Bill Text: MN HF2545 | 2013-2014 | 88th Legislature | Introduced
NOTE: There are more recent revisions of this legislation. Read Latest Draft
Bill Title: Health definitions modified and added, immunization requirement pharmacist participation changed; Board of Pharmacy powers and duties, and business regulation licensing requirements changed; compounding requirements clarified, legend drug purchase allowed by educational institutions, entities allowed to handle drugs in preparation for emergency use, drug manufacturers payment reporting clarified, and substances added to the controlled substances schedules.
Spectrum: Partisan Bill (Democrat 1-0)
Status: (Introduced - Dead) 2014-03-19 - Committee report, to adopt as amended and re-refer to Health and Human Services Policy [HF2545 Detail]
Download: Minnesota-2013-HF2545-Introduced.html
Bill Title: Health definitions modified and added, immunization requirement pharmacist participation changed; Board of Pharmacy powers and duties, and business regulation licensing requirements changed; compounding requirements clarified, legend drug purchase allowed by educational institutions, entities allowed to handle drugs in preparation for emergency use, drug manufacturers payment reporting clarified, and substances added to the controlled substances schedules.
Spectrum: Partisan Bill (Democrat 1-0)
Status: (Introduced - Dead) 2014-03-19 - Committee report, to adopt as amended and re-refer to Health and Human Services Policy [HF2545 Detail]
Download: Minnesota-2013-HF2545-Introduced.html
1.2relating to health; adding and modifying definitions; changing the requirements
1.3for pharmacist participation in immunizations; changing the powers and duties of
1.4the Board of Pharmacy; changing licensing requirements for businesses regulated
1.5by the Board of Pharmacy; clarifying requirements for compounding; allowing
1.6certain educational institutions to purchase legend drugs in limited circumstances;
1.7allowing certain entities to handle drugs in preparation for emergency use;
1.8clarifying the requirement that drug manufacturers report certain payments to the
1.9Board of Pharmacy; adding certain substances to the schedules for controlled
1.10substances;amending Minnesota Statutes 2012, sections 151.01; 151.06;
1.11151.211; 151.26; 151.34; 151.35; 151.361, subdivision 2; 151.37, as amended;
1.12151.44; 151.58, subdivisions 2, 3, 5; 152.02, subdivision 8b; Minnesota Statutes
1.132013 Supplement, sections 151.252, by adding a subdivision; 152.02, subdivision
1.142; proposing coding for new law in Minnesota Statutes, chapter 151.
1.15BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF MINNESOTA:
1.16 Section 1. Minnesota Statutes 2012, section 151.01, is amended to read:
1.17151.01 DEFINITIONS.
1.18 Subdivision 1. Words, terms, and phrases. Unless the language or context clearly
1.19indicates that a different meaning is intended, the following words, terms, and phrases, for
1.20the purposes of this chapter, shall be given the meanings subjoined to them.
1.21 Subd. 2. Pharmacy. "Pharmacy" meansan established a place of business in
1.22whichprescriptions, prescription drugs, medicines, chemicals, and poisons are prepared,
1.23compounded, or dispensed, vended, or sold to or for the use of patients by or under
1.24the supervision of a pharmacist and from which related clinical pharmacy services are
1.25delivered.
1.26 Subd. 2a. Limited service pharmacy. "Limited service pharmacy" means a
1.27pharmacy that has been issued a restricted license by the board to perform a limited range
1.28of the activities that constitute the practice of pharmacy.
2.1 Subd. 3. Pharmacist. The term "pharmacist" means an individual with a currently
2.2valid license issued by the Board of Pharmacy to practice pharmacy.
2.3 Subd. 5. Drug. The term "drug" means all medicinal substances and preparations
2.4recognized by the United States Pharmacopoeia and National Formulary, or any revision
2.5thereof, vaccines and biologicals, and all substances and preparations intended for external
2.6and internal use in the diagnosis, cure, mitigation, treatment, or prevention of disease in
2.7humans or other animals, and all substances and preparations, other than food, intended to
2.8affect the structure or any function of the bodies of humans or other animals. The term drug
2.9shall also mean any compound, substance, or derivative that is not approved for human
2.10consumption by the United States Food and Drug Administration or specifically permitted
2.11for human consumption under Minnesota law that, when introduced into the body, induces
2.12an effect similar to that of a Schedule I or Schedule II controlled substance listed in
2.13section 152.02, subdivisions 2 and 3, or Minnesota Rules, parts 6800.4210 and 6800.4220,
2.14regardless of whether the substance is marketed for the purpose of human consumption.
2.15 Subd. 6. Medicine. The term "medicine" means any remedial agent that has the
2.16property of curing, preventing, treating, or mitigating diseases, or that is used for that
2.17purpose.
2.18 Subd. 7. Poisons. The term "poisons" means any substancewhich that, when
2.19introduced into the system, directly or by absorption, produces violent, morbid, or fatal
2.20changes, orwhich that destroys living tissue with which it comes in contact.
2.21 Subd. 8. Chemical. The term "chemical" means all medicinal or industrial
2.22substances, whether simple or compound, or obtained through the process of the science
2.23and art of chemistry, whether of organic or inorganic origin.
2.24 Subd. 9. Board orState Board of Pharmacy. The term "board" or "State Board of
2.25Pharmacy" means the MinnesotaState Board of Pharmacy.
2.26 Subd. 10. Director. The term "director" means the executive director of the
2.27MinnesotaState Board of Pharmacy.
2.28 Subd. 11. Person. The term "person" means an individual, firm, partnership,
2.29company, corporation, trustee, association, agency, or other public or private entity.
2.30 Subd. 12. Wholesale. The term "wholesale" means and includes any sale for the
2.31purpose of resale.
2.32 Subd. 13. Commercial purposes. The phrase "commercial purposes" means the
2.33ordinary purposes of trade, agriculture, industry, and commerce, exclusive of the practices
2.34of medicineand, pharmacy, and other health care professions.
2.35 Subd. 14. Manufacturing. The term "manufacturing"except in the case of bulk
2.36compounding, prepackaging or extemporaneous compounding within a pharmacy, means
3.1and includes the production, quality control and standardization by mechanical, physical,
3.2chemical, or pharmaceutical means, packing, repacking, tableting, encapsulating, labeling,
3.3relabeling, filling or by any other process, of all drugs, medicines, chemicals, or poisons,
3.4without exception, for medicinal purposes. preparation, propagation, conversion, or
3.5processing of a drug, either directly or indirectly, by extraction from substances of natural
3.6origin or independently by means of chemical or biological synthesis. Manufacturing
3.7includes the packaging or repackaging of a drug, or the labeling or relabeling of
3.8the container of a drug, for resale by pharmacies, practitioners, or other persons.
3.9Manufacturing does not include the prepackaging, extemporaneous compounding, or
3.10anticipatory compounding of a drug within a licensed pharmacy or by a practitioner,
3.11nor the labeling of a container within a pharmacy or by a practitioner for the purpose of
3.12dispensing a drug to a patient pursuant to a valid prescription.
3.13 Subd. 14a. Manufacturer. The term "manufacturer" means any person engaged
3.14in manufacturing.
3.15 Subd. 14b. Outsourcing facility. "Outsourcing facility" means a facility that is
3.16registered by the United States Food and Drug Administration pursuant to United States
3.17Code, title 21, section 353b.
3.18 Subd. 15. Pharmacist intern. The term "pharmacist intern" means (1) a natural
3.19person satisfactorily progressing toward the degree in pharmacy required for licensure, or
3.20(2) a graduate of the University of Minnesota College of Pharmacy, or other pharmacy
3.21college approved by the board, who is registered by theState Board of Pharmacy for the
3.22purpose of obtaining practical experience as a requirement for licensure as a pharmacist,
3.23or (3) a qualified applicant awaiting examination for licensure.
3.24 Subd. 15a. Pharmacy technician. The term "pharmacy technician" means a person
3.25not licensed as a pharmacist or a pharmacist intern, who assists the pharmacist in the
3.26preparation and dispensing of medications by performing computer entry of prescription
3.27data and other manipulative tasks. A pharmacy technician shall not perform tasks
3.28specifically reserved to a licensed pharmacist or requiring professional judgment.
3.29 Subd. 16. Prescription drug order. The term "prescription drug order" means a
3.30signed lawful written order, or an, oral, or electronic order reduced to writing, given by of
3.31 a practitionerlicensed to prescribe drugs for patients in the course of the practitioner's
3.32practice, issued for an individual patient and containing the following: the date of issue,
3.33name and address of the patient, name and quantity of the drug prescribed, directions
3.34for use, and the name and address of the prescriber. for a drug for a specific patient.
3.35Prescription drug orders for controlled substances must be prepared in accordance with the
4.1provisions of section 152.11 and the federal Controlled Substances Act and the regulations
4.2promulgated thereunder.
4.3 Subd. 16a. Prescription. The term "prescription" means a prescription drug order
4.4that is written or printed on paper, an oral order reduced to writing by a pharmacist, or an
4.5electronic order. To be valid, a prescription must be issued for an individual patient by
4.6a practitioner within the scope and usual course of the practitioner's practice, and must
4.7contain the date of issue, name and address of the patient, name and quantity of the drug
4.8prescribed, directions for use, the name and address of the practitioner, and a telephone
4.9number at which the practitioner can be reached. A prescription written or printed on
4.10paper that is given to the patient or an agent of the patient or that is transmitted by fax
4.11must contain the practitioner's manual signature. An electronic prescription must contain
4.12the practitioner's electronic signature.
4.13 Subd. 16b. Chart order. The term "chart order" means a prescription drug order for
4.14a drug that is to be dispensed by a pharmacist, or by a pharmacist intern under the direct
4.15supervision of a pharmacist, and administered by an authorized person only during the
4.16patient's stay in a hospital or long-term care facility. The chart order shall contain the name
4.17of the patient, another patient identifier such as birth date or medical record number, the
4.18drug ordered, and any directions that the practitioner may prescribe concerning strength,
4.19dosage, frequency, and route of administration. The manual or electronic signature of the
4.20practitioner must be affixed to the chart order at the time it is written or at a later date in
4.21the case of verbal chart orders.
4.22 Subd. 17. Legend drug. "Legend drug" means a drugwhich that is required by
4.23federal law tobear the following statement, "Caution: Federal law prohibits dispensing
4.24without prescription." be dispensed only pursuant to the prescription of a licensed
4.25practitioner.
4.26 Subd. 18. Label. "Label" means a display of written, printed, or graphic matter
4.27upon the immediate container of any drug or medicine; and a requirement made by or
4.28under authority of Laws 1969, chapter 933 that. Any word, statement, or other information
4.29appearing required by or under the authority of this chapter to appear on the label shall not
4.30be considered to be complied with unless such word, statement, or other information also
4.31appears appear on the outside container or wrapper, if any there be, of the retail package of
4.32such drug or medicine, oris be easily legible through the outside container or wrapper.
4.33 Subd. 19. Package. "Package" means any container or wrapping in which any
4.34drug or medicine is enclosed for use in the delivery or display of that article to retail
4.35purchasers, but does not include:
5.1(a) shipping containers or wrappings used solely for the transportation of any such
5.2article in bulk or in quantity to manufacturers, packers, processors, or wholesale or
5.3retail distributors;
5.4(b) shipping containers or outer wrappings used by retailers to ship or deliver any
5.5such article to retail customers if such containers and wrappings bear no printed matter
5.6pertaining to any particular drug or medicine.
5.7 Subd. 20. Labeling. "Labeling" means all labels and other written, printed, or
5.8graphic matter (a) upon a drug or medicine or any of its containers or wrappers, or (b)
5.9accompanying such article.
5.10 Subd. 21. Federal act. "Federal act" means the Federal Food, Drug, and Cosmetic
5.11Act, United States Code, title 21, section 301, et seq., as amended.
5.12 Subd. 22. Pharmacist in charge. "Pharmacist in charge" means a duly licensed
5.13pharmacist in the state of Minnesota who has been designated in accordance with the rules
5.14of theState Board of Pharmacy to assume professional responsibility for the operation
5.15of the pharmacy in compliance with the requirements and duties as established by the
5.16board in its rules.
5.17 Subd. 23. Practitioner. "Practitioner" means a licensed doctor of medicine, licensed
5.18doctor of osteopathy duly licensed to practice medicine, licensed doctor of dentistry,
5.19licensed doctor of optometry, licensed podiatrist, or licensed veterinarian. For purposes of
5.20sections151.15, subdivision 4 ; 151.252, subdivision 3;
151.37, subdivision 2 , paragraphs
5.21(b), (e), and (f); and151.461 , "practitioner" also means a physician assistant authorized to
5.22prescribe, dispense, and administer under chapter 147A, or an advanced practice nurse
5.23authorized to prescribe, dispense, and administer under section148.235 . For purposes of
5.24sections151.15, subdivision 4 ; 151.252, subdivision 3;
151.37, subdivision 2 , paragraph
5.25(b); and151.461 , "practitioner" also means a dental therapist authorized to dispense and
5.26administer under chapter 150A.
5.27 Subd. 24. Brand name. "Brand name" means the registered trademark name given
5.28to a drug product by its manufacturer, labeler or distributor.
