (g) Nothing in this chapter prohibits a licensed practitioner from issuing a
57.34prescription or dispensing a legend drug in accordance with the Expedited Partner Therapy
57.35in the Management of Sexually Transmitted Diseases guidance document issued by the
57.36United States Centers for Disease Control.
58.1 (h) Nothing in paragraph (d) or (e) limits prescription, administration, or dispensing
58.2of legend drugs through a public health clinic or other distribution mechanism approved
58.3by the commissioner of health or a board of health in order to prevent, mitigate, or treat
58.4a pandemic illness, infectious disease outbreak, or intentional or accidental release of a
58.5biological, chemical, or radiological agent.
58.6 (i) No pharmacist employed by, under contract to, or working for a pharmacy
58.7licensed under section151.19, subdivision 1 , may dispense a legend drug based on a
58.8prescription that the pharmacist knows, or would reasonably be expected to know, is not
58.9valid under paragraph (d).
58.10 (j) No pharmacist employed by, under contract to, or working for a pharmacy
58.11licensed under section151.19, subdivision 2 , may dispense a legend drug to a resident
58.12of this state based on a prescription that the pharmacist knows, or would reasonably be
58.13expected to know, is not valid under paragraph (d).
58.14(k) Nothing in this chapter prohibits the commissioner of health, if a licensed
58.15practitioner, or, if not a licensed practitioner, a designee of the commissioner who is
58.16a licensed practitioner, from prescribing legend drugs for field-delivered therapy in the
58.17treatment of a communicable disease according to the Centers For Disease Control and
58.18Prevention Partner Services Guidelines.
58.19 Subd. 2a. Delegation. A supervising physician may delegate to a physician assistant
58.20who is registered with the Board of Medical Practice and certified by the National
58.21Commission on Certification of Physician Assistants and who is under the supervising
58.22physician's supervision, the authority to prescribe, dispense, and administer legend drugs
58.23and medical devices, subject to the requirements in chapter 147A and other requirements
58.24established by the Board of Medical Practice in rules.
58.25 Subd. 3. Veterinarians. A licensed doctor of veterinary medicine, in the course of
58.26professional practice only and not for use by a human being, may personally prescribe,
58.27administer, and dispense a legend drug, and may cause the same to be administered or
58.28dispensed by an assistant under the doctor's direction and supervision.
58.29 Subd. 4. Research. (a) Any qualified person may use legend drugs in the course
58.30of a bona fide research project, but cannot administer or dispense such drugs to human
58.31beings unless such drugs are prescribed, dispensed, and administered by a person lawfully
58.32authorized to do so.
58.33 (b) Drugs may be dispensed or distributed by a pharmacy licensed by the board for
58.34use by, or administration to, patients enrolled in a bona fide research study that is being
58.35conducted pursuant to either an investigational new drug application approved by the
59.1United States Food and Drug Administration or that has been approved by an institutional
59.2review board. For the purposes of this subdivision only:
59.3 (1) a prescription drug order is not required for a pharmacy to dispense a research
59.4drug, unless the study protocol requires the pharmacy to receive such an order;
59.5 (2) notwithstanding the prescription labeling requirements found in this chapter or
59.6the rules promulgated by the board, a research drug may be labeled as required by the
59.7study protocol;and
59.8 (3) dispensing and distribution of research drugs by pharmacies shall not be
59.9consideredcompounding, manufacturing, or wholesaling under this chapter.; and
59.10(4) a pharmacy may compound drugs for research studies as provided in
59.11this subdivision but must follow applicable standards established by United States
59.12Pharmacopeia, chapter 795 or 797, for nonsterile and sterile compounding, respectively.
59.13 (c) An entity that is under contract to a federal agency for the purpose of distributing
59.14drugs for bona fide research studies is exempt from the drug wholesaler licensing
59.15requirements of this chapter. Any other entity is exempt from the drug wholesaler
59.16licensing requirements of this chapter if the board finds that the entity is licensed or
59.17registered according to the laws of the state in which it is physically located and it is
59.18distributing drugs for use by, or administration to, patients enrolled in a bona fide research
59.19study that is being conducted pursuant to either an investigational new drug application
59.20approved by the United States Food and Drug Administration or that has been approved
59.21by an institutional review board.
59.22 Subd. 5. Exclusion for course of practice. Nothing in this chapter shall prohibit
59.23the sale to, or the possession of, a legend drug by licensed drug wholesalers, licensed
59.24manufacturers, registered pharmacies, local detoxification centers, licensed hospitals,
59.25bona fide hospitals wherein animals are treated, or licensed pharmacists and licensed
59.26practitioners while acting within the course of their practice only.
59.27 Subd. 6. Exclusion for course of employment. (a) Nothing in this chapter shall
59.28prohibit the possession of a legend drug by an employee, agent, or sales representative of
59.29a registered drug manufacturer, or an employee or agent of a registered drug wholesaler,
59.30or registered pharmacy, while acting in the course of employment.
59.31(b) Nothing in this chapter shall prohibit the following entities from possessing a
59.32legend drug for the purpose of disposing of the legend drug as pharmaceutical waste:
59.33(1) a law enforcement officer;
59.34(2) a hazardous waste transporter licensed by the Department of Transportation;
59.35(3) a facility permitted by the Pollution Control Agency to treat, store, or dispose of
59.36hazardous waste, including household hazardous waste;
60.1(4) a facility licensed by the Pollution Control Agency or a metropolitan county as a
60.2very small quantity generator collection program or a minimal generator;
60.3(5) a county that collects, stores, transports, or disposes of a legend drug pursuant to
60.4a program in compliance with applicable federal law or a person authorized by the county
60.5to conduct one or more of these activities; or
60.6(6) a sanitary district organized under chapter 115, or a special law.
60.7 Subd. 7. Exclusion for prescriptions. (a) Nothing in this chapter shall prohibit the
60.8possession of a legend drug by a person for that person's use when it has been dispensed to
60.9the person in accordance with a valid prescription issued by a practitioner.
60.10(b) Nothing in this chapter shall prohibit a person, for whom a legend drug has
60.11been dispensed in accordance with a written or oral prescription by a practitioner, from
60.12designating a family member, caregiver, or other individual to handle the legend drug for
60.13the purpose of assisting the person in obtaining or administering the drug or sending
60.14the drug for destruction.
60.15(c) Nothing in this chapter shall prohibit a person for whom a prescription drug has
60.16been dispensed in accordance with a valid prescription issued by a practitioner from
60.17transferring the legend drug to a county that collects, stores, transports, or disposes of a
60.18legend drug pursuant to a program in compliance with applicable federal law or to a
60.19person authorized by the county to conduct one or more of these activities.
60.20 Subd. 8. Misrepresentation. It is unlawful for a person to procure, attempt to
60.21procure, possess, or control a legend drug by any of the following means:
60.22(1) deceit, misrepresentation, or subterfuge;
60.23(2) using a false name; or
60.24(3) falsely assuming the title of, or falsely representing a person to be a manufacturer,
60.25wholesaler, pharmacist, practitioner, or other authorized person for the purpose of
60.26obtaining a legend drug.
60.27 Subd. 9. Exclusion for course of laboratory employment. Nothing in this chapter
60.28shall prohibit the possession of a legend drug by an employee or agent of a registered
60.29analytical laboratory while acting in the course of laboratory employment.
60.30 Subd. 10. Purchase of drugs and other agents by commissioner of health. The
60.31commissioner of health, in preparation for and in carrying out the duties of sections
60.32144.05
,
144.4197 , and
144.4198, may purchase, store, and distribute antituberculosis
60.33drugs, biologics, vaccines, antitoxins, serums, immunizing agents, antibiotics, antivirals,
60.34antidotes, other pharmaceutical agents, and medical supplies to treat and prevent
60.35communicable disease.
61.1 Subd. 10a. Emergency use authorizations. Nothing in this chapter shall prohibit
61.2the purchase, possession, or use of a legend drug by an entity acting according to an
61.3emergency use authorization issued by the United States Food and Drug Administration
61.4pursuant to United States Code, title 21, section 360.bbb-3. The entity must be specifically
61.5tasked in a public health response plan to perform critical functions necessary to support
61.6the response to a public health incident or event.
61.7 Subd. 11.Complaint reporting Exclusion for health care educational programs.
61.8The Board of Pharmacy shall report on a quarterly basis to the Board of Optometry any
61.9complaints received regarding the prescription or administration of legend drugs under
61.10section
148.576. Nothing in this section shall prohibit an accredited public or private
61.11postsecondary school from possessing a legend drug that is not a controlled substance
61.12listed in section 152.02, provided that:
61.13(a) the school is approved by the United States secretary of education in accordance
61.14with requirements of the Higher Education Act of 1965, as amended;
61.15(b) the school provides a course of instruction that prepares individuals for
61.16employment in a health care occupation or profession;
61.17(c) the school may only possess those drugs necessary for the instruction of such
61.18individuals; and
61.19(d) the drugs may only be used in the course of providing such instruction and are
61.20labeled by the purchaser to indicate that they are not to be administered to patients.
61.21Those areas of the school in which legend drugs are stored are subject to section
61.22151.06, subdivision 1, paragraph (a), clause (4).
61.23 Sec. 16. Minnesota Statutes 2012, section 151.44, is amended to read:
61.24151.44 DEFINITIONS.
61.25As used in sections151.43 to
151.51 , the following terms have the meanings given
61.26in paragraphs (a) to (h):
61.27(a) "Wholesale drug distribution" means distribution of prescription or
61.28nonprescription drugs to persons other than a consumer or patient or reverse distribution
61.29of such drugs, but does not include:
61.30(1) a sale between a division, subsidiary, parent, affiliated, or related company under
61.31the common ownership and control of a corporate entity;
61.32(2) the purchase or other acquisition, by a hospital or other health care entity that is a
61.33member of a group purchasing organization, of a drug for its own use from the organization
61.34or from other hospitals or health care entities that are members of such organizations;
62.1(3) the sale, purchase, or trade of a drug or an offer to sell, purchase, or trade a
62.2drug by a charitable organization described in section 501(c)(3) of the Internal Revenue
62.3Code of 1986, as amended through December 31, 1988, to a nonprofit affiliate of the
62.4organization to the extent otherwise permitted by law;
62.5(4) the sale, purchase, or trade of a drug or offer to sell, purchase, or trade a drug
62.6among hospitals or other health care entities that are under common control;
62.7(5) the sale, purchase, or trade of a drug or offer to sell, purchase, or trade a drug
62.8for emergency medical reasons;
62.9(6) the sale, purchase, or trade of a drug, an offer to sell, purchase, or trade a drug, or
62.10the dispensing of a drug pursuant to a prescription;
62.11(7) the transfer of prescription or nonprescription drugs by a retail pharmacy to
62.12another retail pharmacy to alleviate a temporary shortage;
62.13(8) the distribution of prescription or nonprescription drug samples by manufacturers
62.14representatives; or
62.15(9) the sale, purchase, or trade of blood and blood components.
62.16(b) "Wholesale drug distributor" means anyone engaged in wholesale drug
62.17distribution including, but not limited to, manufacturers;repackers repackagers; own-label
62.18distributors; jobbers; brokers; warehouses, including manufacturers' and distributors'
62.19warehouses, chain drug warehouses, and wholesale drug warehouses; independent
62.20wholesale drug traders; and pharmacies that conduct wholesale drug distribution. A
62.21wholesale drug distributor does not include a common carrier or individual hired primarily
62.22to transport prescription or nonprescription drugs.
62.23(c) "Manufacturer"means anyone who is engaged in the manufacturing, preparing,
62.24propagating, compounding, processing, packaging, repackaging, or labeling of a
62.25prescription drug has the meaning provided in section 151.01, subdivision 14b.
62.26(d) "Prescription drug" means a drug required by federal or state law or regulation
62.27to be dispensed only by a prescription, including finished dosage forms and active
62.28ingredients subject to United States Code, title 21, sections 811 and 812.
62.29(e) "Blood" means whole blood collected from a single donor and processed either
62.30for transfusion or further manufacturing.
62.31(f) "Blood components" means that part of blood separated by physical or
62.32mechanical means.
62.33(g) "Reverse distribution" means the receipt of prescription or nonprescription drugs
62.34received from or shipped to Minnesota locations for the purpose of returning the drugs
62.35to their producers or distributors.
62.36(h) "Reverse distributor" means a person engaged in the reverse distribution of drugs.
63.1 Sec. 17. Minnesota Statutes 2012, section 151.58, subdivision 2, is amended to read:
63.2 Subd. 2. Definitions. For purposes of this section only, the terms defined in this
63.3subdivision have the meanings given.
63.4(a) "Automated drug distribution system" or "system" means a mechanical system
63.5approved by the board that performs operations or activities, other than compounding or
63.6administration, related to the storage, packaging, or dispensing of drugs, and collects,
63.7controls, and maintains all required transaction information and records.
63.8(b) "Health care facility" means a nursing home licensed under section144A.02 ;
63.9a housing with services establishment registered under section144D.01, subdivision 4 ,
63.10in which a home provider licensed under chapter 144A is providing centralized storage
63.11of medications; or acommunity behavioral health hospital or Minnesota sex offender
63.12program facility operated by the Department of Human Services.
63.13(c) "Managing pharmacy" means a pharmacy licensed by the board that controls and
63.14is responsible for the operation of an automated drug distribution system.
63.15 Sec. 18. Minnesota Statutes 2012, section 151.58, subdivision 3, is amended to read:
63.16 Subd. 3. Authorization. A pharmacy may use an automated drug distribution
63.17system to fill prescription drug orders for patients of a health care facility provided that the
63.18policies and procedures required by this section have been approved by the board. The
63.19automated drug distribution system may be located in a health care facility that is not at
63.20the same location as the managing pharmacy. When located within a health care facility,
63.21the system is considered to be an extension of the managing pharmacy.
63.22 Sec. 19. Minnesota Statutes 2012, section 151.58, subdivision 5, is amended to read:
63.23 Subd. 5. Operation of automated drug distribution systems. (a) The managing
63.24pharmacy and the pharmacist in charge are responsible for the operation of an automated
63.25drug distribution system.
63.26(b) Access to an automated drug distribution system must be limited to pharmacy
63.27and nonpharmacy personnel authorized to procure drugs from the system, except that field
63.28service technicians may access a system located in a health care facility for the purposes of
63.29servicing and maintaining it while being monitored either by the managing pharmacy, or a
63.30licensed nurse within the health care facility. In the case of an automated drug distribution
63.31system that is not physically located within a licensed pharmacy, access for the purpose
63.32of procuring drugs shall be limited to licensed nurses. Each person authorized to access
63.33the system must be assigned an individual specific access code. Alternatively, access to
63.34the system may be controlled through the use of biometric identification procedures. A
64.1policy specifying time access parameters, including time-outs, logoffs, and lockouts,
64.2must be in place.
64.3(c) For the purposes of this section only, the requirements of section151.215 are met
64.4if the following clauses are met:
64.5(1) a pharmacist employed by and working at the managing pharmacy, or at a
64.6pharmacy that is acting as a central services pharmacy for the managing pharmacy,
64.7pursuant to Minnesota Rules, part 6800.4075, must review, interpret, and approve all
64.8prescription drug orders before any drug is distributed from the system to be administered
64.9to a patient. A pharmacy technician may perform data entry of prescription drug orders
64.10provided that a pharmacist certifies the accuracy of the data entry before the drug can
64.11be released from the automated drug distribution system. A pharmacist employed by
64.12and working at the managing pharmacy must certify the accuracy of the filling of any
64.13cassettes, canisters, or other containers that contain drugs that will be loaded into the
64.14automated drug distribution system; and
64.15(2) when the automated drug dispensing system is located and used within the
64.16managing pharmacy, a pharmacist must personally supervise and take responsibility for all
64.17packaging and labeling associated with the use of an automated drug distribution system.
64.18(d) Access to drugs when a pharmacist has not reviewed and approved the
64.19prescription drug order is permitted only when a formal and written decision to allow such
64.20access is issued by the pharmacy and the therapeutics committee or its equivalent. The
64.21committee must specify the patient care circumstances in which such access is allowed,
64.22the drugs that can be accessed, and the staff that are allowed to access the drugs.
64.23(e) In the case of an automated drug distribution system that does not utilize bar
64.24coding in the loading process, the loading of a system located in a health care facility may
64.25be performed by a pharmacy technician, so long as the activity is continuously supervised,
64.26through a two-way audiovisual system by a pharmacist on duty within the managing
64.27pharmacy. In the case of an automated drug distribution system that utilizes bar coding
64.28in the loading process, the loading of a system located in a health care facility may be
64.29performed by a pharmacy technician or a licensed nurse, provided that the managing
64.30pharmacy retains an electronic record of loading activities.
64.31(f) The automated drug distribution system must be under the supervision of a
64.32pharmacist. The pharmacist is not required to be physically present at the site of the
64.33automated drug distribution system if the system is continuously monitored electronically
64.34by the managing pharmacy. A pharmacist on duty within a pharmacy licensed by the
64.35board must be continuously available to address any problems detected by the monitoring
64.36or to answer questions from the staff of the health care facility. The licensed pharmacy
65.1may be the managing pharmacy or a pharmacy which is acting as a central services
65.2pharmacy, pursuant to Minnesota Rules, part 6800.4075, for the managing pharmacy.
65.3 Sec. 20. Minnesota Statutes 2013 Supplement, section 152.02, subdivision 2, is
65.4amended to read:
65.5 Subd. 2. Schedule I. (a) Schedule I consists of the substances listed in this
65.6subdivision.
65.7(b) Opiates. Unless specifically excepted or unless listed in another schedule, any of
65.8the following substances, including their analogs, isomers, esters, ethers, salts, and salts
65.9of isomers, esters, and ethers, whenever the existence of the analogs, isomers, esters,
65.10ethers, and salts is possible:
65.11(1) acetylmethadol;
65.12(2) allylprodine;
65.13(3) alphacetylmethadol (except levo-alphacetylmethadol, also known as
65.14levomethadyl acetate);
65.15(4) alphameprodine;
65.16(5) alphamethadol;
65.17(6) alpha-methylfentanyl benzethidine;
65.18(7) betacetylmethadol;
65.19(8) betameprodine;
65.20(9) betamethadol;
65.21(10) betaprodine;
65.22(11) clonitazene;
65.23(12) dextromoramide;
65.24(13) diampromide;
65.25(14) diethyliambutene;
65.26(15) difenoxin;
65.27(16) dimenoxadol;
65.28(17) dimepheptanol;
65.29(18) dimethyliambutene;
65.30(19) dioxaphetyl butyrate;
65.31(20) dipipanone;
65.32(21) ethylmethylthiambutene;
65.33(22) etonitazene;
65.34(23) etoxeridine;
65.35(24) furethidine;
66.1(25) hydroxypethidine;
66.2(26) ketobemidone;
66.3(27) levomoramide;
66.4(28) levophenacylmorphan;
66.5(29) 3-methylfentanyl;
66.6(30) acetyl-alpha-methylfentanyl;
66.7(31) alpha-methylthiofentanyl;
66.8(32) benzylfentanyl beta-hydroxyfentanyl;
66.9(33) beta-hydroxy-3-methylfentanyl;
66.10(34) 3-methylthiofentanyl;
66.11(35) thenylfentanyl;
66.12(36) thiofentanyl;
66.13(37) para-fluorofentanyl;
66.14(38) morpheridine;
66.15(39) 1-methyl-4-phenyl-4-propionoxypiperidine;
66.16(40) noracymethadol;
66.17(41) norlevorphanol;
66.18(42) normethadone;
66.19(43) norpipanone;
66.20(44) 1-(2-phenylethyl)-4-phenyl-4-acetoxypiperidine (PEPAP);
66.21(45) phenadoxone;
66.22(46) phenampromide;
66.23(47) phenomorphan;
66.24(48) phenoperidine;
66.25(49) piritramide;
66.26(50) proheptazine;
66.27(51) properidine;
66.28(52) propiram;
66.29(53) racemoramide;
66.30(54) tilidine;
66.31(55) trimeperidine.;
66.32(56) N-(1-Phenethylpiperidin-4-yl)-N-phenylacetamide (acetyl fentanyl).
66.33(c) Opium derivatives. Any of the following substances, their analogs, salts, isomers,
66.34and salts of isomers, unless specifically excepted or unless listed in another schedule,
66.35whenever the existence of the analogs, salts, isomers, and salts of isomers is possible:
66.36(1) acetorphine;
67.1(2) acetyldihydrocodeine;
67.2(3) benzylmorphine;
67.3(4) codeine methylbromide;
67.4(5) codeine-n-oxide;
67.5(6) cyprenorphine;
67.6(7) desomorphine;
67.7(8) dihydromorphine;
67.8(9) drotebanol;
67.9(10) etorphine;
67.10(11) heroin;
67.11(12) hydromorphinol;
67.12(13) methyldesorphine;
67.13(14) methyldihydromorphine;
67.14(15) morphine methylbromide;
67.15(16) morphine methylsulfonate;
67.16(17) morphine-n-oxide;
67.17(18) myrophine;
67.18(19) nicocodeine;
67.19(20) nicomorphine;
67.20(21) normorphine;
67.21(22) pholcodine;
67.22(23) thebacon.
67.23(d) Hallucinogens. Any material, compound, mixture or preparation which contains
67.24any quantity of the following substances, their analogs, salts, isomers (whether optical,
67.25positional, or geometric), and salts of isomers, unless specifically excepted or unless listed
67.26in another schedule, whenever the existence of the analogs, salts, isomers, and salts of
67.27isomers is possible:
67.28(1) methylenedioxy amphetamine;
67.29(2) methylenedioxymethamphetamine;
67.30(3) methylenedioxy-N-ethylamphetamine (MDEA);
67.31(4) n-hydroxy-methylenedioxyamphetamine;
67.32(5) 4-bromo-2,5-dimethoxyamphetamine (DOB);
67.33(6) 2,5-dimethoxyamphetamine (2,5-DMA);
67.34(7) 4-methoxyamphetamine;
67.35(8) 5-methoxy-3, 4-methylenedioxy amphetamine;
67.36(9) alpha-ethyltryptamine;
68.1(10) bufotenine;
68.2(11) diethyltryptamine;
68.3(12) dimethyltryptamine;
68.4(13) 3,4,5-trimethoxy amphetamine;
68.5(14) 4-methyl-2, 5-dimethoxyamphetamine (DOM);
68.6(15) ibogaine;
68.7(16) lysergic acid diethylamide (LSD);
68.8(17) mescaline;
68.9(18) parahexyl;
68.10(19) N-ethyl-3-piperidyl benzilate;
68.11(20) N-methyl-3-piperidyl benzilate;
68.12(21) psilocybin;
68.13(22) psilocyn;
68.14(23) tenocyclidine (TPCP or TCP);
68.15(24) N-ethyl-1-phenyl-cyclohexylamine (PCE);
68.16(25) 1-(1-phenylcyclohexyl) pyrrolidine (PCPy);
68.17(26) 1-[1-(2-thienyl)cyclohexyl]-pyrrolidine (TCPy);
68.18(27) 4-chloro-2,5-dimethoxyamphetamine (DOC);
68.19(28) 4-ethyl-2,5-dimethoxyamphetamine (DOET);
68.20(29) 4-iodo-2,5-dimethoxyamphetamine (DOI);
68.21(30) 4-bromo-2,5-dimethoxyphenethylamine (2C-B);
68.22(31) 4-chloro-2,5-dimethoxyphenethylamine (2C-C);
68.23(32) 4-methyl-2,5-dimethoxyphenethylamine (2-CD);
68.24(33) 4-ethyl-2,5-dimethoxyphenethylamine (2C-E);
68.25(34) 4-iodo-2,5-dimethoxyphenethylamine (2C-I);
68.26(35) 4-propyl-2,5-dimethoxyphenethylamine (2C-P);
68.27(36) 4-isopropylthio-2,5-dimethoxyphenethylamine (2C-T-4);
68.28(37) 4-propylthio-2,5-dimethoxyphenethylamine (2C-T-7);
68.29(38) 2-(8-bromo-2,3,6,7-tetrahydrofuro [2,3-f][1]benzofuran-4-yl)ethanamine
68.30(2-CB-FLY);
68.31(39) bromo-benzodifuranyl-isopropylamine (Bromo-DragonFLY);
68.32(40) alpha-methyltryptamine (AMT);
68.33(41) N,N-diisopropyltryptamine (DiPT);
68.34(42) 4-acetoxy-N,N-dimethyltryptamine (4-AcO-DMT);
68.35(43) 4-acetoxy-N,N-diethyltryptamine (4-AcO-DET);
68.36(44) 4-hydroxy-N-methyl-N-propyltryptamine (4-HO-MPT);
69.1(45) 4-hydroxy-N,N-dipropyltryptamine (4-HO-DPT);
69.2(46) 4-hydroxy-N,N-diallyltryptamine (4-HO-DALT);
69.3(47) 4-hydroxy-N,N-diisopropyltryptamine (4-HO-DiPT);
69.4(48) 5-methoxy-N,N-diisopropyltryptamine (5-MeO-DiPT);
69.5(49) 5-methoxy-α-methyltryptamine (5-MeO-AMT);
69.6(50) 5-methoxy-N,N-dimethyltryptamine (5-MeO-DMT);
69.7(51) 5-methylthio-N,N-dimethyltryptamine (5-MeS-DMT);
69.8(52) 5-methoxy-N-methyl-N-propyltryptamine (5-MeO-MiPT);
69.9(53) 5-methoxy-α-ethyltryptamine (5-MeO-AET);
69.10(54) 5-methoxy-N,N-dipropyltryptamine (5-MeO-DPT);
69.11(55) 5-methoxy-N,N-diethyltryptamine (5-MeO-DET);
69.12(56) 5-methoxy-N,N-diallytryptamine (5-MeO-DALT);
69.13(57) methoxetamine (MXE);
69.14(58) 5-iodo-2-aminoindane (5-IAI);
69.15(59) 5,6-methylenedioxy-2-aminoindane (MDAI);
69.16(60) 2-(4-iodo-2,5-dimethoxyphenyl)-N-[(2-methoxyphenyl)methyl]ethanamine
69.17(25I-NBOMe).
69.18(e) Peyote. All parts of the plant presently classified botanically as Lophophora
69.19williamsii Lemaire, whether growing or not, the seeds thereof, any extract from any part
69.20of the plant, and every compound, manufacture, salts, derivative, mixture, or preparation
69.21of the plant, its seeds or extracts. The listing of peyote as a controlled substance in
69.22Schedule I does not apply to the nondrug use of peyote in bona fide religious ceremonies
69.23of the American Indian Church, and members of the American Indian Church are exempt
69.24from registration. Any person who manufactures peyote for or distributes peyote to the
69.25American Indian Church, however, is required to obtain federal registration annually and
69.26to comply with all other requirements of law.
69.27(f) Central nervous system depressants. Unless specifically excepted or unless listed
69.28in another schedule, any material compound, mixture, or preparation which contains any
69.29quantity of the following substances, their analogs, salts, isomers, and salts of isomers
69.30whenever the existence of the analogs, salts, isomers, and salts of isomers is possible:
69.31(1) mecloqualone;
69.32(2) methaqualone;
69.33(3) gamma-hydroxybutyric acid (GHB), including its esters and ethers;
69.34(4) flunitrazepam.
69.35(g) Stimulants. Unless specifically excepted or unless listed in another schedule, any
69.36material compound, mixture, or preparation which contains any quantity of the following
70.1substances, their analogs, salts, isomers, and salts of isomers whenever the existence of
70.2the analogs, salts, isomers, and salts of isomers is possible:
70.3 (1) aminorex;
70.4(2) cathinone;
70.5(3) fenethylline;
70.6 (4) methcathinone;
70.7(5) methylaminorex;
70.8(6) N,N-dimethylamphetamine;
70.9(7) N-benzylpiperazine (BZP);
70.10(8) methylmethcathinone (mephedrone);
70.11(9) 3,4-methylenedioxy-N-methylcathinone (methylone);
70.12(10) methoxymethcathinone (methedrone);
70.13(11) methylenedioxypyrovalerone (MDPV);
70.14(12) fluoromethcathinone;
70.15(13) methylethcathinone (MEC);
70.16(14) 1-benzofuran-6-ylpropan-2-amine (6-APB);
70.17(15) dimethylmethcathinone (DMMC);
70.18(16) fluoroamphetamine;
70.19(17) fluoromethamphetamine;
70.20(18) α-methylaminobutyrophenone (MABP or buphedrone);
70.21(19) β-keto-N-methylbenzodioxolylpropylamine (bk-MBDB or butylone);
70.22(20) 2-(methylamino)-1-(4-methylphenyl)butan-1-one (4-MEMABP or BZ-6378);
70.23(21) naphthylpyrovalerone (naphyrone);and
70.24(22) (RS)-1-phenyl-2-(1-pyrrolidinyl)-1-pentanone (alpha-PVP or
70.25alpha-pyrrolidinovalerophenone;
70.26(23) (RS)-1-(4-methylphenyl)-2-(1-pyrrolidinyl)-1-hexanone (4-Me-PHP oe
70.27MPHP); and
70.28(22) (24) any other substance, except bupropion or compounds listed under a
70.29different schedule, that is structurally derived from 2-aminopropan-1-one by substitution
70.30at the 1-position with either phenyl, naphthyl, or thiophene ring systems, whether or not
70.31the compound is further modified in any of the following ways:
70.32(i) by substitution in the ring system to any extent with alkyl, alkylenedioxy, alkoxy,
70.33haloalkyl, hydroxyl, or halide substituents, whether or not further substituted in the ring
70.34system by one or more other univalent substituents;
70.35(ii) by substitution at the 3-position with an acyclic alkyl substituent;
71.1(iii) by substitution at the 2-amino nitrogen atom with alkyl, dialkyl, benzyl, or
71.2methoxybenzyl groups; or
71.3(iv) by inclusion of the 2-amino nitrogen atom in a cyclic structure.