5.29 Subd. 25. Generic name. "Generic name" means the established name or official
5.30name of a drug or drug product.
5.31 Subd. 26. Finished dosage form. "Finished dosage form" means that form of a
5.32drugwhich that is or is intended to be dispensed or administered to the patient and requires
5.33no further manufacturing or processing other than packaging, reconstitution, or labeling.
5.34 Subd. 27. Practice of pharmacy. "Practice of pharmacy" means:
5.35 (1) interpretation and evaluation of prescription drug orders;
6.1 (2) compounding, labeling, and dispensing drugs and devices (except labeling by
6.2a manufacturer or packager of nonprescription drugs or commercially packaged legend
6.3drugs and devices);
6.4 (3) participation in clinical interpretations and monitoring of drug therapy for
6.5assurance of safe and effective use of drugs, including the performance of laboratory tests
6.6that are waived under the federal Clinical Laboratory Improvement Act of 1988, United
6.7States Code, title 42, section 263a et seq., provided that a pharmacist may interpret the
6.8results of laboratory tests but may modify drug therapy only pursuant to a protocol or
6.9collaborative practice agreement;
6.10 (4) participation in drug and therapeutic device selection; drug administration for first
6.11dosage and medical emergencies; drug regimen reviews; and drug or drug-related research;
6.12 (5) participation in administration of influenza vaccines to all eligible individuals ten
6.13years of age and older and all other vaccines to patients 18 years of age and olderunder
6.14standing orders from a physician licensed under chapter 147 or by written protocol with a
6.15physician licensed under chapter 147, a physician assistant authorized to prescribe drugs
6.16under chapter 147A, or an advanced practice nurse authorized to prescribe drugs under
6.17section 148.235, provided that:
6.18(i) the protocol includes, at a minimum:
6.19(A) the name, dose, and route of each vaccine that may be given;
6.20(B) the patient population for whom the vaccine may be given;
6.21(C) contraindications and precautions to the vaccine;
6.22(D) the procedure for handling an adverse reaction;
6.23(E) the name, signature, and address of the physician, physician assistant, or
6.24advanced nurse practitioner;
6.25(F) a telephone number at which the physician, physician assistant, or advanced
6.26nurse practitioner can be contacted; and
6.27(G) the date and time period for which the protocol is valid;
6.28(i) (ii) the pharmacist is trained in has successfully completed a program approved
6.29by theAmerican Accreditation Council of Pharmaceutical for Pharmacy Education
6.30specifically for the administration of immunizations orgraduated from a college of
6.31pharmacy in 2001 or thereafter a program approved by the board; and
6.32(ii) (iii) the pharmacist reports the administration of the immunization to the patient's
6.33primary physician or clinic or to the Minnesota Immunization Information Connection; and
6.34(iv) the pharmacist complies with guidelines for vaccines and immunizations
6.35established by the federal Advisory Committee on Immunization Practices, except that a
6.36pharmacist does not need to comply with those portions of the guidelines that establish
7.1immunization schedules when administering a vaccine pursuant to a valid, patient-specific
7.2order issued by a physician licensed under chapter 147, a physician assistant authorized to
7.3prescribe drugs under chapter 147A, or an advanced practice nurse authorized to prescribe
7.4drugs under section 148.235, provided that the order is consistent with the United States
7.5Food and Drug Administration approved labeling of the vaccine;
7.6 (6) participation in thepractice of managing drug therapy and modifying initiation,
7.7management, modification, and discontinuation of drug therapy, according to section
7.8151.21, subdivision 1, according to a written protocol or collaborative practice agreement
7.9betweenthe specific pharmacist: (i) one or more pharmacists and the individual dentist,
7.10optometrist, physician, podiatrist, or veterinarian who is responsible for the patient's
7.11care and authorized to independently prescribe drugs one or more dentists, optometrists,
7.12physicians, podiatrists, or veterinarians; or (ii) one or more pharmacists and one or more
7.13physician assistants authorized to prescribe, dispense, and administer under chapter 147A,
7.14or advanced practice nurses authorized to prescribe, dispense, and administer under
7.15section 148.235. Anysignificant changes in drug therapy made pursuant to a protocol or
7.16collaborative practice agreement must bereported documented by the pharmacist to in
7.17 the patient's medical record or reported by the pharmacist to a practitioner responsible
7.18for the patient's care;
7.19 (7) participation in the storage of drugs and the maintenance of records;
7.20 (8)responsibility for participation in patient counseling on therapeutic values,
7.21content, hazards, and uses of drugs and devices; and
7.22 (9) offering or performing those acts, services, operations, or transactions necessary
7.23in the conduct, operation, management, and control of a pharmacy.
7.24 Subd. 27a. Protocol. "Protocol" means:
7.25(1) a specific written plan that describes the nature and scope of activities that a
7.26pharmacist may engage in when initiating, managing, modifying, or discontinuing drug
7.27therapy as allowed in subdivision 27, clause (6); or
7.28(2) a specific written plan that authorizes a pharmacist to administer vaccines and
7.29that complies with subdivision 27, clause (5).
7.30 Subd. 27b. Collaborative practice. "Collaborative practice" means patient care
7.31activities, consistent with subdivision 27, engaged in by one or more pharmacists who
7.32have agreed to work in collaboration with one or more practitioners to initiate, manage,
7.33and modify drug therapy under specified conditions mutually agreed to by the pharmacists
7.34and practitioners.
8.1 Subd. 27c. Collaborative practice agreement. "Collaborative practice agreement"
8.2means a written and signed agreement between one or more pharmacists and one or more
8.3practitioners that allows the pharmacist or pharmacists to engage in collaborative practice.
8.4 Subd. 28. Veterinary legend drug. "Veterinary legend drug" means a drug that is
8.5required by federal law tobear the following statement: "Caution: Federal law restricts
8.6this drug to use by or on the order of a licensed veterinarian." be dispensed only pursuant
8.7to the prescription of a licensed veterinarian.
8.8 Subd. 29. Legend medical gas. "Legend medical gas" means a liquid or gaseous
8.9substance used for medical purposes and that is required by federal law tobear the
8.10following statement: "Caution: Federal law prohibits dispensing without a prescription."
8.11 be dispensed only pursuant to the prescription of a licensed practitioner.
8.12 Subd. 30. Dispense or dispensing. "Dispense or dispensing" means thepreparation
8.13or delivery of a drug pursuant to a lawful order of a practitioner in a suitable container
8.14appropriately labeled for subsequent administration to or use by a patient or other individual
8.15entitled to receive the drug. interpretation, evaluation, and processing of a prescription
8.16drug order and includes those processes specified by the board in rule that are necessary
8.17for the preparation and provision of a drug to a patient or patient's agent in a suitable
8.18container appropriately labeled for subsequent administration to, or use by, a patient.
8.19 Subd. 31. Central service pharmacy. "Central service pharmacy" means a
8.20pharmacy that may provide dispensing functions, drug utilization review, packaging,
8.21labeling, or delivery of a prescription product to another pharmacy for the purpose of
8.22filling a prescription.
8.23 Subd. 32. Electronic signature. "Electronic signature" means an electronic sound,
8.24symbol, or process attached to or associated with a record and executed or adopted by a
8.25person with the intent to sign the record.
8.26 Subd. 33. Electronic transmission. "Electronic transmission" means transmission
8.27of information in electronic form.
8.28 Subd. 34. Health professional shortage area. "Health professional shortage area"
8.29means an area designated as such by the federal Secretary of Health and Human Services,
8.30as provided under Code of Federal Regulations, title 42, part 5, and United States Code,
8.31title 42, section 254E.
8.32 Subd. 35. Compounding. "Compounding" means preparing, mixing, assembling,
8.33packaging, and labeling a drug for an identified individual patient as a result of
8.34a practitioner's prescription drug order. Compounding also includes anticipatory
8.35compounding, as defined in this section, and the preparation of drugs in which all bulk
8.36drug substances and components are nonprescription substances. Compounding does
9.1not include mixing or reconstituting a drug according to the product's labeling or to the
9.2manufacturer's directions. Compounding does not include the preparation of a drug for the
9.3purpose of, or incident to, research, teaching, or chemical analysis, provided that the drug
9.4is not prepared for dispensing or administration to patients. All compounding, regardless
9.5of the type of product, must be done pursuant to a prescription drug order unless otherwise
9.6permitted in this chapter or by the rules of the board.
9.7 Subd. 36. Anticipatory compounding. "Anticipatory compounding" means the
9.8preparation by a pharmacy of a supply of a compounded drug product that is sufficient to
9.9meet the short-term anticipated need of the pharmacy for the filling of prescription drug
9.10orders. In the case of practitioners only, anticipatory compounding means the preparation
9.11of a supply of a compounded drug product that is sufficient to meet the practitioner's
9.12short-term anticipated need for dispensing or administering the drug to patients treated
9.13by the practitioner. Anticipatory compounding is not the preparation of a compounded
9.14drug product for wholesale distribution.
9.15 Subd. 37. Extemporaneous compounding. "Extemporaneous compounding"
9.16means the compounding of a drug product pursuant to a prescription drug order for a specific
9.17patient that is issued in advance of the compounding. Extemporaneous compounding is
9.18not the preparation of a compounded drug product for wholesale distribution.
9.19 Subd. 38. Compounded positron emission tomography drug. "Compounded
9.20positron emission tomography drug" means a drug that:
9.21(1) exhibits spontaneous disintegration of unstable nuclei by the emission of
9.22positrons and is used for the purpose of providing dual photon positron emission
9.23tomographic diagnostic images;
9.24(2) has been compounded by or on the order of a practitioner in accordance with the
9.25relevant parts of Minnesota Rules, chapters 4731 and 6800, for a patient or for research,
9.26teaching, or quality control; and
9.27(3) includes any nonradioactive reagent, reagent kit, ingredient, nuclide generator,
9.28accelerator, target material, electronic synthesizer, or other apparatus or computer program
9.29to be used in the preparation of such a drug.
9.30 Sec. 2. Minnesota Statutes 2012, section 151.06, is amended to read:
9.31151.06 POWERS AND DUTIES.
9.32 Subdivision 1. Generally; rules. (a) Powers and duties. The Board of Pharmacy
9.33shall have the power and it shall be its duty:
9.34 (1) to regulate the practice of pharmacy;
9.35 (2) to regulate the manufacture, wholesale, and retail sale of drugs within this state;
10.1 (3) to regulate the identity, labeling, purity, and quality of all drugs and medicines
10.2dispensed in this state, using the United States Pharmacopeia and the National Formulary,
10.3or any revisions thereof, or standards adopted under the federal act as the standard;
10.4 (4) to enter and inspect by its authorized representative any and all places where
10.5drugs, medicines, medical gases, or veterinary drugs or devices are sold, vended, given
10.6away, compounded, dispensed, manufactured, wholesaled, or held; it may secure samples
10.7or specimens of any drugs, medicines, medical gases, or veterinary drugs or devices
10.8after paying or offering to pay for such sample; it shall be entitled to inspect and make
10.9copies of any and all records of shipment, purchase, manufacture, quality control, and
10.10sale of these items provided, however, that such inspection shall not extend to financial
10.11data, sales data, or pricing data;
10.12 (5) to examine and license as pharmacists all applicants whom it shall deem qualified
10.13to be such;
10.14 (6) to license wholesale drug distributors;
10.15 (7) todeny, suspend, revoke, or refuse to renew take disciplinary action against any
10.16registration or license required under this chapter, to any applicant or registrant or licensee
10.17 upon any of thefollowing grounds: listed in section 151.071, and in accordance with
10.18the provisions of section 151.071;
10.19(i) fraud or deception in connection with the securing of such license or registration;
10.20(ii) in the case of a pharmacist, conviction in any court of a felony;
10.21(iii) in the case of a pharmacist, conviction in any court of an offense involving
10.22moral turpitude;
10.23(iv) habitual indulgence in the use of narcotics, stimulants, or depressant drugs;
10.24or habitual indulgence in intoxicating liquors in a manner which could cause conduct
10.25endangering public health;
10.26(v) unprofessional conduct or conduct endangering public health;
10.27(vi) gross immorality;
10.28(vii) employing, assisting, or enabling in any manner an unlicensed person to
10.29practice pharmacy;
10.30(viii) conviction of theft of drugs, or the unauthorized use, possession, or sale thereof;
10.31(ix) violation of any of the provisions of this chapter or any of the rules of the State
10.32Board of Pharmacy;
10.33(x) in the case of a pharmacy license, operation of such pharmacy without a
10.34pharmacist present and on duty;
10.35(xi) in the case of a pharmacist, physical or mental disability which could cause
10.36incompetency in the practice of pharmacy;
11.1(xii) in the case of a pharmacist, the suspension or revocation of a license to practice
11.2pharmacy in another state; or
11.3(xiii) in the case of a pharmacist, aiding suicide or aiding attempted suicide in
11.4violation of section
609.215 as established by any of the following:
11.5(A) a copy of the record of criminal conviction or plea of guilty for a felony in
11.6violation of section
609.215, subdivision 1 or 2;
11.7(B) a copy of the record of a judgment of contempt of court for violating an
11.8injunction issued under section
609.215, subdivision 4;
11.9(C) a copy of the record of a judgment assessing damages under section
609.215,
11.10subdivision 5
; or
11.11(D) a finding by the board that the person violated section
609.215, subdivision
11.121
or 2. The board shall investigate any complaint of a violation of section
609.215,
11.13subdivision 1
or 2;
11.14 (8) to employ necessary assistants and adopt rules for the conduct of its business;
11.15 (9) to register as pharmacy technicians all applicants who the board determines are
11.16qualified to carry out the duties of a pharmacy technician;and
11.17 (10) to perform such other duties and exercise such other powers as the provisions of
11.18the act may require.; and
11.19(11) to enter and inspect any business to which it issues a license or registration.
11.20(b) Temporary suspension. In addition to any other remedy provided by law, the board
11.21may, without a hearing, temporarily suspend a license for not more than 60 days if the board
11.22finds that a pharmacist has violated a statute or rule that the board is empowered to enforce
11.23and continued practice by the pharmacist would create an imminent risk of harm to others.
11.24The suspension shall take effect upon written notice to the pharmacist, specifying the
11.25statute or rule violated. At the time it issues the suspension notice, the board shall schedule
11.26a disciplinary hearing to be held under the Administrative Procedure Act. The pharmacist
11.27shall be provided with at least 20 days' notice of any hearing held under this subdivision.
11.28(c) (b) Rules. For the purposes aforesaid, it shall be the duty of the board to make
11.29and publish uniform rules not inconsistent herewith for carrying out and enforcing
11.30the provisions of this chapter. The board shall adopt rules regarding prospective drug
11.31utilization review and patient counseling by pharmacists. A pharmacist in the exercise of
11.32the pharmacist's professional judgment, upon the presentation of anew prescription by a
11.33patient or the patient's caregiver or agent, shall perform the prospective drug utilization
11.34review required by rules issued under this subdivision.
11.35(d) (c) Substitution; rules. If the United States Food and Drug Administration
11.36(FDA) determines that the substitution of drugs used for the treatment of epilepsy or
12.1seizures poses a health risk to patients, the board shall adopt rules in accordance with
12.2accompanying FDA interchangeability standards regarding the use of substitution for
12.3these drugs. If the board adopts a rule regarding the substitution of drugs used for the
12.4treatment of epilepsy or seizures that conflicts with the substitution requirements of
12.5section151.21, subdivision 3 , the rule shall supersede the conflicting statute. If the rule
12.6proposed by the board would increase state costs for state public health care programs,
12.7the board shall report to the chairs and ranking minority members of the senate Health
12.8and Human Services Budget Division and the house of representatives Health Care and
12.9Human Services Finance Division the proposed rule and the increased cost associated
12.10with the proposed rule before the board may adopt the rule.
12.11 Subd. 1a.Disciplinary action Cease and desist orders. It shall be grounds for
12.12disciplinary action by the Board of Pharmacy against the registration of the pharmacy if
12.13the Board of Pharmacy determines that any person with supervisory responsibilities at the
12.14pharmacy sets policies that prevent a licensed pharmacist from providing drug utilization
12.15review and patient counseling as required by rules adopted under subdivision 1. The
12.16Board of Pharmacy shall follow the requirements of chapter 14 in any disciplinary actions
12.17taken under this section. (a) Whenever it appears to the board that a person has engaged in
12.18an act or practice constituting a violation of a law, rule, or other order related to the duties
12.19and responsibilities entrusted to the board, the board may issue and cause to be served
12.20upon the person an order requiring the person to cease and desist from violations.
12.21(b) The cease and desist order must state the reasons for the issuance of the order
12.22and must give reasonable notice of the rights of the person to request a hearing before
12.23an administrative law judge. A hearing must be held not later than ten days after the
12.24request for the hearing is received by the board. After the completion of the hearing,
12.25the administrative law judge shall issue a report within ten days. Within 15 days after
12.26receiving the report of the administrative law judge, the board shall issue a further order
12.27vacating or making permanent the cease and desist order. The time periods provided in
12.28this provision may be waived by agreement of the executive director of the board and the
12.29person against whom the cease and desist order was issued. If the person to whom a cease
12.30and desist order is issued fails to appear at the hearing after being duly notified, the person
12.31is in default, and the proceeding may be determined against that person upon consideration
12.32of the cease and desist order, the allegations of which may be considered to be true. Unless
12.33otherwise provided, all hearings must be conducted according to chapter 14. The board
12.34may adopt rules of procedure concerning all proceedings conducted under this subdivision.
12.35(c) If no hearing is requested within 30 days of service of the order, the cease and
12.36desist order will become permanent.
13.1(d) A cease and desist order issued under this subdivision remains in effect until
13.2it is modified or vacated by the board. The administrative proceeding provided by this
13.3subdivision, and subsequent appellate judicial review of that administrative proceeding,
13.4constitutes the exclusive remedy for determining whether the board properly issued the
13.5cease and desist order and whether the cease and desist order should be vacated or made
13.6permanent.
13.7 Subd. 1b. Enforcement of violations of cease and desist orders. (a) Whenever
13.8the board under subdivision 1a seeks to enforce compliance with a cease and desist
13.9order that has been made permanent, the allegations of the cease and desist order are
13.10considered conclusively established for purposes of proceeding under subdivision 1a for
13.11permanent or temporary relief to enforce the cease and desist order. Whenever the board
13.12under subdivision 1a seeks to enforce compliance with a cease and desist order when a
13.13hearing or hearing request on the cease and desist order is pending, or the time has not
13.14yet expired to request a hearing on whether a cease and desist order should be vacated or
13.15made permanent, the allegations in the cease and desist order are considered conclusively
13.16established for the purposes of proceeding under subdivision 1a for temporary relief to
13.17enforce the cease and desist order.
13.18(b) Notwithstanding this subdivision or subdivision 1a, the person against whom
13.19the cease and desist order is issued and who has requested a hearing under subdivision 1a
13.20may, within 15 days after service of the cease and desist order, bring an action in Ramsey
13.21County District Court for issuance of an injunction to suspend enforcement of the cease
13.22and desist order pending a final decision of the board under subdivision 1a to vacate or
13.23make permanent the cease and desist order. The court shall determine whether to issue
13.24such an injunction based on traditional principles of temporary relief.
13.25 Subd. 2. Application. In the case of a facility licensed or registered by the board,
13.26the provisions of subdivision 1 shall apply to an individual owner or sole proprietor and
13.27shall also apply to the following:
13.28(1) In the case of a partnership, each partner thereof;
13.29(2) In the case of an association, each member thereof;
13.30(3) In the case of a corporation, each officer or director thereof and each shareholder
13.31owning 30 percent or more of the voting stock of such corporation.
13.32Subd. 3. Application of Administrative Procedure Act. The board shall comply
13.33with the provisions of chapter 14, before it fails to issue, renew, suspends, or revokes any
13.34license or registration issued under this chapter.
13.35Subd. 4. Reinstatement. Any license or registration which has been suspended
13.36or revoked may be reinstated by the board provided the holder thereof shall pay all costs
14.1of the proceedings resulting in the suspension or revocation, and, in addition thereto,
14.2pay a fee set by the board.
14.3Subd. 5. Costs; penalties. The board may impose a civil penalty not exceeding
14.4$10,000 for each separate violation, the amount of the civil penalty to be fixed so as
14.5to deprive a licensee or registrant of any economic advantage gained by reason of
14.6the violation, to discourage similar violations by the licensee or registrant or any other
14.7licensee or registrant, or to reimburse the board for the cost of the investigation and
14.8proceeding, including, but not limited to, fees paid for services provided by the Office of
14.9Administrative Hearings, legal and investigative services provided by the Office of the
14.10Attorney General, court reporters, witnesses, reproduction of records, board members'
14.11per diem compensation, board staff time, and travel costs and expenses incurred by board
14.12staff and board members.
14.13 Sec. 3. [151.071] DISCIPLINARY ACTION.
14.14 Subdivision 1. Forms of disciplinary action. When the board finds that a licensee,
14.15registrant, or applicant has engaged in conduct prohibited under subdivision 2, it may
14.16do one or more of the following:
14.17(1) deny the issuance of a license or registration;
14.18(2) refuse to renew a license or registration;
14.19(3) revoke the license or registration;
14.20(4) suspend the license or registration;
14.21(5) impose limitations, conditions, or both on the license or registration, including
14.22but not limited to: the limitation of practice designated settings; the imposition of
14.23retraining or rehabilitation requirements; the requirement of practice under supervision;
14.24the requirement of participation in a diversion program such as that established pursuant to
14.25section 214.31 or the conditioning of continued practice on demonstration of knowledge
14.26or skills by appropriate examination or other review of skill and competence;
14.27(6) impose a civil penalty not exceeding $10,000 for each separate violation, the
14.28amount of the civil penalty to be fixed so as to deprive a licensee or registrant of any
14.29economic advantage gained by reason of the violation, to discourage similar violations
14.30by the licensee or registrant or any other licensee or registrant, or to reimburse the board
14.31for the cost of the investigation and proceeding, including but not limited to, fees paid
14.32for services provided by the Office of Administrative Hearings, legal and investigative
14.33services provided by the Office of the Attorney General, court reporters, witnesses,
14.34reproduction of records, board members' per diem compensation, board staff time, and
14.35travel costs and expenses incurred by board staff and board members; and
15.1(7) reprimand the licensee or registrant.
15.2 Subd. 2. Grounds for disciplinary action. The following conduct is prohibited and
15.3is grounds for disciplinary action:
15.4(1) failure to demonstrate the qualifications or satisfy the requirements for a license
15.5or registration contained in this chapter or the rules of the board. The burden of proof is on
15.6the applicant to demonstrate such qualifications or satisfaction of such requirements;
15.7(2) obtaining a license by fraud or by misleading the board in any way during
15.8the application process or obtaining a license by cheating, or attempting to subvert
15.9the licensing examination process. Conduct that subverts or attempts to subvert the
15.10licensing examination process includes, but is not limited to: (i) conduct that violates the
15.11security of the examination materials, such as removing examination materials from the
15.12examination room or having unauthorized possession of any portion of a future, current,
15.13or previously administered licensing examination; (ii) conduct that violates the standard of
15.14test administration, such as communicating with another examinee during administration
15.15of the examination, copying another examinee's answers, permitting another examinee
15.16to copy one's answers, or possessing unauthorized materials; or (iii) impersonating an
15.17examinee or permitting an impersonator to take the examination on one's own behalf;
15.18(3) for a pharmacist, pharmacy technician, pharmacist intern, applicant for a
15.19pharmacist or pharmacy license, or applicant for a pharmacy technician or pharmacist
15.20intern registration, conviction of a felony reasonably related to the practice of pharmacy.