71.4(h) Marijuana, tetrahydrocannabinols, and synthetic cannabinoids. Unless
71.5specifically excepted or unless listed in another schedule, any natural or synthetic material,
71.6compound, mixture, or preparation that contains any quantity of the following substances,
71.7their analogs, isomers, esters, ethers, salts, and salts of isomers, esters, and ethers,
71.8whenever the existence of the isomers, esters, ethers, or salts is possible:
71.9(1) marijuana;
71.10(2) tetrahydrocannabinols naturally contained in a plant of the genus Cannabis,
71.11synthetic equivalents of the substances contained in the cannabis plant or in the
71.12resinous extractives of the plant, or synthetic substances with similar chemical structure
71.13and pharmacological activity to those substances contained in the plant or resinous
71.14extract, including, but not limited to, 1 cis or trans tetrahydrocannabinol, 6 cis or trans
71.15tetrahydrocannabinol, and 3,4 cis or trans tetrahydrocannabinol;
71.16(3) synthetic cannabinoids, including the following substances:
71.17(i) Naphthoylindoles, which are any compounds containing a 3-(1-napthoyl)indole
71.18structure with substitution at the nitrogen atom of the indole ring by an alkyl, haloalkyl,
71.19alkenyl, cycloalkylmethyl, cycloalkylethyl, 1-(N-methyl-2-piperidinyl)methyl or
71.202-(4-morpholinyl)ethyl group, whether or not further substituted in the indole ring to any
71.21extent and whether or not substituted in the naphthyl ring to any extent. Examples of
71.22naphthoylindoles include, but are not limited to:
71.23(A) 1-Pentyl-3-(1-naphthoyl)indole (JWH-018 and AM-678);
71.24(B) 1-Butul-3-(1-naphthoyl)indole (JWH-073);
71.25(C) 1-Pentyl-3-(4-methoxy-1-naphthoyl)indole (JWH-081);
71.26(D) 1-[2-(4-morpholinyl)ethyl]-3-(1-naphthoyl)indole (JWH-200);
71.27(E) 1-Propyl-2-methyl-3-(1-naphthoyl)indole (JWH-015);
71.28(F) 1-Hexyl-3-(1-naphthoyl)indole (JWH-019);
71.29(G) 1-Pentyl-3-(4-methyl-1-naphthoyl)indole (JWH-122);
71.30(H) 1-Pentyl-3-(4-ethyl-1-naphthoyl)indole (JWH-210);
71.31(I) 1-Pentyl-3-(4-chloro-1-naphthoyl)indole (JWH-398);
71.32(J) 1-(5-fluoropentyl)-3-(1-naphthoyl)indole (AM-2201).
71.33(ii) Napthylmethylindoles, which are any compounds containing a
71.341H-indol-3-yl-(1-naphthyl)methane structure with substitution at the nitrogen atom
71.35of the indole ring by an alkyl, haloalkyl, alkenyl, cycloalkylmethyl, cycloalkylethyl,
71.361-(N-methyl-2-piperidinyl)methyl or 2-(4-morpholinyl)ethyl group, whether or not further
72.1substituted in the indole ring to any extent and whether or not substituted in the naphthyl
72.2ring to any extent. Examples of naphthylmethylindoles include, but are not limited to:
72.3(A) 1-Pentyl-1H-indol-3-yl-(1-naphthyl)methane (JWH-175);
72.4(B) 1-Pentyl-1H-indol-3-yl-(4-methyl-1-naphthyl)methan (JWH-184).
72.5(iii) Naphthoylpyrroles, which are any compounds containing a
72.63-(1-naphthoyl)pyrrole structure with substitution at the nitrogen atom of the
72.7pyrrole ring by an alkyl, haloalkyl, alkenyl, cycloalkylmethyl, cycloalkylethyl,
72.81-(N-methyl-2-piperidinyl)methyl or 2-(4-morpholinyl)ethyl group whether or not
72.9further substituted in the pyrrole ring to any extent, whether or not substituted in the
72.10naphthyl ring to any extent. Examples of naphthoylpyrroles include, but are not limited to,
72.11(5-(2-fluorophenyl)-1-pentylpyrrol-3-yl)-naphthalen-1-ylmethanone (JWH-307).
72.12(iv) Naphthylmethylindenes, which are any compounds containing a
72.13naphthylideneindene structure with substitution at the 3-position of the indene
72.14ring by an allkyl, haloalkyl, alkenyl, cycloalkylmethyl, cycloalkylethyl,
72.151-(N-methyl-2-piperidinyl)methyl or 2-(4-morpholinyl)ethyl group whether or not further
72.16substituted in the indene ring to any extent, whether or not substituted in the naphthyl
72.17ring to any extent. Examples of naphthylemethylindenes include, but are not limited to,
72.18E-1-[1-(1-naphthalenylmethylene)-1H-inden-3-yl]pentane (JWH-176).
72.19(v) Phenylacetylindoles, which are any compounds containing a 3-phenylacetylindole
72.20structure with substitution at the nitrogen atom of the indole ring by an alkyl, haloalkyl,
72.21alkenyl, cycloalkylmethyl, cycloalkylethyl, 1-(N-methyl-2-piperidinyl)methyl or
72.222-(4-morpholinyl)ethyl group whether or not further substituted in the indole ring to
72.23any extent, whether or not substituted in the phenyl ring to any extent. Examples of
72.24phenylacetylindoles include, but are not limited to:
72.25(A) 1-(2-cyclohexylethyl)-3-(2-methoxyphenylacetyl)indole (RCS-8);
72.26(B) 1-pentyl-3-(2-methoxyphenylacetyl)indole (JWH-250);
72.27(C) 1-pentyl-3-(2-methylphenylacetyl)indole (JWH-251);
72.28(D) 1-pentyl-3-(2-chlorophenylacetyl)indole (JWH-203).
72.29(vi) Cyclohexylphenols, which are compounds containing a
72.302-(3-hydroxycyclohexyl)phenol structure with substitution at the 5-position
72.31of the phenolic ring by an alkyl, haloalkyl, alkenyl, cycloalkylmethyl, cycloalkylethyl,
72.321-(N-methyl-2-piperidinyl)methyl or 2-(4-morpholinyl)ethyl group whether or not
72.33substituted in the cyclohexyl ring to any extent. Examples of cyclohexylphenols include,
72.34but are not limited to:
72.35(A) 5-(1,1-dimethylheptyl)-2-[(1R,3S)-3-hydroxycyclohexyl]-phenol (CP 47,497);
73.1(B) 5-(1,1-dimethyloctyl)-2-[(1R,3S)-3-hydroxycyclohexyl]-phenol
73.2(Cannabicyclohexanol or CP 47,497 C8 homologue);
73.3(C) 5-(1,1-dimethylheptyl)-2-[(1R,2R)-5-hydroxy-2-(3-hydroxypropyl)cyclohexyl]
73.4-phenol (CP 55,940).
73.5(vii) Benzoylindoles, which are any compounds containing a 3-(benzoyl)indole
73.6structure with substitution at the nitrogen atom of the indole ring by an alkyl, haloalkyl,
73.7alkenyl, cycloalkylmethyl, cycloalkylethyl, 1-(N-methyl-2-piperidinyl)methyl or
73.82-(4-morpholinyl)ethyl group whether or not further substituted in the indole ring to
73.9any extent and whether or not substituted in the phenyl ring to any extent. Examples of
73.10benzoylindoles include, but are not limited to:
73.11(A) 1-Pentyl-3-(4-methoxybenzoyl)indole (RCS-4);
73.12(B) 1-(5-fluoropentyl)-3-(2-iodobenzoyl)indole (AM-694);
73.13(C) (4-methoxyphenyl-[2-methyl-1-(2-(4-morpholinyl)ethyl)indol-3-yl]methanone
73.14(WIN 48,098 or Pravadoline).
73.15(viii) Others specifically named:
73.16(A) (6aR,10aR)-9-(hydroxymethyl)-6,6-dimethyl-3-(2-methyloctan-2-yl)
73.17-6a,7,10,10a-tetrahydrobenzo[c]chromen-1-ol (HU-210);
73.18(B) (6aS,10aS)-9-(hydroxymethyl)-6,6-dimethyl-3-(2-methyloctan-2-yl)
73.19-6a,7,10,10a-tetrahydrobenzo[c]chromen-1-ol (Dexanabinol or HU-211);
73.20(C) 2,3-dihydro-5-methyl-3-(4-morpholinylmethyl)pyrrolo[1,2,3-de]
73.21-1,4-benzoxazin-6-yl-1-naphthalenylmethanone (WIN 55,212-2);
73.22(D) (1-pentylindol-3-yl)-(2,2,3,3-tetramethylcyclopropyl)methanone (UR-144);
73.23(E) (1-(5-fluoropentyl)-1H-indol-3-yl)(2,2,3,3-tetramethylcyclopropyl)methanone
73.24(XLR-11);
73.25(F) 1-pentyl-N-tricyclo[3.3.1.13,7]dec-1-yl-1H-indazole-3-carboxamide
73.26(AKB-48(APINACA));
73.27(G) N-((3s,5s,7s)-adamantan-1-yl)-1-(5-fluoropentyl)-1H-indazole-3-carboxamide
73.28(5-Fluoro-AKB-48);
73.29(H) 1-pentyl-8-quinolinyl ester-1H-indole-3-carboxylic acid (PB-22);
73.30(I) 8-quinolinyl ester-1-(5-fluoropentyl)-1H-indole-3-carboxylic acid (5-Fluoro
73.31PB-22).;
73.32(J) N-[(1S)-1-(aminocarbonyl)-2-methylpropyl]-1-pentyl-1H-indazole-
73.333-carboxamide (AB-PINACA);
73.34(K) N-[(1S)-1-(aminocarbonyl)-2-methylpropyl]-1-[(4-fluorophenyl)methyl]-
73.351H-indazole-3-carboxamide (AB-FUBINACA).
74.1(i) A controlled substance analog, to the extent that it is implicitly or explicitly
74.2intended for human consumption.
74.3 Sec. 21. Minnesota Statutes 2012, section 152.02, subdivision 8b, is amended to read:
74.4 Subd. 8b. Board of Pharmacy; expedited scheduling of additional substances.
74.5(a) The state Board of Pharmacy may, by rule, add a substance to Schedule I provided that
74.6it finds that the substance has a high potential for abuse, has no currently accepted medical
74.7use in the United States, has a lack of accepted safety for use under medical supervision,
74.8has known adverse health effects, and is currently available for use within the state. For
74.9the purposes of this subdivision only, the board may use the expedited rulemaking process
74.10under section14.389 . The scheduling of a substance under this subdivision expires the
74.11day after the adjournment of the legislative session immediately following the substance's
74.12scheduling unless the legislature by law ratifies the action.
74.13(b) If the board schedules a substance under this subdivision, the board shall notify
74.14in a timely manner the chairs and ranking minority members of the senate and house of
74.15representatives committees having jurisdiction over criminal justice and health policy
74.16and finance of the action and the reasons for it. The notice must include a copy of the
74.17administrative law judge's decision on the matter.
74.18(c) This subdivision expires August 1, 2014.
74.19 Sec. 22. Minnesota Statutes 2012, section 152.126, as amended by Laws 2013, chapter
74.20113, article 3, section 3, is amended to read:
74.21152.126CONTROLLED SUBSTANCES PRESCRIPTION ELECTRONIC
74.22REPORTING SYSTEM PRESCRIPTION MONITORING PROGRAM.
74.23 Subdivision 1. Definitions. (a) For purposes of this section, the terms defined in
74.24this subdivision have the meanings given.
74.25(a) (b) "Board" means the Minnesota State Board of Pharmacy established under
74.26chapter 151.
74.27(b) (c) "Controlled substances" means those substances listed in section
152.02 ,
74.28subdivisions 3 to5 6, and those substances defined by the board pursuant to section
74.29152.02, subdivisions 7
, 8, and 12. For the purposes of this section, controlled substances
74.30includes tramadol and butalbital.
74.31(c) (d) "Dispense" or "dispensing" has the meaning given in section
151.01,
74.32subdivision 30 . Dispensing does not include the direct administering of a controlled
74.33substance to a patient by a licensed health care professional.
75.1(d) (e) "Dispenser" means a person authorized by law to dispense a controlled
75.2substance, pursuant to a valid prescription. For the purposes of this section, a dispenser
75.3does not include a licensed hospital pharmacy that distributes controlled substances for
75.4inpatient hospital care, a licensed pharmacy, located on the same premises as a residential
75.5hospice, when the licensed pharmacy is dispensing controlled substances to be used
75.6by an individual who is a resident of the hospice or a veterinarian who is dispensing
75.7prescriptions under section156.18 .
75.8(e) (f) "Prescriber" means a licensed health care professional who is authorized to
75.9prescribe a controlled substance under section152.12, subdivision 1 or 2.
75.10(f) (g) "Prescription" has the meaning given in section
151.01, subdivision 16 .
75.11 Subd. 1a. Treatment of intractable pain. This section is not intended to limit or
75.12interfere with the legitimate prescribing of controlled substances for pain. No prescriber
75.13shall be subject to disciplinary action by a health-related licensing board for prescribing a
75.14controlled substance according to the provisions of section152.125 .
75.15 Subd. 2. Prescription electronic reporting system. (a) The board shall establish
75.16by January 1, 2010, an electronic system for reporting the information required under
75.17subdivision 4 for all controlled substances dispensed within the state.
75.18 (b) The board may contract with a vendor for the purpose of obtaining technical
75.19assistance in the design, implementation, operation, and maintenance of the electronic
75.20reporting system.
75.21 Subd. 3. PrescriptionElectronic Reporting Monitoring Program Advisory
75.22Committee Task Force. (a) The board shall convene may appoint an advisory committee.
75.23The committee must include task force consisting of at least one representative of:
75.24 (1) the Department of Health;
75.25 (2) the Department of Human Services;
75.26 (3) each health-related licensing board that licenses prescribers;
75.27 (4) a professional medical association, which may include an association of pain
75.28management and chemical dependency specialists;
75.29 (5) a professional pharmacy association;
75.30 (6) a professional nursing association;
75.31 (7) a professional dental association;
75.32 (8) a consumer privacy or security advocate;and
75.33 (9) a consumer or patient rights organization.; and
75.34 (10) an association of medical examiners and coroners.
76.1 (b) The advisorycommittee task force shall advise the board on the development and
76.2operation of theelectronic reporting system prescription monitoring program, including,
76.3but not limited to:
76.4 (1) technical standards for electronic prescription drug reporting;
76.5 (2) proper analysis and interpretation of prescription monitoring data;and
76.6 (3) an evaluation process for the program; and
76.7 (4) criteria for the unsolicited provision of prescription monitoring data by the
76.8board to prescribers and dispensers.
76.9(c) The task force is governed by section 15.059. Notwithstanding section 15.059,
76.10subdivision 5, the task force shall not expire.
76.11 Subd. 4. Reporting requirements; notice. (a) Each dispenser must submit the
76.12following data to the board or its designated vendor, subject to the notice required under
76.13paragraph (d):
76.14 (1) name of the prescriber;
76.15 (2) national provider identifier of the prescriber;
76.16 (3) name of the dispenser;
76.17 (4) national provider identifier of the dispenser;
76.18 (5) prescription number;
76.19 (6) name of the patient for whom the prescription was written;
76.20 (7) address of the patient for whom the prescription was written;
76.21 (8) date of birth of the patient for whom the prescription was written;
76.22 (9) date the prescription was written;
76.23 (10) date the prescription was filled;
76.24 (11) name and strength of the controlled substance;
76.25 (12) quantity of controlled substance prescribed;
76.26 (13) quantity of controlled substance dispensed; and
76.27 (14) number of days supply.
76.28 (b) The dispenser must submit the required information by a procedure and in a
76.29format established by the board. The board may allow dispensers to omit data listed in this
76.30subdivision or may require the submission of data not listed in this subdivision provided
76.31the omission or submission is necessary for the purpose of complying with the electronic
76.32reporting or data transmission standards of the American Society for Automation in
76.33Pharmacy, the National Council on Prescription Drug Programs, or other relevant national
76.34standard-setting body.
76.35 (c) A dispenser is not required to submit this data for those controlled substance
76.36prescriptions dispensed for:
77.1(1) individuals residing in licensed skilled nursing or intermediate care facilities;
77.2(2) individuals receiving assisted living services under chapter 144G or through a
77.3medical assistance home and community-based waiver;
77.4(3) individuals receiving medication intravenously;
77.5(4) individuals receiving hospice and other palliative or end-of-life care; and
77.6(5) individuals receiving services from a home care provider regulated under chapter
77.7144A.
77.8 (1) individuals residing in a health care facility as defined in section 151.58,
77.9subdivision 2, paragraph (b), when a drug is distributed through the use of an automated
77.10drug distribution system according to section 151.58; and
77.11 (2) individuals receiving a drug sample that was packaged by a manufacturer and
77.12provided to the dispenser for dispensing as a professional sample pursuant to Code of
77.13Federal Regulations, title 21, section 203, subpart D.
77.14 (d) A dispenser mustnot submit data under this subdivision unless provide to the
77.15patient for whom the prescription was written a conspicuous notice of the reporting
77.16requirements of this sectionis given to the patient for whom the prescription was written
77.17 and notice that the information may be used for program administration purposes.
77.18 Subd. 5. Use of data by board. (a) The board shall develop and maintain a database
77.19of the data reported under subdivision 4. The board shall maintain data that could identify
77.20an individual prescriber or dispenser in encrypted form. Except as otherwise allowed
77.21under subdivision 6, the database may be used by permissible users identified under
77.22subdivision 6 for the identification of:
77.23 (1) individuals receiving prescriptions for controlled substances from prescribers
77.24who subsequently obtain controlled substances from dispensers in quantities or with a
77.25frequency inconsistent with generally recognized standards of use for those controlled
77.26substances, including standards accepted by national and international pain management
77.27associations; and
77.28 (2) individuals presenting forged or otherwise false or altered prescriptions for
77.29controlled substances to dispensers.
77.30 (b) No permissible user identified under subdivision 6 may access the database
77.31for the sole purpose of identifying prescribers of controlled substances for unusual or
77.32excessive prescribing patterns without a valid search warrant or court order.
77.33 (c) No personnel of a state or federal occupational licensing board or agency may
77.34access the database for the purpose of obtaining information to be used to initiate or
77.35substantiate a disciplinary action against a prescriber when the disciplinary action relates
78.1to allegations involving unusual or excessive prescribing of the drugs for which data
78.2is collected under subdivision 4.
78.3 (d) Data reported under subdivision 4 shall beretained by the board in the
78.4databasefor a 12-month period, and shall be removed from the database no later than 12
78.5months from the last day of the month during which the data was received. made available
78.6to permissible users for a 12-month period beginning the day the data was received and
78.7ending 12 months from the last day of the month in which the data was received, except
78.8that permissible users defined in subdivision 6, paragraph (b), clauses (6) and (7), may
78.9use all data collected under this section for the purposes of administering, operating, and
78.10maintaining the prescription monitoring program and conducting trend analyses and other
78.11studies necessary to evaluate the effectiveness of the program.
78.12(e) The board shall not retain data reported under subdivision 4 for a period longer
78.13than five years from the date the data was received.
78.14 Subd. 6. Access to reporting system data. (a) Except as indicated in this
78.15subdivision, the data submitted to the board under subdivision 4 is private data on
78.16individuals as defined in section13.02, subdivision 12 , and not subject to public disclosure.
78.17 (b) Except as specified in subdivision 5, the following persons shall be considered
78.18permissible users and may access the data submitted under subdivision 4 in the same or
78.19similar manner, and for the same or similar purposes, as those persons who are authorized
78.20to access similar private data on individuals under federal and state law:
78.21 (1) a prescriber or an agent or employee of the prescriber to whom the prescriber has
78.22delegated the task of accessing the data, to the extent the information relates specifically to
78.23a current patient, to whom the prescriber is prescribing or considering prescribing any
78.24controlled substance or to whom the prescriber is providing other medical treatment for
78.25which access to the data may be necessary and with the provision that the prescriber remains
78.26responsible for the use or misuse of data accessed by a delegated agent or employee;
78.27 (2) a dispenser or an agent or employee of the dispenser to whom the dispenser has
78.28delegated the task of accessing the data, to the extent the information relates specifically
78.29to a current patient to whom that dispenser is dispensing or considering dispensing any
78.30controlled substance and with the provision that the dispenser remains responsible for the
78.31use or misuse of data accessed by a delegated agent or employee;
78.32 (3) a licensed pharmacist who is providing pharmaceutical care for which access to
78.33the data may be necessary to the extent that the information relates specifically to a current
78.34patient for whom the pharmacist is providing pharmaceutical care;
78.35(3) (4) an individual who is the recipient of a controlled substance prescription for
78.36which data was submitted under subdivision 4, or a guardian of the individual, parent or
79.1guardian of a minor, or health care agent of the individual acting under a health care
79.2directive under chapter 145C;
79.3(4) (5) personnel of the a health-related licensing board specifically listed in section
79.4214.01, subdivision 2, or the Emergency Medical Services Regulatory Board, assigned to
79.5conduct a bona fide investigation of a complaint received by that board alleging that a
79.6 specific licensee is impaired by use of a drug for which data is collected under subdivision
79.74, has engaged in activity that would constitute a crime as defined in section 152.025, or
79.8has engaged in the behavior specified in section 152.126, subdivision 5, paragraph (a);
79.9(5) (6) personnel of the board engaged in the collection, review, and analysis
79.10 of controlled substance prescription information as part of the assigned duties and
79.11responsibilities under this section;
79.12(6) (7) authorized personnel of a vendor under contract with the board state of
79.13Minnesota who are engaged in the design, implementation, operation, and maintenance of
79.14theelectronic reporting system prescription monitoring program as part of the assigned
79.15duties and responsibilities of their employment, provided that access to data is limited to
79.16the minimum amount necessary to carry out such duties and responsibilities;
79.17(7) (8) federal, state, and local law enforcement authorities acting pursuant to a
79.18valid search warrant;
79.19(8) (9) personnel of the medical assistance program Minnesota health care programs
79.20assigned to use the data collected under this section to identify and manage recipients
79.21whose usage of controlled substances may warrant restriction to a single primary care
79.22physician provider, a single outpatient pharmacy, or and a single hospital; and
79.23(9) (10) personnel of the Department of Human Services assigned to access the
79.24data pursuant to paragraph (h).;
79.25(11) a coroner or medical examiner, or an agent or employee of the coroner or
79.26medical examiner to whom the coroner or medical examiner has delegated the task of
79.27accessing the data, conducting an investigation pursuant to section 390.11, and with the
79.28provision that the coroner or medical examiner remains responsible for the use or misuse
79.29of data accessed by a delegated agent or employee; and
79.30(12) personnel of the health professionals services program established under
79.31section 214.31, to the extent that the information relates specifically to an individual who
79.32is currently enrolled in and being monitored by the program. The health professionals
79.33services program personnel shall not provide this data to a health-related licensing board
79.34or the Emergency Medical Services Regulatory Board, except as permitted under section
79.35214.33, subdivision 3.
80.1 For purposes of clause(3) (4), access by an individual includes persons in the
80.2definition of an individual under section13.02 .
80.3 (c)Any A permissible user identified in paragraph (b), who clauses (1), (2), (3), (6),
80.4(7), (9), (10), and (11) may directlyaccesses access the data electronically,. If the data
80.5is directly accessed electronically, the permissible user shall implement and maintain a
80.6comprehensive information security program that contains administrative, technical,
80.7and physical safeguards that are appropriate to the user's size and complexity, and the
80.8sensitivity of the personal information obtained. The permissible user shall identify
80.9reasonably foreseeable internal and external risks to the security, confidentiality, and
80.10integrity of personal information that could result in the unauthorized disclosure, misuse,
80.11or other compromise of the information and assess the sufficiency of any safeguards in
80.12place to control the risks.
80.13 (d) The board shall not release data submitted underthis section subdivision 4 unless
80.14it is provided with evidence, satisfactory to the board, that the person requesting the
80.15information is entitled to receive the data.
80.16(e) The board shall not release the name of a prescriber without the written consent
80.17of the prescriber or a valid search warrant or court order. The board shall provide a
80.18mechanism for a prescriber to submit to the board a signed consent authorizing the release
80.19of the prescriber's name when data containing the prescriber's name is requested.
80.20(f) (e) The board shall maintain a log of all persons who access the data for a period
80.21of at least three years and shall ensure that any permissible user complies with paragraph
80.22(c) prior to attaining direct access to the data.
80.23(g) (f) Section
13.05, subdivision 6 , shall apply to any contract the board enters into
80.24pursuant to subdivision 2. A vendor shall not use data collected under this section for
80.25any purpose not specified in this section.
80.26(g) The board may participate in an interstate prescription monitoring program data
80.27exchange system provided that permissible users in other states have access to the data
80.28only as allowed under this section, and that section 13.05, subdivision 6, applies to any
80.29contract or memorandum of understanding that the board enters into under this paragraph.
80.30(h) With available appropriations, the commissioner of human services shall
80.31establish and implement a system through which the Department of Human Services shall
80.32routinely access the data for the purpose of determining whether any client enrolled in
80.33an opioid treatment program licensed according to chapter 245A has been prescribed or
80.34dispensed a controlled substance in addition to that administered or dispensed by the
80.35opioid treatment program. When the commissioner determines there have been multiple
80.36prescribers or multiple prescriptions of controlled substances, the commissioner shall:
81.1(1) inform the medical director of the opioid treatment program only that the
81.2commissioner determined the existence of multiple prescribers or multiple prescriptions of
81.3controlled substances; and
81.4(2) direct the medical director of the opioid treatment program to access the data
81.5directly, review the effect of the multiple prescribers or multiple prescriptions, and
81.6document the review.
81.7If determined necessary, the commissioner of human services shall seek a federal waiver
81.8of, or exception to, any applicable provision of Code of Federal Regulations, title 42, part
81.92.34
, item (c), prior to implementing this paragraph.
81.10(i) The board may provide data submitted under subdivision 4 for public research,
81.11policy, or education purposes, but only after the removal of any information that is likely
81.12to reveal the identity of the patient, prescriber, or dispenser who is the subject of the data.
81.13(j) The board shall review the data submitted under subdivision 4 on at least a
81.14quarterly basis and shall establish criteria, in consultation with the advisory task force,
81.15for referring information about a patient to prescribers and dispensers who prescribed or
81.16dispensed the prescriptions in question if the criteria are met.
81.17 Subd. 7. Disciplinary action. (a) A dispenser who knowingly fails to submit data to
81.18the board as required under this section is subject to disciplinary action by the appropriate
81.19health-related licensing board.
81.20 (b) A prescriber or dispenser authorized to access the data who knowingly discloses
81.21the data in violation of state or federal laws relating to the privacy of health care data
81.22shall be subject to disciplinary action by the appropriate health-related licensing board,
81.23and appropriate civil penalties.
81.24Subd. 8. Evaluation and reporting. (a) The board shall evaluate the prescription
81.25electronic reporting system to determine if the system is negatively impacting appropriate
81.26prescribing practices of controlled substances. The board may contract with a vendor to
81.27design and conduct the evaluation.
81.28(b) The board shall submit the evaluation of the system to the legislature by July
81.2915, 2011.
81.30 Subd. 9. Immunity from liability; no requirement to obtain information. (a) A
81.31pharmacist, prescriber, or other dispenser making a report to the program in good faith
81.32under this section is immune from any civil, criminal, or administrative liability, which
81.33might otherwise be incurred or imposed as a result of the report, or on the basis that the
81.34pharmacist or prescriber did or did not seek or obtain or use information from the program.
81.35 (b) Nothing in this section shall require a pharmacist, prescriber, or other dispenser
81.36to obtain information about a patient from the program, and the pharmacist, prescriber,
82.1or other dispenser, if acting in good faith, is immune from any civil, criminal, or
82.2administrative liability that might otherwise be incurred or imposed for requesting,
82.3receiving, or using information from the program.
82.4 Subd. 10. Funding. (a) The board may seek grants and private funds from nonprofit
82.5charitable foundations, the federal government, and other sources to fund the enhancement
82.6and ongoing operations of the prescriptionelectronic reporting system monitoring
82.7program established under this section. Any funds received shall be appropriated to the
82.8board for this purpose. The board may not expend funds to enhance the program in a way
82.9that conflicts with this section without seeking approval from the legislature.
82.10(b) Notwithstanding any other section, the administrative services unit for the
82.11health-related licensing boards shall apportion between the Board of Medical Practice, the
82.12Board of Nursing, the Board of Dentistry, the Board of Podiatric Medicine, the Board of
82.13Optometry, the Board of Veterinary Medicine, and the Board of Pharmacy an amount to
82.14be paid through fees by each respective board. The amount apportioned to each board
82.15shall equal each board's share of the annual appropriation to the Board of Pharmacy
82.16from the state government special revenue fund for operating the prescriptionelectronic
82.17reporting system monitoring program under this section. Each board's apportioned share
82.18shall be based on the number of prescribers or dispensers that each board identified in
82.19this paragraph licenses as a percentage of the total number of prescribers and dispensers
82.20licensed collectively by these boards. Each respective board may adjust the fees that the
82.21boards are required to collect to compensate for the amount apportioned to each board by
82.22the administrative services unit.