15.21Conviction as used in this subdivision includes a conviction of an offense that if committed
15.22in this state would be deemed a felony without regard to its designation elsewhere, or
15.23a criminal proceeding where a finding or verdict of guilt is made or returned but the
15.24adjudication of guilt is either withheld or not entered thereon. The board may delay the
15.25issuance of a new license or registration if the applicant has been charged with a felony
15.26until the matter has been adjudicated;
15.27(4) for a facility, other than a pharmacy, licensed or registered by the board, if an
15.28owner or applicant is convicted of a felony reasonably related to the operation of the
15.29facility. The board may delay the issuance of a new license or registration if the owner or
15.30applicant has been charged with a felony until the matter has been adjudicated;
15.31(5) for a controlled substance researcher, conviction of a felony reasonably related
15.32to controlled substances or to the practice of the researcher's profession. The board may
15.33delay the issuance of a registration if the applicant has been charged with a felony until
15.34the matter has been adjudicated;
15.35(6) disciplinary action taken by another state or by one of this state's health licensing
15.36agencies:
16.1(i) revocation, suspension, restriction, limitation, or other disciplinary action against
16.2a license or registration in another state or jurisdiction, failure to report to the board that
16.3charges or allegations regarding the person's license or registration have been brought in
16.4another state or jurisdiction, or having been refused a license or registration by any other
16.5state or jurisdiction. The board may delay the issuance of a new license or registration if
16.6an investigation or disciplinary action is pending in another state or jurisdiction until the
16.7investigation or action has been dismissed or otherwise resolved; and
16.8(ii) revocation, suspension, restriction, limitation, or other disciplinary action against
16.9a license or registration issued by another of this state's health licensing agencies, failure
16.10to report to the board that charges regarding the person's license or registration have been
16.11brought by another of this state's health licensing agencies, or having been refused a
16.12license or registration by another of this state's health licensing agencies. The board may
16.13delay the issuance of a new license or registration if a disciplinary action is pending before
16.14another of this state's health licensing agencies until the action has been dismissed or
16.15otherwise resolved;
16.16(7) for a pharmacist, pharmacy, pharmacy technician, or pharmacist intern, violation
16.17of any order of the board, of any of the provisions of this chapter or any rules of the
16.18board or violation of any federal, state, or local law or rule reasonably pertaining to the
16.19practice of pharmacy;
16.20(8) for a facility, other than a pharmacy, licensed by the board, violations of any
16.21order of the board, of any of the provisions of this chapter or the rules of the board or
16.22violation of any federal, state, or local law relating to the operation of the facility;
16.23(9) engaging in any unethical conduct; conduct likely to deceive, defraud, or harm
16.24the public, or demonstrating a willful or careless disregard for the health, welfare, or safety
16.25of a patient; or pharmacy practice that is professionally incompetent, in that it may create
16.26unnecessary danger to any patient's life, health, or safety, in any of which cases, proof
16.27of actual injury need not be established;
16.28(10) aiding or abetting an unlicensed person in the practice of pharmacy, except
16.29that it is not a violation of this clause for a pharmacist to supervise a properly registered
16.30pharmacy technician or pharmacist intern if that person is performing duties allowed
16.31by this chapter or the rules of the board;
16.32(11) for an individual licensed or registered by the board, adjudication as mentally ill
16.33or developmentally disabled, or as a chemically dependent person, a person dangerous
16.34to the public, a sexually dangerous person, or a person who has a sexual psychopathic
16.35personality, by a court of competent jurisdiction, within or without this state. Such
17.1adjudication shall automatically suspend a license for the duration thereof unless the
17.2board orders otherwise;
17.3(12) for a pharmacist or pharmacy intern, engaging in unprofessional conduct as
17.4specified in the board's rules. In the case of a pharmacy technician, engaging in conduct
17.5specified in board rules that would be unprofessional if it were engaged in by a pharmacist
17.6or pharmacist intern or performing duties specifically reserved for pharmacists under this
17.7chapter or the rules of the board;
17.8(13) for a pharmacy, operation of the pharmacy without a pharmacist present and on
17.9duty except as allowed by a variance approved by the board;
17.10(14) for a pharmacist, the inability to practice pharmacy with reasonable skill and
17.11safety to patients by reason of illness, drunkenness, use of drugs, narcotics, chemicals, or
17.12any other type of material or as a result of any mental or physical condition, including
17.13deterioration through the aging process or loss of motor skills. In the case of registered
17.14pharmacy technicians, pharmacist interns, or controlled substance researchers, the
17.15inability to carry out duties allowed under this chapter or the rules of the board with
17.16reasonable skill and safety to patients by reason of illness, drunkenness, use of drugs,
17.17narcotics, chemicals, or any other type of material or as a result of any mental or physical
17.18condition, including deterioration through the aging process or loss of motor skills;
17.19(15) for a pharmacist, pharmacy, pharmacist intern, pharmacy technician, medical
17.20gas distributor, or controlled substance researcher, revealing a privileged communication
17.21from or relating to a patient except when otherwise required or permitted by law;
17.22(16) for a pharmacist or pharmacy, improper management of patient records,
17.23including failure to maintain adequate patient records, to comply with a patient's request
17.24made pursuant to sections 144.291 to 144.298, or to furnish a patient record or report
17.25required by law;
17.26(17) paying, offering to pay, receiving, or agreeing to receive, a commission, rebate,
17.27kickback, or other form of remuneration, directly or indirectly, for the referral of patients
17.28or the dispensing of drugs or devices;
17.29(18) engaging in abusive or fraudulent billing practices, including violations of the
17.30federal Medicare and Medicaid laws or state medical assistance laws or rules;
17.31(19) engaging in conduct with a patient that is sexual or may reasonably be
17.32interpreted by the patient as sexual, or in any verbal behavior that is seductive or sexually
17.33demeaning to a patient;
17.34(20) failure to make reports as required by section 151.072 or to cooperate with an
17.35investigation of the board as required by section 151.074;
18.1(21) knowingly providing false or misleading information that is directly related
18.2to the care of a patient unless done for an accepted therapeutic purpose such as the
18.3dispensing and administration of a placebo;
18.4(22) aiding suicide or aiding attempted suicide in violation of section 609.215 as
18.5established by any of the following:
18.6(i) a copy of the record of criminal conviction or plea of guilty for a felony in
18.7violation of section 609.215, subdivision 1 or 2;
18.8(ii) a copy of the record of a judgment of contempt of court for violating an
18.9injunction issued under section 609.215, subdivision 4;
18.10(iii) a copy of the record of a judgment assessing damages under section 609.215,
18.11subdivision 5; or
18.12(iv) a finding by the board that the person violated section 609.215, subdivision
18.131 or 2. The board shall investigate any complaint of a violation of section 609.215,
18.14subdivision 1 or 2;
18.15(23) for a pharmacist, practice of pharmacy under a lapsed or nonrenewed license.
18.16For a pharmacist intern, pharmacy technician, or controlled substance researcher,
18.17performing duties permitted to such individuals by this chapter or the rules of the board
18.18under a lapsed or nonrenewed registration. For a facility required to be licensed under this
18.19chapter, operation of the facility under a lapsed or nonrenewed license or registration; and
18.20(24) for a pharmacist, pharmacist intern, or pharmacy technician, termination
18.21or discharge from the health professional services program for reasons other than the
18.22satisfactory completion of the program.
18.23 Subd. 3. Automatic suspension. (a) A license or registration issued under this
18.24chapter to a pharmacist, pharmacist intern, pharmacy technician, or controlled substance
18.25researcher is automatically suspended if: (1) a guardian of a licensee or registrant is
18.26appointed by order of a court pursuant to sections 524.5-101 to 524.5-502, for reasons
18.27other than the minority of the licensee or registrant; or (2) the licensee or registrant is
18.28committed by order of a court pursuant to chapter 253B. The license or registration
18.29remains suspended until the licensee is restored to capacity by a court and, upon petition
18.30by the licensee or registrant, the suspension is terminated by the board after a hearing.
18.31(b) For a pharmacist, pharmacy intern, or pharmacy technician, upon notice to the
18.32board of a judgment of, or a plea of guilty to, a felony reasonably related to the practice
18.33of pharmacy, the license or registration of the regulated person may be automatically
18.34suspended by the board. The license or registration will remain suspended until, upon
18.35petition by the regulated individual and after a hearing, the suspension is terminated by
18.36the board. The board may indefinitely suspend or revoke the license or registration of the
19.1regulated individual if, after a hearing before the board, the board finds that the felonious
19.2conduct would cause a serious risk of harm to the public.
19.3(c) For a facility that is licensed or registered by the board, upon notice to the
19.4board that an owner of the facility is subject to a judgment of, or a plea of guilty to,
19.5a felony reasonably related to the operation of the facility, the license or registration of
19.6the facility may be automatically suspended by the board. The license or registration will
19.7remain suspended until, upon petition by the facility and after a hearing, the suspension
19.8is terminated by the board. The board may indefinitely suspend or revoke the license or
19.9registration of the facility if, after a hearing before the board, the board finds that the
19.10felonious conduct would cause a serious risk of harm to the public.
19.11(d) For licenses and registrations that have been suspended or revoked pursuant
19.12to paragraphs (a) and (b), the regulated individual may have a license or registration
19.13reinstated, either with or without restrictions, by demonstrating clear and convincing
19.14evidence of rehabilitation, as provided in section 364.03. If the regulated individual has
19.15the conviction subsequently overturned by court decision, the board shall conduct a
19.16hearing to review the suspension within 30 days after the receipt of the court decision.
19.17The regulated individual is not required to prove rehabilitation if the subsequent court
19.18decision overturns previous court findings of public risk.
19.19(e) For licenses and registrations that have been suspended or revoked pursuant to
19.20paragraph (c), the regulated facility may have a license or registration reinstated, either with
19.21or without restrictions, conditions, or limitations, by demonstrating clear and convincing
19.22evidence of rehabilitation of the convicted owner, as provided in section 364.03. If the
19.23convicted owner has the conviction subsequently overturned by court decision, the board
19.24shall conduct a hearing to review the suspension within 30 days after receipt of the court
19.25decision. The regulated facility is not required to prove rehabilitation of the convicted
19.26owner if the subsequent court decision overturns previous court findings of public risk.
19.27(f) The board may, upon majority vote of a quorum of its appointed members,
19.28suspend the license or registration of a regulated individual without a hearing if the
19.29regulated individual fails to maintain a current name and address with the board, as
19.30described in paragraphs (h) and (i), while the regulated individual is: (1) under board
19.31investigation, and a notice of conference has been issued by the board; (2) party to a
19.32contested case with the board; (3) party to an agreement for corrective action with the
19.33board; or (4) under a board order for disciplinary action. The suspension shall remain
19.34in effect until lifted by the board to the board's receipt of a petition from the regulated
19.35individual, along with the current name and address of the regulated individual.
20.1(g) The board may, upon majority vote of a quorum of its appointed members,
20.2suspend the license or registration of a regulated facility without a hearing if the regulated
20.3facility fails to maintain a current name and address of the owner of the facility with the
20.4board, as described in paragraphs (h) and (i), while the regulated facility is: (1) under
20.5board investigation, and a notice of conference has been issued by the board; (2) party
20.6to a contested case with the board; (3) party to an agreement for corrective action with
20.7the board; or (4) under a board order for disciplinary action. The suspension shall remain
20.8in effect until lifted by the board pursuant to the board's receipt of a petition from the
20.9regulated facility, along with the current name and address of the owner of the facility.
20.10(h) An individual licensed or registered by the board shall maintain a current name
20.11and home address with the board and shall notify the board in writing within 30 days of
20.12any change in name or home address. An individual regulated by the board shall also
20.13maintain a current business address with the board as required by section 214.073. For
20.14an individual, if a name change only is requested, the regulated individual must request
20.15a revised license or registration. The board may require the individual to substantiate
20.16the name change by submitting official documentation from a court of law or agency
20.17authorized under law to receive and officially record a name change. In the case of an
20.18individual, if an address change only is requested, no request for a revised license or
20.19registration is required. If the current license or registration of an individual has been lost,
20.20stolen, or destroyed, the individual shall provide a written explanation to the board.
20.21(i) A facility licensed or registered by the board shall maintain a current name and
20.22address with the board. A facility shall notify the board in writing within 30 days of any
20.23change in name. A facility licensed or registered by the board but located outside of the
20.24state must notify the board within 30 days of an address change. A facility licensed or
20.25registered by the board and located within the state must notify the board at least 60
20.26days in advance of a change of address that will result from the move of the facility to a
20.27different location and must pass an inspection at the new location as required by the board.
20.28If the current license or registration of a facility has been lost, stolen, or destroyed, the
20.29facility shall provide a written explanation to the board.
20.30 Subd. 4. Effective dates. A suspension, revocation, condition, limitation,
20.31qualification, or restriction of a license or registration shall be in effect pending
20.32determination of an appeal. A revocation of a license pursuant to subdivision 1a is not
20.33appealable and shall remain in effect indefinitely.
20.34 Subd. 5. Conditions on reissued license. In its discretion, the board may restore
20.35and reissue a license or registration issued under this chapter, but as a condition thereof
20.36may impose any disciplinary or corrective measure that it might originally have imposed.
21.1 Subd. 6. Temporary suspension of license for pharmacists. In addition to any
21.2other remedy provided by law, the board may, without a hearing, temporarily suspend the
21.3license of a pharmacist if the board finds that the pharmacist has violated a statute or rule
21.4that the board is empowered to enforce and continued practice by the pharmacist would
21.5create a serious risk of harm to the public. The suspension shall take effect upon written
21.6notice to the pharmacist, specifying the statute or rule violated. The suspension shall
21.7remain in effect until the board issues a final order in the matter after a hearing. At the
21.8time it issues the suspension notice, the board shall schedule a disciplinary hearing to be
21.9held pursuant to the Administrative Procedure Act. The pharmacist shall be provided with
21.10at least 20 days' notice of any hearing held pursuant to this subdivision. The hearing shall
21.11be scheduled to begin no later than 30 days after the issuance of the suspension order.
21.12 Subd. 7. Temporary suspension of license for pharmacist interns, pharmacy
21.13technicians, and controlled substance researchers. In addition to any other remedy
21.14provided by law, the board may, without a hearing, temporarily suspend the registration of
21.15a pharmacist intern, pharmacy technician, or controlled substance researcher if the board
21.16finds that the registrant has violated a statute or rule that the board is empowered to enforce
21.17and continued registration of the registrant would create a serious risk of harm to the
21.18public. The suspension shall take effect upon written notice to the registrant, specifying
21.19the statute or rule violated. The suspension shall remain in effect until the board issues a
21.20final order in the matter after a hearing. At the time it issues the suspension notice, the
21.21board shall schedule a disciplinary hearing to be held pursuant to the Administrative
21.22Procedure Act. The licensee or registrant shall be provided with at least 20 days' notice of
21.23any hearing held pursuant to this subdivision. The hearing shall be scheduled to begin no
21.24later than 30 days after the issuance of the suspension order.
21.25 Subd. 8. Temporary suspension of license for pharmacies, drug wholesalers,
21.26drug manufacturers, medical gas manufacturers, and medical gas distributors.