82.23EFFECTIVE DATE.This section is effective the day following final enactment.
82.24 Sec. 23. STUDY REQUIRED; PRESCRIPTION MONITORING PROGRAM
82.25DATABASE.
82.26The Board of Pharmacy, in collaboration with the Prescription Monitoring Program
82.27Advisory Task Force, shall study program database and report to the chairs and ranking
82.28minority members of the senate health and human services policy and finance division and
82.29the house of representatives health and human services policy and finance committees by
82.30December 15, 2014, with recommendations on whether or not to (1) require the use of
82.31the prescription monitoring by prescribers when prescribing or considering prescribing,
82.32and pharmacists when dispensing or considering dispensing, a controlled substance as
82.33defined in Minnesota Statutes, section 152.126, subdivision 1, paragraph (c); and (2)
82.34allow for the use of the prescription monitoring program database to identify potentially
82.35inappropriate prescribing of controlled substances.
83.1 Sec. 24. APPROPRIATION.
83.2(a) $210,000 in fiscal year 2015 is appropriated from the state government special
83.3revenue fund to the Board of Pharmacy to implement changes to the prescription monitoring
83.4program. The base for this appropriation is $171,000 in fiscal years 2016 and 2017.
83.5(b) $5,000 in fiscal year 2015 is appropriated from the state government special
83.6revenue fund to the Board of Pharmacy for costs attributable to the board's cease and
83.7desist authority.
1.3the administration of influenza vaccine by qualified dentists under certain
1.4circumstances; providing penalties; modifying grounds for disciplinary
1.5action by the Board of Nursing; modifying the health professionals services
1.6program; modifying the compensation paid to the health-related licensing board
1.7members; making changes to the Minnesota prescription monitoring program;
1.8adding and modifying definitions; changing the requirements for pharmacist
1.9participation in immunizations; changing the powers and duties of the Board
1.10of Pharmacy; changing licensing requirements for businesses regulated by the
1.11Board of Pharmacy; clarifying requirements for compounding; allowing certain
1.12educational institutions to purchase legend drugs in limited circumstances;
1.13allowing certain entities to handle drugs in preparation for emergency use;
1.14clarifying the requirement that drug manufacturers report certain payments to the
1.15Board of Pharmacy; adding certain substances to the schedules for controlled
1.16substances; requiring a report; appropriating money;amending Minnesota
1.17Statutes 2012, sections 148.261, subdivisions 1, 4, by adding a subdivision;
1.18150A.01, subdivision 8a; 150A.06, subdivisions 1, 1a, 1c, 1d, 2, 2a, 2d, 3, 8;
1.19150A.091, subdivisions 3, 8, 16; 150A.10; 151.01; 151.06; 151.211; 151.26;
1.20151.34; 151.35; 151.361, subdivision 2; 151.37, as amended; 151.44; 151.58,
1.21subdivisions 2, 3, 5; 152.02, subdivision 8b; 152.126, as amended; 214.09,
1.22subdivision 3; 214.32, by adding a subdivision; 214.33, subdivision 3; Minnesota
1.23Statutes 2013 Supplement, sections 151.252, by adding a subdivision; 152.02,
1.24subdivision 2; 364.09; proposing coding for new law in Minnesota Statutes,
1.25chapters 150A; 151.
1.26BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF MINNESOTA:
1.29 Section 1. Minnesota Statutes 2012, section 148.261, subdivision 1, is amended to read:
1.30 Subdivision 1. Grounds listed. The board may deny, revoke, suspend, limit, or
1.31condition the license and registration of any person to practice professional, advanced
1.32practice registered, or practical nursing under sections
2.1discipline a licensee or applicant as described in section
2.2grounds for disciplinary action:
2.3(1) Failure to demonstrate the qualifications or satisfy the requirements for a license
2.4contained in sections
2.5applying for a license, the burden of proof is upon the applicant to demonstrate the
2.6qualifications or satisfaction of the requirements.
2.7(2) Employing fraud or deceit in procuring or attempting to procure a permit, license,
2.8or registration certificate to practice professional or practical nursing or attempting to
2.9subvert the licensing examination process. Conduct that subverts or attempts to subvert
2.10the licensing examination process includes, but is not limited to:
2.11(i) conduct that violates the security of the examination materials, such as removing
2.12examination materials from the examination room or having unauthorized possession of
2.13any portion of a future, current, or previously administered licensing examination;
2.14(ii) conduct that violates the standard of test administration, such as communicating
2.15with another examinee during administration of the examination, copying another
2.16examinee's answers, permitting another examinee to copy one's answers, or possessing
2.17unauthorized materials; or
2.18(iii) impersonating an examinee or permitting an impersonator to take the
2.19examination on one's own behalf.
2.20(3) Conviction of a felony or gross misdemeanor reasonably related to the practice
2.21of professional, advanced practice registered, or practical nursing. Conviction as used in
2.22this subdivision includes a conviction of an offense that if committed in this state would
2.23be considered a felony or gross misdemeanor without regard to its designation elsewhere,
2.24or a criminal proceeding where a finding or verdict of guilt is made or returned but the
2.25adjudication of guilt is either withheld or not entered.
2.26(4) Revocation, suspension, limitation, conditioning, or other disciplinary action
2.27against the person's professional or practical nursing license or advanced practice
2.28registered nursing credential, in another state, territory, or country; failure to report to the
2.29board that charges regarding the person's nursing license or other credential are pending in
2.30another state, territory, or country; or having been refused a license or other credential by
2.31another state, territory, or country.
2.32(5) Failure to or inability to perform professional or practical nursing as defined in
2.33section
2.34of a registered nurse to supervise or a licensed practical nurse to monitor adequately the
2.35performance of acts by any person working at the nurse's direction.
3.1(6) Engaging in unprofessional conduct, including, but not limited to, a departure
3.2from or failure to conform to board rules of professional or practical nursing practice that
3.3interpret the statutory definition of professional or practical nursing as well as provide
3.4criteria for violations of the statutes, or, if no rule exists, to the minimal standards of
3.5acceptable and prevailing professional or practical nursing practice, or any nursing
3.6practice that may create unnecessary danger to a patient's life, health, or safety. Actual
3.7injury to a patient need not be established under this clause.
3.8(7) Failure of an advanced practice registered nurse to practice with reasonable
3.9skill and safety or departure from or failure to conform to standards of acceptable and
3.10prevailing advanced practice registered nursing.
3.11(8) Delegating or accepting the delegation of a nursing function or a prescribed
3.12health care function when the delegation or acceptance could reasonably be expected to
3.13result in unsafe or ineffective patient care.
3.14(9) Actual or potential inability to practice nursing with reasonable skill and safety
3.15to patients by reason of illness, use of alcohol, drugs, chemicals, or any other material, or
3.16as a result of any mental or physical condition.
3.17(10) Adjudication as mentally incompetent, mentally ill, a chemically dependent
3.18person, or a person dangerous to the public by a court of competent jurisdiction, within or
3.19without this state.
3.20(11) Engaging in any unethical conduct, including, but not limited to, conduct likely
3.21to deceive, defraud, or harm the public, or demonstrating a willful or careless disregard
3.22for the health, welfare, or safety of a patient. Actual injury need not be established under
3.23this clause.
3.24(12) Engaging in conduct with a patient that is sexual or may reasonably be
3.25interpreted by the patient as sexual, or in any verbal behavior that is seductive or sexually
3.26demeaning to a patient, or engaging in sexual exploitation of a patient or former patient.
3.27(13) Obtaining money, property, or services from a patient, other than reasonable
3.28fees for services provided to the patient, through the use of undue influence, harassment,
3.29duress, deception, or fraud.
3.30(14) Revealing a privileged communication from or relating to a patient except when
3.31otherwise required or permitted by law.
3.32(15) Engaging in abusive or fraudulent billing practices, including violations of
3.33federal Medicare and Medicaid laws or state medical assistance laws.
3.34(16) Improper management of patient records, including failure to maintain adequate
3.35patient records, to comply with a patient's request made pursuant to sections
3.36144.298, or to furnish a patient record or report required by law.
4.1(17) Knowingly aiding, assisting, advising, or allowing an unlicensed person to
4.2engage in the unlawful practice of professional, advanced practice registered, or practical
4.3nursing.
4.4(18) Violating a rule adopted by the board, an order of the board, or a state or federal
4.5law relating to the practice of professional, advanced practice registered, or practical
4.6nursing, or a state or federal narcotics or controlled substance law.
4.7(19) Knowingly providing false or misleading information that is directly related
4.8to the care of that patient unless done for an accepted therapeutic purpose such as the
4.9administration of a placebo.
4.10(20) Aiding suicide or aiding attempted suicide in violation of section
4.11established by any of the following:
4.12(i) a copy of the record of criminal conviction or plea of guilty for a felony in
4.13violation of section
4.14(ii) a copy of the record of a judgment of contempt of court for violating an
4.15injunction issued under section
4.16(iii) a copy of the record of a judgment assessing damages under section
4.17subdivision 5
4.18(iv) a finding by the board that the person violated section
4.191
4.20subdivision 1
4.21(21) Practicing outside the scope of practice authorized by section
4.22subdivision 5
4.23(22) Practicing outside the specific field of nursing practice for which an advanced
4.24practice registered nurse is certified unless the practice is authorized under section
4.25(23) Making a false statement or knowingly providing false information to the
4.26board, failing to make reports as required by section
4.27an investigation of the board as required by section
4.28(24) Engaging in false, fraudulent, deceptive, or misleading advertising.
4.29(25) Failure to inform the board of the person's certification status as a nurse
4.30anesthetist, nurse-midwife, nurse practitioner, or clinical nurse specialist.
4.31(26) Engaging in clinical nurse specialist practice, nurse-midwife practice, nurse
4.32practitioner practice, or registered nurse anesthetist practice without current certification
4.33by a national nurse certification organization acceptable to the board, except during the
4.34period between completion of an advanced practice registered nurse course of study and
4.35certification, not to exceed six months or as authorized by the board.
4.36(27) Engaging in conduct that is prohibited under section
5.1(28) Failing to report employment to the board as required by section
5.2subdivision 2a
5.3report as required by section
5.4(29) Discharge from the health professionals services program as described in
5.5sections 214.31 to 214.37, or any other alternative monitoring or diversion program for
5.6reasons other than satisfactory completion of the program as set forth in the participation
5.7agreement.
5.8 Sec. 2. Minnesota Statutes 2012, section 148.261, is amended by adding a subdivision
5.9to read:
5.10 Subd. 1a. Conviction of a felony-level criminal sexual offense. (a) Except as
5.11provided in paragraph (e), the board may not grant or renew a license to practice nursing
5.12to any person who has been convicted on or after August 1, 2014, of any of the provisions
5.13of sections
5.14paragraphs (c) to (o), or
5.15in another jurisdiction.
5.16(b) A license to practice nursing is automatically revoked if the licensee is convicted
5.17of an offense listed in paragraph (a) of this section.
5.18(c) A license to practice nursing that has been denied or revoked under this
5.19subdivision is not subject to chapter 364.
5.20(d) For purposes of this subdivision, "conviction" means a plea of guilty, a verdict of
5.21guilty by a jury, or a finding of guilty by the court, unless the court stays imposition or
5.22execution of the sentence and final disposition of the case is accomplished at a nonfelony
5.23level.
5.24(e) The board may establish criteria whereby an individual convicted of an offense
5.25listed in paragraph (a) of this subdivision may become licensed provided that the criteria:
5.26(1) utilize a rebuttable presumption that the applicant is not suitable for licensing;
5.27(2) provide a standard for overcoming the presumption; and
5.28(3) require that a minimum of ten years has elapsed since the applicant's sentence
5.29was discharged.
5.30The board shall not consider an application under this paragraph if the board
5.31determines that the victim involved in the offense was a patient or a client of the applicant
5.32at the time of the offense.
5.33 Sec. 3. Minnesota Statutes 2012, section 148.261, subdivision 4, is amended to read:
6.1 Subd. 4. Evidence. In disciplinary actions alleging a violation of subdivision 1,
6.2clause (3) or (4), or subdivision 1a, a copy of the judgment or proceeding under the seal
6.3of the court administrator or of the administrative agency that entered the same shall be
6.4admissible into evidence without further authentication and shall constitute prima facie
6.5evidence of the violation concerned.
6.6 Sec. 4. Minnesota Statutes 2012, section 150A.01, subdivision 8a, is amended to read:
6.7 Subd. 8a. Resident dentist. "Resident dentist" means a person who is licensed to
6.8practice dentistry as an enrolled graduate student or student of an advanced education
6.9program accredited by the
6.10Accreditation.
6.11 Sec. 5. [150A.055] ADMINISTRATION OF INFLUENZA IMMUNIZATIONS.
6.12 Subdivision 1. Practice of dentistry. A person licensed to practice dentistry under
6.13sections 150A.01 to 150A.14 shall be deemed to be practicing dentistry while participating
6.14in the administration of an influenza vaccination.
6.15 Subd. 2. Qualified dentists. (a) The influenza immunization shall be administered
6.16only to patients 19 years of age and older and only by licensed dentists who:
6.17(1) have immediate access to emergency response equipment, including but not
6.18limited to oxygen administration equipment, epinephrine, and other allergic reaction
6.19response equipment; and
6.20(2) are trained in or have successfully completed a program approved by the
6.21Minnesota Board of Dentistry, specifically for the administration of immunizations. The
6.22training or program must include:
6.23(i) educational material on the disease of influenza and vaccination as prevention
6.24of the disease;
6.25(ii) contraindications and precautions;
6.26(iii) intramuscular administration;
6.27(iv) communication of risk and benefits of influenza vaccination and legal
6.28requirements involved;
6.29(v) reporting of adverse events;
6.30(vi) documentation required by federal law; and
6.31(vii) storage and handling of vaccines.
6.32(b) Any dentist giving influenza vaccinations under this section shall comply
6.33with guidelines established by the federal Advisory Committee on Immunization
6.34Practices relating to vaccines and immunizations, which includes, but is not limited to,
7.1vaccine storage and handling, vaccine administration and documentation, and vaccine
7.2contraindications and precautions.
7.3 Subd. 3. Coordination of care. After a dentist qualified under subdivision 2 has
7.4administered an influenza vaccine to a patient, the dentist shall report the administration of
7.5the immunization to the Minnesota Immunization Information Connection or otherwise
7.6notify the patient's primary physician or clinic of the administration of the immunization.
7.7EFFECTIVE DATE.This section is effective January 1, 2015, and applies to
7.8influenza immunizations performed on or after that date.
7.9 Sec. 6. Minnesota Statutes 2012, section 150A.06, subdivision 1, is amended to read:
7.10 Subdivision 1. Dentists. A person of good moral character who has graduated from
7.11a dental program accredited by the Commission on Dental Accreditation
7.12
7.13may be examined by the board or by an agency pursuant to section
7.141
7.15college in another country must not be disqualified from examination solely because of
7.16the applicant's foreign training if the board determines that the training is equivalent to or
7.17higher than that provided by a dental college accredited by the Commission on Dental
7.18Accreditation
7.19pursuant to section
7.20applying to the board for licensure. The examination shall include an examination of the
7.21applicant's knowledge of the laws of Minnesota relating to dentistry and the rules of the
7.22board. An applicant is ineligible to retake the clinical examination required by the board
7.23after failing it twice until further education and training are obtained as specified by the
7.24board by rule. A separate, nonrefundable fee may be charged for each time a person applies.
7.25An applicant who passes the examination in compliance with subdivision 2b, abides by
7.26professional ethical conduct requirements, and meets all other requirements of the board
7.27shall be licensed to practice dentistry and granted a general dentist license by the board.
7.28 Sec. 7. Minnesota Statutes 2012, section 150A.06, subdivision 1a, is amended to read:
7.29 Subd. 1a. Faculty dentists. (a) Faculty members of a school of dentistry must be
7.30licensed in order to practice dentistry as defined in section
7.31issue to members of the faculty of a school of dentistry a license designated as either a
7.32"limited faculty license" or a "full faculty license" entitling the holder to practice dentistry
7.33within the terms described in paragraph (b) or (c). The dean of a school of dentistry and
7.34program directors of a Minnesota dental hygiene or dental assisting school accredited by
8.1the Commission on Dental Accreditation
8.2to the board those members of the school's faculty who practice dentistry but are not
8.3licensed to practice dentistry in Minnesota. A faculty member who practices dentistry as
8.4defined in section
8.5hygiene or dental assisting school, shall apply to the board for a limited or full faculty
8.6license. Pursuant to Minnesota Rules, chapter 3100, and at the discretion of the board,
8.7a limited faculty license must be renewed annually and a full faculty license must be
8.8renewed biennially. The faculty applicant shall pay a nonrefundable fee set by the board
8.9for issuing and renewing the faculty license. The faculty license is valid during the time
8.10the holder remains a member of the faculty of a school of dentistry or a dental hygiene or
8.11dental assisting school and subjects the holder to this chapter.
8.12(b) The board may issue to dentist members of the faculty of a Minnesota school
8.13of dentistry, dental hygiene, or dental assisting accredited by the Commission on Dental
8.14Accreditation
8.15faculty license entitling the holder to practice dentistry within the school and its affiliated
8.16teaching facilities, but only for the purposes of teaching or conducting research. The
8.17practice of dentistry at a school facility for purposes other than teaching or research is not
8.18allowed unless the dentist was a faculty member on August 1, 1993.
8.19(c) The board may issue to dentist members of the faculty of a Minnesota school
8.20of dentistry, dental hygiene, or dental assisting accredited by the Commission on Dental
8.21Accreditation
8.22license entitling the holder to practice dentistry within the school and its affiliated teaching
8.23facilities and elsewhere if the holder of the license is employed 50 percent time or more by
8.24the school in the practice of teaching or research, and upon successful review by the board
8.25of the applicant's qualifications as described in subdivisions 1, 1c, and 4 and board rule.
8.26The board, at its discretion, may waive specific licensing prerequisites.
8.27 Sec. 8. Minnesota Statutes 2012, section 150A.06, subdivision 1c, is amended to read:
8.28 Subd. 1c. Specialty dentists. (a) The board may grant
8.29
8.30
8.31(b) An applicant for a specialty license shall:
8.32(1) have successfully completed a postdoctoral specialty
8.33accredited by the Commission on Dental Accreditation
8.34
9.1(2) have been certified by a specialty
9.2Board of Dentistry, or provide evidence of having passed a clinical examination for
9.3licensure required for practice in any state or Canadian province, or in the case of oral and
9.4maxillofacial surgeons only, have a Minnesota medical license in good standing;
9.5(3) have been in active practice or a postdoctoral specialty education program or
9.6United States government service at least 2,000 hours in the 36 months prior to applying
9.7for a specialty license;
9.8(4) if requested by the board, be interviewed by a committee of the board, which
9.9may include the assistance of specialists in the evaluation process, and satisfactorily
9.10respond to questions designed to determine the applicant's knowledge of dental subjects
9.11and ability to practice;
9.12(5) if requested by the board, present complete records on a sample of patients
9.13treated by the applicant. The sample must be drawn from patients treated by the applicant
9.14during the 36 months preceding the date of application. The number of records shall be
9.15established by the board. The records shall be reasonably representative of the treatment
9.16typically provided by the applicant for each specialty area;
9.17(6) at board discretion, pass a board-approved English proficiency test if English is
9.18not the applicant's primary language;
9.19(7) pass all components of the National Board Dental Examinations;
9.20(8) pass the Minnesota Board of Dentistry jurisprudence examination;
9.21(9) abide by professional ethical conduct requirements; and
9.22(10) meet all other requirements prescribed by the Board of Dentistry.
9.23(c) The application must include:
9.24(1) a completed application furnished by the board;
9.25(2) at least two character references from two different dentists for each specialty
9.26area, one of whom must be a dentist practicing in the same specialty area, and the other
9.27 from the director of
9.28(3) a licensed physician's statement attesting to the applicant's physical and mental
9.29condition;
9.30(4) a statement from a licensed ophthalmologist or optometrist attesting to the
9.31applicant's visual acuity;
9.32(5) a nonrefundable fee; and
9.33(6) a notarized, unmounted passport-type photograph, three inches by three inches,
9.34taken not more than six months before the date of application.
9.35(d) A specialty dentist holding
9.36practicing in the dentist's designated specialty area or areas. The scope of practice must be
10.1defined by each national specialty board recognized by the
10.2 Commission on Dental Accreditation.
10.3(e) A specialty dentist holding a general
10.4in the dentist's designated specialty area or areas if the dentist has announced a limitation
10.5of practice. The scope of practice must be defined by each national specialty board
10.6recognized by the
10.7(f) All specialty dentists who have fulfilled the specialty dentist requirements and
10.8who intend to limit their practice to a particular specialty area or areas may apply for
10.9
10.10 Sec. 9. Minnesota Statutes 2012, section 150A.06, subdivision 1d, is amended to read:
10.11 Subd. 1d. Dental therapists. A person of good moral character who has graduated
10.12with a baccalaureate degree or a master's degree from a dental therapy education program
10.13that has been approved by the board or accredited by the
10.14 Commission on Dental Accreditation or another board-approved national accreditation
10.15organization may apply for licensure.
10.16The applicant must submit an application and fee as prescribed by the board and a
10.17diploma or certificate from a dental therapy education program. Prior to being licensed,
10.18the applicant must pass a comprehensive, competency-based clinical examination that is
10.19approved by the board and administered independently of an institution providing dental
10.20therapy education. The applicant must also pass an examination testing the applicant's
10.21knowledge of the Minnesota laws and rules relating to the practice of dentistry. An
10.22applicant who has failed the clinical examination twice is ineligible to retake the clinical
10.23examination until further education and training are obtained as specified by the board. A
10.24separate, nonrefundable fee may be charged for each time a person applies. An applicant
10.25who passes the examination in compliance with subdivision 2b, abides by professional
10.26ethical conduct requirements, and meets all the other requirements of the board shall
10.27be licensed as a dental therapist.
10.28 Sec. 10. Minnesota Statutes 2012, section 150A.06, subdivision 2, is amended to read:
10.29 Subd. 2. Dental hygienists. A person of good moral character, who has graduated
10.30from a dental hygiene program accredited by the Commission on Dental Accreditation
10.31
10.32recognized by the United States Department of Education to offer college-level programs,
10.33may apply for licensure. The dental hygiene program must provide a minimum of two
10.34academic years of dental hygiene education. The applicant must submit an application and
11.1fee as prescribed by the board and a diploma or certificate of dental hygiene. Prior to being
11.2licensed, the applicant must pass the National Board of Dental Hygiene examination and a
11.3board approved examination designed to determine the applicant's clinical competency. In
11.4the case of examinations conducted pursuant to section
11.5shall take the examination before applying to the board for licensure. The applicant must
11.6also pass an examination testing the applicant's knowledge of the laws of Minnesota relating
11.7to the practice of dentistry and of the rules of the board. An applicant is ineligible to retake
11.8the clinical examination required by the board after failing it twice until further education
11.9and training are obtained as specified by board rule. A separate, nonrefundable fee may
11.10be charged for each time a person applies. An applicant who passes the examination in
11.11compliance with subdivision 2b, abides by professional ethical conduct requirements, and
11.12meets all the other requirements of the board shall be licensed as a dental hygienist.
11.13 Sec. 11. Minnesota Statutes 2012, section 150A.06, subdivision 2a, is amended to read:
11.14 Subd. 2a. Licensed dental assistant. A person of good moral character, who has
11.15graduated from a dental assisting program accredited by the Commission on Dental
11.16Accreditation
11.17must submit an application and fee as prescribed by the board and the diploma or
11.18certificate of dental assisting. In the case of examinations conducted pursuant to section
11.20for licensure. The examination shall include an examination of the applicant's knowledge
11.21of the laws of Minnesota relating to dentistry and the rules of the board. An applicant is
11.22ineligible to retake the licensure examination required by the board after failing it twice
11.23until further education and training are obtained as specified by board rule. A separate,
11.24nonrefundable fee may be charged for each time a person applies. An applicant who
11.25passes the examination in compliance with subdivision 2b, abides by professional ethical
11.26conduct requirements, and meets all the other requirements of the board shall be licensed
11.27as a dental assistant.
11.28 Sec. 12. Minnesota Statutes 2012, section 150A.06, subdivision 2d, is amended to read:
11.29 Subd. 2d. Continuing education and professional development waiver. (a) The
11.30board shall grant a waiver to the continuing education requirements under this chapter for
11.31a licensed dentist, licensed dental therapist, licensed dental hygienist, or licensed dental
11.32assistant who documents to the satisfaction of the board that the dentist, dental therapist,
11.33dental hygienist, or licensed dental assistant has retired from active practice in the state
11.34and limits the provision of dental care services to those offered without compensation
12.1in a public health, community, or tribal clinic or a nonprofit organization that provides
12.2services to the indigent or to recipients of medical assistance, general assistance medical
12.3care, or MinnesotaCare programs.
12.4(b) The board may require written documentation from the volunteer and retired
12.5dentist, dental therapist, dental hygienist, or licensed dental assistant prior to granting
12.6this waiver.
12.7(c) The board shall require the volunteer and retired dentist, dental therapist, dental
12.8hygienist, or licensed dental assistant to meet the following requirements:
12.9(1) a licensee seeking a waiver under this subdivision must complete and document
12.10at least five hours of approved courses in infection control, medical emergencies, and
12.11medical management for the continuing education cycle; and
12.12(2) provide documentation of current CPR certification from completion of the
12.13American Heart Association healthcare provider course
12.14professional rescuer course
12.15 Sec. 13. Minnesota Statutes 2012, section 150A.06, subdivision 3, is amended to read:
12.16 Subd. 3. Waiver of examination. (a) All or any part of the examination for
12.17dentists or dental hygienists, except that pertaining to the law of Minnesota relating to
12.18dentistry and the rules of the board, may, at the discretion of the board, be waived for an
12.19applicant who presents a certificate of having passed all components of the National Board
12.20Dental Examinations or evidence of having maintained an adequate scholastic standing
12.21as determined by the board, in dental school as to dentists, or dental hygiene school as
12.22to dental hygienists.
12.23(b) The board shall waive the clinical examination required for licensure for any
12.24dentist applicant who is a graduate of a dental school accredited by the Commission on
12.25Dental Accreditation
12.26of the National Board Dental Examinations, and who has satisfactorily completed a
12.27Minnesota-based postdoctoral general dentistry residency program (GPR) or an advanced
12.28education in general dentistry (AEGD) program after January 1, 2004. The postdoctoral
12.29program must be accredited by the Commission on Dental Accreditation
12.30
12.31evaluation assessing the resident's competence to practice dentistry. The board may require
12.32the applicant to submit any information deemed necessary by the board to determine
12.33whether the waiver is applicable.
12.34
12.35
13.1 Sec. 14. Minnesota Statutes 2012, section 150A.06, subdivision 8, is amended to read:
13.2 Subd. 8. Licensure by credentials. (a) Any dental assistant may, upon application
13.3and payment of a fee established by the board, apply for licensure based on an evaluation
13.4of the applicant's education, experience, and performance record in lieu of completing a
13.5board-approved dental assisting program for expanded functions as defined in rule, and
13.6may be interviewed by the board to determine if the applicant:
13.7(1) has graduated from an accredited dental assisting program accredited by the
13.8Commission
13.9currently certified by the Dental Assisting National Board;
13.10(2) is not subject to any pending or final disciplinary action in another state or
13.11Canadian province, or if not currently certified or registered, previously had a certification
13.12or registration in another state or Canadian province in good standing that was not subject
13.13to any final or pending disciplinary action at the time of surrender;
13.14(3) is of good moral character and abides by professional ethical conduct
13.15requirements;
13.16(4) at board discretion, has passed a board-approved English proficiency test if
13.17English is not the applicant's primary language; and
13.18(5) has met all expanded functions curriculum equivalency requirements of a
13.19Minnesota board-approved dental assisting program.
13.20(b) The board, at its discretion, may waive specific licensure requirements in
13.21paragraph (a).
13.22(c) An applicant who fulfills the conditions of this subdivision and demonstrates the
13.23minimum knowledge in dental subjects required for licensure under subdivision 2a must
13.24be licensed to practice the applicant's profession.
13.25(d) If the applicant does not demonstrate the minimum knowledge in dental subjects
13.26required for licensure under subdivision 2a, the application must be denied. If licensure is
13.27denied, the board may notify the applicant of any specific remedy that the applicant could
13.28take which, when passed, would qualify the applicant for licensure. A denial does not
13.29prohibit the applicant from applying for licensure under subdivision 2a.
13.30(e) A candidate whose application has been denied may appeal the decision to the
13.31board according to subdivision 4a.
13.32 Sec. 15. Minnesota Statutes 2012, section 150A.091, subdivision 3, is amended to read:
13.33 Subd. 3. Initial license or permit fees. Along with the application fee, each of the
13.34following applicants shall submit a separate
13.35
14.1
14.2exceed the following
14.3(1) dentist or full faculty dentist,
14.4
14.5(2) dental therapist,
14.6(3) dental hygienist,
14.7(4) licensed dental assistant,
14.8 $36; and
14.9(5) dental assistant with a permit as described in Minnesota Rules, part 3100.8500,
14.10subpart 3,
14.11 Sec. 16. Minnesota Statutes 2012, section 150A.091, subdivision 8, is amended to read:
14.12 Subd. 8. Duplicate license or certificate fee. Each applicant shall submit, with
14.13a request for issuance of a duplicate of the original license, or of an annual or biennial
14.14renewal certificate for a license or permit, a fee in the following amounts:
14.15(1) original dentist, full faculty dentist, dental therapist, dental hygiene, or dental
14.16assistant license, $35;
14.17(2) annual or biennial renewal certificates, $10
14.18(3) wallet-sized license and renewal certificate, $15.
14.19 Sec. 17. Minnesota Statutes 2012, section 150A.091, subdivision 16, is amended to
14.20read:
14.21 Subd. 16. Failure of professional development portfolio audit.
14.22
14.23
14.24a licensee fails a professional development portfolio audit under Minnesota Rules, part
14.253100.5300, the board is authorized to take the following actions:
14.26(1) for the first failure, the board may issue a warning to the licensee;
14.27(2) for the second failure within ten years, the board may assess a penalty of not
14.28more than $250; and
14.29(3) for any additional failures within the ten year period, the board may assess a
14.30penalty of not more than $1000.
14.31(b) In addition to the penalty fee, the board may initiate the complaint process to
14.32address multiple failed audits.
15.1 Sec. 18. Minnesota Statutes 2012, section 150A.10, is amended to read:
15.2150A.10 ALLIED DENTAL PERSONNEL.
15.3 Subdivision 1. Dental hygienists. Any licensed dentist, licensed dental therapist,
15.4public institution, or school authority may obtain services from a licensed dental hygienist.
15.5The licensed dental hygienist may provide those services defined in section
15.6subdivision 1a
15.7diagnosis or treatment plan for a dental patient. All services shall be provided under
15.8supervision of a licensed dentist. Any licensed dentist who shall permit any dental service
15.9by a dental hygienist other than those authorized by the Board of Dentistry, shall be deemed
15.10to be violating the provisions of sections
15.11service by a dental hygienist shall constitute a violation of sections
15.12 Subd. 1a. Limited authorization for dental hygienists. (a) Notwithstanding
15.13subdivision 1, a dental hygienist licensed under this chapter may be employed or retained
15.14by a health care facility, program, or nonprofit organization to perform dental hygiene
15.15services described under paragraph (b) without the patient first being examined by a
15.16licensed dentist if the dental hygienist:
15.17(1) has been engaged in the active practice of clinical dental hygiene for not less than
15.182,400 hours in the past 18 months or a career total of 3,000 hours, including a minimum of
15.19200 hours of clinical practice in two of the past three years;
15.20(2) has entered into a collaborative agreement with a licensed dentist that designates
15.21authorization for the services provided by the dental hygienist;
15.22(3) has documented participation in courses in infection control and medical
15.23emergencies within each continuing education cycle; and
15.24(4) maintains current CPR certification from completion of the American Heart
15.25Association healthcare provider course
15.26course
15.27(b) The dental hygiene services authorized to be performed by a dental hygienist
15.28under this subdivision are limited to:
15.29(1) oral health promotion and disease prevention education;
15.30(2) removal of deposits and stains from the surfaces of the teeth;
15.31(3) application of topical preventive or prophylactic agents, including fluoride
15.32varnishes and pit and fissure sealants;
15.33(4) polishing and smoothing restorations;
15.34(5) removal of marginal overhangs;
15.35(6) performance of preliminary charting;
15.36(7) taking of radiographs; and
16.1(8) performance of scaling and root planing.
16.2The dental hygienist may administer injections of local anesthetic agents or nitrous
16.3oxide inhalation analgesia as specifically delegated in the collaborative agreement with
16.4a licensed dentist. The dentist need not first examine the patient or be present. If the
16.5patient is considered medically compromised, the collaborative dentist shall review the
16.6patient record, including the medical history, prior to the provision of these services.
16.7Collaborating dental hygienists may work with unlicensed and licensed dental assistants
16.8who may only perform duties for which licensure is not required. The performance of
16.9dental hygiene services in a health care facility, program, or nonprofit organization as
16.10authorized under this subdivision is limited to patients, students, and residents of the
16.11facility, program, or organization.
16.12(c) A collaborating dentist must be licensed under this chapter and may enter into
16.13a collaborative agreement with no more than four dental hygienists unless otherwise
16.14authorized by the board. The board shall develop parameters and a process for obtaining
16.15authorization to collaborate with more than four dental hygienists. The collaborative
16.16agreement must include:
16.17(1) consideration for medically compromised patients and medical conditions for
16.18which a dental evaluation and treatment plan must occur prior to the provision of dental
16.19hygiene services;
16.20(2) age- and procedure-specific standard collaborative practice protocols, including
16.21recommended intervals for the performance of dental hygiene services and a period of
16.22time in which an examination by a dentist should occur;
16.23(3) copies of consent to treatment form provided to the patient by the dental hygienist;
16.24(4) specific protocols for the placement of pit and fissure sealants and requirements
16.25for follow-up care to assure the efficacy of the sealants after application; and
16.26(5) a procedure for creating and maintaining dental records for the patients that are
16.27treated by the dental hygienist. This procedure must specify where these records are
16.28to be located.
16.29The collaborative agreement must be signed and maintained by the dentist, the dental
16.30hygienist, and the facility, program, or organization; must be reviewed annually by the
16.31collaborating dentist and dental hygienist; and must be made available to the board
16.32upon request.
16.33(d) Before performing any services authorized under this subdivision, a dental
16.34hygienist must provide the patient with a consent to treatment form which must include a
16.35statement advising the patient that the dental hygiene services provided are not a substitute
16.36for a dental examination by a licensed dentist. If the dental hygienist makes any referrals
17.1to the patient for further dental procedures, the dental hygienist must fill out a referral form
17.2and provide a copy of the form to the collaborating dentist.
17.3(e) For the purposes of this subdivision, a "health care facility, program, or
17.4nonprofit organization" is limited to a hospital; nursing home; home health agency; group
17.5home serving the elderly, disabled, or juveniles; state-operated facility licensed by the
17.6commissioner of human services or the commissioner of corrections; and federal, state, or
17.7local public health facility, community clinic, tribal clinic, school authority, Head Start
17.8program, or nonprofit organization that serves individuals who are uninsured or who are
17.9Minnesota health care public program recipients.
17.10(f) For purposes of this subdivision, a "collaborative agreement" means a written
17.11agreement with a licensed dentist who authorizes and accepts responsibility for the
17.12services performed by the dental hygienist. The services authorized under this subdivision
17.13and the collaborative agreement may be performed without the presence of a licensed
17.14dentist and may be performed at a location other than the usual place of practice of the
17.15dentist or dental hygienist and without a dentist's diagnosis and treatment plan, unless
17.16specified in the collaborative agreement.
17.17 Subd. 2. Dental assistants. Every licensed dentist and dental therapist who uses the
17.18services of any unlicensed person for the purpose of assistance in the practice of dentistry
17.19or dental therapy shall be responsible for the acts of such unlicensed person while engaged
17.20in such assistance. The dentist or dental therapist shall permit the unlicensed assistant to
17.21perform only those acts which are authorized to be delegated to unlicensed assistants
17.22by the Board of Dentistry. The acts shall be performed under supervision of a licensed
17.23dentist or dental therapist. A licensed dental therapist shall not supervise more than four
17.24
17.25may permit differing levels of dental assistance based upon recognized educational
17.26standards, approved by the board, for the training of dental assistants. The board may also
17.27define by rule the scope of practice of licensed and unlicensed dental assistants. The
17.28board by rule may require continuing education for differing levels of dental assistants,
17.29as a condition to their license or authority to perform their authorized duties. Any
17.30licensed dentist or dental therapist who permits an unlicensed assistant to perform any
17.31dental service other than that authorized by the board shall be deemed to be enabling an
17.32unlicensed person to practice dentistry, and commission of such an act by an unlicensed
17.33assistant shall constitute a violation of sections
17.34 Subd. 3. Dental technicians. Every licensed dentist and dental therapist who uses
17.35the services of any unlicensed person, other than under the dentist's or dental therapist's
17.36supervision and within the same practice setting, for the purpose of constructing, altering,
18.1repairing or duplicating any denture, partial denture, crown, bridge, splint, orthodontic,
18.2prosthetic or other dental appliance, shall be required to furnish such unlicensed person
18.3with a written work order in such form as shall be prescribed by the rules of the board. The
18.4work order shall be made in duplicate form, a duplicate copy to be retained in a permanent
18.5file of the dentist or dental therapist at the practice setting for a period of two years, and
18.6the original to be retained in a permanent file for a period of two years by the unlicensed
18.7person in that person's place of business. The permanent file of work orders to be kept
18.8by the dentist, dental therapist, or unlicensed person shall be open to inspection at any
18.9reasonable time by the board or its duly constituted agent.
18.10 Subd. 4. Restorative procedures. (a) Notwithstanding subdivisions 1, 1a, and
18.112, a licensed dental hygienist or licensed dental assistant may perform the following
18.12restorative procedures:
18.13(1) place, contour, and adjust amalgam restorations;
18.14(2) place, contour, and adjust glass ionomer;
18.15(3) adapt and cement stainless steel crowns;
18.16(4) place, contour, and adjust class I and class V supragingival composite restorations
18.17where the margins are entirely within the enamel
18.18(5) place, contour, and adjust class II and class V supragingival composite
18.19restorations on primary teeth.
18.20(b) The restorative procedures described in paragraph (a) may be performed only if:
18.21(1) the licensed dental hygienist or licensed dental assistant has completed a
18.22board-approved course on the specific procedures;
18.23(2) the board-approved course includes a component that sufficiently prepares the
18.24licensed dental hygienist or licensed dental assistant to adjust the occlusion on the newly
18.25placed restoration;
18.26(3) a licensed dentist or licensed advanced dental therapist has authorized the
18.27procedure to be performed; and
18.28(4) a licensed dentist or licensed advanced dental therapist is available in the clinic
18.29while the procedure is being performed.
18.30(c) The dental faculty who teaches the educators of the board-approved courses
18.31specified in paragraph (b) must have prior experience teaching these procedures in an
18.32accredited dental education program.
18.33 Sec. 19. Minnesota Statutes 2012, section 214.09, subdivision 3, is amended to read:
18.34 Subd. 3. Compensation. (a)
18.35
19.1
19.2day spent on board activities and members of nonhealth-related licensing boards may be
19.3compensated at the rate of $55 a day spent on board activities when authorized by the
19.4board, plus expenses in the same manner and amount as authorized by the commissioner's
19.5plan adopted under section
19.6attending board meetings, incur child care expenses that would not otherwise have been
19.7incurred, may be reimbursed for those expenses upon board authorization.
19.8(b) Members who are state employees or employees of the political subdivisions
19.9of the state must not receive the daily payment for activities that occur during working
19.10hours for which they are also compensated by the state or political subdivision. However,
19.11a state or political subdivision employee may receive the daily payment if the employee
19.12uses vacation time or compensatory time accumulated in accordance with a collective
19.13bargaining agreement or compensation plan for board activity. Members who are state
19.14employees or employees of the political subdivisions of the state may receive the expenses
19.15provided for in this subdivision unless the expenses are reimbursed by another source.
19.16Members who are state employees or employees of political subdivisions of the state
19.17may be reimbursed for child care expenses only for time spent on board activities that
19.18are outside their working hours.
19.19(c) Each board must adopt internal standards prescribing what constitutes a day
19.20spent on board activities for purposes of making daily payments under this subdivision.
19.21 Sec. 20. Minnesota Statutes 2012, section 214.32, is amended by adding a subdivision
19.22to read:
19.23 Subd. 6. Duties of a participating board. Upon receiving a report from the program
19.24manager in accordance with section 214.33, subdivision 3, that a regulated person has been
19.25discharged from the program due to noncompliance based on allegations that the regulated
19.26person has engaged in conduct that might cause risk to the public, the participating board
19.27may temporarily suspend the regulated person's professional license until the completion of
19.28a disciplinary investigation. The board must complete the disciplinary investigation within
19.2960 days of receipt of the report from the program. If the investigation is not completed by
19.30the board within 60 days, the temporary suspension shall be lifted, unless the regulated
19.31person requests a delay in the disciplinary proceedings for any reason, upon which the
19.32temporary suspension shall remain in place until the completion of the investigation.
19.33 Sec. 21. Minnesota Statutes 2012, section 214.33, subdivision 3, is amended to read:
20.1 Subd. 3. Program manager. (a) The program manager shall report to the
20.2appropriate participating board a regulated person who:
20.3(1) does not meet program admission criteria
20.4(2) violates the terms of the program participation agreement
20.5(3) leaves or is discharged from the program except upon fulfilling the terms for
20.6successful completion of the program as set forth in the participation agreement
20.7(4) is subject to the provisions of sections 214.17 to 214.25;
20.8(5) causes identifiable patient harm;
20.9(6) unlawfully substitutes or adulterates medications;
20.10(7) writes a prescription or causes a prescription to be dispensed in the name of a
20.11person, other than the prescriber, or veterinary patient for the personal use of the prescriber;
20.12(8) alters a prescription without the knowledge of the prescriber for the purpose of
20.13obtaining a drug for personal use;
20.14(9) unlawfully uses a controlled or mood-altering substance or uses alcohol while
20.15providing patient care or during the period of time in which the regulated person may be
20.16contacted to provide patient care or is otherwise on duty, if current use is the reason for
20.17participation in the program or the use occurs while the regulated person is participating
20.18in the program; or
20.19
20.20
20.21are outside the authority of the health professionals services program as described in
20.22sections
20.23(b) The program manager shall inform any reporting person of the disposition of the
20.24person's report to the program.
20.25EFFECTIVE DATE.This section is effective August 1, 2014, and applies to
20.26violations that occur after the effective date.
20.27 Sec. 22. Minnesota Statutes 2013 Supplement, section 364.09, is amended to read:
20.28364.09 EXCEPTIONS.
20.29(a) This chapter does not apply to the licensing process for peace officers; to law
20.30enforcement agencies as defined in section
20.31protection agencies; to eligibility for a private detective or protective agent license; to the
20.32licensing and background study process under chapters 245A and 245C; to eligibility
20.33for school bus driver endorsements; to eligibility for special transportation service
20.34endorsements; to eligibility for a commercial driver training instructor license, which is
21.1governed by section
21.2services personnel, or to the licensing by political subdivisions of taxicab drivers, if the
21.3applicant for the license has been discharged from sentence for a conviction within the ten
21.4years immediately preceding application of a violation of any of the following:
21.5(1) sections
21.6subdivision 2 or 3;
21.7(2) any provision of chapter 152 that is punishable by a maximum sentence of
21.815 years or more; or
21.9(3) a violation of chapter 169 or 169A involving driving under the influence, leaving
21.10the scene of an accident, or reckless or careless driving.
21.11This chapter also shall not apply to eligibility for juvenile corrections employment, where
21.12the offense involved child physical or sexual abuse or criminal sexual conduct.
21.13(b) This chapter does not apply to a school district or to eligibility for a license
21.14issued or renewed by the Board of Teaching or the commissioner of education.
21.15(c) Nothing in this section precludes the Minnesota Police and Peace Officers
21.16Training Board or the state fire marshal from recommending policies set forth in this
21.17chapter to the attorney general for adoption in the attorney general's discretion to apply to
21.18law enforcement or fire protection agencies.
21.19(d) This chapter does not apply to a license to practice medicine that has been denied
21.20or revoked by the Board of Medical Practice pursuant to section
21.21(e) This chapter does not apply to any person who has been denied a license to
21.22practice chiropractic or whose license to practice chiropractic has been revoked by the
21.23board in accordance with section
21.24(f) This chapter does not apply to any license, registration, or permit that has
21.25been denied or revoked by the Board of Nursing in accordance with section 148.261,
21.26subdivision 1a.
21.27
21.28criminal history background investigation or consider criminal history records in hiring
21.29for particular types of employment.
| 21.30 |
APPROPRIATIONS |
||||||
| 21.31 |
Available for the Year |
||||||
| 21.32 |
Ending June 30 |
||||||
| 21.33 |
2014 |
2015 |
|||||
| 21.34 |
Sec. 23. APPROPRIATIONS |
$ |
$ |
||||
| 21.35 |
Board of Behavioral Health and Therapy |
-0- |
8,000 |
||||
22.2government special revenue fund for board
22.3member per diem payments and licensing
22.4activity.
| 22.5 |
Board of Chiropractic Examiners |
-0- |
10,000 |
||||
22.7government special revenue fund for board
22.8member per diem payments.
| 22.9 |
Board of Dentistry |
-0- |
39,000 |
||||
22.11government special revenue fund for board
22.12member per diem payments.
| 22.13 |
Board of Dietetics and Nutrition Practice |
-0- |
1,000 |
||||
22.15government special revenue fund for board
22.16member per diem payments.
| 22.17 |
Board of Marriage and Family Therapy |
-0- |
4,000 |
||||
22.19government special revenue fund for board
22.20member per diem payments and licensing
22.21activity.
| 22.22 |
Board of Medical Practice |
-0- |
38,000 |
||||
22.24government special revenue fund for board
22.25member per diem payments.
| 22.26 |
Board of Nursing |
-0- |
266,000 |
||||
22.28government special revenue fund for board
22.29member per diem payments and licensing
22.30activity.
| 22.31 |
Board of Nursing Home Administrators |
-0- |
2,000 |
||||
23.2government special revenue fund for board
23.3member per diem payments.
| 23.4 |
Board of Optometry |
-0- |
1,000 |
||||
23.6government special revenue fund for board
23.7member per diem payments.
| 23.8 |
Board of Pharmacy |
-0- |
2,000 |
||||
23.10government special revenue fund for board
23.11member per diem payments.
| 23.12 |
Board of Physical Therapy |
-0- |
4,000 |
||||
23.14government special revenue fund for board
23.15member per diem payments.
| 23.16 |
Board of Podiatric Medicine |
-0- |
1,000 |
||||
23.18government special revenue fund for board
23.19member per diem payments.
| 23.20 |
Board of Psychology |
-0- |
15,000 |
||||
23.22government special revenue fund for board
23.23member per diem payments.
| 23.24 |
Board of Social Work |
-0- |
17,000 |
||||
23.26government special revenue fund for board
23.27member per diem payments and licensing
23.28activity.
| 23.29 |
Board of Veterinary Medicine |
-0- |
2,000 |
||||
23.31government special revenue fund for board
23.32member per diem payments.
24.3 Section 1. Minnesota Statutes 2012, section 151.01, is amended to read:
24.4151.01 DEFINITIONS.
24.5 Subdivision 1. Words, terms, and phrases. Unless the language or context clearly
24.6indicates that a different meaning is intended, the following words, terms, and phrases, for
24.7the purposes of this chapter, shall be given the meanings subjoined to them.
24.8 Subd. 2. Pharmacy. "Pharmacy" means
24.9which
24.10compounded, or dispensed
24.11the supervision of a pharmacist and from which related clinical pharmacy services are
24.12delivered.
24.13 Subd. 2a. Limited service pharmacy. "Limited service pharmacy" means a
24.14pharmacy that has been issued a restricted license by the board to perform a limited range
24.15of the activities that constitute the practice of pharmacy.
24.16 Subd. 3. Pharmacist. The term "pharmacist" means an individual with a currently
24.17valid license issued by the Board of Pharmacy to practice pharmacy.
24.18 Subd. 5. Drug. The term "drug" means all medicinal substances and preparations
24.19recognized by the United States Pharmacopoeia and National Formulary, or any revision
24.20thereof, vaccines and biologicals, and all substances and preparations intended for external
24.21and internal use in the diagnosis, cure, mitigation, treatment, or prevention of disease in
24.22humans or other animals, and all substances and preparations, other than food, intended to
24.23affect the structure or any function of the bodies of humans or other animals. The term drug
24.24shall also mean any compound, substance, or derivative that is not approved for human
24.25consumption by the United States Food and Drug Administration or specifically permitted
24.26for human consumption under Minnesota law and, when introduced into the body, induces
24.27an effect similar to that of a Schedule I or Schedule II controlled substance listed in
24.28section 152.02, subdivisions 2 and 3, or Minnesota Rules, parts 6800.4210 and 6800.4220,
24.29regardless of whether the substance is marketed for the purpose of human consumption.
24.30 Subd. 6. Medicine. The term "medicine" means any remedial agent that has the
24.31property of curing, preventing, treating, or mitigating diseases, or that is used for that
24.32purpose.
24.33 Subd. 7. Poisons. The term "poisons" means any substance
24.34introduced into the system, directly or by absorption, produces violent, morbid, or fatal
24.35changes, or
25.1 Subd. 8. Chemical. The term "chemical" means all medicinal or industrial
25.2substances, whether simple or compound, or obtained through the process of the science
25.3and art of chemistry, whether of organic or inorganic origin.
25.4 Subd. 9. Board or
25.5Pharmacy" means the Minnesota
25.6 Subd. 10. Director. The term "director" means the executive director of the
25.7Minnesota
25.8 Subd. 11. Person. The term "person" means an individual, firm, partnership,
25.9company, corporation, trustee, association, agency, or other public or private entity.
25.10 Subd. 12. Wholesale. The term "wholesale" means and includes any sale for the
25.11purpose of resale.
25.12 Subd. 13. Commercial purposes. The phrase "commercial purposes" means the
25.13ordinary purposes of trade, agriculture, industry, and commerce, exclusive of the practices
25.14of medicine
25.15 Subd. 14. Manufacturing. The term "manufacturing"
25.16
25.17
25.18
25.19
25.20
25.21processing of a drug, either directly or indirectly, by extraction from substances of natural
25.22origin or independently by means of chemical or biological synthesis. Manufacturing
25.23includes the packaging or repackaging of a drug, or the labeling or relabeling of
25.24the container of a drug, for resale by pharmacies, practitioners, or other persons.
25.25Manufacturing does not include the prepackaging, extemporaneous compounding, or
25.26anticipatory compounding of a drug within a licensed pharmacy or by a practitioner,
25.27nor the labeling of a container within a pharmacy or by a practitioner for the purpose of
25.28dispensing a drug to a patient pursuant to a valid prescription.
25.29 Subd. 14a. Manufacturer. The term "manufacturer" means any person engaged
25.30in manufacturing.
25.31 Subd. 14b. Outsourcing facility. "Outsourcing facility" means a facility that is
25.32registered by the United States Food and Drug Administration pursuant to United States
25.33Code, title 21, section 353b.
25.34 Subd. 15. Pharmacist intern. The term "pharmacist intern" means (1) a natural
25.35person satisfactorily progressing toward the degree in pharmacy required for licensure, or
25.36(2) a graduate of the University of Minnesota College of Pharmacy, or other pharmacy
26.1college approved by the board, who is registered by the
26.2purpose of obtaining practical experience as a requirement for licensure as a pharmacist,
26.3or (3) a qualified applicant awaiting examination for licensure.
26.4 Subd. 15a. Pharmacy technician. The term "pharmacy technician" means a person
26.5not licensed as a pharmacist or a pharmacist intern, who assists the pharmacist in the
26.6preparation and dispensing of medications by performing computer entry of prescription
26.7data and other manipulative tasks. A pharmacy technician shall not perform tasks
26.8specifically reserved to a licensed pharmacist or requiring professional judgment.
26.9 Subd. 16. Prescription drug order. The term "prescription drug order" means a
26.10
26.11 a practitioner
26.12
26.13
26.14
26.15Prescription drug orders for controlled substances must be prepared in accordance with the
26.16provisions of section 152.11 and the federal Controlled Substances Act and the regulations
26.17promulgated thereunder.
26.18 Subd. 16a. Prescription. The term "prescription" means a prescription drug order
26.19that is written or printed on paper, an oral order reduced to writing by a pharmacist, or an
26.20electronic order. To be valid, a prescription must be issued for an individual patient by
26.21a practitioner within the scope and usual course of the practitioner's practice, and must
26.22contain the date of issue, name and address of the patient, name and quantity of the drug
26.23prescribed, directions for use, the name and address of the practitioner, and a telephone
26.24number at which the practitioner can be reached. A prescription written or printed on
26.25paper that is given to the patient or an agent of the patient or that is transmitted by fax
26.26must contain the practitioner's manual signature. An electronic prescription must contain
26.27the practitioner's electronic signature.
26.28 Subd. 16b. Chart order. The term "chart order" means a prescription drug order for
26.29a drug that is to be dispensed by a pharmacist, or by a pharmacist intern under the direct
26.30supervision of a pharmacist, and administered by an authorized person only during the
26.31patient's stay in a hospital or long-term care facility. The chart order shall contain the name
26.32of the patient, another patient identifier such as birth date or medical record number, the
26.33drug ordered, and any directions that the practitioner may prescribe concerning strength,
26.34dosage, frequency, and route of administration. The manual or electronic signature of the
26.35practitioner must be affixed to the chart order at the time it is written or at a later date in
26.36the case of verbal chart orders.
27.1 Subd. 17. Legend drug. "Legend drug" means a drug
27.2federal law to
27.3
27.4practitioner.
27.5 Subd. 18. Label. "Label" means a display of written, printed, or graphic matter
27.6upon the immediate container of any drug or medicine
27.7
27.8
27.9
27.10
27.11such drug or medicine, or
27.12 Subd. 19. Package. "Package" means any container or wrapping in which any
27.13drug or medicine is enclosed for use in the delivery or display of that article to retail
27.14purchasers, but does not include:
27.15(a) shipping containers or wrappings used solely for the transportation of any such
27.16article in bulk or in quantity to manufacturers, packers, processors, or wholesale or
27.17retail distributors;
27.18(b) shipping containers or outer wrappings used by retailers to ship or deliver any
27.19such article to retail customers if such containers and wrappings bear no printed matter
27.20pertaining to any particular drug or medicine.
27.21 Subd. 20. Labeling. "Labeling" means all labels and other written, printed, or
27.22graphic matter (a) upon a drug or medicine or any of its containers or wrappers, or (b)
27.23accompanying such article.
27.24 Subd. 21. Federal act. "Federal act" means the Federal Food, Drug, and Cosmetic
27.25Act, United States Code, title 21, section 301, et seq., as amended.
27.26 Subd. 22. Pharmacist in charge. "Pharmacist in charge" means a duly licensed
27.27pharmacist in the state of Minnesota who has been designated in accordance with the rules
27.28of the
27.29of the pharmacy in compliance with the requirements and duties as established by the
27.30board in its rules.
27.31 Subd. 23. Practitioner. "Practitioner" means a licensed doctor of medicine, licensed
27.32doctor of osteopathy duly licensed to practice medicine, licensed doctor of dentistry,
27.33licensed doctor of optometry, licensed podiatrist, or licensed veterinarian. For purposes of
27.34sections
27.35(b), (e), and (f); and
27.36prescribe, dispense, and administer under chapter 147A, or an advanced practice nurse
28.1authorized to prescribe, dispense, and administer under section
28.2sections
28.3(b); and
28.4administer under chapter 150A.
28.5 Subd. 24. Brand name. "Brand name" means the registered trademark name given
28.6to a drug product by its manufacturer, labeler or distributor.
28.7 Subd. 25. Generic name. "Generic name" means the established name or official
28.8name of a drug or drug product.
28.9 Subd. 26. Finished dosage form. "Finished dosage form" means that form of a
28.10drug
28.11no further manufacturing or processing other than packaging, reconstitution, or labeling.
28.12 Subd. 27. Practice of pharmacy. "Practice of pharmacy" means:
28.13 (1) interpretation and evaluation of prescription drug orders;
28.14 (2) compounding, labeling, and dispensing drugs and devices (except labeling by
28.15a manufacturer or packager of nonprescription drugs or commercially packaged legend
28.16drugs and devices);
28.17 (3) participation in clinical interpretations and monitoring of drug therapy for
28.18assurance of safe and effective use of drugs, including the performance of laboratory tests
28.19that are waived under the federal Clinical Laboratory Improvement Act of 1988, United
28.20States Code, title 42, section 263a et seq., provided that a pharmacist may interpret the
28.21results of laboratory tests but may modify drug therapy only pursuant to a protocol or
28.22collaborative practice agreement;
28.23 (4) participation in drug and therapeutic device selection; drug administration for first
28.24dosage and medical emergencies; drug regimen reviews; and drug or drug-related research;
28.25 (5) participation in administration of influenza vaccines to all eligible individuals ten
28.26years of age and older and all other vaccines to patients 18 years of age and older
28.27
28.28physician licensed under chapter 147, a physician assistant authorized to prescribe drugs
28.29under chapter 147A, or an advanced practice nurse authorized to prescribe drugs under
28.30section 148.235, provided that:
28.31(i) the protocol includes, at a minimum:
28.32(A) the name, dose, and route of each vaccine that may be given;
28.33(B) the patient population for whom the vaccine may be given;
28.34(C) contraindications and precautions to the vaccine;
28.35(D) the procedure for handling an adverse reaction;
29.1(E) the name, signature, and address of the physician, physician assistant, or
29.2advanced nurse practitioner;
29.3(F) a telephone number at which the physician, physician assistant, or advanced
29.4nurse practitioner can be contacted; and
29.5(G) the date and time period for which the protocol is valid;
29.6
29.7by the
29.8specifically for the administration of immunizations or
29.9
29.10
29.11primary physician or clinic or to the Minnesota Immunization Information Connection; and
29.12(iv) the pharmacist complies with guidelines for vaccines and immunizations
29.13established by the federal Advisory Committee on Immunization Practices, except that a
29.14pharmacist does not need to comply with those portions of the guidelines that establish
29.15immunization schedules when administering a vaccine pursuant to a valid, patient-specific
29.16order issued by a physician licensed under chapter 147, a physician assistant authorized to
29.17prescribe drugs under chapter 147A, or an advanced practice nurse authorized to prescribe
29.18drugs under section 148.235, provided that the order is consistent with the United States
29.19Food and Drug Administration approved labeling of the vaccine;
29.20 (6) participation in the
29.21management, modification, and discontinuation of drug therapy
29.22
29.23between
29.24
29.25
29.26physicians, podiatrists, or veterinarians; or (ii) one or more pharmacists and one or more
29.27physician assistants authorized to prescribe, dispense, and administer under chapter 147A,
29.28or advanced practice nurses authorized to prescribe, dispense, and administer under
29.29section 148.235. Any
29.30collaborative practice agreement must be
29.31 the patient's medical record or reported by the pharmacist to a practitioner responsible
29.32for the patient's care;
29.33 (7) participation in the storage of drugs and the maintenance of records;
29.34 (8)
29.35content, hazards, and uses of drugs and devices; and
30.1 (9) offering or performing those acts, services, operations, or transactions necessary
30.2in the conduct, operation, management, and control of a pharmacy.