21.27In addition to any other remedy provided by law, the board may, without a hearing,
21.28temporarily suspend the license or registration of a pharmacy, drug wholesaler, drug
21.29manufacturer, medical gas manufacturer, or medical gas distributor if the board finds
21.30that the licensee or registrant has violated a statute or rule that the board is empowered
21.31to enforce and continued operation of the licensed facility would create a serious risk of
21.32harm to the public. The suspension shall take effect upon written notice to the licensee or
21.33registrant, specifying the statute or rule violated. The suspension shall remain in effect
21.34until the board issues a final order in the matter after a hearing. At the time it issues the
21.35suspension notice, the board shall schedule a disciplinary hearing to be held pursuant to
21.36the Administrative Procedure Act. The licensee or registrant shall be provided with at
22.1least 20 days' notice of any hearing held pursuant to this subdivision. The hearing shall be
22.2scheduled to begin no later than 30 days after the issuance of the suspension order.
22.3 Subd. 9. Evidence. In disciplinary actions alleging a violation of subdivision 2,
22.4clause (4), (5), (6), or (7), a copy of the judgment or proceeding under the seal of the court
22.5administrator or of the administrative agency that entered the same shall be admissible
22.6into evidence without further authentication and shall constitute prima facie evidence
22.7of the contents thereof.
22.8 Subd. 10. Mental examination; access to medical data. (a) If the board has
22.9probable cause to believe that an individual licensed or registered by the board falls under
22.10subdivision 2, clause (14), it may direct the individual to submit to a mental or physical
22.11examination. For the purpose of this subdivision, every licensed or registered individual is
22.12deemed to have consented to submit to a mental or physical examination when directed in
22.13writing by the board and further to have waived all objections to the admissibility of the
22.14examining practitioner's testimony or examination reports on the grounds that the same
22.15constitute a privileged communication. Failure of a licensed or registered individual to
22.16submit to an examination when directed constitutes an admission of the allegations against
22.17the individual, unless the failure was due to circumstances beyond the individual's control,
22.18in which case a default and final order may be entered without the taking of testimony or
22.19presentation of evidence. Pharmacists affected under this paragraph shall at reasonable
22.20intervals be given an opportunity to demonstrate that they can resume the competent
22.21practice of the profession of pharmacy with reasonable skill and safety to the public.
22.22Pharmacist interns, pharmacy technicians, or controlled substance researchers affected
22.23under this paragraph shall at reasonable intervals be given an opportunity to demonstrate
22.24that they can competently resume the duties that can be performed, under this chapter or
22.25the rules of the board, by similarly registered persons with reasonable skill and safety to
22.26the public. In any proceeding under this paragraph, neither the record of proceedings nor
22.27the orders entered by the board shall be used against a licensed or registered individual
22.28in any other proceeding.
22.29(b) In addition to ordering a physical or mental examination, the board may,
22.30notwithstanding section 13.384, 144.651, or any other law limiting access to medical or
22.31other health data, obtain medical data and health records relating to an individual licensed
22.32or registered by the board, or to an applicant for licensure or registration, without the
22.33individual's consent, if the board has probable cause to believe that the individual falls
22.34under subdivision 2, clause (14). The medical data may be requested from a provider,
22.35as defined in section 144.291, subdivision 2, paragraph (h), an insurance company, or a
22.36government agency, including the Department of Human Services. A provider, insurance
23.1company, or government agency shall comply with any written request of the board under
23.2this subdivision and is not liable in any action for damages for releasing the data requested
23.3by the board if the data are released pursuant to a written request under this subdivision,
23.4unless the information is false and the provider giving the information knew, or had reason
23.5to believe, the information was false. Information obtained under this subdivision is
23.6classified as private under sections 13.01 to 13.87.
23.7 Subd. 11. Tax clearance certificate. (a) In addition to the provisions of subdivision
23.81, the board may not issue or renew a license or registration if the commissioner of
23.9revenue notifies the board and the licensee or applicant for a license that the licensee or
23.10applicant owes the state delinquent taxes in the amount of $500 or more. The board may
23.11issue or renew the license or registration only if (1) the commissioner of revenue issues a
23.12tax clearance certificate, and (2) the commissioner of revenue or the licensee, registrant, or
23.13applicant forwards a copy of the clearance to the board. The commissioner of revenue
23.14may issue a clearance certificate only if the licensee, registrant, or applicant does not owe
23.15the state any uncontested delinquent taxes.
23.16(b) For purposes of this subdivision, the following terms have the meanings given.
23.17(1) "Taxes" are all taxes payable to the commissioner of revenue, including penalties
23.18and interest due on those taxes.
23.19(2) "Delinquent taxes" do not include a tax liability if (i) an administrative or court
23.20action that contests the amount or validity of the liability has been filed or served, (ii) the
23.21appeal period to contest the tax liability has not expired, or (iii) the licensee or applicant
23.22has entered into a payment agreement to pay the liability and is current with the payments.
23.23(c) In lieu of the notice and hearing requirements of subdivision 1, when a licensee,
23.24registrant, or applicant is required to obtain a clearance certificate under this subdivision,
23.25a contested case hearing must be held if the licensee or applicant requests a hearing in
23.26writing to the commissioner of revenue within 30 days of the date of the notice provided
23.27in paragraph (a). The hearing must be held within 45 days of the date the commissioner of
23.28revenue refers the case to the Office of Administrative Hearings. Notwithstanding any law
23.29to the contrary, the licensee or applicant must be served with 20 days' notice in writing
23.30specifying the time and place of the hearing and the allegations against the licensee or
23.31applicant. The notice may be served personally or by mail.
23.32(d) A licensee or applicant must provide the licensee's or applicant's Social Security
23.33number and Minnesota business identification number on all license applications. Upon
23.34request of the commissioner of revenue, the board must provide to the commissioner of
23.35revenue a list of all licensees and applicants that includes the licensee's or applicant's
23.36name, address, Social Security number, and business identification number. The
24.1commissioner of revenue may request a list of the licensees and applicants no more than
24.2once each calendar year.
24.3 Subd. 12. Limitation. No board proceeding against a regulated person or facility
24.4shall be instituted unless commenced within seven years from the date of the commission
24.5of some portion of the offense or misconduct complained of except for alleged violations
24.6of subdivision 2, clause (21).
24.7 Sec. 4. [151.072] REPORTING OBLIGATIONS.
24.8 Subdivision 1. Permission to report. A person who has knowledge of any conduct
24.9constituting grounds for discipline under the provisions of this chapter or the rules of the
24.10board may report the violation to the board.
24.11 Subd. 2. Pharmacies. A pharmacy located in this state must report to the board any
24.12discipline that is related to an incident involving conduct that would constitute grounds
24.13for discipline under the provisions of this chapter or the rules of the board, that is taken
24.14by the pharmacy or any of its administrators against a pharmacist, pharmacist intern, or
24.15pharmacy technician, including the termination of employment of the individual or the
24.16revocation, suspension, restriction, limitation, or conditioning of an individual's ability
24.17to practice or work at or on behalf of the pharmacy. The pharmacy shall also report the
24.18resignation of any pharmacist, pharmacist intern, or technician prior to the conclusion of
24.19any disciplinary proceeding, or prior to the commencement of formal charges but after the
24.20individual had knowledge that formal charges were contemplated or in preparation. Each
24.21report made under this subdivision must state the nature of the action taken and state in
24.22detail the reasons for the action. Failure to report violations as required by this subdivision
24.23is a basis for discipline pursuant to section 151.071, subdivision 2, clause (8).
24.24 Subd. 3. Licensees and registrants of the board. A licensee or registrant of
24.25the board shall report to the board personal knowledge of any conduct that the person
24.26reasonably believes constitutes grounds for disciplinary action under this chapter or
24.27the rules of the board by any pharmacist, pharmacist intern, pharmacy technician, or
24.28controlled substance researcher, including any conduct indicating that the person may be
24.29professionally incompetent, or may have engaged in unprofessional conduct or may be
24.30medically or physically unable to engage safely in the practice of pharmacy or to carry
24.31out the duties permitted to the person by this chapter or the rules of the board. Failure
24.32to report violations as required by this subdivision is a basis for discipline pursuant to
24.33section 151.071, subdivision 2, clause (20).
24.34 Subd. 4. Courts. The court administrator of a district court or any other court of
24.35competent jurisdiction shall report to the board any judgment or other determination of
25.1the court that: adjudges or includes a finding that a licensee or registrant of the board is
25.2mentally ill, mentally incompetent, guilty of a felony, or guilty of a violation of federal
25.3or state narcotics laws or controlled substances act, guilty of an abuse or fraud under
25.4Medicare or Medicaid; appoints a guardian of the licensee or registrant pursuant to sections
25.5524.5-101 to 524.5-502; or commits a licensee or registrant pursuant to chapter 253B.
25.6 Subd. 5. Self-reporting. A licensee or registrant of the board shall report to the
25.7board any personal action that would require that a report be filed with the board pursuant
25.8to subdivision 2 or 4.
25.9 Subd. 6. Deadlines; forms. Reports required by subdivisions 2 to 5 must be
25.10submitted not later than 30 days after the occurrence of the reportable event or transaction.
25.11The board may provide forms for the submission of reports required by this section, may
25.12require that reports be submitted on the forms provided, and may adopt rules necessary
25.13to assure prompt and accurate reporting.
25.14 Subd. 7. Subpoenas. The board may issue subpoenas for the production of any
25.15reports required by subdivisions 2 to 5 or any related documents.
25.16 Sec. 5. [151.073] IMMUNITY.
25.17 Subdivision 1. Reporting. Any person, health care facility, business, or organization
25.18is immune from civil liability or criminal prosecution for submitting in good faith a report
25.19to the board under section 151.072 or for otherwise reporting in good faith to the board
25.20violations or alleged violations of this chapter or the rules of the board. All such reports
25.21are investigative data as defined in chapter 13.
25.22 Subd. 2. Investigation. (a) Members of the board and persons employed by the board
25.23or engaged on behalf of the board in the investigation of violations and in the preparation
25.24and management of charges or violations of this chapter of the rules of the board, or persons
25.25participating in the investigation or testifying regarding charges of violations, are immune
25.26from civil liability and criminal prosecution for any actions, transactions, or publications
25.27in the execution of, or relating to, their duties under this chapter or the rules of the board.
25.28(b) Members of the board and persons employed by the board or engaged in
25.29maintaining records and making reports regarding adverse health care events are immune
25.30from civil liability and criminal prosecution for any actions, transactions, or publications
25.31in the execution of, or relating to, their duties under section 151.301.
25.32 Sec. 6. [151.074] LICENSEE OR REGISTRANT COOPERATION.
25.33An individual who is licensed or registered by the board, who is the subject of an
25.34investigation by or on behalf of the board, shall cooperate fully with the investigation.
26.1An owner or employee of a facility that is licensed or registered by the board, when the
26.2facility is the subject of an investigation by or on behalf of the board, shall cooperate
26.3fully with the investigation. Cooperation includes responding fully and promptly to any
26.4question raised by, or on behalf of, the board relating to the subject of the investigation and
26.5providing copies of patient pharmacy records and other relevant records, as reasonably
26.6requested by the board, to assist the board in its investigation. The board shall maintain
26.7any records obtained pursuant to this section as investigative data pursuant to chapter 13.
26.8 Sec. 7. [151.075] DISCIPLINARY RECORD ON JUDICIAL REVIEW.
26.9Upon judicial review of any board disciplinary action taken under this chapter, the
26.10reviewing court shall seal the administrative record, except for the board's final decision,
26.11and shall not make the administrative record available to the public.
26.12 Sec. 8. Minnesota Statutes 2012, section 151.211, is amended to read:
26.13151.211 RECORDS OF PRESCRIPTIONS.
26.14 Subdivision 1. Retention of prescription drug orders. Allprescriptions dispensed
26.15 prescription drug orders shall be kept on file at the locationin from which such dispensing
26.16occurred of the ordered drug occurs for a period of at least two years. Prescription drug
26.17orders that are electronically prescribed must be kept on file in the format in which
26.18they were originally received. Written or printed prescription drug orders and verbal
26.19prescription drug orders reduced to writing, must be kept on file as received or transcribed,
26.20except that such orders may be kept in an electronic format as allowed by the board.
26.21Electronic systems used to process and store prescription drug orders must be compliant
26.22with the requirements of this chapter and the rules of the board. Prescription drug orders
26.23that are stored in an electronic format, as permitted by this subdivision, may be kept on
26.24file at a remote location provided that they are readily and securely accessible from the
26.25location at which dispensing of the ordered drug occurred.
26.26 Subd. 2. Refill requirements.No A prescription shall drug order may be refilled
26.27except only with the written, electronic, or verbal consent of the prescriber and in
26.28accordance with the requirements of this chapter, the rules of the board, and where
26.29applicable, section 152.11. The date of such refill must be recorded and initialed upon
26.30the original prescription drug order, or within the electronically maintained record of the
26.31original prescription drug order, by the pharmacist, pharmacist intern, or practitioner
26.32who refills the prescription.
26.33 Sec. 9. [151.251] COMPOUNDING.
27.1 Subdivision 1. Exemption from manufacturing licensure requirement. Section
27.2151.252 shall not apply to:
27.3(1) a practitioner engaged in extemporaneous compounding, anticipatory
27.4compounding, or compounding not done pursuant to a prescription drug order when
27.5permitted by this chapter or the rules of the board; and
27.6(2) a pharmacy in which a pharmacist is engaged in extemporaneous compounding,
27.7anticipatory compounding, or compounding not done pursuant to a prescription drug order
27.8when permitted by this chapter or the rules of the board.