30.3 Subd. 27a. Protocol. "Protocol" means:
30.4(1) a specific written plan that describes the nature and scope of activities that a
30.5pharmacist may engage in when initiating, managing, modifying, or discontinuing drug
30.6therapy as allowed in subdivision 27, clause (6); or
30.7(2) a specific written plan that authorizes a pharmacist to administer vaccines and
30.8that complies with subdivision 27, clause (5).
30.9 Subd. 27b. Collaborative practice. "Collaborative practice" means patient care
30.10activities, consistent with subdivision 27, engaged in by one or more pharmacists who
30.11have agreed to work in collaboration with one or more practitioners to initiate, manage,
30.12and modify drug therapy under specified conditions mutually agreed to by the pharmacists
30.13and practitioners.
30.14 Subd. 27c. Collaborative practice agreement. "Collaborative practice agreement"
30.15means a written and signed agreement between one or more pharmacists and one or more
30.16practitioners that allows the pharmacist or pharmacists to engage in collaborative practice.
30.17 Subd. 28. Veterinary legend drug. "Veterinary legend drug" means a drug that is
30.18required by federal law to
30.19
30.20to the prescription of a licensed veterinarian.
30.21 Subd. 29. Legend medical gas. "Legend medical gas" means a liquid or gaseous
30.22substance used for medical purposes and that is required by federal law to
30.23
30.24 be dispensed only pursuant to the prescription of a licensed practitioner.
30.25 Subd. 30. Dispense or dispensing. "Dispense or dispensing" means the
30.26
30.27
30.28
30.29drug order and includes those processes specified by the board in rule that are necessary
30.30for the preparation and provision of a drug to a patient or patient's agent in a suitable
30.31container appropriately labeled for subsequent administration to, or use by, a patient.
30.32 Subd. 31. Central service pharmacy. "Central service pharmacy" means a
30.33pharmacy that may provide dispensing functions, drug utilization review, packaging,
30.34labeling, or delivery of a prescription product to another pharmacy for the purpose of
30.35filling a prescription.
31.1 Subd. 32. Electronic signature. "Electronic signature" means an electronic sound,
31.2symbol, or process attached to or associated with a record and executed or adopted by a
31.3person with the intent to sign the record.
31.4 Subd. 33. Electronic transmission. "Electronic transmission" means transmission
31.5of information in electronic form.
31.6 Subd. 34. Health professional shortage area. "Health professional shortage area"
31.7means an area designated as such by the federal Secretary of Health and Human Services,
31.8as provided under Code of Federal Regulations, title 42, part 5, and United States Code,
31.9title 42, section 254E.
31.10 Subd. 35. Compounding. "Compounding" means preparing, mixing, assembling,
31.11packaging, and labeling a drug for an identified individual patient as a result of
31.12a practitioner's prescription drug order. Compounding also includes anticipatory
31.13compounding, as defined in this section, and the preparation of drugs in which all bulk
31.14drug substances and components are nonprescription substances. Compounding does
31.15not include mixing or reconstituting a drug according to the product's labeling or to the
31.16manufacturer's directions. Compounding does not include the preparation of a drug for the
31.17purpose of, or incident to, research, teaching, or chemical analysis, provided that the drug
31.18is not prepared for dispensing or administration to patients. All compounding, regardless
31.19of the type of product, must be done pursuant to a prescription drug order unless otherwise
31.20permitted in this chapter or by the rules of the board. Compounding does not include a
31.21minor deviation from such directions with regard to radioactivity, volume, or stability,
31.22which is made by or under the supervision of a licensed nuclear pharmacist or a physician,
31.23and which is necessary in order to accommodate circumstances not contemplated in the
31.24manufacturer's instructions, such as the rate of radioactive decay or geographical distance
31.25from the patient.
31.26 Subd. 36. Anticipatory compounding. "Anticipatory compounding" means the
31.27preparation by a pharmacy of a supply of a compounded drug product that is sufficient to
31.28meet the short-term anticipated need of the pharmacy for the filling of prescription drug
31.29orders. In the case of practitioners only, anticipatory compounding means the preparation
31.30of a supply of a compounded drug product that is sufficient to meet the practitioner's
31.31short-term anticipated need for dispensing or administering the drug to patients treated
31.32by the practitioner. Anticipatory compounding is not the preparation of a compounded
31.33drug product for wholesale distribution.
31.34 Subd. 37. Extemporaneous compounding. "Extemporaneous compounding"
31.35means the compounding of a drug product pursuant to a prescription drug order for a specific
32.1patient that is issued in advance of the compounding. Extemporaneous compounding is
32.2not the preparation of a compounded drug product for wholesale distribution.
32.3 Subd. 38. Compounded positron emission tomography drug. "Compounded
32.4positron emission tomography drug" means a drug that:
32.5(1) exhibits spontaneous disintegration of unstable nuclei by the emission of
32.6positrons and is used for the purpose of providing dual photon positron emission
32.7tomographic diagnostic images;
32.8(2) has been compounded by or on the order of a practitioner in accordance with the
32.9relevant parts of Minnesota Rules, chapters 4731 and 6800, for a patient or for research,
32.10teaching, or quality control; and
32.11(3) includes any nonradioactive reagent, reagent kit, ingredient, nuclide generator,
32.12accelerator, target material, electronic synthesizer, or other apparatus or computer program
32.13to be used in the preparation of such a drug.
32.14 Sec. 2. Minnesota Statutes 2012, section 151.06, is amended to read:
32.15151.06 POWERS AND DUTIES.
32.16 Subdivision 1. Generally; rules. (a) Powers and duties. The Board of Pharmacy
32.17shall have the power and it shall be its duty:
32.18 (1) to regulate the practice of pharmacy;
32.19 (2) to regulate the manufacture, wholesale, and retail sale of drugs within this state;
32.20 (3) to regulate the identity, labeling, purity, and quality of all drugs and medicines
32.21dispensed in this state, using the United States Pharmacopeia and the National Formulary,
32.22or any revisions thereof, or standards adopted under the federal act as the standard;
32.23 (4) to enter and inspect by its authorized representative any and all places where
32.24drugs, medicines, medical gases, or veterinary drugs or devices are sold, vended, given
32.25away, compounded, dispensed, manufactured, wholesaled, or held; it may secure samples
32.26or specimens of any drugs, medicines, medical gases, or veterinary drugs or devices
32.27after paying or offering to pay for such sample; it shall be entitled to inspect and make
32.28copies of any and all records of shipment, purchase, manufacture, quality control, and
32.29sale of these items provided, however, that such inspection shall not extend to financial
32.30data, sales data, or pricing data;
32.31 (5) to examine and license as pharmacists all applicants whom it shall deem qualified
32.32to be such;
32.33 (6) to license wholesale drug distributors;
32.34 (7) to
32.35registration or license required under this chapter
33.1 upon any of the
33.2the provisions of section 151.071;
33.3
33.4
33.5
33.6
33.7
33.8
33.9
33.10
33.11
33.12
33.13
33.14
33.15
33.16
33.17
33.18
33.19
33.20
33.21
33.22
33.23
33.24
33.25
33.26
33.27
33.28
33.29
33.30
33.31
33.32
33.33
33.34 (8) to employ necessary assistants and adopt rules for the conduct of its business;
33.35 (9) to register as pharmacy technicians all applicants who the board determines are
33.36qualified to carry out the duties of a pharmacy technician;
34.1 (10) to perform such other duties and exercise such other powers as the provisions of
34.2the act may require
34.3(11) to enter and inspect any business to which it issues a license or registration.
34.4
34.5
34.6
34.7
34.8
34.9
34.10
34.11
34.12
34.13and publish uniform rules not inconsistent herewith for carrying out and enforcing
34.14the provisions of this chapter. The board shall adopt rules regarding prospective drug
34.15utilization review and patient counseling by pharmacists. A pharmacist in the exercise of
34.16the pharmacist's professional judgment, upon the presentation of a
34.17patient or the patient's caregiver or agent, shall perform the prospective drug utilization
34.18review required by rules issued under this subdivision.
34.19
34.20(FDA) determines that the substitution of drugs used for the treatment of epilepsy or
34.21seizures poses a health risk to patients, the board shall adopt rules in accordance with
34.22accompanying FDA interchangeability standards regarding the use of substitution for
34.23these drugs. If the board adopts a rule regarding the substitution of drugs used for the
34.24treatment of epilepsy or seizures that conflicts with the substitution requirements of
34.25section
34.26proposed by the board would increase state costs for state public health care programs,
34.27the board shall report to the chairs and ranking minority members of the senate Health
34.28and Human Services Budget Division and the house of representatives Health Care and
34.29Human Services Finance Division the proposed rule and the increased cost associated
34.30with the proposed rule before the board may adopt the rule.
34.31 Subd. 1a.
34.32
34.33
34.34
34.35
34.36
35.1
35.2an act or practice constituting a violation of a law, rule, or other order related to the duties
35.3and responsibilities entrusted to the board, the board may issue and cause to be served
35.4upon the person an order requiring the person to cease and desist from violations.
35.5(b) The cease and desist order must state the reasons for the issuance of the order
35.6and must give reasonable notice of the rights of the person to request a hearing before
35.7an administrative law judge. A hearing must be held not later than ten days after the
35.8request for the hearing is received by the board. After the completion of the hearing,
35.9the administrative law judge shall issue a report within ten days. Within 15 days after
35.10receiving the report of the administrative law judge, the board shall issue a further order
35.11vacating or making permanent the cease and desist order. The time periods provided in
35.12this provision may be waived by agreement of the executive director of the board and the
35.13person against whom the cease and desist order was issued. If the person to whom a cease
35.14and desist order is issued fails to appear at the hearing after being duly notified, the person
35.15is in default, and the proceeding may be determined against that person upon consideration
35.16of the cease and desist order, the allegations of which may be considered to be true. Unless
35.17otherwise provided, all hearings must be conducted according to chapter 14. The board
35.18may adopt rules of procedure concerning all proceedings conducted under this subdivision.
35.19(c) If no hearing is requested within 30 days of service of the order, the cease and
35.20desist order will become permanent.
35.21(d) A cease and desist order issued under this subdivision remains in effect until
35.22it is modified or vacated by the board. The administrative proceeding provided by this
35.23subdivision, and subsequent appellate judicial review of that administrative proceeding,
35.24constitutes the exclusive remedy for determining whether the board properly issued the
35.25cease and desist order and whether the cease and desist order should be vacated or made
35.26permanent.
35.27 Subd. 1b. Enforcement of violations of cease and desist orders. (a) Whenever
35.28the board under subdivision 1a seeks to enforce compliance with a cease and desist
35.29order that has been made permanent, the allegations of the cease and desist order are
35.30considered conclusively established for purposes of proceeding under subdivision 1a for
35.31permanent or temporary relief to enforce the cease and desist order. Whenever the board
35.32under subdivision 1a seeks to enforce compliance with a cease and desist order when a
35.33hearing or hearing request on the cease and desist order is pending, or the time has not
35.34yet expired to request a hearing on whether a cease and desist order should be vacated or
35.35made permanent, the allegations in the cease and desist order are considered conclusively
36.1established for the purposes of proceeding under subdivision 1a for temporary relief to
36.2enforce the cease and desist order.
36.3(b) Notwithstanding this subdivision or subdivision 1a, the person against whom
36.4the cease and desist order is issued and who has requested a hearing under subdivision 1a
36.5may, within 15 days after service of the cease and desist order, bring an action in Ramsey
36.6County District Court for issuance of an injunction to suspend enforcement of the cease
36.7and desist order pending a final decision of the board under subdivision 1a to vacate or
36.8make permanent the cease and desist order. The court shall determine whether to issue
36.9such an injunction based on traditional principles of temporary relief.
36.10 Subd. 2. Application. In the case of a facility licensed or registered by the board,
36.11the provisions of subdivision 1 shall apply to an individual owner or sole proprietor and
36.12shall also apply to the following:
36.13(1) In the case of a partnership, each partner thereof;
36.14(2) In the case of an association, each member thereof;
36.15(3) In the case of a corporation, each officer or director thereof and each shareholder
36.16owning 30 percent or more of the voting stock of such corporation.
36.17
36.18
36.19
36.20
36.21
36.22
36.23
36.24
36.25
36.26
36.27
36.28
36.29
36.30
36.31
36.32
36.33
36.34EFFECTIVE DATE.Subdivisions 1a and 1b are effective August 1, 2014, and
36.35apply to violations occurring on or after that date.
37.1 Sec. 3. [151.071] DISCIPLINARY ACTION.
37.2 Subdivision 1. Forms of disciplinary action. When the board finds that a licensee,
37.3registrant, or applicant has engaged in conduct prohibited under subdivision 2, it may
37.4do one or more of the following:
37.5(1) deny the issuance of a license or registration;
37.6(2) refuse to renew a license or registration;
37.7(3) revoke the license or registration;
37.8(4) suspend the license or registration;
37.9(5) impose limitations, conditions, or both on the license or registration, including
37.10but not limited to: the limitation of practice designated settings; the imposition of
37.11retraining or rehabilitation requirements; the requirement of practice under supervision;
37.12the requirement of participation in a diversion program such as that established pursuant to
37.13section 214.31 or the conditioning of continued practice on demonstration of knowledge
37.14or skills by appropriate examination or other review of skill and competence;
37.15(6) impose a civil penalty not exceeding $10,000 for each separate violation, the
37.16amount of the civil penalty to be fixed so as to deprive a licensee or registrant of any
37.17economic advantage gained by reason of the violation, to discourage similar violations
37.18by the licensee or registrant or any other licensee or registrant, or to reimburse the board
37.19for the cost of the investigation and proceeding, including but not limited to, fees paid
37.20for services provided by the Office of Administrative Hearings, legal and investigative
37.21services provided by the Office of the Attorney General, court reporters, witnesses,
37.22reproduction of records, board members' per diem compensation, board staff time, and
37.23travel costs and expenses incurred by board staff and board members; and
37.24(7) reprimand the licensee or registrant.
37.25 Subd. 2. Grounds for disciplinary action. The following conduct is prohibited and
37.26is grounds for disciplinary action:
37.27(1) failure to demonstrate the qualifications or satisfy the requirements for a license
37.28or registration contained in this chapter or the rules of the board. The burden of proof is on
37.29the applicant to demonstrate such qualifications or satisfaction of such requirements;
37.30(2) obtaining a license by fraud or by misleading the board in any way during
37.31the application process or obtaining a license by cheating, or attempting to subvert
37.32the licensing examination process. Conduct that subverts or attempts to subvert the
37.33licensing examination process includes, but is not limited to: (i) conduct that violates the
37.34security of the examination materials, such as removing examination materials from the
37.35examination room or having unauthorized possession of any portion of a future, current,
37.36or previously administered licensing examination; (ii) conduct that violates the standard of
38.1test administration, such as communicating with another examinee during administration
38.2of the examination, copying another examinee's answers, permitting another examinee
38.3to copy one's answers, or possessing unauthorized materials; or (iii) impersonating an
38.4examinee or permitting an impersonator to take the examination on one's own behalf;
38.5(3) for a pharmacist, pharmacy technician, pharmacist intern, applicant for a
38.6pharmacist or pharmacy license, or applicant for a pharmacy technician or pharmacist
38.7intern registration, conviction of a felony reasonably related to the practice of pharmacy.
38.8Conviction as used in this subdivision includes a conviction of an offense that if committed
38.9in this state would be deemed a felony without regard to its designation elsewhere, or
38.10a criminal proceeding where a finding or verdict of guilt is made or returned but the
38.11adjudication of guilt is either withheld or not entered thereon. The board may delay the
38.12issuance of a new license or registration if the applicant has been charged with a felony
38.13until the matter has been adjudicated;
38.14(4) for a facility, other than a pharmacy, licensed or registered by the board, if an
38.15owner or applicant is convicted of a felony reasonably related to the operation of the
38.16facility. The board may delay the issuance of a new license or registration if the owner or
38.17applicant has been charged with a felony until the matter has been adjudicated;
38.18(5) for a controlled substance researcher, conviction of a felony reasonably related
38.19to controlled substances or to the practice of the researcher's profession. The board may
38.20delay the issuance of a registration if the applicant has been charged with a felony until
38.21the matter has been adjudicated;
38.22(6) disciplinary action taken by another state or by one of this state's health licensing
38.23agencies:
38.24(i) revocation, suspension, restriction, limitation, or other disciplinary action against
38.25a license or registration in another state or jurisdiction, failure to report to the board that
38.26charges or allegations regarding the person's license or registration have been brought in
38.27another state or jurisdiction, or having been refused a license or registration by any other
38.28state or jurisdiction. The board may delay the issuance of a new license or registration if
38.29an investigation or disciplinary action is pending in another state or jurisdiction until the
38.30investigation or action has been dismissed or otherwise resolved; and
38.31(ii) revocation, suspension, restriction, limitation, or other disciplinary action against
38.32a license or registration issued by another of this state's health licensing agencies, failure
38.33to report to the board that charges regarding the person's license or registration have been
38.34brought by another of this state's health licensing agencies, or having been refused a
38.35license or registration by another of this state's health licensing agencies. The board may
38.36delay the issuance of a new license or registration if a disciplinary action is pending before
39.1another of this state's health licensing agencies until the action has been dismissed or
39.2otherwise resolved;
39.3(7) for a pharmacist, pharmacy, pharmacy technician, or pharmacist intern, violation
39.4of any order of the board, of any of the provisions of this chapter or any rules of the
39.5board or violation of any federal, state, or local law or rule reasonably pertaining to the
39.6practice of pharmacy;
39.7(8) for a facility, other than a pharmacy, licensed by the board, violations of any
39.8order of the board, of any of the provisions of this chapter or the rules of the board or
39.9violation of any federal, state, or local law relating to the operation of the facility;
39.10(9) engaging in any unethical conduct; conduct likely to deceive, defraud, or harm
39.11the public, or demonstrating a willful or careless disregard for the health, welfare, or safety
39.12of a patient; or pharmacy practice that is professionally incompetent, in that it may create
39.13unnecessary danger to any patient's life, health, or safety, in any of which cases, proof
39.14of actual injury need not be established;
39.15(10) aiding or abetting an unlicensed person in the practice of pharmacy, except
39.16that it is not a violation of this clause for a pharmacist to supervise a properly registered
39.17pharmacy technician or pharmacist intern if that person is performing duties allowed
39.18by this chapter or the rules of the board;
39.19(11) for an individual licensed or registered by the board, adjudication as mentally ill
39.20or developmentally disabled, or as a chemically dependent person, a person dangerous
39.21to the public, a sexually dangerous person, or a person who has a sexual psychopathic
39.22personality, by a court of competent jurisdiction, within or without this state. Such
39.23adjudication shall automatically suspend a license for the duration thereof unless the
39.24board orders otherwise;
39.25(12) for a pharmacist or pharmacy intern, engaging in unprofessional conduct as
39.26specified in the board's rules. In the case of a pharmacy technician, engaging in conduct
39.27specified in board rules that would be unprofessional if it were engaged in by a pharmacist
39.28or pharmacist intern or performing duties specifically reserved for pharmacists under this
39.29chapter or the rules of the board;
39.30(13) for a pharmacy, operation of the pharmacy without a pharmacist present and on
39.31duty except as allowed by a variance approved by the board;
39.32(14) for a pharmacist, the inability to practice pharmacy with reasonable skill and
39.33safety to patients by reason of illness, drunkenness, use of drugs, narcotics, chemicals, or
39.34any other type of material or as a result of any mental or physical condition, including
39.35deterioration through the aging process or loss of motor skills. In the case of registered
39.36pharmacy technicians, pharmacist interns, or controlled substance researchers, the
40.1inability to carry out duties allowed under this chapter or the rules of the board with
40.2reasonable skill and safety to patients by reason of illness, drunkenness, use of drugs,
40.3narcotics, chemicals, or any other type of material or as a result of any mental or physical
40.4condition, including deterioration through the aging process or loss of motor skills;
40.5(15) for a pharmacist, pharmacy, pharmacist intern, pharmacy technician, medical
40.6gas distributor, or controlled substance researcher, revealing a privileged communication
40.7from or relating to a patient except when otherwise required or permitted by law;
40.8(16) for a pharmacist or pharmacy, improper management of patient records,
40.9including failure to maintain adequate patient records, to comply with a patient's request
40.10made pursuant to sections 144.291 to 144.298, or to furnish a patient record or report
40.11required by law;
40.12(17) paying, offering to pay, receiving, or agreeing to receive, a commission, rebate,
40.13kickback, or other form of remuneration, directly or indirectly, for the referral of patients
40.14or the dispensing of drugs or devices;
40.15(18) engaging in abusive or fraudulent billing practices, including violations of the
40.16federal Medicare and Medicaid laws or state medical assistance laws or rules;
40.17(19) engaging in conduct with a patient that is sexual or may reasonably be
40.18interpreted by the patient as sexual, or in any verbal behavior that is seductive or sexually
40.19demeaning to a patient;
40.20(20) failure to make reports as required by section 151.072 or to cooperate with an
40.21investigation of the board as required by section 151.074;
40.22(21) knowingly providing false or misleading information that is directly related
40.23to the care of a patient unless done for an accepted therapeutic purpose such as the
40.24dispensing and administration of a placebo;
40.25(22) aiding suicide or aiding attempted suicide in violation of section 609.215 as
40.26established by any of the following:
40.27(i) a copy of the record of criminal conviction or plea of guilty for a felony in
40.28violation of section 609.215, subdivision 1 or 2;
40.29(ii) a copy of the record of a judgment of contempt of court for violating an
40.30injunction issued under section 609.215, subdivision 4;
40.31(iii) a copy of the record of a judgment assessing damages under section 609.215,
40.32subdivision 5; or
40.33(iv) a finding by the board that the person violated section 609.215, subdivision
40.341 or 2. The board shall investigate any complaint of a violation of section 609.215,
40.35subdivision 1 or 2;
41.1(23) for a pharmacist, practice of pharmacy under a lapsed or nonrenewed license.
41.2For a pharmacist intern, pharmacy technician, or controlled substance researcher,
41.3performing duties permitted to such individuals by this chapter or the rules of the board
41.4under a lapsed or nonrenewed registration. For a facility required to be licensed under this
41.5chapter, operation of the facility under a lapsed or nonrenewed license or registration; and
41.6(24) for a pharmacist, pharmacist intern, or pharmacy technician, termination
41.7or discharge from the health professional services program for reasons other than the
41.8satisfactory completion of the program.
41.9 Subd. 3. Automatic suspension. (a) A license or registration issued under this
41.10chapter to a pharmacist, pharmacist intern, pharmacy technician, or controlled substance
41.11researcher is automatically suspended if: (1) a guardian of a licensee or registrant is
41.12appointed by order of a court pursuant to sections 524.5-101 to 524.5-502, for reasons
41.13other than the minority of the licensee or registrant; or (2) the licensee or registrant is
41.14committed by order of a court pursuant to chapter 253B. The license or registration
41.15remains suspended until the licensee is restored to capacity by a court and, upon petition
41.16by the licensee or registrant, the suspension is terminated by the board after a hearing.
41.17(b) For a pharmacist, pharmacy intern, or pharmacy technician, upon notice to the
41.18board of a judgment of, or a plea of guilty to, a felony reasonably related to the practice
41.19of pharmacy, the license or registration of the regulated person may be automatically
41.20suspended by the board. The license or registration will remain suspended until, upon
41.21petition by the regulated individual and after a hearing, the suspension is terminated by
41.22the board. The board may indefinitely suspend or revoke the license or registration of the
41.23regulated individual if, after a hearing before the board, the board finds that the felonious
41.24conduct would cause a serious risk of harm to the public.
41.25(c) For a facility that is licensed or registered by the board, upon notice to the
41.26board that an owner of the facility is subject to a judgment of, or a plea of guilty to,
41.27a felony reasonably related to the operation of the facility, the license or registration of
41.28the facility may be automatically suspended by the board. The license or registration will
41.29remain suspended until, upon petition by the facility and after a hearing, the suspension
41.30is terminated by the board. The board may indefinitely suspend or revoke the license or
41.31registration of the facility if, after a hearing before the board, the board finds that the
41.32felonious conduct would cause a serious risk of harm to the public.
41.33(d) For licenses and registrations that have been suspended or revoked pursuant
41.34to paragraphs (a) and (b), the regulated individual may have a license or registration
41.35reinstated, either with or without restrictions, by demonstrating clear and convincing
41.36evidence of rehabilitation, as provided in section 364.03. If the regulated individual has
42.1the conviction subsequently overturned by court decision, the board shall conduct a
42.2hearing to review the suspension within 30 days after the receipt of the court decision.
42.3The regulated individual is not required to prove rehabilitation if the subsequent court
42.4decision overturns previous court findings of public risk.
42.5(e) For licenses and registrations that have been suspended or revoked pursuant to
42.6paragraph (c), the regulated facility may have a license or registration reinstated, either with
42.7or without restrictions, conditions, or limitations, by demonstrating clear and convincing
42.8evidence of rehabilitation of the convicted owner, as provided in section 364.03. If the
42.9convicted owner has the conviction subsequently overturned by court decision, the board
42.10shall conduct a hearing to review the suspension within 30 days after receipt of the court
42.11decision. The regulated facility is not required to prove rehabilitation of the convicted
42.12owner if the subsequent court decision overturns previous court findings of public risk.
42.13(f) The board may, upon majority vote of a quorum of its appointed members,
42.14suspend the license or registration of a regulated individual without a hearing if the
42.15regulated individual fails to maintain a current name and address with the board, as
42.16described in paragraphs (h) and (i), while the regulated individual is: (1) under board
42.17investigation, and a notice of conference has been issued by the board; (2) party to a
42.18contested case with the board; (3) party to an agreement for corrective action with the
42.19board; or (4) under a board order for disciplinary action. The suspension shall remain
42.20in effect until lifted by the board to the board's receipt of a petition from the regulated
42.21individual, along with the current name and address of the regulated individual.
42.22(g) The board may, upon majority vote of a quorum of its appointed members,
42.23suspend the license or registration of a regulated facility without a hearing if the regulated
42.24facility fails to maintain a current name and address of the owner of the facility with the
42.25board, as described in paragraphs (h) and (i), while the regulated facility is: (1) under
42.26board investigation, and a notice of conference has been issued by the board; (2) party
42.27to a contested case with the board; (3) party to an agreement for corrective action with
42.28the board; or (4) under a board order for disciplinary action. The suspension shall remain
42.29in effect until lifted by the board pursuant to the board's receipt of a petition from the
42.30regulated facility, along with the current name and address of the owner of the facility.
42.31(h) An individual licensed or registered by the board shall maintain a current name
42.32and home address with the board and shall notify the board in writing within 30 days of
42.33any change in name or home address. An individual regulated by the board shall also
42.34maintain a current business address with the board as required by section 214.073. For
42.35an individual, if a name change only is requested, the regulated individual must request
42.36a revised license or registration. The board may require the individual to substantiate
43.1the name change by submitting official documentation from a court of law or agency
43.2authorized under law to receive and officially record a name change. In the case of an
43.3individual, if an address change only is requested, no request for a revised license or
43.4registration is required. If the current license or registration of an individual has been lost,
43.5stolen, or destroyed, the individual shall provide a written explanation to the board.
43.6(i) A facility licensed or registered by the board shall maintain a current name and
43.7address with the board. A facility shall notify the board in writing within 30 days of any
43.8change in name. A facility licensed or registered by the board but located outside of the
43.9state must notify the board within 30 days of an address change. A facility licensed or
43.10registered by the board and located within the state must notify the board at least 60
43.11days in advance of a change of address that will result from the move of the facility to a
43.12different location and must pass an inspection at the new location as required by the board.
43.13If the current license or registration of a facility has been lost, stolen, or destroyed, the
43.14facility shall provide a written explanation to the board.
43.15 Subd. 4. Effective dates. A suspension, revocation, condition, limitation,
43.16qualification, or restriction of a license or registration shall be in effect pending
43.17determination of an appeal. A revocation of a license pursuant to subdivision 1 is not
43.18appealable and shall remain in effect indefinitely.
43.19 Subd. 5. Conditions on reissued license. In its discretion, the board may restore
43.20and reissue a license or registration issued under this chapter, but as a condition thereof
43.21may impose any disciplinary or corrective measure that it might originally have imposed.
43.22 Subd. 6. Temporary suspension of license for pharmacists. In addition to any
43.23other remedy provided by law, the board may, without a hearing, temporarily suspend the
43.24license of a pharmacist if the board finds that the pharmacist has violated a statute or rule
43.25that the board is empowered to enforce and continued practice by the pharmacist would
43.26create a serious risk of harm to the public. The suspension shall take effect upon written
43.27notice to the pharmacist, specifying the statute or rule violated. The suspension shall
43.28remain in effect until the board issues a final order in the matter after a hearing. At the
43.29time it issues the suspension notice, the board shall schedule a disciplinary hearing to be
43.30held pursuant to the Administrative Procedure Act. The pharmacist shall be provided with
43.31at least 20 days' notice of any hearing held pursuant to this subdivision. The hearing shall
43.32be scheduled to begin no later than 30 days after the issuance of the suspension order.