27.9 Subd. 2. Compounded drug. A drug product may be compounded under this
27.10section if a pharmacist or practitioner:
27.11(a) compounds the drug product using bulk drug substances, as defined in the federal
27.12regulations published in Code of Federal Regulations, title 21, section 207.3(a)(4):
27.13(1) that:
27.14(i) comply with the standards of an applicable United States Pharmacopoeia
27.15or National Formulary monograph, if a monograph exists, and the United States
27.16Pharmacopoeia chapter on pharmacy compounding;
27.17(ii) if such a monograph does not exist, are drug substances that are components of
27.18drugs approved for use in this country by the United States Food and Drug Administration;
27.19or
27.20(iii) if such a monograph does not exist and the drug substance is not a component of
27.21a drug approved for use in this country by the United States Food and Drug Administration,
27.22that appear on a list developed by the United States Food and Drug Administration through
27.23regulations issued by the secretary of the federal Department of Health and Human
27.24Services pursuant to section 503a of the Food, Drug and Cosmetic Act under paragraph (d);
27.25(2) that are manufactured by an establishment that is registered under section 360
27.26of the federal Food, Drug and Cosmetic Act, including a foreign establishment that is
27.27registered under section 360(i) of that act; and
27.28(3) that are accompanied by valid certificates of analysis for each bulk drug substance;
27.29(b) compounds the drug product using ingredients, other than bulk drug substances,
27.30that comply with the standards of an applicable United States Pharmacopoeia or National
27.31Formulary monograph, if a monograph exists, and the United States Pharmacopoeia
27.32chapters on pharmacy compounding;
27.33(c) does not compound a drug product that appears on a list published by the secretary
27.34of the federal Department of Health and Human Services in the Federal Register of drug
27.35products that have been withdrawn or removed from the market because such drug products
27.36or components of such drug products have been found to be unsafe or not effective;
28.1(d) does not compound any drug products that are essentially copies of a
28.2commercially available drug product; and
28.3(e) does not compound any drug product that has been identified pursuant to
28.4United States Code, title 21, section 353a, as a drug product that presents demonstrable
28.5difficulties for compounding that reasonably demonstrate an adverse effect on the safety
28.6or effectiveness of that drug product.
28.7The term "essentially a copy of a commercially available drug product" does not
28.8include a drug product in which there is a change, made for an identified individual
28.9patient, that produces for that patient a significant difference, as determined by the
28.10prescribing practitioner, between the compounded drug and the comparable commercially
28.11available drug product.
28.12 Subd. 3. Exceptions. This section shall not apply to:
28.13(1) compounded positron emission tomography drugs as defined in section 151.01,
28.14subdivision 38; or
28.15(2) radiopharmaceuticals.
28.16 Sec. 10. Minnesota Statutes 2013 Supplement, section 151.252, is amended by adding
28.17a subdivision to read:
28.18 Subd. 1a. Outsourcing facility. (a) No person shall act as an outsourcing facility
28.19without first obtaining a license from the board and paying any applicable manufacturer
28.20licensing fee specified in section 151.065.
28.21(b) Application for an outsourcing facility license under this section shall be made
28.22in a manner specified by the board and may differ from the application required of other
28.23drug manufacturers.
28.24(c) No license shall be issued or renewed for an outsourcing facility unless the
28.25applicant agrees to operate in a manner prescribed for outsourcing facilities by federal and
28.26state law and according to Minnesota Rules.
28.27(d) No license shall be issued or renewed for an outsourcing facility unless the
28.28applicant supplies the board with proof of such registration by the United States Food and
28.29Drug Administration as required by United States Code, title 21, section 353b.
28.30(e) No license shall be issued or renewed for an outsourcing facility that is required
28.31to be licensed or registered by the state in which it is physically located unless the
28.32applicant supplies the board with proof of such licensure or registration. The board may
28.33establish, by rule, standards for the licensure of an outsourcing facility that is not required
28.34to be licensed or registered by the state in which it is physically located.
29.1(f) The board shall require a separate license for each outsourcing facility located
29.2within the state and for each outsourcing facility located outside of the state at which drugs
29.3that are shipped into the state are prepared.
29.4(g) The board shall not issue an initial or renewed license for an outsourcing facility
29.5unless the facility passes an inspection conducted by an authorized representative of the
29.6board. In the case of an outsourcing facility located outside of the state, the board may
29.7require the applicant to pay the cost of the inspection, in addition to the license fee in
29.8section 151.065, unless the applicant furnishes the board with a report, issued by the
29.9appropriate regulatory agency of the state in which the facility is located or by the United
29.10States Food and Drug Administration, of an inspection that has occurred within the 24
29.11months immediately preceding receipt of the license application by the board. The board
29.12may deny licensure unless the applicant submits documentation satisfactory to the board
29.13that any deficiencies noted in an inspection report have been corrected.
29.14 Sec. 11. Minnesota Statutes 2012, section 151.26, is amended to read:
29.15151.26 EXCEPTIONS.
29.16 Subdivision 1. Generally. Nothing in this chapter shall subject a person duly
29.17licensed in this state to practice medicine, dentistry, or veterinary medicine, to inspection
29.18by the State Board of Pharmacy, nor prevent the person from administering drugs,
29.19medicines, chemicals, or poisons in the person's practice, nor prevent a duly licensed
29.20practitioner from furnishing to a patient properly packaged and labeled drugs, medicines,
29.21chemicals, or poisons as may be considered appropriate in the treatment of such patient;
29.22unless the person is engaged in the dispensing, sale, or distribution of drugs and the board
29.23provides reasonable notice of an inspection.
29.24Except for the provisions of section151.37 , nothing in this chapter applies to or
29.25interferes with the dispensing, in its original package and at no charge to the patient, of a
29.26legend drug, other than a controlled substance, that was packaged by a manufacturer and
29.27provided to the dispenser for distribution as a professional sample.
29.28Nothing in this chapter shall prevent the sale of drugs, medicines, chemicals, or
29.29poisons at wholesale to licensed physicians, dentists and veterinarians for use in their
29.30practice, nor to hospitals for use therein.
29.31Nothing in this chapter shall prevent the sale of drugs, chemicals, or poisons either
29.32at wholesale or retail for use for commercial purposes, or in the arts, nor interfere with the
29.33sale of insecticides, as defined in Minnesota Statutes 1974, section24.069 , and nothing in
29.34this chapter shall prevent the sale of common household preparations and other drugs,
29.35chemicals, and poisons sold exclusively for use for nonmedicinal purposes.; provided
30.1that this exception does not apply to any compound, substance, or derivative that is not
30.2approved for human consumption by the United States Food and Drug Administration
30.3or specifically permitted for human consumption under Minnesota law that, when
30.4introduced into the body, induces an effect similar to that of a Schedule I or Schedule II
30.5controlled substance listed in section 152.02, subdivisions 2 and 3, or Minnesota Rules,
30.6parts 6800.4210 and 6800.4220, regardless of whether the substance is marketed for the
30.7purpose of human consumption.
30.8Nothing in this chapter shall apply to or interfere with the vending or retailing of
30.9any nonprescription medicine or drug not otherwise prohibited by statutewhich that is
30.10prepackaged, fully prepared by the manufacturer or producer for use by the consumer, and
30.11labeled in accordance with the requirements of the state or federal Food and Drug Act; nor
30.12to the manufacture, wholesaling, vending, or retailing of flavoring extracts, toilet articles,
30.13cosmetics, perfumes, spices, and other commonly used household articles of a chemical
30.14nature, for use for nonmedicinal purposes.; provided that this exception does not apply
30.15to any compound, substance, or derivative that is not approved for human consumption
30.16by the United States Food and Drug Administration or specifically permitted for human
30.17consumption under Minnesota law that, when introduced into the body, induces an effect
30.18similar to that of a Schedule I or Schedule II controlled substance listed in section 152.02,
30.19subdivisions 2 and 3, or Minnesota Rules, parts 6800.4210 and 6800.4220, regardless of
30.20whether the substance is marketed for the purpose of human consumption. Nothing in
30.21this chapter shall prevent the sale of drugs or medicines by licensed pharmacists at a
30.22discount to persons over 65 years of age.
30.23 Sec. 12. Minnesota Statutes 2012, section 151.34, is amended to read:
30.24151.34 PROHIBITED ACTS.
30.25It shall be unlawful to:
30.26(1) manufacture, sell or deliver, hold or offer for sale any drug that is adulterated
30.27or misbranded;
30.28(2) adulterate or misbrand any drug;
30.29(3) receive in commerce any drug that is adulterated or misbranded, and to deliver or
30.30proffer delivery thereof for pay or otherwise;
30.31(4) refuse to permit entry or inspection, or to permit the taking of a sample, or to
30.32permit access to or copying of any record as authorized by this chapter;
30.33(5) remove or dispose of a detained or embargoed article in violation of this chapter;
31.1(6) alter, mutilate, destroy, obliterate, or remove the whole or any part of the labeling
31.2of, or to do any other act with respect to a drug, if such act is done while such drug is held
31.3for sale and results in such drug being adulterated or misbranded;
31.4(7) use for a person's own advantage or to reveal other than to the board or its
31.5authorized representative or to the courts when required in any judicial proceeding under
31.6this chapter any information acquired under authority of this chapter concerning any
31.7method or processwhich that is a trade secret and entitled to protection;
31.8(8) use on the labeling of any drug any representation or suggestion that an
31.9application with respect to such drug is effective under the federal act or that such drug
31.10complies with such provisions;
31.11(9) in the case of a manufacturer, packer, or distributor offering legend drugs for sale
31.12within this state, fail to maintain for transmittal or to transmit, to any practitioner licensed
31.13by applicable law to administer such drug who makes written request for information as to
31.14such drug, true and correct copies of all printed matterwhich that is required to be included
31.15in any package in which that drug is distributed or sold, or such other printed matter as is
31.16approved under the federal act. Nothing in this paragraph shall be construed to exempt
31.17any person from any labeling requirement imposed by or under provisions of this chapter;
31.18(10) conduct a pharmacy without a pharmacist in charge;
31.19(11) dispense a legend drug without first obtaining a valid prescription for that drug;
31.20(12) conduct a pharmacy without proper registration with the board;
31.21(13) practice pharmacy without being licensed to do so by the board;or
31.22(14) sell at retail federally restricted medical gases without proper registration with
31.23the board except as provided in this chapter.; or
31.24(15) sell any compound, substance, or derivative that is not approved for human
31.25consumption by the United States Food and Drug Administration or specifically permitted
31.26for human consumption under Minnesota law that, when introduced into the body, induces
31.27an effect similar to that of a Schedule I or Schedule II controlled substance listed in
31.28section 152.02, subdivisions 2 and 3, or Minnesota Rules, parts 6800.4210 and 6800.4220,
31.29regardless of whether the substance is marketed for the purpose of human consumption.
31.30 Sec. 13. Minnesota Statutes 2012, section 151.35, is amended to read:
31.31151.35 DRUGS, ADULTERATION.
31.32A drug shall be deemed to be adulterated:
31.33(1) if it consists in whole or in part of any filthy, putrid or decomposed substance; or
31.34if it has been produced, prepared, packed, or held under unsanitary conditions whereby it
31.35may have been rendered injurious to health, or whereby it may have been contaminated
32.1with filth; or if the methods used in, or the facilities or controls used for, its manufacture,
32.2processing, packing, or holding do not conform to or are not operated or administered
32.3in conformity with current good manufacturing practice as required under the federal
32.4act to assure that such drug is safe and has the identity, strength, quality, and purity
32.5characteristics, which it purports or is represented to possess; or the facility in which it
32.6was produced was not registered by the United States Food and Drug Administration or
32.7licensed by the board; or, its container is composed, in whole or in part, of any poisonous
32.8or deleterious substance which may render the contents injurious to health; or it bears
32.9or contains, for purposes of coloring only, a color additive which is unsafe within the
32.10meaning of the federal act, or it is a color additive, the intended use of which in or on drugs
32.11is for the purposes of coloring only, and is unsafe within the meaning of the federal act;
32.12(2) if it purports to be or is represented as a drug the name of which is recognized in
32.13the United States Pharmacopoeia or the National Formulary, and its strength differs from,
32.14or its quality or purity falls below, the standard set forth therein. Such determination as
32.15to strength, quality, or purity shall be made in accordance with the tests or methods of
32.16assay set forth in such compendium, or in the absence of or inadequacy of such tests or
32.17methods of assay, those prescribed under authority of the federal act. No drug defined
32.18in the United States Pharmacopoeia or the National Formulary shall be deemed to be
32.19adulterated under this paragraph because it differs from the standard of strength, quality,
32.20or purity therefor set forth in such compendium, if its difference in strength, quality, or
32.21purity from such standard is plainly stated on its label;
32.22(3) if it is not subject to the provisions of paragraph (2) of this section and its
32.23strength differs from, or its purity or quality differs from that which it purports or is
32.24represented to possess;
32.25(4) if any substance has been mixed or packed therewith so as to reduce its quality or
32.26strength, or substituted wholly or in part therefor.
32.27 Sec. 14. Minnesota Statutes 2012, section 151.361, subdivision 2, is amended to read:
32.28 Subd. 2. After January 1, 1983. (a) No legend drug in solid oral dosage form
32.29may be manufactured, packaged or distributed for sale in this state after January 1, 1983
32.30unless it is clearly marked or imprinted with a symbol, number, company name, words,
32.31letters, national drug code or other mark uniquely identifiable to that drug product. An
32.32identifying mark or imprint made as required by federal law or by the federal Food and
32.33Drug Administration shall be deemed to be in compliance with this section.
32.34(b) The Board of Pharmacy may grant exemptions from the requirements of this
32.35section on its own initiative or upon application of a manufacturer, packager, or distributor
33.1indicating size or other characteristicswhich that render the product impractical for the
33.2imprinting required by this section.
33.3(c) The provisions of clauses (a) and (b) shall not apply to any of the following:
33.4(1) Drugs purchased by a pharmacy, pharmacist, or licensed wholesaler prior to
33.5January 1, 1983, and held in stock for resale.
33.6(2) Drugs which are manufactured by or upon the order of a practitioner licensed by
33.7law to prescribe or administer drugs and which are to be used solely by the patient for
33.8whom prescribed.
33.9 Sec. 15. Minnesota Statutes 2012, section 151.37, as amended by Laws 2013, chapter
33.1043, section 30, Laws 2013, chapter 55, section 2, and Laws 2013, chapter 108, article
33.1110, section 5, is amended to read:
33.12151.37 LEGEND DRUGS, WHO MAY PRESCRIBE, POSSESS.
33.13 Subdivision 1. Prohibition. Except as otherwise provided in this chapter, it shall be
33.14unlawful for any person to have in possession, or to sell, give away, barter, exchange, or
33.15distribute a legend drug.
33.16 Subd. 2. Prescribing and filing. (a) A licensed practitioner in the course of
33.17professional practice only, may prescribe, administer, and dispense a legend drug, and
33.18may cause the same to be administered by a nurse, a physician assistant, or medical
33.19student or resident under the practitioner's direction and supervision, and may cause a
33.20person who is an appropriately certified, registered, or licensed health care professional
33.21to prescribe, dispense, and administer the same within the expressed legal scope of the
33.22person's practice as defined in Minnesota Statutes. A licensed practitioner may prescribe a
33.23legend drug, without reference to a specific patient, by directing a licensed dietitian or
33.24licensed nutritionist, pursuant to section148.634 ; a nurse, pursuant to section
148.235 ,
33.25subdivisions 8 and 9; physician assistant; medical student or resident; or pharmacist
33.26according to section 151.01, subdivision 27, to adhere to a particular practice guideline or
33.27protocol when treating patients whose condition falls within such guideline or protocol,
33.28and when such guideline or protocol specifies the circumstances under which the legend
33.29drug is to be prescribed and administered. An individual who verbally, electronically, or
33.30otherwise transmits a written, oral, or electronic order, as an agent of a prescriber, shall
33.31not be deemed to have prescribed the legend drug. This paragraph applies to a physician
33.32assistant only if the physician assistant meets the requirements of section147A.18 .
33.33(b) The commissioner of health, if a licensed practitioner, or a person designated
33.34by the commissioner who is a licensed practitioner, may prescribe a legend drug to an
33.35individual or by protocol for mass dispensing purposes where the commissioner finds that
34.1the conditions triggering section144.4197 or
144.4198, subdivision 2 , paragraph (b), exist.
34.2The commissioner, if a licensed practitioner, or a designated licensed practitioner, may
34.3prescribe, dispense, or administer a legend drug or other substance listed in subdivision 10
34.4to control tuberculosis and other communicable diseases. The commissioner may modify
34.5state drug labeling requirements, and medical screening criteria and documentation, where
34.6time is critical and limited labeling and screening are most likely to ensure legend drugs
34.7reach the maximum number of persons in a timely fashion so as to reduce morbidity
34.8and mortality.
34.9 (c) A licensed practitioner that dispenses for profit a legend drug that is to be
34.10administered orally, is ordinarily dispensed by a pharmacist, and is not a vaccine, must
34.11file with the practitioner's licensing board a statement indicating that the practitioner
34.12dispenses legend drugs for profit, the general circumstances under which the practitioner
34.13dispenses for profit, and the types of legend drugs generally dispensed. It is unlawful to
34.14dispense legend drugs for profit after July 31, 1990, unless the statement has been filed
34.15with the appropriate licensing board. For purposes of this paragraph, "profit" means (1)
34.16any amount received by the practitioner in excess of the acquisition cost of a legend drug
34.17for legend drugs that are purchased in prepackaged form, or (2) any amount received
34.18by the practitioner in excess of the acquisition cost of a legend drug plus the cost of
34.19making the drug available if the legend drug requires compounding, packaging, or other
34.20treatment. The statement filed under this paragraph is public data under section13.03 .
34.21This paragraph does not apply to a licensed doctor of veterinary medicine or a registered
34.22pharmacist. Any person other than a licensed practitioner with the authority to prescribe,
34.23dispense, and administer a legend drug under paragraph (a) shall not dispense for profit.
34.24To dispense for profit does not include dispensing by a community health clinic when the
34.25profit from dispensing is used to meet operating expenses.
34.26 (d) A prescriptionor drug order for the following drugs is not valid, unless it can
34.27be established that the prescriptionor drug order was based on a documented patient
34.28evaluation, including an examination, adequate to establish a diagnosis and identify
34.29underlying conditions and contraindications to treatment:
34.30 (1) controlled substance drugs listed in section152.02, subdivisions 3 to 5;
34.31 (2) drugs defined by the Board of Pharmacy as controlled substances under section
34.32152.02, subdivisions 7
, 8, and 12;
34.33 (3) muscle relaxants;
34.34 (4) centrally acting analgesics with opioid activity;
34.35 (5) drugs containing butalbital; or
34.36 (6) phoshodiesterase type 5 inhibitors when used to treat erectile dysfunction.
35.1 (e) For the purposes of paragraph (d), the requirement for an examination shall be
35.2met if an in-person examination has been completed in any of the following circumstances:
35.3 (1) the prescribing practitioner examines the patient at the time the prescription
35.4or drug order is issued;
35.5 (2) the prescribing practitioner has performed a prior examination of the patient;
35.6 (3) another prescribing practitioner practicing within the same group or clinic as the
35.7prescribing practitioner has examined the patient;
35.8 (4) a consulting practitioner to whom the prescribing practitioner has referred the
35.9patient has examined the patient; or
35.10 (5) the referring practitioner has performed an examination in the case of a
35.11consultant practitioner issuing a prescription or drug order when providing services by
35.12means of telemedicine.
35.13 (f) Nothing in paragraph (d) or (e) prohibits a licensed practitioner from prescribing
35.14a drug through the use of a guideline or protocol pursuant to paragraph (a).
35.15 (g) Nothing in this chapter prohibits a licensed practitioner from issuing a
35.16prescription or dispensing a legend drug in accordance with the Expedited Partner Therapy
35.17in the Management of Sexually Transmitted Diseases guidance document issued by the
35.18United States Centers for Disease Control.
35.19 (h) Nothing in paragraph (d) or (e) limits prescription, administration, or dispensing
35.20of legend drugs through a public health clinic or other distribution mechanism approved
35.21by the commissioner of health or a board of health in order to prevent, mitigate, or treat
35.22a pandemic illness, infectious disease outbreak, or intentional or accidental release of a
35.23biological, chemical, or radiological agent.
35.24 (i) No pharmacist employed by, under contract to, or working for a pharmacy
35.25licensed under section151.19, subdivision 1 , may dispense a legend drug based on a
35.26prescription that the pharmacist knows, or would reasonably be expected to know, is not
35.27valid under paragraph (d).
35.28 (j) No pharmacist employed by, under contract to, or working for a pharmacy
35.29licensed under section151.19, subdivision 2 , may dispense a legend drug to a resident
35.30of this state based on a prescription that the pharmacist knows, or would reasonably be
35.31expected to know, is not valid under paragraph (d).
35.32(k) Nothing in this chapter prohibits the commissioner of health, if a licensed
35.33practitioner, or, if not a licensed practitioner, a designee of the commissioner who is
35.34a licensed practitioner, from prescribing legend drugs for field-delivered therapy in the
35.35treatment of a communicable disease according to the Centers For Disease Control and
35.36Prevention Partner Services Guidelines.
36.1 Subd. 2a. Delegation. A supervising physician may delegate to a physician assistant
36.2who is registered with the Board of Medical Practice and certified by the National
36.3Commission on Certification of Physician Assistants and who is under the supervising
36.4physician's supervision, the authority to prescribe, dispense, and administer legend drugs
36.5and medical devices, subject to the requirements in chapter 147A and other requirements
36.6established by the Board of Medical Practice in rules.
36.7 Subd. 3. Veterinarians. A licensed doctor of veterinary medicine, in the course of
36.8professional practice only and not for use by a human being, may personally prescribe,
36.9administer, and dispense a legend drug, and may cause the same to be administered or
36.10dispensed by an assistant under the doctor's direction and supervision.
36.11 Subd. 4. Research. (a) Any qualified person may use legend drugs in the course
36.12of a bona fide research project, but cannot administer or dispense such drugs to human
36.13beings unless such drugs are prescribed, dispensed, and administered by a person lawfully
36.14authorized to do so.
36.15 (b) Drugs may be dispensed or distributed by a pharmacy licensed by the board for
36.16use by, or administration to, patients enrolled in a bona fide research study that is being
36.17conducted pursuant to either an investigational new drug application approved by the
36.18United States Food and Drug Administration or that has been approved by an institutional
36.19review board. For the purposes of this subdivision only:
36.20 (1) a prescription drug order is not required for a pharmacy to dispense a research
36.21drug, unless the study protocol requires the pharmacy to receive such an order;
36.22 (2) notwithstanding the prescription labeling requirements found in this chapter or
36.23the rules promulgated by the board, a research drug may be labeled as required by the
36.24study protocol;and
36.25 (3) dispensing and distribution of research drugs by pharmacies shall not be
36.26consideredcompounding, manufacturing, or wholesaling under this chapter.; and
36.27(4) a pharmacy may compound drugs for research studies as provided in
36.28this subdivision but must follow applicable standards established by United States
36.29Pharmacopeia, chapter 795 or 797, for nonsterile and sterile compounding, respectively.
36.30 (c) An entity that is under contract to a federal agency for the purpose of distributing
36.31drugs for bona fide research studies is exempt from the drug wholesaler licensing
36.32requirements of this chapter. Any other entity is exempt from the drug wholesaler
36.33licensing requirements of this chapter if the board finds that the entity is licensed or
36.34registered according to the laws of the state in which it is physically located and it is
36.35distributing drugs for use by, or administration to, patients enrolled in a bona fide research
36.36study that is being conducted pursuant to either an investigational new drug application
37.1approved by the United States Food and Drug Administration or that has been approved
37.2by an institutional review board.
37.3 Subd. 5. Exclusion for course of practice. Nothing in this chapter shall prohibit
37.4the sale to, or the possession of, a legend drug by licensed drug wholesalers, licensed
37.5manufacturers, registered pharmacies, local detoxification centers, licensed hospitals,
37.6bona fide hospitals wherein animals are treated, or licensed pharmacists and licensed
37.7practitioners while acting within the course of their practice only.
37.8 Subd. 6. Exclusion for course of employment. (a) Nothing in this chapter shall
37.9prohibit the possession of a legend drug by an employee, agent, or sales representative of
37.10a registered drug manufacturer, or an employee or agent of a registered drug wholesaler,
37.11or registered pharmacy, while acting in the course of employment.
37.12(b) Nothing in this chapter shall prohibit the following entities from possessing a
37.13legend drug for the purpose of disposing of the legend drug as pharmaceutical waste:
37.14(1) a law enforcement officer;
37.15(2) a hazardous waste transporter licensed by the Department of Transportation;
37.16(3) a facility permitted by the Pollution Control Agency to treat, store, or dispose of
37.17hazardous waste, including household hazardous waste;
37.18(4) a facility licensed by the Pollution Control Agency or a metropolitan county as a
37.19very small quantity generator collection program or a minimal generator;
37.20(5) a county that collects, stores, transports, or disposes of a legend drug pursuant to
37.21a program in compliance with applicable federal law or a person authorized by the county
37.22to conduct one or more of these activities; or
37.23(6) a sanitary district organized under chapter 115, or a special law.
37.24 Subd. 7. Exclusion for prescriptions. (a) Nothing in this chapter shall prohibit the
37.25possession of a legend drug by a person for that person's use when it has been dispensed to
37.26the person in accordance with a valid prescription issued by a practitioner.
37.27(b) Nothing in this chapter shall prohibit a person, for whom a legend drug has
37.28been dispensed in accordance with a written or oral prescription by a practitioner, from
37.29designating a family member, caregiver, or other individual to handle the legend drug for
37.30the purpose of assisting the person in obtaining or administering the drug or sending
37.31the drug for destruction.