43.33 Subd. 7. Temporary suspension of license for pharmacist interns, pharmacy
43.34technicians, and controlled substance researchers. In addition to any other remedy
43.35provided by law, the board may, without a hearing, temporarily suspend the registration of
43.36a pharmacist intern, pharmacy technician, or controlled substance researcher if the board
44.1finds that the registrant has violated a statute or rule that the board is empowered to enforce
44.2and continued registration of the registrant would create a serious risk of harm to the
44.3public. The suspension shall take effect upon written notice to the registrant, specifying
44.4the statute or rule violated. The suspension shall remain in effect until the board issues a
44.5final order in the matter after a hearing. At the time it issues the suspension notice, the
44.6board shall schedule a disciplinary hearing to be held pursuant to the Administrative
44.7Procedure Act. The licensee or registrant shall be provided with at least 20 days' notice of
44.8any hearing held pursuant to this subdivision. The hearing shall be scheduled to begin no
44.9later than 30 days after the issuance of the suspension order.
44.10 Subd. 8. Temporary suspension of license for pharmacies, drug wholesalers,
44.11drug manufacturers, medical gas manufacturers, and medical gas distributors.
44.12In addition to any other remedy provided by law, the board may, without a hearing,
44.13temporarily suspend the license or registration of a pharmacy, drug wholesaler, drug
44.14manufacturer, medical gas manufacturer, or medical gas distributor if the board finds
44.15that the licensee or registrant has violated a statute or rule that the board is empowered
44.16to enforce and continued operation of the licensed facility would create a serious risk of
44.17harm to the public. The suspension shall take effect upon written notice to the licensee or
44.18registrant, specifying the statute or rule violated. The suspension shall remain in effect
44.19until the board issues a final order in the matter after a hearing. At the time it issues the
44.20suspension notice, the board shall schedule a disciplinary hearing to be held pursuant to
44.21the Administrative Procedure Act. The licensee or registrant shall be provided with at
44.22least 20 days' notice of any hearing held pursuant to this subdivision. The hearing shall be
44.23scheduled to begin no later than 30 days after the issuance of the suspension order.
44.24 Subd. 9. Evidence. In disciplinary actions alleging a violation of subdivision 2,
44.25clause (4), (5), (6), or (7), a copy of the judgment or proceeding under the seal of the court
44.26administrator or of the administrative agency that entered the same shall be admissible
44.27into evidence without further authentication and shall constitute prima facie evidence
44.28of the contents thereof.
44.29 Subd. 10. Mental examination; access to medical data. (a) If the board has
44.30probable cause to believe that an individual licensed or registered by the board falls under
44.31subdivision 2, clause (14), it may direct the individual to submit to a mental or physical
44.32examination. For the purpose of this subdivision, every licensed or registered individual is
44.33deemed to have consented to submit to a mental or physical examination when directed in
44.34writing by the board and further to have waived all objections to the admissibility of the
44.35examining practitioner's testimony or examination reports on the grounds that the same
44.36constitute a privileged communication. Failure of a licensed or registered individual to
45.1submit to an examination when directed constitutes an admission of the allegations against
45.2the individual, unless the failure was due to circumstances beyond the individual's control,
45.3in which case a default and final order may be entered without the taking of testimony or
45.4presentation of evidence. Pharmacists affected under this paragraph shall at reasonable
45.5intervals be given an opportunity to demonstrate that they can resume the competent
45.6practice of the profession of pharmacy with reasonable skill and safety to the public.
45.7Pharmacist interns, pharmacy technicians, or controlled substance researchers affected
45.8under this paragraph shall at reasonable intervals be given an opportunity to demonstrate
45.9that they can competently resume the duties that can be performed, under this chapter or
45.10the rules of the board, by similarly registered persons with reasonable skill and safety to
45.11the public. In any proceeding under this paragraph, neither the record of proceedings nor
45.12the orders entered by the board shall be used against a licensed or registered individual
45.13in any other proceeding.
45.14(b) In addition to ordering a physical or mental examination, the board may,
45.15notwithstanding section 13.384, 144.651, or any other law limiting access to medical or
45.16other health data, obtain medical data and health records relating to an individual licensed
45.17or registered by the board, or to an applicant for licensure or registration, without the
45.18individual's consent, if the board has probable cause to believe that the individual falls
45.19under subdivision 2, clause (14). The medical data may be requested from a provider,
45.20as defined in section 144.291, subdivision 2, paragraph (h), an insurance company, or a
45.21government agency, including the Department of Human Services. A provider, insurance
45.22company, or government agency shall comply with any written request of the board under
45.23this subdivision and is not liable in any action for damages for releasing the data requested
45.24by the board if the data are released pursuant to a written request under this subdivision,
45.25unless the information is false and the provider giving the information knew, or had reason
45.26to believe, the information was false. Information obtained under this subdivision is
45.27classified as private under sections 13.01 to 13.87.
45.28 Subd. 11. Tax clearance certificate. (a) In addition to the provisions of subdivision
45.291, the board may not issue or renew a license or registration if the commissioner of
45.30revenue notifies the board and the licensee or applicant for a license that the licensee or
45.31applicant owes the state delinquent taxes in the amount of $500 or more. The board may
45.32issue or renew the license or registration only if (1) the commissioner of revenue issues a
45.33tax clearance certificate, and (2) the commissioner of revenue or the licensee, registrant, or
45.34applicant forwards a copy of the clearance to the board. The commissioner of revenue
45.35may issue a clearance certificate only if the licensee, registrant, or applicant does not owe
45.36the state any uncontested delinquent taxes.
46.1(b) For purposes of this subdivision, the following terms have the meanings given.
46.2(1) "Taxes" are all taxes payable to the commissioner of revenue, including penalties
46.3and interest due on those taxes.
46.4(2) "Delinquent taxes" do not include a tax liability if (i) an administrative or court
46.5action that contests the amount or validity of the liability has been filed or served, (ii) the
46.6appeal period to contest the tax liability has not expired, or (iii) the licensee or applicant
46.7has entered into a payment agreement to pay the liability and is current with the payments.
46.8(c) In lieu of the notice and hearing requirements of subdivision 1, when a licensee,
46.9registrant, or applicant is required to obtain a clearance certificate under this subdivision,
46.10a contested case hearing must be held if the licensee or applicant requests a hearing in
46.11writing to the commissioner of revenue within 30 days of the date of the notice provided
46.12in paragraph (a). The hearing must be held within 45 days of the date the commissioner of
46.13revenue refers the case to the Office of Administrative Hearings. Notwithstanding any law
46.14to the contrary, the licensee or applicant must be served with 20 days' notice in writing
46.15specifying the time and place of the hearing and the allegations against the licensee or
46.16applicant. The notice may be served personally or by mail.
46.17(d) A licensee or applicant must provide the licensee's or applicant's Social Security
46.18number and Minnesota business identification number on all license applications. Upon
46.19request of the commissioner of revenue, the board must provide to the commissioner of
46.20revenue a list of all licensees and applicants that includes the licensee's or applicant's
46.21name, address, Social Security number, and business identification number. The
46.22commissioner of revenue may request a list of the licensees and applicants no more than
46.23once each calendar year.
46.24 Subd. 12. Limitation. No board proceeding against a regulated person or facility
46.25shall be instituted unless commenced within seven years from the date of the commission
46.26of some portion of the offense or misconduct complained of except for alleged violations
46.27of subdivision 2, clause (21).
46.28 Sec. 4. [151.072] REPORTING OBLIGATIONS.
46.29 Subdivision 1. Permission to report. A person who has knowledge of any conduct
46.30constituting grounds for discipline under the provisions of this chapter or the rules of the
46.31board may report the violation to the board.
46.32 Subd. 2. Pharmacies. A pharmacy located in this state must report to the board any
46.33discipline that is related to an incident involving conduct that would constitute grounds
46.34for discipline under the provisions of this chapter or the rules of the board, that is taken
46.35by the pharmacy or any of its administrators against a pharmacist, pharmacist intern, or
47.1pharmacy technician, including the termination of employment of the individual or the
47.2revocation, suspension, restriction, limitation, or conditioning of an individual's ability
47.3to practice or work at or on behalf of the pharmacy. The pharmacy shall also report the
47.4resignation of any pharmacist, pharmacist intern, or technician prior to the conclusion of
47.5any disciplinary proceeding, or prior to the commencement of formal charges but after the
47.6individual had knowledge that formal charges were contemplated or in preparation. Each
47.7report made under this subdivision must state the nature of the action taken and state in
47.8detail the reasons for the action. Failure to report violations as required by this subdivision
47.9is a basis for discipline pursuant to section 151.071, subdivision 2, clause (8).
47.10 Subd. 3. Licensees and registrants of the board. A licensee or registrant of
47.11the board shall report to the board personal knowledge of any conduct that the person
47.12reasonably believes constitutes grounds for disciplinary action under this chapter or
47.13the rules of the board by any pharmacist, pharmacist intern, pharmacy technician, or
47.14controlled substance researcher, including any conduct indicating that the person may be
47.15professionally incompetent, or may have engaged in unprofessional conduct or may be
47.16medically or physically unable to engage safely in the practice of pharmacy or to carry
47.17out the duties permitted to the person by this chapter or the rules of the board. Failure
47.18to report violations as required by this subdivision is a basis for discipline pursuant to
47.19section 151.071, subdivision 2, clause (20).
47.20 Subd. 4. Self-reporting. A licensee or registrant of the board shall report to the
47.21board any personal action that would require that a report be filed with the board pursuant
47.22to subdivision 2.
47.23 Subd. 5. Deadlines; forms. Reports required by subdivisions 2 to 4 must be
47.24submitted not later than 30 days after the occurrence of the reportable event or transaction.
47.25The board may provide forms for the submission of reports required by this section, may
47.26require that reports be submitted on the forms provided, and may adopt rules necessary
47.27to assure prompt and accurate reporting.
47.28 Subd. 6. Subpoenas. The board may issue subpoenas for the production of any
47.29reports required by subdivisions 2 to 4 or any related documents.
47.30 Sec. 5. [151.073] IMMUNITY.
47.31 Subdivision 1. Reporting. Any person, health care facility, business, or organization
47.32is immune from civil liability or criminal prosecution for submitting in good faith a report
47.33to the board under section 151.072 or for otherwise reporting in good faith to the board
47.34violations or alleged violations of this chapter or the rules of the board. All such reports
47.35are investigative data as defined in chapter 13.
48.1 Subd. 2. Investigation. (a) Members of the board and persons employed by the board
48.2or engaged on behalf of the board in the investigation of violations and in the preparation
48.3and management of charges or violations of this chapter of the rules of the board, or persons
48.4participating in the investigation or testifying regarding charges of violations, are immune
48.5from civil liability and criminal prosecution for any actions, transactions, or publications
48.6in the execution of, or relating to, their duties under this chapter or the rules of the board.
48.7(b) Members of the board and persons employed by the board or engaged in
48.8maintaining records and making reports regarding adverse health care events are immune
48.9from civil liability and criminal prosecution for any actions, transactions, or publications
48.10in the execution of, or relating to, their duties under section 151.301.
48.11 Sec. 6. [151.074] LICENSEE OR REGISTRANT COOPERATION.
48.12An individual who is licensed or registered by the board, who is the subject of an
48.13investigation by or on behalf of the board, shall cooperate fully with the investigation.
48.14An owner or employee of a facility that is licensed or registered by the board, when the
48.15facility is the subject of an investigation by or on behalf of the board, shall cooperate
48.16fully with the investigation. Cooperation includes responding fully and promptly to any
48.17question raised by, or on behalf of, the board relating to the subject of the investigation and
48.18providing copies of patient pharmacy records and other relevant records, as reasonably
48.19requested by the board, to assist the board in its investigation. The board shall maintain
48.20any records obtained pursuant to this section as investigative data pursuant to chapter 13.
48.21 Sec. 7. [151.075] DISCIPLINARY RECORD ON JUDICIAL REVIEW.
48.22Upon judicial review of any board disciplinary action taken under this chapter, the
48.23reviewing court shall seal the administrative record, except for the board's final decision,
48.24and shall not make the administrative record available to the public.
48.25 Sec. 8. Minnesota Statutes 2012, section 151.211, is amended to read:
48.26151.211 RECORDS OF PRESCRIPTIONS.
48.27 Subdivision 1. Retention of prescription drug orders. All
48.28 prescription drug orders shall be kept on file at the location
48.29
48.30orders that are electronically prescribed must be kept on file in the format in which
48.31they were originally received. Written or printed prescription drug orders and verbal
48.32prescription drug orders reduced to writing, must be kept on file as received or transcribed,
48.33except that such orders may be kept in an electronic format as allowed by the board.
49.1Electronic systems used to process and store prescription drug orders must be compliant
49.2with the requirements of this chapter and the rules of the board. Prescription drug orders
49.3that are stored in an electronic format, as permitted by this subdivision, may be kept on
49.4file at a remote location provided that they are readily and securely accessible from the
49.5location at which dispensing of the ordered drug occurred.
49.6 Subd. 2. Refill requirements.
49.7
49.8accordance with the requirements of this chapter, the rules of the board, and where
49.9applicable, section 152.11. The date of such refill must be recorded and initialed upon
49.10the original prescription drug order, or within the electronically maintained record of the
49.11original prescription drug order, by the pharmacist, pharmacist intern, or practitioner
49.12who refills the prescription.
49.13 Sec. 9. [151.251] COMPOUNDING.
49.14 Subdivision 1. Exemption from manufacturing licensure requirement. Section
49.15151.252 shall not apply to:
49.16(1) a practitioner engaged in extemporaneous compounding, anticipatory
49.17compounding, or compounding not done pursuant to a prescription drug order when
49.18permitted by this chapter or the rules of the board; and
49.19(2) a pharmacy in which a pharmacist is engaged in extemporaneous compounding,
49.20anticipatory compounding, or compounding not done pursuant to a prescription drug order
49.21when permitted by this chapter or the rules of the board.
49.22 Subd. 2. Compounded drug. A drug product may be compounded under this
49.23section if a pharmacist or practitioner:
49.24(a) compounds the drug product using bulk drug substances, as defined in the federal
49.25regulations published in Code of Federal Regulations, title 21, section 207.3(a)(4):
49.26(1) that:
49.27(i) comply with the standards of an applicable United States Pharmacopoeia
49.28or National Formulary monograph, if a monograph exists, and the United States
49.29Pharmacopoeia chapter on pharmacy compounding;
49.30(ii) if such a monograph does not exist, are drug substances that are components of
49.31drugs approved for use in this country by the United States Food and Drug Administration;
49.32or
49.33(iii) if such a monograph does not exist and the drug substance is not a component of
49.34a drug approved for use in this country by the United States Food and Drug Administration,
49.35that appear on a list developed by the United States Food and Drug Administration through
50.1regulations issued by the secretary of the federal Department of Health and Human
50.2Services pursuant to section 503a of the Food, Drug and Cosmetic Act under paragraph (d);
50.3(2) that are manufactured by an establishment that is registered under section 360
50.4of the federal Food, Drug and Cosmetic Act, including a foreign establishment that is
50.5registered under section 360(i) of that act; and
50.6(3) that are accompanied by valid certificates of analysis for each bulk drug substance;
50.7(b) compounds the drug product using ingredients, other than bulk drug substances,
50.8that comply with the standards of an applicable United States Pharmacopoeia or National
50.9Formulary monograph, if a monograph exists, and the United States Pharmacopoeia
50.10chapters on pharmacy compounding;
50.11(c) does not compound a drug product that appears on a list published by the secretary
50.12of the federal Department of Health and Human Services in the Federal Register of drug
50.13products that have been withdrawn or removed from the market because such drug products
50.14or components of such drug products have been found to be unsafe or not effective;
50.15(d) does not compound any drug products that are essentially copies of a
50.16commercially available drug product; and
50.17(e) does not compound any drug product that has been identified pursuant to
50.18United States Code, title 21, section 353a, as a drug product that presents demonstrable
50.19difficulties for compounding that reasonably demonstrate an adverse effect on the safety
50.20or effectiveness of that drug product.
50.21The term "essentially a copy of a commercially available drug product" does not
50.22include a drug product in which there is a change, made for an identified individual
50.23patient, that produces for that patient a significant difference, as determined by the
50.24prescribing practitioner, between the compounded drug and the comparable commercially
50.25available drug product.
50.26 Subd. 3. Exceptions. This section shall not apply to:
50.27(1) compounded positron emission tomography drugs as defined in section 151.01,
50.28subdivision 38; or
50.29(2) radiopharmaceuticals.
50.30 Sec. 10. Minnesota Statutes 2013 Supplement, section 151.252, is amended by adding
50.31a subdivision to read:
50.32 Subd. 1a. Outsourcing facility. (a) No person shall act as an outsourcing facility
50.33without first obtaining a license from the board and paying any applicable manufacturer
50.34licensing fee specified in section 151.065.
51.1(b) Application for an outsourcing facility license under this section shall be made
51.2in a manner specified by the board and may differ from the application required of other
51.3drug manufacturers.
51.4(c) No license shall be issued or renewed for an outsourcing facility unless the
51.5applicant agrees to operate in a manner prescribed for outsourcing facilities by federal and
51.6state law and according to Minnesota Rules.
51.7(d) No license shall be issued or renewed for an outsourcing facility unless the
51.8applicant supplies the board with proof of such registration by the United States Food and
51.9Drug Administration as required by United States Code, title 21, section 353b.
51.10(e) No license shall be issued or renewed for an outsourcing facility that is required
51.11to be licensed or registered by the state in which it is physically located unless the
51.12applicant supplies the board with proof of such licensure or registration. The board may
51.13establish, by rule, standards for the licensure of an outsourcing facility that is not required
51.14to be licensed or registered by the state in which it is physically located.
51.15(f) The board shall require a separate license for each outsourcing facility located
51.16within the state and for each outsourcing facility located outside of the state at which drugs
51.17that are shipped into the state are prepared.
51.18(g) The board shall not issue an initial or renewed license for an outsourcing facility
51.19unless the facility passes an inspection conducted by an authorized representative of the
51.20board. In the case of an outsourcing facility located outside of the state, the board may
51.21require the applicant to pay the cost of the inspection, in addition to the license fee in
51.22section 151.065, unless the applicant furnishes the board with a report, issued by the
51.23appropriate regulatory agency of the state in which the facility is located or by the United
51.24States Food and Drug Administration, of an inspection that has occurred within the 24
51.25months immediately preceding receipt of the license application by the board. The board
51.26may deny licensure unless the applicant submits documentation satisfactory to the board
51.27that any deficiencies noted in an inspection report have been corrected.
51.28 Sec. 11. Minnesota Statutes 2012, section 151.26, is amended to read:
51.29151.26 EXCEPTIONS.
51.30 Subdivision 1. Generally. Nothing in this chapter shall subject a person duly
51.31licensed in this state to practice medicine, dentistry, or veterinary medicine, to inspection
51.32by the State Board of Pharmacy, nor prevent the person from administering drugs,
51.33medicines, chemicals, or poisons in the person's practice, nor prevent a duly licensed
51.34practitioner from furnishing to a patient properly packaged and labeled drugs, medicines,
51.35chemicals, or poisons as may be considered appropriate in the treatment of such patient;
52.1unless the person is engaged in the dispensing, sale, or distribution of drugs and the board
52.2provides reasonable notice of an inspection.
52.3Except for the provisions of section
52.4interferes with the dispensing, in its original package and at no charge to the patient, of
52.5a legend drug
52.6and provided to the dispenser for
52.7long as the sample is prepared and distributed pursuant to Code of Federal Regulations,
52.8title 21, section 203, subpart D.
52.9Nothing in this chapter shall prevent the sale of drugs, medicines, chemicals, or
52.10poisons at wholesale to licensed physicians, dentists and veterinarians for use in their
52.11practice, nor to hospitals for use therein.
52.12Nothing in this chapter shall prevent the sale of drugs, chemicals, or poisons either
52.13at wholesale or retail for use for commercial purposes, or in the arts, nor interfere with the
52.14sale of insecticides, as defined in Minnesota Statutes 1974, section
52.15this chapter shall prevent the sale of common household preparations and other drugs,
52.16chemicals, and poisons sold exclusively for use for nonmedicinal purposes
52.17that this exception does not apply to any compound, substance, or derivative that is not
52.18approved for human consumption by the United States Food and Drug Administration
52.19or specifically permitted for human consumption under Minnesota law and, when
52.20introduced into the body, induces an effect similar to that of a Schedule I or Schedule II
52.21controlled substance listed in section 152.02, subdivisions 2 and 3, or Minnesota Rules,
52.22parts 6800.4210 and 6800.4220, regardless of whether the substance is marketed for the
52.23purpose of human consumption.
52.24Nothing in this chapter shall apply to or interfere with the vending or retailing of
52.25any nonprescription medicine or drug not otherwise prohibited by statute
52.26prepackaged, fully prepared by the manufacturer or producer for use by the consumer, and
52.27labeled in accordance with the requirements of the state or federal Food and Drug Act; nor
52.28to the manufacture, wholesaling, vending, or retailing of flavoring extracts, toilet articles,
52.29cosmetics, perfumes, spices, and other commonly used household articles of a chemical
52.30nature, for use for nonmedicinal purposes
52.31to any compound, substance, or derivative that is not approved for human consumption
52.32by the United States Food and Drug Administration or specifically permitted for human
52.33consumption under Minnesota law that, when introduced into the body, induces an effect
52.34similar to that of a Schedule I or Schedule II controlled substance listed in section 152.02,
52.35subdivisions 2 and 3, or Minnesota Rules, parts 6800.4210 and 6800.4220, regardless of
52.36whether the substance is marketed for the purpose of human consumption. Nothing in
53.1this chapter shall prevent the sale of drugs or medicines by licensed pharmacists at a
53.2discount to persons over 65 years of age.
53.3 Sec. 12. Minnesota Statutes 2012, section 151.34, is amended to read:
53.4151.34 PROHIBITED ACTS.
53.5It shall be unlawful to:
53.6(1) manufacture, sell or deliver, hold or offer for sale any drug that is adulterated
53.7or misbranded;
53.8(2) adulterate or misbrand any drug;
53.9(3) receive in commerce any drug that is adulterated or misbranded, and to deliver or
53.10proffer delivery thereof for pay or otherwise;
53.11(4) refuse to permit entry or inspection, or to permit the taking of a sample, or to
53.12permit access to or copying of any record as authorized by this chapter;
53.13(5) remove or dispose of a detained or embargoed article in violation of this chapter;
53.14(6) alter, mutilate, destroy, obliterate, or remove the whole or any part of the labeling
53.15of, or to do any other act with respect to a drug, if such act is done while such drug is held
53.16for sale and results in such drug being adulterated or misbranded;
53.17(7) use for a person's own advantage or to reveal other than to the board or its
53.18authorized representative or to the courts when required in any judicial proceeding under
53.19this chapter any information acquired under authority of this chapter concerning any
53.20method or process
53.21(8) use on the labeling of any drug any representation or suggestion that an
53.22application with respect to such drug is effective under the federal act or that such drug
53.23complies with such provisions;
53.24(9) in the case of a manufacturer, packer, or distributor offering legend drugs for sale
53.25within this state, fail to maintain for transmittal or to transmit, to any practitioner licensed
53.26by applicable law to administer such drug who makes written request for information as to
53.27such drug, true and correct copies of all printed matter
53.28in any package in which that drug is distributed or sold, or such other printed matter as is
53.29approved under the federal act. Nothing in this paragraph shall be construed to exempt
53.30any person from any labeling requirement imposed by or under provisions of this chapter;
53.31(10) conduct a pharmacy without a pharmacist in charge;
53.32(11) dispense a legend drug without first obtaining a valid prescription for that drug;
53.33(12) conduct a pharmacy without proper registration with the board;
53.34(13) practice pharmacy without being licensed to do so by the board;
54.1(14) sell at retail federally restricted medical gases without proper registration with
54.2the board except as provided in this chapter
54.3(15) sell any compound, substance, or derivative that is not approved for human
54.4consumption by the United States Food and Drug Administration or specifically permitted
54.5for human consumption under Minnesota law and, when introduced into the body, induces
54.6an effect similar to that of a Schedule I or Schedule II controlled substance listed in
54.7section 152.02, subdivisions 2 and 3, or Minnesota Rules, parts 6800.4210 and 6800.4220,
54.8regardless of whether the substance is marketed for the purpose of human consumption.
54.9EFFECTIVE DATE.This section is effective August 1, 2014, and applies to sales
54.10on or after that date.
54.11 Sec. 13. Minnesota Statutes 2012, section 151.35, is amended to read:
54.12151.35 DRUGS, ADULTERATION.
54.13A drug shall be deemed to be adulterated:
54.14(1) if it consists in whole or in part of any filthy, putrid or decomposed substance; or
54.15if it has been produced, prepared, packed, or held under unsanitary conditions whereby it
54.16may have been rendered injurious to health, or whereby it may have been contaminated
54.17with filth; or if the methods used in, or the facilities or controls used for, its manufacture,
54.18processing, packing, or holding do not conform to or are not operated or administered
54.19in conformity with current good manufacturing practice as required under the federal
54.20act to assure that such drug is safe and has the identity, strength, quality, and purity
54.21characteristics, which it purports or is represented to possess; or the facility in which it
54.22was produced was not registered by the United States Food and Drug Administration or
54.23licensed by the board; or, its container is composed, in whole or in part, of any poisonous
54.24or deleterious substance which may render the contents injurious to health; or it bears
54.25or contains, for purposes of coloring only, a color additive which is unsafe within the
54.26meaning of the federal act, or it is a color additive, the intended use of which in or on drugs
54.27is for the purposes of coloring only, and is unsafe within the meaning of the federal act;
54.28(2) if it purports to be or is represented as a drug the name of which is recognized in
54.29the United States Pharmacopoeia or the National Formulary, and its strength differs from,
54.30or its quality or purity falls below, the standard set forth therein. Such determination as
54.31to strength, quality, or purity shall be made in accordance with the tests or methods of
54.32assay set forth in such compendium, or in the absence of or inadequacy of such tests or
54.33methods of assay, those prescribed under authority of the federal act. No drug defined
54.34in the United States Pharmacopoeia or the National Formulary shall be deemed to be
55.1adulterated under this paragraph because it differs from the standard of strength, quality,
55.2or purity therefor set forth in such compendium, if its difference in strength, quality, or
55.3purity from such standard is plainly stated on its label;
55.4(3) if it is not subject to the provisions of paragraph (2) of this section and its
55.5strength differs from, or its purity or quality differs from that which it purports or is
55.6represented to possess;
55.7(4) if any substance has been mixed or packed therewith so as to reduce its quality or
55.8strength, or substituted wholly or in part therefor.
55.9 Sec. 14. Minnesota Statutes 2012, section 151.361, subdivision 2, is amended to read:
55.10 Subd. 2. After January 1, 1983. (a) No legend drug in solid oral dosage form
55.11may be manufactured, packaged or distributed for sale in this state after January 1, 1983
55.12unless it is clearly marked or imprinted with a symbol, number, company name, words,
55.13letters, national drug code or other mark uniquely identifiable to that drug product. An
55.14identifying mark or imprint made as required by federal law or by the federal Food and
55.15Drug Administration shall be deemed to be in compliance with this section.
55.16(b) The Board of Pharmacy may grant exemptions from the requirements of this
55.17section on its own initiative or upon application of a manufacturer, packager, or distributor
55.18indicating size or other characteristics
55.19imprinting required by this section.
55.20
55.21
55.22
55.23
55.24
55.25
55.26 Sec. 15. Minnesota Statutes 2012, section 151.37, as amended by Laws 2013, chapter
55.2743, section 30, Laws 2013, chapter 55, section 2, and Laws 2013, chapter 108, article
55.2810, section 5, is amended to read:
55.29151.37 LEGEND DRUGS, WHO MAY PRESCRIBE, POSSESS.
55.30 Subdivision 1. Prohibition. Except as otherwise provided in this chapter, it shall be
55.31unlawful for any person to have in possession, or to sell, give away, barter, exchange, or
55.32distribute a legend drug.
55.33 Subd. 2. Prescribing and filing. (a) A licensed practitioner in the course of
55.34professional practice only, may prescribe, administer, and dispense a legend drug, and
56.1may cause the same to be administered by a nurse, a physician assistant, or medical
56.2student or resident under the practitioner's direction and supervision, and may cause a
56.3person who is an appropriately certified, registered, or licensed health care professional
56.4to prescribe, dispense, and administer the same within the expressed legal scope of the
56.5person's practice as defined in Minnesota Statutes. A licensed practitioner may prescribe a
56.6legend drug, without reference to a specific patient, by directing a licensed dietitian or
56.7licensed nutritionist, pursuant to section
56.8subdivisions 8 and 9; physician assistant; medical student or resident; or pharmacist
56.9according to section 151.01, subdivision 27, to adhere to a particular practice guideline or
56.10protocol when treating patients whose condition falls within such guideline or protocol,
56.11and when such guideline or protocol specifies the circumstances under which the legend
56.12drug is to be prescribed and administered. An individual who verbally, electronically, or
56.13otherwise transmits a written, oral, or electronic order, as an agent of a prescriber, shall
56.14not be deemed to have prescribed the legend drug. This paragraph applies to a physician
56.15assistant only if the physician assistant meets the requirements of section
56.16(b) The commissioner of health, if a licensed practitioner, or a person designated
56.17by the commissioner who is a licensed practitioner, may prescribe a legend drug to an
56.18individual or by protocol for mass dispensing purposes where the commissioner finds that
56.19the conditions triggering section
56.20The commissioner, if a licensed practitioner, or a designated licensed practitioner, may
56.21prescribe, dispense, or administer a legend drug or other substance listed in subdivision 10
56.22to control tuberculosis and other communicable diseases. The commissioner may modify
56.23state drug labeling requirements, and medical screening criteria and documentation, where
56.24time is critical and limited labeling and screening are most likely to ensure legend drugs
56.25reach the maximum number of persons in a timely fashion so as to reduce morbidity
56.26and mortality.
56.27 (c) A licensed practitioner that dispenses for profit a legend drug that is to be
56.28administered orally, is ordinarily dispensed by a pharmacist, and is not a vaccine, must
56.29file with the practitioner's licensing board a statement indicating that the practitioner
56.30dispenses legend drugs for profit, the general circumstances under which the practitioner
56.31dispenses for profit, and the types of legend drugs generally dispensed. It is unlawful to
56.32dispense legend drugs for profit after July 31, 1990, unless the statement has been filed
56.33with the appropriate licensing board. For purposes of this paragraph, "profit" means (1)
56.34any amount received by the practitioner in excess of the acquisition cost of a legend drug
56.35for legend drugs that are purchased in prepackaged form, or (2) any amount received
56.36by the practitioner in excess of the acquisition cost of a legend drug plus the cost of
57.1making the drug available if the legend drug requires compounding, packaging, or other
57.2treatment. The statement filed under this paragraph is public data under section
57.3This paragraph does not apply to a licensed doctor of veterinary medicine or a registered
57.4pharmacist. Any person other than a licensed practitioner with the authority to prescribe,
57.5dispense, and administer a legend drug under paragraph (a) shall not dispense for profit.
57.6To dispense for profit does not include dispensing by a community health clinic when the
57.7profit from dispensing is used to meet operating expenses.
57.8 (d) A prescription
57.9be established that the prescription
57.10evaluation, including an examination, adequate to establish a diagnosis and identify
57.11underlying conditions and contraindications to treatment:
57.12 (1) controlled substance drugs listed in section
57.13 (2) drugs defined by the Board of Pharmacy as controlled substances under section
57.15 (3) muscle relaxants;
57.16 (4) centrally acting analgesics with opioid activity;
57.17 (5) drugs containing butalbital; or
57.18 (6) phoshodiesterase type 5 inhibitors when used to treat erectile dysfunction.
57.19 (e) For the purposes of paragraph (d), the requirement for an examination shall be
57.20met if an in-person examination has been completed in any of the following circumstances:
57.21 (1) the prescribing practitioner examines the patient at the time the prescription
57.22or drug order is issued;
57.23 (2) the prescribing practitioner has performed a prior examination of the patient;
57.24 (3) another prescribing practitioner practicing within the same group or clinic as the
57.25prescribing practitioner has examined the patient;
57.26 (4) a consulting practitioner to whom the prescribing practitioner has referred the
57.27patient has examined the patient; or
57.28 (5) the referring practitioner has performed an examination in the case of a
57.29consultant practitioner issuing a prescription or drug order when providing services by
57.30means of telemedicine.
57.31 (f) Nothing in paragraph (d) or (e) prohibits a licensed practitioner from prescribing
57.32a drug through the use of a guideline or protocol pursuant to paragraph (a).
57.33 (g) Nothing in this chapter prohibits a licensed practitioner from issuing a
57.34prescription or dispensing a legend drug in accordance with the Expedited Partner Therapy
57.35in the Management of Sexually Transmitted Diseases guidance document issued by the
57.36United States Centers for Disease Control.
58.1 (h) Nothing in paragraph (d) or (e) limits prescription, administration, or dispensing
58.2of legend drugs through a public health clinic or other distribution mechanism approved
58.3by the commissioner of health or a board of health in order to prevent, mitigate, or treat
58.4a pandemic illness, infectious disease outbreak, or intentional or accidental release of a
58.5biological, chemical, or radiological agent.
58.6 (i) No pharmacist employed by, under contract to, or working for a pharmacy
58.7licensed under section
58.8prescription that the pharmacist knows, or would reasonably be expected to know, is not
58.9valid under paragraph (d).
58.10 (j) No pharmacist employed by, under contract to, or working for a pharmacy
58.11licensed under section
58.12of this state based on a prescription that the pharmacist knows, or would reasonably be
58.13expected to know, is not valid under paragraph (d).
58.14(k) Nothing in this chapter prohibits the commissioner of health, if a licensed
58.15practitioner, or, if not a licensed practitioner, a designee of the commissioner who is
58.16a licensed practitioner, from prescribing legend drugs for field-delivered therapy in the
58.17treatment of a communicable disease according to the Centers For Disease Control and
58.18Prevention Partner Services Guidelines.
58.19 Subd. 2a. Delegation. A supervising physician may delegate to a physician assistant
58.20who is registered with the Board of Medical Practice and certified by the National
58.21Commission on Certification of Physician Assistants and who is under the supervising
58.22physician's supervision, the authority to prescribe, dispense, and administer legend drugs
58.23and medical devices, subject to the requirements in chapter 147A and other requirements
58.24established by the Board of Medical Practice in rules.
58.25 Subd. 3. Veterinarians. A licensed doctor of veterinary medicine, in the course of
58.26professional practice only and not for use by a human being, may personally prescribe,
58.27administer, and dispense a legend drug, and may cause the same to be administered or
58.28dispensed by an assistant under the doctor's direction and supervision.
58.29 Subd. 4. Research. (a) Any qualified person may use legend drugs in the course
58.30of a bona fide research project, but cannot administer or dispense such drugs to human
58.31beings unless such drugs are prescribed, dispensed, and administered by a person lawfully
58.32authorized to do so.
58.33 (b) Drugs may be dispensed or distributed by a pharmacy licensed by the board for
58.34use by, or administration to, patients enrolled in a bona fide research study that is being
58.35conducted pursuant to either an investigational new drug application approved by the
59.1United States Food and Drug Administration or that has been approved by an institutional
59.2review board. For the purposes of this subdivision only:
59.3 (1) a prescription drug order is not required for a pharmacy to dispense a research
59.4drug, unless the study protocol requires the pharmacy to receive such an order;
59.5 (2) notwithstanding the prescription labeling requirements found in this chapter or
59.6the rules promulgated by the board, a research drug may be labeled as required by the
59.7study protocol;
59.8 (3) dispensing and distribution of research drugs by pharmacies shall not be
59.9considered
59.10(4) a pharmacy may compound drugs for research studies as provided in
59.11this subdivision but must follow applicable standards established by United States
59.12Pharmacopeia, chapter 795 or 797, for nonsterile and sterile compounding, respectively.
59.13 (c) An entity that is under contract to a federal agency for the purpose of distributing
59.14drugs for bona fide research studies is exempt from the drug wholesaler licensing
59.15requirements of this chapter. Any other entity is exempt from the drug wholesaler
59.16licensing requirements of this chapter if the board finds that the entity is licensed or
59.17registered according to the laws of the state in which it is physically located and it is
59.18distributing drugs for use by, or administration to, patients enrolled in a bona fide research
59.19study that is being conducted pursuant to either an investigational new drug application
59.20approved by the United States Food and Drug Administration or that has been approved
59.21by an institutional review board.
59.22 Subd. 5. Exclusion for course of practice. Nothing in this chapter shall prohibit
59.23the sale to, or the possession of, a legend drug by licensed drug wholesalers, licensed
59.24manufacturers, registered pharmacies, local detoxification centers, licensed hospitals,
59.25bona fide hospitals wherein animals are treated, or licensed pharmacists and licensed
59.26practitioners while acting within the course of their practice only.
59.27 Subd. 6. Exclusion for course of employment. (a) Nothing in this chapter shall
59.28prohibit the possession of a legend drug by an employee, agent, or sales representative of
59.29a registered drug manufacturer, or an employee or agent of a registered drug wholesaler,
59.30or registered pharmacy, while acting in the course of employment.
59.31(b) Nothing in this chapter shall prohibit the following entities from possessing a
59.32legend drug for the purpose of disposing of the legend drug as pharmaceutical waste:
59.33(1) a law enforcement officer;
59.34(2) a hazardous waste transporter licensed by the Department of Transportation;
59.35(3) a facility permitted by the Pollution Control Agency to treat, store, or dispose of
59.36hazardous waste, including household hazardous waste;
60.1(4) a facility licensed by the Pollution Control Agency or a metropolitan county as a
60.2very small quantity generator collection program or a minimal generator;
60.3(5) a county that collects, stores, transports, or disposes of a legend drug pursuant to
60.4a program in compliance with applicable federal law or a person authorized by the county
60.5to conduct one or more of these activities; or
60.6(6) a sanitary district organized under chapter 115, or a special law.
60.7 Subd. 7. Exclusion for prescriptions. (a) Nothing in this chapter shall prohibit the
60.8possession of a legend drug by a person for that person's use when it has been dispensed to
60.9the person in accordance with a valid prescription issued by a practitioner.
60.10(b) Nothing in this chapter shall prohibit a person, for whom a legend drug has
60.11been dispensed in accordance with a written or oral prescription by a practitioner, from
60.12designating a family member, caregiver, or other individual to handle the legend drug for
60.13the purpose of assisting the person in obtaining or administering the drug or sending
60.14the drug for destruction.
60.15(c) Nothing in this chapter shall prohibit a person for whom a prescription drug has
60.16been dispensed in accordance with a valid prescription issued by a practitioner from
60.17transferring the legend drug to a county that collects, stores, transports, or disposes of a
60.18legend drug pursuant to a program in compliance with applicable federal law or to a
60.19person authorized by the county to conduct one or more of these activities.
60.20 Subd. 8. Misrepresentation. It is unlawful for a person to procure, attempt to
60.21procure, possess, or control a legend drug by any of the following means:
60.22(1) deceit, misrepresentation, or subterfuge;
60.23(2) using a false name; or
60.24(3) falsely assuming the title of, or falsely representing a person to be a manufacturer,
60.25wholesaler, pharmacist, practitioner, or other authorized person for the purpose of
60.26obtaining a legend drug.
60.27 Subd. 9. Exclusion for course of laboratory employment. Nothing in this chapter
60.28shall prohibit the possession of a legend drug by an employee or agent of a registered
60.29analytical laboratory while acting in the course of laboratory employment.
60.30 Subd. 10. Purchase of drugs and other agents by commissioner of health. The
60.31commissioner of health, in preparation for and in carrying out the duties of sections
60.33drugs, biologics, vaccines, antitoxins, serums, immunizing agents, antibiotics, antivirals,
60.34antidotes, other pharmaceutical agents, and medical supplies to treat and prevent
60.35communicable disease.
61.1 Subd. 10a. Emergency use authorizations. Nothing in this chapter shall prohibit
61.2the purchase, possession, or use of a legend drug by an entity acting according to an
61.3emergency use authorization issued by the United States Food and Drug Administration
61.4pursuant to United States Code, title 21, section 360.bbb-3. The entity must be specifically
61.5tasked in a public health response plan to perform critical functions necessary to support
61.6the response to a public health incident or event.
61.7 Subd. 11.
61.8
61.9
61.10
61.11postsecondary school from possessing a legend drug that is not a controlled substance
61.12listed in section 152.02, provided that:
61.13(a) the school is approved by the United States secretary of education in accordance
61.14with requirements of the Higher Education Act of 1965, as amended;
61.15(b) the school provides a course of instruction that prepares individuals for
61.16employment in a health care occupation or profession;
61.17(c) the school may only possess those drugs necessary for the instruction of such
61.18individuals; and
61.19(d) the drugs may only be used in the course of providing such instruction and are
61.20labeled by the purchaser to indicate that they are not to be administered to patients.
61.21Those areas of the school in which legend drugs are stored are subject to section
61.22151.06, subdivision 1, paragraph (a), clause (4).
61.23 Sec. 16. Minnesota Statutes 2012, section 151.44, is amended to read:
61.24151.44 DEFINITIONS.
61.25As used in sections
61.26in paragraphs (a) to (h):
61.27(a) "Wholesale drug distribution" means distribution of prescription or
61.28nonprescription drugs to persons other than a consumer or patient or reverse distribution
61.29of such drugs, but does not include:
61.30(1) a sale between a division, subsidiary, parent, affiliated, or related company under
61.31the common ownership and control of a corporate entity;
61.32(2) the purchase or other acquisition, by a hospital or other health care entity that is a
61.33member of a group purchasing organization, of a drug for its own use from the organization
61.34or from other hospitals or health care entities that are members of such organizations;
62.1(3) the sale, purchase, or trade of a drug or an offer to sell, purchase, or trade a
62.2drug by a charitable organization described in section 501(c)(3) of the Internal Revenue
62.3Code of 1986, as amended through December 31, 1988, to a nonprofit affiliate of the
62.4organization to the extent otherwise permitted by law;
62.5(4) the sale, purchase, or trade of a drug or offer to sell, purchase, or trade a drug
62.6among hospitals or other health care entities that are under common control;
62.7(5) the sale, purchase, or trade of a drug or offer to sell, purchase, or trade a drug
62.8for emergency medical reasons;
62.9(6) the sale, purchase, or trade of a drug, an offer to sell, purchase, or trade a drug, or
62.10the dispensing of a drug pursuant to a prescription;
62.11(7) the transfer of prescription or nonprescription drugs by a retail pharmacy to
62.12another retail pharmacy to alleviate a temporary shortage;
62.13(8) the distribution of prescription or nonprescription drug samples by manufacturers
62.14representatives; or
62.15(9) the sale, purchase, or trade of blood and blood components.
62.16(b) "Wholesale drug distributor" means anyone engaged in wholesale drug
62.17distribution including, but not limited to, manufacturers;
62.18distributors; jobbers; brokers; warehouses, including manufacturers' and distributors'
62.19warehouses, chain drug warehouses, and wholesale drug warehouses; independent
62.20wholesale drug traders; and pharmacies that conduct wholesale drug distribution. A
62.21wholesale drug distributor does not include a common carrier or individual hired primarily
62.22to transport prescription or nonprescription drugs.
62.23(c) "Manufacturer"
62.24
62.25
62.26(d) "Prescription drug" means a drug required by federal or state law or regulation
62.27to be dispensed only by a prescription, including finished dosage forms and active
62.28ingredients subject to United States Code, title 21, sections 811 and 812.
62.29(e) "Blood" means whole blood collected from a single donor and processed either
62.30for transfusion or further manufacturing.
62.31(f) "Blood components" means that part of blood separated by physical or
62.32mechanical means.
62.33(g) "Reverse distribution" means the receipt of prescription or nonprescription drugs
62.34received from or shipped to Minnesota locations for the purpose of returning the drugs
62.35to their producers or distributors.
62.36(h) "Reverse distributor" means a person engaged in the reverse distribution of drugs.
63.1 Sec. 17. Minnesota Statutes 2012, section 151.58, subdivision 2, is amended to read:
63.2 Subd. 2. Definitions. For purposes of this section only, the terms defined in this
63.3subdivision have the meanings given.
63.4(a) "Automated drug distribution system" or "system" means a mechanical system
63.5approved by the board that performs operations or activities, other than compounding or
63.6administration, related to the storage, packaging, or dispensing of drugs, and collects,
63.7controls, and maintains all required transaction information and records.
63.8(b) "Health care facility" means a nursing home licensed under section
63.9a housing with services establishment registered under section
63.10in which a home provider licensed under chapter 144A is providing centralized storage
63.11of medications; or a
63.12program facility operated by the Department of Human Services.
63.13(c) "Managing pharmacy" means a pharmacy licensed by the board that controls and
63.14is responsible for the operation of an automated drug distribution system.
63.15 Sec. 18. Minnesota Statutes 2012, section 151.58, subdivision 3, is amended to read:
63.16 Subd. 3. Authorization. A pharmacy may use an automated drug distribution
63.17system to fill prescription drug orders for patients of a health care facility provided that the
63.18policies and procedures required by this section have been approved by the board. The
63.19automated drug distribution system may be located in a health care facility that is not at
63.20the same location as the managing pharmacy. When located within a health care facility,
63.21the system is considered to be an extension of the managing pharmacy.
63.22 Sec. 19. Minnesota Statutes 2012, section 151.58, subdivision 5, is amended to read:
63.23 Subd. 5. Operation of automated drug distribution systems. (a) The managing
63.24pharmacy and the pharmacist in charge are responsible for the operation of an automated
63.25drug distribution system.
63.26(b) Access to an automated drug distribution system must be limited to pharmacy
63.27and nonpharmacy personnel authorized to procure drugs from the system, except that field
63.28service technicians may access a system located in a health care facility for the purposes of
63.29servicing and maintaining it while being monitored either by the managing pharmacy, or a
63.30licensed nurse within the health care facility. In the case of an automated drug distribution
63.31system that is not physically located within a licensed pharmacy, access for the purpose
63.32of procuring drugs shall be limited to licensed nurses. Each person authorized to access
63.33the system must be assigned an individual specific access code. Alternatively, access to
63.34the system may be controlled through the use of biometric identification procedures. A
64.1policy specifying time access parameters, including time-outs, logoffs, and lockouts,
64.2must be in place.
64.3(c) For the purposes of this section only, the requirements of section
64.4if the following clauses are met:
64.5(1) a pharmacist employed by and working at the managing pharmacy, or at a
64.6pharmacy that is acting as a central services pharmacy for the managing pharmacy,
64.7pursuant to Minnesota Rules, part 6800.4075, must review, interpret, and approve all
64.8prescription drug orders before any drug is distributed from the system to be administered
64.9to a patient. A pharmacy technician may perform data entry of prescription drug orders
64.10provided that a pharmacist certifies the accuracy of the data entry before the drug can
64.11be released from the automated drug distribution system. A pharmacist employed by
64.12and working at the managing pharmacy must certify the accuracy of the filling of any
64.13cassettes, canisters, or other containers that contain drugs that will be loaded into the
64.14automated drug distribution system; and
64.15(2) when the automated drug dispensing system is located and used within the
64.16managing pharmacy, a pharmacist must personally supervise and take responsibility for all
64.17packaging and labeling associated with the use of an automated drug distribution system.
64.18(d) Access to drugs when a pharmacist has not reviewed and approved the
64.19prescription drug order is permitted only when a formal and written decision to allow such
64.20access is issued by the pharmacy and the therapeutics committee or its equivalent. The
64.21committee must specify the patient care circumstances in which such access is allowed,
64.22the drugs that can be accessed, and the staff that are allowed to access the drugs.
64.23(e) In the case of an automated drug distribution system that does not utilize bar
64.24coding in the loading process, the loading of a system located in a health care facility may
64.25be performed by a pharmacy technician, so long as the activity is continuously supervised,
64.26through a two-way audiovisual system by a pharmacist on duty within the managing
64.27pharmacy. In the case of an automated drug distribution system that utilizes bar coding
64.28in the loading process, the loading of a system located in a health care facility may be
64.29performed by a pharmacy technician or a licensed nurse, provided that the managing
64.30pharmacy retains an electronic record of loading activities.
64.31(f) The automated drug distribution system must be under the supervision of a
64.32pharmacist. The pharmacist is not required to be physically present at the site of the
64.33automated drug distribution system if the system is continuously monitored electronically
64.34by the managing pharmacy. A pharmacist on duty within a pharmacy licensed by the
64.35board must be continuously available to address any problems detected by the monitoring
64.36or to answer questions from the staff of the health care facility. The licensed pharmacy
65.1may be the managing pharmacy or a pharmacy which is acting as a central services
65.2pharmacy, pursuant to Minnesota Rules, part 6800.4075, for the managing pharmacy.
65.3 Sec. 20. Minnesota Statutes 2013 Supplement, section 152.02, subdivision 2, is
65.4amended to read:
65.5 Subd. 2. Schedule I. (a) Schedule I consists of the substances listed in this
65.6subdivision.
65.7(b) Opiates. Unless specifically excepted or unless listed in another schedule, any of
65.8the following substances, including their analogs, isomers, esters, ethers, salts, and salts
65.9of isomers, esters, and ethers, whenever the existence of the analogs, isomers, esters,
65.10ethers, and salts is possible:
65.11(1) acetylmethadol;
65.12(2) allylprodine;
65.13(3) alphacetylmethadol (except levo-alphacetylmethadol, also known as
65.14levomethadyl acetate);
65.15(4) alphameprodine;
65.16(5) alphamethadol;
65.17(6) alpha-methylfentanyl benzethidine;
65.18(7) betacetylmethadol;
65.19(8) betameprodine;
65.20(9) betamethadol;
65.21(10) betaprodine;
65.22(11) clonitazene;
65.23(12) dextromoramide;
65.24(13) diampromide;
65.25(14) diethyliambutene;
65.26(15) difenoxin;
65.27(16) dimenoxadol;
65.28(17) dimepheptanol;
65.29(18) dimethyliambutene;
65.30(19) dioxaphetyl butyrate;
65.31(20) dipipanone;
65.32(21) ethylmethylthiambutene;
65.33(22) etonitazene;
65.34(23) etoxeridine;
65.35(24) furethidine;
66.1(25) hydroxypethidine;
66.2(26) ketobemidone;
66.3(27) levomoramide;
66.4(28) levophenacylmorphan;
66.5(29) 3-methylfentanyl;
66.6(30) acetyl-alpha-methylfentanyl;
66.7(31) alpha-methylthiofentanyl;
66.8(32) benzylfentanyl beta-hydroxyfentanyl;
66.9(33) beta-hydroxy-3-methylfentanyl;
66.10(34) 3-methylthiofentanyl;
66.11(35) thenylfentanyl;
66.12(36) thiofentanyl;
66.13(37) para-fluorofentanyl;
66.14(38) morpheridine;
66.15(39) 1-methyl-4-phenyl-4-propionoxypiperidine;
66.16(40) noracymethadol;
66.17(41) norlevorphanol;
66.18(42) normethadone;
66.19(43) norpipanone;
66.20(44) 1-(2-phenylethyl)-4-phenyl-4-acetoxypiperidine (PEPAP);
66.21(45) phenadoxone;
66.22(46) phenampromide;
66.23(47) phenomorphan;
66.24(48) phenoperidine;
66.25(49) piritramide;
66.26(50) proheptazine;
66.27(51) properidine;
66.28(52) propiram;
66.29(53) racemoramide;
66.30(54) tilidine;
66.31(55) trimeperidine
66.32(56) N-(1-Phenethylpiperidin-4-yl)-N-phenylacetamide (acetyl fentanyl).
66.33(c) Opium derivatives. Any of the following substances, their analogs, salts, isomers,
66.34and salts of isomers, unless specifically excepted or unless listed in another schedule,
66.35whenever the existence of the analogs, salts, isomers, and salts of isomers is possible:
66.36(1) acetorphine;
67.1(2) acetyldihydrocodeine;
67.2(3) benzylmorphine;
67.3(4) codeine methylbromide;
67.4(5) codeine-n-oxide;
67.5(6) cyprenorphine;
67.6(7) desomorphine;
67.7(8) dihydromorphine;
67.8(9) drotebanol;
67.9(10) etorphine;
67.10(11) heroin;
67.11(12) hydromorphinol;
67.12(13) methyldesorphine;
67.13(14) methyldihydromorphine;
67.14(15) morphine methylbromide;
67.15(16) morphine methylsulfonate;
67.16(17) morphine-n-oxide;
67.17(18) myrophine;
67.18(19) nicocodeine;
67.19(20) nicomorphine;
67.20(21) normorphine;
67.21(22) pholcodine;
67.22(23) thebacon.
67.23(d) Hallucinogens. Any material, compound, mixture or preparation which contains
67.24any quantity of the following substances, their analogs, salts, isomers (whether optical,
67.25positional, or geometric), and salts of isomers, unless specifically excepted or unless listed
67.26in another schedule, whenever the existence of the analogs, salts, isomers, and salts of
67.27isomers is possible:
67.28(1) methylenedioxy amphetamine;
67.29(2) methylenedioxymethamphetamine;
67.30(3) methylenedioxy-N-ethylamphetamine (MDEA);
67.31(4) n-hydroxy-methylenedioxyamphetamine;
67.32(5) 4-bromo-2,5-dimethoxyamphetamine (DOB);
67.33(6) 2,5-dimethoxyamphetamine (2,5-DMA);
67.34(7) 4-methoxyamphetamine;
67.35(8) 5-methoxy-3, 4-methylenedioxy amphetamine;
67.36(9) alpha-ethyltryptamine;
68.1(10) bufotenine;
68.2(11) diethyltryptamine;
68.3(12) dimethyltryptamine;
68.4(13) 3,4,5-trimethoxy amphetamine;
68.5(14) 4-methyl-2, 5-dimethoxyamphetamine (DOM);
68.6(15) ibogaine;
68.7(16) lysergic acid diethylamide (LSD);
68.8(17) mescaline;
68.9(18) parahexyl;
68.10(19) N-ethyl-3-piperidyl benzilate;
68.11(20) N-methyl-3-piperidyl benzilate;
68.12(21) psilocybin;
68.13(22) psilocyn;
68.14(23) tenocyclidine (TPCP or TCP);
68.15(24) N-ethyl-1-phenyl-cyclohexylamine (PCE);
68.16(25) 1-(1-phenylcyclohexyl) pyrrolidine (PCPy);
68.17(26) 1-[1-(2-thienyl)cyclohexyl]-pyrrolidine (TCPy);
68.18(27) 4-chloro-2,5-dimethoxyamphetamine (DOC);
68.19(28) 4-ethyl-2,5-dimethoxyamphetamine (DOET);
68.20(29) 4-iodo-2,5-dimethoxyamphetamine (DOI);
68.21(30) 4-bromo-2,5-dimethoxyphenethylamine (2C-B);
68.22(31) 4-chloro-2,5-dimethoxyphenethylamine (2C-C);
68.23(32) 4-methyl-2,5-dimethoxyphenethylamine (2-CD);
68.24(33) 4-ethyl-2,5-dimethoxyphenethylamine (2C-E);
68.25(34) 4-iodo-2,5-dimethoxyphenethylamine (2C-I);
68.26(35) 4-propyl-2,5-dimethoxyphenethylamine (2C-P);
68.27(36) 4-isopropylthio-2,5-dimethoxyphenethylamine (2C-T-4);
68.28(37) 4-propylthio-2,5-dimethoxyphenethylamine (2C-T-7);
68.29(38) 2-(8-bromo-2,3,6,7-tetrahydrofuro [2,3-f][1]benzofuran-4-yl)ethanamine
68.30(2-CB-FLY);
68.31(39) bromo-benzodifuranyl-isopropylamine (Bromo-DragonFLY);
68.32(40) alpha-methyltryptamine (AMT);
68.33(41) N,N-diisopropyltryptamine (DiPT);
68.34(42) 4-acetoxy-N,N-dimethyltryptamine (4-AcO-DMT);
68.35(43) 4-acetoxy-N,N-diethyltryptamine (4-AcO-DET);
68.36(44) 4-hydroxy-N-methyl-N-propyltryptamine (4-HO-MPT);
69.1(45) 4-hydroxy-N,N-dipropyltryptamine (4-HO-DPT);
69.2(46) 4-hydroxy-N,N-diallyltryptamine (4-HO-DALT);
69.3(47) 4-hydroxy-N,N-diisopropyltryptamine (4-HO-DiPT);
69.4(48) 5-methoxy-N,N-diisopropyltryptamine (5-MeO-DiPT);
69.5(49) 5-methoxy-α-methyltryptamine (5-MeO-AMT);
69.6(50) 5-methoxy-N,N-dimethyltryptamine (5-MeO-DMT);
69.7(51) 5-methylthio-N,N-dimethyltryptamine (5-MeS-DMT);
69.8(52) 5-methoxy-N-methyl-N-propyltryptamine (5-MeO-MiPT);
69.9(53) 5-methoxy-α-ethyltryptamine (5-MeO-AET);
69.10(54) 5-methoxy-N,N-dipropyltryptamine (5-MeO-DPT);
69.11(55) 5-methoxy-N,N-diethyltryptamine (5-MeO-DET);
69.12(56) 5-methoxy-N,N-diallytryptamine (5-MeO-DALT);
69.13(57) methoxetamine (MXE);
69.14(58) 5-iodo-2-aminoindane (5-IAI);
69.15(59) 5,6-methylenedioxy-2-aminoindane (MDAI);
69.16(60) 2-(4-iodo-2,5-dimethoxyphenyl)-N-[(2-methoxyphenyl)methyl]ethanamine
69.17(25I-NBOMe).
69.18(e) Peyote. All parts of the plant presently classified botanically as Lophophora
69.19williamsii Lemaire, whether growing or not, the seeds thereof, any extract from any part
69.20of the plant, and every compound, manufacture, salts, derivative, mixture, or preparation
69.21of the plant, its seeds or extracts. The listing of peyote as a controlled substance in
69.22Schedule I does not apply to the nondrug use of peyote in bona fide religious ceremonies
69.23of the American Indian Church, and members of the American Indian Church are exempt
69.24from registration. Any person who manufactures peyote for or distributes peyote to the
69.25American Indian Church, however, is required to obtain federal registration annually and
69.26to comply with all other requirements of law.
69.27(f) Central nervous system depressants. Unless specifically excepted or unless listed
69.28in another schedule, any material compound, mixture, or preparation which contains any
69.29quantity of the following substances, their analogs, salts, isomers, and salts of isomers
69.30whenever the existence of the analogs, salts, isomers, and salts of isomers is possible:
69.31(1) mecloqualone;
69.32(2) methaqualone;
69.33(3) gamma-hydroxybutyric acid (GHB), including its esters and ethers;
69.34(4) flunitrazepam.
69.35(g) Stimulants. Unless specifically excepted or unless listed in another schedule, any
69.36material compound, mixture, or preparation which contains any quantity of the following
70.1substances, their analogs, salts, isomers, and salts of isomers whenever the existence of
70.2the analogs, salts, isomers, and salts of isomers is possible:
70.3 (1) aminorex;
70.4(2) cathinone;
70.5(3) fenethylline;
70.6 (4) methcathinone;
70.7(5) methylaminorex;
70.8(6) N,N-dimethylamphetamine;
70.9(7) N-benzylpiperazine (BZP);
70.10(8) methylmethcathinone (mephedrone);
70.11(9) 3,4-methylenedioxy-N-methylcathinone (methylone);
70.12(10) methoxymethcathinone (methedrone);
70.13(11) methylenedioxypyrovalerone (MDPV);
70.14(12) fluoromethcathinone;
70.15(13) methylethcathinone (MEC);
70.16(14) 1-benzofuran-6-ylpropan-2-amine (6-APB);
70.17(15) dimethylmethcathinone (DMMC);
70.18(16) fluoroamphetamine;
70.19(17) fluoromethamphetamine;
70.20(18) α-methylaminobutyrophenone (MABP or buphedrone);
70.21(19) β-keto-N-methylbenzodioxolylpropylamine (bk-MBDB or butylone);
70.22(20) 2-(methylamino)-1-(4-methylphenyl)butan-1-one (4-MEMABP or BZ-6378);
70.23(21) naphthylpyrovalerone (naphyrone);
70.24(22) (RS)-1-phenyl-2-(1-pyrrolidinyl)-1-pentanone (alpha-PVP or
70.25alpha-pyrrolidinovalerophenone;
70.26(23) (RS)-1-(4-methylphenyl)-2-(1-pyrrolidinyl)-1-hexanone (4-Me-PHP oe
70.27MPHP); and
70.28
70.29different schedule, that is structurally derived from 2-aminopropan-1-one by substitution
70.30at the 1-position with either phenyl, naphthyl, or thiophene ring systems, whether or not
70.31the compound is further modified in any of the following ways:
70.32(i) by substitution in the ring system to any extent with alkyl, alkylenedioxy, alkoxy,
70.33haloalkyl, hydroxyl, or halide substituents, whether or not further substituted in the ring
70.34system by one or more other univalent substituents;
70.35(ii) by substitution at the 3-position with an acyclic alkyl substituent;
71.1(iii) by substitution at the 2-amino nitrogen atom with alkyl, dialkyl, benzyl, or
71.2methoxybenzyl groups; or
71.3(iv) by inclusion of the 2-amino nitrogen atom in a cyclic structure.
71.4(h) Marijuana, tetrahydrocannabinols, and synthetic cannabinoids. Unless
71.5specifically excepted or unless listed in another schedule, any natural or synthetic material,
71.6compound, mixture, or preparation that contains any quantity of the following substances,
71.7their analogs, isomers, esters, ethers, salts, and salts of isomers, esters, and ethers,
71.8whenever the existence of the isomers, esters, ethers, or salts is possible:
71.9(1) marijuana;
71.10(2) tetrahydrocannabinols naturally contained in a plant of the genus Cannabis,
71.11synthetic equivalents of the substances contained in the cannabis plant or in the
71.12resinous extractives of the plant, or synthetic substances with similar chemical structure
71.13and pharmacological activity to those substances contained in the plant or resinous
71.14extract, including, but not limited to, 1 cis or trans tetrahydrocannabinol, 6 cis or trans
71.15tetrahydrocannabinol, and 3,4 cis or trans tetrahydrocannabinol;
71.16(3) synthetic cannabinoids, including the following substances:
71.17(i) Naphthoylindoles, which are any compounds containing a 3-(1-napthoyl)indole
71.18structure with substitution at the nitrogen atom of the indole ring by an alkyl, haloalkyl,
71.19alkenyl, cycloalkylmethyl, cycloalkylethyl, 1-(N-methyl-2-piperidinyl)methyl or
71.202-(4-morpholinyl)ethyl group, whether or not further substituted in the indole ring to any
71.21extent and whether or not substituted in the naphthyl ring to any extent. Examples of
71.22naphthoylindoles include, but are not limited to:
71.23(A) 1-Pentyl-3-(1-naphthoyl)indole (JWH-018 and AM-678);
71.24(B) 1-Butul-3-(1-naphthoyl)indole (JWH-073);
71.25(C) 1-Pentyl-3-(4-methoxy-1-naphthoyl)indole (JWH-081);
71.26(D) 1-[2-(4-morpholinyl)ethyl]-3-(1-naphthoyl)indole (JWH-200);
71.27(E) 1-Propyl-2-methyl-3-(1-naphthoyl)indole (JWH-015);
71.28(F) 1-Hexyl-3-(1-naphthoyl)indole (JWH-019);
71.29(G) 1-Pentyl-3-(4-methyl-1-naphthoyl)indole (JWH-122);
71.30(H) 1-Pentyl-3-(4-ethyl-1-naphthoyl)indole (JWH-210);
71.31(I) 1-Pentyl-3-(4-chloro-1-naphthoyl)indole (JWH-398);
71.32(J) 1-(5-fluoropentyl)-3-(1-naphthoyl)indole (AM-2201).
71.33(ii) Napthylmethylindoles, which are any compounds containing a
71.341H-indol-3-yl-(1-naphthyl)methane structure with substitution at the nitrogen atom
71.35of the indole ring by an alkyl, haloalkyl, alkenyl, cycloalkylmethyl, cycloalkylethyl,
71.361-(N-methyl-2-piperidinyl)methyl or 2-(4-morpholinyl)ethyl group, whether or not further
72.1substituted in the indole ring to any extent and whether or not substituted in the naphthyl
72.2ring to any extent. Examples of naphthylmethylindoles include, but are not limited to:
72.3(A) 1-Pentyl-1H-indol-3-yl-(1-naphthyl)methane (JWH-175);
72.4(B) 1-Pentyl-1H-indol-3-yl-(4-methyl-1-naphthyl)methan (JWH-184).
72.5(iii) Naphthoylpyrroles, which are any compounds containing a
72.63-(1-naphthoyl)pyrrole structure with substitution at the nitrogen atom of the
72.7pyrrole ring by an alkyl, haloalkyl, alkenyl, cycloalkylmethyl, cycloalkylethyl,
72.81-(N-methyl-2-piperidinyl)methyl or 2-(4-morpholinyl)ethyl group whether or not
72.9further substituted in the pyrrole ring to any extent, whether or not substituted in the
72.10naphthyl ring to any extent. Examples of naphthoylpyrroles include, but are not limited to,
72.11(5-(2-fluorophenyl)-1-pentylpyrrol-3-yl)-naphthalen-1-ylmethanone (JWH-307).
72.12(iv) Naphthylmethylindenes, which are any compounds containing a
72.13naphthylideneindene structure with substitution at the 3-position of the indene
72.14ring by an allkyl, haloalkyl, alkenyl, cycloalkylmethyl, cycloalkylethyl,
72.151-(N-methyl-2-piperidinyl)methyl or 2-(4-morpholinyl)ethyl group whether or not further
72.16substituted in the indene ring to any extent, whether or not substituted in the naphthyl
72.17ring to any extent. Examples of naphthylemethylindenes include, but are not limited to,
72.18E-1-[1-(1-naphthalenylmethylene)-1H-inden-3-yl]pentane (JWH-176).
72.19(v) Phenylacetylindoles, which are any compounds containing a 3-phenylacetylindole
72.20structure with substitution at the nitrogen atom of the indole ring by an alkyl, haloalkyl,
72.21alkenyl, cycloalkylmethyl, cycloalkylethyl, 1-(N-methyl-2-piperidinyl)methyl or
72.222-(4-morpholinyl)ethyl group whether or not further substituted in the indole ring to
72.23any extent, whether or not substituted in the phenyl ring to any extent. Examples of
72.24phenylacetylindoles include, but are not limited to:
72.25(A) 1-(2-cyclohexylethyl)-3-(2-methoxyphenylacetyl)indole (RCS-8);
72.26(B) 1-pentyl-3-(2-methoxyphenylacetyl)indole (JWH-250);
72.27(C) 1-pentyl-3-(2-methylphenylacetyl)indole (JWH-251);
72.28(D) 1-pentyl-3-(2-chlorophenylacetyl)indole (JWH-203).
72.29(vi) Cyclohexylphenols, which are compounds containing a
72.302-(3-hydroxycyclohexyl)phenol structure with substitution at the 5-position
72.31of the phenolic ring by an alkyl, haloalkyl, alkenyl, cycloalkylmethyl, cycloalkylethyl,
72.321-(N-methyl-2-piperidinyl)methyl or 2-(4-morpholinyl)ethyl group whether or not
72.33substituted in the cyclohexyl ring to any extent. Examples of cyclohexylphenols include,
72.34but are not limited to:
72.35(A) 5-(1,1-dimethylheptyl)-2-[(1R,3S)-3-hydroxycyclohexyl]-phenol (CP 47,497);
73.1(B) 5-(1,1-dimethyloctyl)-2-[(1R,3S)-3-hydroxycyclohexyl]-phenol
73.2(Cannabicyclohexanol or CP 47,497 C8 homologue);
73.3(C) 5-(1,1-dimethylheptyl)-2-[(1R,2R)-5-hydroxy-2-(3-hydroxypropyl)cyclohexyl]
73.4-phenol (CP 55,940).
73.5(vii) Benzoylindoles, which are any compounds containing a 3-(benzoyl)indole
73.6structure with substitution at the nitrogen atom of the indole ring by an alkyl, haloalkyl,
73.7alkenyl, cycloalkylmethyl, cycloalkylethyl, 1-(N-methyl-2-piperidinyl)methyl or
73.82-(4-morpholinyl)ethyl group whether or not further substituted in the indole ring to
73.9any extent and whether or not substituted in the phenyl ring to any extent. Examples of
73.10benzoylindoles include, but are not limited to:
73.11(A) 1-Pentyl-3-(4-methoxybenzoyl)indole (RCS-4);
73.12(B) 1-(5-fluoropentyl)-3-(2-iodobenzoyl)indole (AM-694);
73.13(C) (4-methoxyphenyl-[2-methyl-1-(2-(4-morpholinyl)ethyl)indol-3-yl]methanone
73.14(WIN 48,098 or Pravadoline).
73.15(viii) Others specifically named:
73.16(A) (6aR,10aR)-9-(hydroxymethyl)-6,6-dimethyl-3-(2-methyloctan-2-yl)
73.17-6a,7,10,10a-tetrahydrobenzo[c]chromen-1-ol (HU-210);
73.18(B) (6aS,10aS)-9-(hydroxymethyl)-6,6-dimethyl-3-(2-methyloctan-2-yl)
73.19-6a,7,10,10a-tetrahydrobenzo[c]chromen-1-ol (Dexanabinol or HU-211);
73.20(C) 2,3-dihydro-5-methyl-3-(4-morpholinylmethyl)pyrrolo[1,2,3-de]
73.21-1,4-benzoxazin-6-yl-1-naphthalenylmethanone (WIN 55,212-2);
73.22(D) (1-pentylindol-3-yl)-(2,2,3,3-tetramethylcyclopropyl)methanone (UR-144);
73.23(E) (1-(5-fluoropentyl)-1H-indol-3-yl)(2,2,3,3-tetramethylcyclopropyl)methanone
73.24(XLR-11);
73.25(F) 1-pentyl-N-tricyclo[3.3.1.13,7]dec-1-yl-1H-indazole-3-carboxamide
73.26(AKB-48(APINACA));
73.27(G) N-((3s,5s,7s)-adamantan-1-yl)-1-(5-fluoropentyl)-1H-indazole-3-carboxamide
73.28(5-Fluoro-AKB-48);
73.29(H) 1-pentyl-8-quinolinyl ester-1H-indole-3-carboxylic acid (PB-22);
73.30(I) 8-quinolinyl ester-1-(5-fluoropentyl)-1H-indole-3-carboxylic acid (5-Fluoro
73.31PB-22)
73.32(J) N-[(1S)-1-(aminocarbonyl)-2-methylpropyl]-1-pentyl-1H-indazole-
73.333-carboxamide (AB-PINACA);
73.34(K) N-[(1S)-1-(aminocarbonyl)-2-methylpropyl]-1-[(4-fluorophenyl)methyl]-
73.351H-indazole-3-carboxamide (AB-FUBINACA).
74.1(i) A controlled substance analog, to the extent that it is implicitly or explicitly
74.2intended for human consumption.
74.3 Sec. 21. Minnesota Statutes 2012, section 152.02, subdivision 8b, is amended to read:
74.4 Subd. 8b. Board of Pharmacy; expedited scheduling of additional substances.
74.5
74.6it finds that the substance has a high potential for abuse, has no currently accepted medical
74.7use in the United States, has a lack of accepted safety for use under medical supervision,
74.8has known adverse health effects, and is currently available for use within the state. For
74.9the purposes of this subdivision only, the board may use the expedited rulemaking process
74.10under section
74.11
74.12
74.13
74.14
74.15
74.16
74.17
74.18
74.19 Sec. 22. Minnesota Statutes 2012, section 152.126, as amended by Laws 2013, chapter
74.20113, article 3, section 3, is amended to read:
74.21152.126
74.22
74.23 Subdivision 1. Definitions. (a) For purposes of this section, the terms defined in
74.24this subdivision have the meanings given.
74.25
74.26chapter 151.
74.27
74.28subdivisions 3 to
74.30includes tramadol and butalbital.
74.31
74.32subdivision 30
74.33substance to a patient by a licensed health care professional.
75.1
75.2substance, pursuant to a valid prescription. For the purposes of this section, a dispenser
75.3does not include a licensed hospital pharmacy that distributes controlled substances for
75.4inpatient hospital care, a licensed pharmacy, located on the same premises as a residential
75.5hospice, when the licensed pharmacy is dispensing controlled substances to be used
75.6by an individual who is a resident of the hospice or a veterinarian who is dispensing
75.7prescriptions under section
75.8
75.9prescribe a controlled substance under section
75.10
75.11 Subd. 1a. Treatment of intractable pain. This section is not intended to limit or
75.12interfere with the legitimate prescribing of controlled substances for pain. No prescriber
75.13shall be subject to disciplinary action by a health-related licensing board for prescribing a
75.14controlled substance according to the provisions of section
75.15 Subd. 2. Prescription electronic reporting system. (a) The board shall establish
75.16by January 1, 2010, an electronic system for reporting the information required under
75.17subdivision 4 for all controlled substances dispensed within the state.
75.18 (b) The board may contract with a vendor for the purpose of obtaining technical
75.19assistance in the design, implementation, operation, and maintenance of the electronic
75.20reporting system.
75.21 Subd. 3. Prescription
75.22
75.23
75.24 (1) the Department of Health;
75.25 (2) the Department of Human Services;
75.26 (3) each health-related licensing board that licenses prescribers;
75.27 (4) a professional medical association, which may include an association of pain
75.28management and chemical dependency specialists;
75.29 (5) a professional pharmacy association;
75.30 (6) a professional nursing association;
75.31 (7) a professional dental association;
75.32 (8) a consumer privacy or security advocate;
75.33 (9) a consumer or patient rights organization
75.34 (10) an association of medical examiners and coroners.
76.1 (b) The advisory
76.2operation of the
76.3but not limited to:
76.4 (1) technical standards for electronic prescription drug reporting;
76.5 (2) proper analysis and interpretation of prescription monitoring data;
76.6 (3) an evaluation process for the program; and
76.7 (4) criteria for the unsolicited provision of prescription monitoring data by the
76.8board to prescribers and dispensers.
76.9(c) The task force is governed by section 15.059. Notwithstanding section 15.059,
76.10subdivision 5, the task force shall not expire.
76.11 Subd. 4. Reporting requirements; notice. (a) Each dispenser must submit the
76.12following data to the board or its designated vendor
76.13
76.14 (1) name of the prescriber;
76.15 (2) national provider identifier of the prescriber;
76.16 (3) name of the dispenser;
76.17 (4) national provider identifier of the dispenser;
76.18 (5) prescription number;
76.19 (6) name of the patient for whom the prescription was written;
76.20 (7) address of the patient for whom the prescription was written;
76.21 (8) date of birth of the patient for whom the prescription was written;
76.22 (9) date the prescription was written;
76.23 (10) date the prescription was filled;
76.24 (11) name and strength of the controlled substance;
76.25 (12) quantity of controlled substance prescribed;
76.26 (13) quantity of controlled substance dispensed; and
76.27 (14) number of days supply.
76.28 (b) The dispenser must submit the required information by a procedure and in a
76.29format established by the board. The board may allow dispensers to omit data listed in this
76.30subdivision or may require the submission of data not listed in this subdivision provided
76.31the omission or submission is necessary for the purpose of complying with the electronic
76.32reporting or data transmission standards of the American Society for Automation in
76.33Pharmacy, the National Council on Prescription Drug Programs, or other relevant national
76.34standard-setting body.
76.35 (c) A dispenser is not required to submit this data for those controlled substance
76.36prescriptions dispensed for:
77.1
77.2
77.3
77.4
77.5
77.6
77.7
77.8 (1) individuals residing in a health care facility as defined in section 151.58,
77.9subdivision 2, paragraph (b), when a drug is distributed through the use of an automated
77.10drug distribution system according to section 151.58; and
77.11 (2) individuals receiving a drug sample that was packaged by a manufacturer and
77.12provided to the dispenser for dispensing as a professional sample pursuant to Code of
77.13Federal Regulations, title 21, section 203, subpart D.
77.14 (d) A dispenser must
77.15patient for whom the prescription was written a conspicuous notice of the reporting
77.16requirements of this section
77.17 and notice that the information may be used for program administration purposes.
77.18 Subd. 5. Use of data by board. (a) The board shall develop and maintain a database
77.19of the data reported under subdivision 4. The board shall maintain data that could identify
77.20an individual prescriber or dispenser in encrypted form. Except as otherwise allowed
77.21under subdivision 6, the database may be used by permissible users identified under
77.22subdivision 6 for the identification of:
77.23 (1) individuals receiving prescriptions for controlled substances from prescribers
77.24who subsequently obtain controlled substances from dispensers in quantities or with a
77.25frequency inconsistent with generally recognized standards of use for those controlled
77.26substances, including standards accepted by national and international pain management
77.27associations; and
77.28 (2) individuals presenting forged or otherwise false or altered prescriptions for
77.29controlled substances to dispensers.
77.30 (b) No permissible user identified under subdivision 6 may access the database
77.31for the sole purpose of identifying prescribers of controlled substances for unusual or
77.32excessive prescribing patterns without a valid search warrant or court order.
77.33 (c) No personnel of a state or federal occupational licensing board or agency may
77.34access the database for the purpose of obtaining information to be used to initiate or
77.35substantiate a disciplinary action against a prescriber when the disciplinary action relates
78.1to allegations involving unusual or excessive prescribing of the drugs for which data
78.2is collected under subdivision 4.
78.3 (d) Data reported under subdivision 4 shall be
78.4
78.5
78.6to permissible users for a 12-month period beginning the day the data was received and
78.7ending 12 months from the last day of the month in which the data was received, except
78.8that permissible users defined in subdivision 6, paragraph (b), clauses (6) and (7), may
78.9use all data collected under this section for the purposes of administering, operating, and
78.10maintaining the prescription monitoring program and conducting trend analyses and other
78.11studies necessary to evaluate the effectiveness of the program.
78.12(e) The board shall not retain data reported under subdivision 4 for a period longer
78.13than five years from the date the data was received.
78.14 Subd. 6. Access to reporting system data. (a) Except as indicated in this
78.15subdivision, the data submitted to the board under subdivision 4 is private data on
78.16individuals as defined in section
78.17 (b) Except as specified in subdivision 5, the following persons shall be considered
78.18permissible users and may access the data submitted under subdivision 4 in the same or
78.19similar manner, and for the same or similar purposes, as those persons who are authorized
78.20to access similar private data on individuals under federal and state law:
78.21 (1) a prescriber or an agent or employee of the prescriber to whom the prescriber has
78.22delegated the task of accessing the data, to the extent the information relates specifically to
78.23a current patient, to whom the prescriber is prescribing or considering prescribing any
78.24controlled substance or to whom the prescriber is providing other medical treatment for
78.25which access to the data may be necessary and with the provision that the prescriber remains
78.26responsible for the use or misuse of data accessed by a delegated agent or employee;
78.27 (2) a dispenser or an agent or employee of the dispenser to whom the dispenser has
78.28delegated the task of accessing the data, to the extent the information relates specifically
78.29to a current patient to whom that dispenser is dispensing or considering dispensing any
78.30controlled substance and with the provision that the dispenser remains responsible for the
78.31use or misuse of data accessed by a delegated agent or employee;
78.32 (3) a licensed pharmacist who is providing pharmaceutical care for which access to
78.33the data may be necessary to the extent that the information relates specifically to a current
78.34patient for whom the pharmacist is providing pharmaceutical care;
78.35
78.36which data was submitted under subdivision 4, or a guardian of the individual, parent or
79.1guardian of a minor, or health care agent of the individual acting under a health care
79.2directive under chapter 145C;
79.3
79.4214.01, subdivision 2, or the Emergency Medical Services Regulatory Board, assigned to
79.5conduct a bona fide investigation of a complaint received by that board alleging that a
79.6 specific licensee is impaired by use of a drug for which data is collected under subdivision
79.74, has engaged in activity that would constitute a crime as defined in section 152.025, or
79.8has engaged in the behavior specified in section 152.126, subdivision 5, paragraph (a);
79.9
79.10 of controlled substance prescription information as part of the assigned duties and
79.11responsibilities under this section;
79.12
79.13Minnesota who are engaged in the design, implementation, operation, and maintenance of
79.14the
79.15duties and responsibilities of their employment, provided that access to data is limited to
79.16the minimum amount necessary to carry out such duties and responsibilities;
79.17
79.18valid search warrant;
79.19
79.20assigned to use the data collected under this section to identify and manage recipients
79.21whose usage of controlled substances may warrant restriction to a single primary care
79.22
79.23
79.24data pursuant to paragraph (h)
79.25(11) a coroner or medical examiner, or an agent or employee of the coroner or
79.26medical examiner to whom the coroner or medical examiner has delegated the task of
79.27accessing the data, conducting an investigation pursuant to section 390.11, and with the
79.28provision that the coroner or medical examiner remains responsible for the use or misuse
79.29of data accessed by a delegated agent or employee; and
79.30(12) personnel of the health professionals services program established under
79.31section 214.31, to the extent that the information relates specifically to an individual who
79.32is currently enrolled in and being monitored by the program. The health professionals
79.33services program personnel shall not provide this data to a health-related licensing board
79.34or the Emergency Medical Services Regulatory Board, except as permitted under section
79.35214.33, subdivision 3.
80.1 For purposes of clause
80.2definition of an individual under section
80.3 (c)
80.4(7), (9), (10), and (11) may directly
80.5is directly accessed electronically, the permissible user shall implement and maintain a
80.6comprehensive information security program that contains administrative, technical,
80.7and physical safeguards that are appropriate to the user's size and complexity, and the
80.8sensitivity of the personal information obtained. The permissible user shall identify
80.9reasonably foreseeable internal and external risks to the security, confidentiality, and
80.10integrity of personal information that could result in the unauthorized disclosure, misuse,
80.11or other compromise of the information and assess the sufficiency of any safeguards in
80.12place to control the risks.
80.13 (d) The board shall not release data submitted under
80.14it is provided with evidence, satisfactory to the board, that the person requesting the
80.15information is entitled to receive the data.
80.16
80.17
80.18
80.19
80.20
80.21of at least three years and shall ensure that any permissible user complies with paragraph
80.22(c) prior to attaining direct access to the data.
80.23
80.24pursuant to subdivision 2. A vendor shall not use data collected under this section for
80.25any purpose not specified in this section.
80.26(g) The board may participate in an interstate prescription monitoring program data
80.27exchange system provided that permissible users in other states have access to the data
80.28only as allowed under this section, and that section 13.05, subdivision 6, applies to any
80.29contract or memorandum of understanding that the board enters into under this paragraph.
80.30(h) With available appropriations, the commissioner of human services shall
80.31establish and implement a system through which the Department of Human Services shall
80.32routinely access the data for the purpose of determining whether any client enrolled in
80.33an opioid treatment program licensed according to chapter 245A has been prescribed or
80.34dispensed a controlled substance in addition to that administered or dispensed by the
80.35opioid treatment program. When the commissioner determines there have been multiple
80.36prescribers or multiple prescriptions of controlled substances, the commissioner shall:
81.1(1) inform the medical director of the opioid treatment program only that the
81.2commissioner determined the existence of multiple prescribers or multiple prescriptions of
81.3controlled substances; and
81.4(2) direct the medical director of the opioid treatment program to access the data
81.5directly, review the effect of the multiple prescribers or multiple prescriptions, and
81.6document the review.
81.7If determined necessary, the commissioner of human services shall seek a federal waiver
81.8of, or exception to, any applicable provision of Code of Federal Regulations, title 42, part
81.10(i) The board may provide data submitted under subdivision 4 for public research,
81.11policy, or education purposes, but only after the removal of any information that is likely
81.12to reveal the identity of the patient, prescriber, or dispenser who is the subject of the data.
81.13(j) The board shall review the data submitted under subdivision 4 on at least a
81.14quarterly basis and shall establish criteria, in consultation with the advisory task force,
81.15for referring information about a patient to prescribers and dispensers who prescribed or
81.16dispensed the prescriptions in question if the criteria are met.
81.17 Subd. 7. Disciplinary action. (a) A dispenser who knowingly fails to submit data to
81.18the board as required under this section is subject to disciplinary action by the appropriate
81.19health-related licensing board.
81.20 (b) A prescriber or dispenser authorized to access the data who knowingly discloses
81.21the data in violation of state or federal laws relating to the privacy of health care data
81.22shall be subject to disciplinary action by the appropriate health-related licensing board,
81.23and appropriate civil penalties.
81.24
81.25
81.26
81.27
81.28
81.29
81.30 Subd. 9. Immunity from liability; no requirement to obtain information. (a) A
81.31pharmacist, prescriber, or other dispenser making a report to the program in good faith
81.32under this section is immune from any civil, criminal, or administrative liability, which
81.33might otherwise be incurred or imposed as a result of the report, or on the basis that the
81.34pharmacist or prescriber did or did not seek or obtain or use information from the program.
81.35 (b) Nothing in this section shall require a pharmacist, prescriber, or other dispenser
81.36to obtain information about a patient from the program, and the pharmacist, prescriber,
82.1or other dispenser, if acting in good faith, is immune from any civil, criminal, or
82.2administrative liability that might otherwise be incurred or imposed for requesting,
82.3receiving, or using information from the program.
82.4 Subd. 10. Funding. (a) The board may seek grants and private funds from nonprofit
82.5charitable foundations, the federal government, and other sources to fund the enhancement
82.6and ongoing operations of the prescription
82.7program established under this section. Any funds received shall be appropriated to the
82.8board for this purpose. The board may not expend funds to enhance the program in a way
82.9that conflicts with this section without seeking approval from the legislature.
82.10(b) Notwithstanding any other section, the administrative services unit for the
82.11health-related licensing boards shall apportion between the Board of Medical Practice, the
82.12Board of Nursing, the Board of Dentistry, the Board of Podiatric Medicine, the Board of
82.13Optometry, the Board of Veterinary Medicine, and the Board of Pharmacy an amount to
82.14be paid through fees by each respective board. The amount apportioned to each board
82.15shall equal each board's share of the annual appropriation to the Board of Pharmacy
82.16from the state government special revenue fund for operating the prescription
82.17
82.18shall be based on the number of prescribers or dispensers that each board identified in
82.19this paragraph licenses as a percentage of the total number of prescribers and dispensers
82.20licensed collectively by these boards. Each respective board may adjust the fees that the
82.21boards are required to collect to compensate for the amount apportioned to each board by
82.22the administrative services unit.
82.23EFFECTIVE DATE.This section is effective the day following final enactment.
82.24 Sec. 23. STUDY REQUIRED; PRESCRIPTION MONITORING PROGRAM
82.25DATABASE.
82.26The Board of Pharmacy, in collaboration with the Prescription Monitoring Program
82.27Advisory Task Force, shall study program database and report to the chairs and ranking
82.28minority members of the senate health and human services policy and finance division and
82.29the house of representatives health and human services policy and finance committees by
82.30December 15, 2014, with recommendations on whether or not to (1) require the use of
82.31the prescription monitoring by prescribers when prescribing or considering prescribing,
82.32and pharmacists when dispensing or considering dispensing, a controlled substance as
82.33defined in Minnesota Statutes, section 152.126, subdivision 1, paragraph (c); and (2)
82.34allow for the use of the prescription monitoring program database to identify potentially
82.35inappropriate prescribing of controlled substances.
83.1 Sec. 24. APPROPRIATION.
83.2(a) $210,000 in fiscal year 2015 is appropriated from the state government special
83.3revenue fund to the Board of Pharmacy to implement changes to the prescription monitoring
83.4program. The base for this appropriation is $171,000 in fiscal years 2016 and 2017.
83.5(b) $5,000 in fiscal year 2015 is appropriated from the state government special
83.6revenue fund to the Board of Pharmacy for costs attributable to the board's cease and
83.7desist authority.