37.32(c) Nothing in this chapter shall prohibit a person for whom a prescription drug has
37.33been dispensed in accordance with a valid prescription issued by a practitioner from
37.34transferring the legend drug to a county that collects, stores, transports, or disposes of a
37.35legend drug pursuant to a program in compliance with applicable federal law or to a
37.36person authorized by the county to conduct one or more of these activities.
38.1 Subd. 8. Misrepresentation. It is unlawful for a person to procure, attempt to
38.2procure, possess, or control a legend drug by any of the following means:
38.3(1) deceit, misrepresentation, or subterfuge;
38.4(2) using a false name; or
38.5(3) falsely assuming the title of, or falsely representing a person to be a manufacturer,
38.6wholesaler, pharmacist, practitioner, or other authorized person for the purpose of
38.7obtaining a legend drug.
38.8 Subd. 9. Exclusion for course of laboratory employment. Nothing in this chapter
38.9shall prohibit the possession of a legend drug by an employee or agent of a registered
38.10analytical laboratory while acting in the course of laboratory employment.
38.11 Subd. 10. Purchase of drugs and other agents by commissioner of health. The
38.12commissioner of health, in preparation for and in carrying out the duties of sections
38.13144.05
,
144.4197 , and
144.4198, may purchase, store, and distribute antituberculosis
38.14drugs, biologics, vaccines, antitoxins, serums, immunizing agents, antibiotics, antivirals,
38.15antidotes, other pharmaceutical agents, and medical supplies to treat and prevent
38.16communicable disease.
38.17 Subd. 10a. Emergency use authorizations. Nothing in this chapter shall prohibit
38.18the purchase, possession, or use of a legend drug by an entity acting according to an
38.19emergency use authorization issued by the United States Food and Drug Administration
38.20pursuant to United States Code, title 21, section 360.bbb-3. The entity must be specifically
38.21tasked in a public health response plan to perform critical functions necessary to support
38.22the response to a public health incident or event.
38.23 Subd. 11.Complaint reporting Exclusion for health care educational programs.
38.24The Board of Pharmacy shall report on a quarterly basis to the Board of Optometry any
38.25complaints received regarding the prescription or administration of legend drugs under
38.26section
148.576. Nothing in this section shall prohibit an accredited public or private
38.27postsecondary school from possessing a legend drug that is not a controlled substance
38.28listed in section 152.02, provided that:
38.29(a) the school is approved by the United States secretary of education in accordance
38.30with requirements of the Higher Education Act of 1965, as amended;
38.31(b) the school provides a course of instruction that prepares individuals for
38.32employment in a health care occupation or profession;
38.33(c) the school may only possess those drugs necessary for the instruction of such
38.34individuals; and
38.35(d) the drugs may only be used in the course of providing such instruction and are
38.36labeled by the purchaser to indicate that they are not to be administered to patients.
39.1Those areas of the school in which legend drugs are stored are subject to section
39.2151.06, subdivision 1, paragraph (a), clause (4).
39.3 Sec. 16. Minnesota Statutes 2012, section 151.44, is amended to read:
39.4151.44 DEFINITIONS.
39.5As used in sections151.43 to
151.51 , the following terms have the meanings given
39.6in paragraphs (a) to (h):
39.7(a) "Wholesale drug distribution" means distribution of prescription or
39.8nonprescription drugs to persons other than a consumer or patient or reverse distribution
39.9of such drugs, but does not include:
39.10(1) a sale between a division, subsidiary, parent, affiliated, or related company under
39.11the common ownership and control of a corporate entity;
39.12(2) the purchase or other acquisition, by a hospital or other health care entity that is a
39.13member of a group purchasing organization, of a drug for its own use from the organization
39.14or from other hospitals or health care entities that are members of such organizations;
39.15(3) the sale, purchase, or trade of a drug or an offer to sell, purchase, or trade a
39.16drug by a charitable organization described in section 501(c)(3) of the Internal Revenue
39.17Code of 1986, as amended through December 31, 1988, to a nonprofit affiliate of the
39.18organization to the extent otherwise permitted by law;
39.19(4) the sale, purchase, or trade of a drug or offer to sell, purchase, or trade a drug
39.20among hospitals or other health care entities that are under common control;
39.21(5) the sale, purchase, or trade of a drug or offer to sell, purchase, or trade a drug
39.22for emergency medical reasons;
39.23(6) the sale, purchase, or trade of a drug, an offer to sell, purchase, or trade a drug, or
39.24the dispensing of a drug pursuant to a prescription;
39.25(7) the transfer of prescription or nonprescription drugs by a retail pharmacy to
39.26another retail pharmacy to alleviate a temporary shortage;
39.27(8) the distribution of prescription or nonprescription drug samples by manufacturers
39.28representatives; or
39.29(9) the sale, purchase, or trade of blood and blood components.
39.30(b) "Wholesale drug distributor" means anyone engaged in wholesale drug
39.31distribution including, but not limited to, manufacturers;repackers repackagers; own-label
39.32distributors; jobbers; brokers; warehouses, including manufacturers' and distributors'
39.33warehouses, chain drug warehouses, and wholesale drug warehouses; independent
39.34wholesale drug traders; and pharmacies that conduct wholesale drug distribution. A
40.1wholesale drug distributor does not include a common carrier or individual hired primarily
40.2to transport prescription or nonprescription drugs.
40.3(c) "Manufacturer"means anyone who is engaged in the manufacturing, preparing,
40.4propagating, compounding, processing, packaging, repackaging, or labeling of a
40.5prescription drug has the meaning provided in section 151.01, subdivision 14b.
40.6(d) "Prescription drug" means a drug required by federal or state law or regulation
40.7to be dispensed only by a prescription, including finished dosage forms and active
40.8ingredients subject to United States Code, title 21, sections 811 and 812.
40.9(e) "Blood" means whole blood collected from a single donor and processed either
40.10for transfusion or further manufacturing.
40.11(f) "Blood components" means that part of blood separated by physical or
40.12mechanical means.
40.13(g) "Reverse distribution" means the receipt of prescription or nonprescription drugs
40.14received from or shipped to Minnesota locations for the purpose of returning the drugs
40.15to their producers or distributors.
40.16(h) "Reverse distributor" means a person engaged in the reverse distribution of drugs.
40.17 Sec. 17. Minnesota Statutes 2012, section 151.58, subdivision 2, is amended to read:
40.18 Subd. 2. Definitions. For purposes of this section only, the terms defined in this
40.19subdivision have the meanings given.
40.20(a) "Automated drug distribution system" or "system" means a mechanical system
40.21approved by the board that performs operations or activities, other than compounding or
40.22administration, related to the storage, packaging, or dispensing of drugs, and collects,
40.23controls, and maintains all required transaction information and records.
40.24(b) "Health care facility" means a nursing home licensed under section144A.02 ;
40.25a housing with services establishment registered under section144D.01, subdivision 4 ,
40.26in which a home provider licensed under chapter 144A is providing centralized storage
40.27of medications; or acommunity behavioral health hospital or Minnesota sex offender
40.28program facility operated by the Department of Human Services.
40.29(c) "Managing pharmacy" means a pharmacy licensed by the board that controls and
40.30is responsible for the operation of an automated drug distribution system.
40.31 Sec. 18. Minnesota Statutes 2012, section 151.58, subdivision 3, is amended to read:
40.32 Subd. 3. Authorization. A pharmacy may use an automated drug distribution
40.33system to fill prescription drug orders for patients of a health care facility provided that the
40.34policies and procedures required by this section have been approved by the board. The
41.1automated drug distribution system may be located in a health care facility that is not at
41.2the same location as the managing pharmacy. When located within a health care facility,
41.3the system is considered to be an extension of the managing pharmacy.
41.4 Sec. 19. Minnesota Statutes 2012, section 151.58, subdivision 5, is amended to read:
41.5 Subd. 5. Operation of automated drug distribution systems. (a) The managing
41.6pharmacy and the pharmacist in charge are responsible for the operation of an automated
41.7drug distribution system.
41.8(b) Access to an automated drug distribution system must be limited to pharmacy
41.9and nonpharmacy personnel authorized to procure drugs from the system, except that field
41.10service technicians may access a system located in a health care facility for the purposes of
41.11servicing and maintaining it while being monitored either by the managing pharmacy, or a
41.12licensed nurse within the health care facility. In the case of an automated drug distribution
41.13system that is not physically located within a licensed pharmacy, access for the purpose
41.14of procuring drugs shall be limited to licensed nurses. Each person authorized to access
41.15the system must be assigned an individual specific access code. Alternatively, access to
41.16the system may be controlled through the use of biometric identification procedures. A
41.17policy specifying time access parameters, including time-outs, logoffs, and lockouts,
41.18must be in place.
41.19(c) For the purposes of this section only, the requirements of section151.215 are met
41.20if the following clauses are met:
41.21(1) a pharmacist employed by and working at the managing pharmacy, or at a
41.22pharmacy that is acting as a central services pharmacy for the managing pharmacy,
41.23pursuant to Minnesota Rules, part 6800.4075, must review, interpret, and approve all
41.24prescription drug orders before any drug is distributed from the system to be administered
41.25to a patient. A pharmacy technician may perform data entry of prescription drug orders
41.26provided that a pharmacist certifies the accuracy of the data entry before the drug can
41.27be released from the automated drug distribution system. A pharmacist employed by
41.28and working at the managing pharmacy must certify the accuracy of the filling of any
41.29cassettes, canisters, or other containers that contain drugs that will be loaded into the
41.30automated drug distribution system; and
41.31(2) when the automated drug dispensing system is located and used within the
41.32managing pharmacy, a pharmacist must personally supervise and take responsibility for all
41.33packaging and labeling associated with the use of an automated drug distribution system.
41.34(d) Access to drugs when a pharmacist has not reviewed and approved the
41.35prescription drug order is permitted only when a formal and written decision to allow such
42.1access is issued by the pharmacy and the therapeutics committee or its equivalent. The
42.2committee must specify the patient care circumstances in which such access is allowed,
42.3the drugs that can be accessed, and the staff that are allowed to access the drugs.
42.4(e) In the case of an automated drug distribution system that does not utilize bar
42.5coding in the loading process, the loading of a system located in a health care facility may
42.6be performed by a pharmacy technician, so long as the activity is continuously supervised,
42.7through a two-way audiovisual system by a pharmacist on duty within the managing
42.8pharmacy. In the case of an automated drug distribution system that utilizes bar coding
42.9in the loading process, the loading of a system located in a health care facility may be
42.10performed by a pharmacy technician or a licensed nurse, provided that the managing
42.11pharmacy retains an electronic record of loading activities.
42.12(f) The automated drug distribution system must be under the supervision of a
42.13pharmacist. The pharmacist is not required to be physically present at the site of the
42.14automated drug distribution system if the system is continuously monitored electronically
42.15by the managing pharmacy. A pharmacist on duty within a pharmacy licensed by the
42.16board must be continuously available to address any problems detected by the monitoring
42.17or to answer questions from the staff of the health care facility. The licensed pharmacy
42.18may be the managing pharmacy or a pharmacy which is acting as a central services
42.19pharmacy, pursuant to Minnesota Rules, part 6800.4075, for the managing pharmacy.
42.20 Sec. 20. Minnesota Statutes 2013 Supplement, section 152.02, subdivision 2, is
42.21amended to read:
42.22 Subd. 2. Schedule I. (a) Schedule I consists of the substances listed in this
42.23subdivision.
42.24(b) Opiates. Unless specifically excepted or unless listed in another schedule, any of
42.25the following substances, including their analogs, isomers, esters, ethers, salts, and salts
42.26of isomers, esters, and ethers, whenever the existence of the analogs, isomers, esters,
42.27ethers, and salts is possible:
42.28(1) acetylmethadol;
42.29(2) allylprodine;
42.30(3) alphacetylmethadol (except levo-alphacetylmethadol, also known as
42.31levomethadyl acetate);
42.32(4) alphameprodine;
42.33(5) alphamethadol;
42.34(6) alpha-methylfentanyl benzethidine;
42.35(7) betacetylmethadol;
43.1(8) betameprodine;
43.2(9) betamethadol;
43.3(10) betaprodine;
43.4(11) clonitazene;
43.5(12) dextromoramide;
43.6(13) diampromide;
43.7(14) diethyliambutene;
43.8(15) difenoxin;
43.9(16) dimenoxadol;
43.10(17) dimepheptanol;
43.11(18) dimethyliambutene;
43.12(19) dioxaphetyl butyrate;
43.13(20) dipipanone;
43.14(21) ethylmethylthiambutene;
43.15(22) etonitazene;
43.16(23) etoxeridine;
43.17(24) furethidine;
43.18(25) hydroxypethidine;
43.19(26) ketobemidone;
43.20(27) levomoramide;
43.21(28) levophenacylmorphan;
43.22(29) 3-methylfentanyl;
43.23(30) acetyl-alpha-methylfentanyl;
43.24(31) alpha-methylthiofentanyl;
43.25(32) benzylfentanyl beta-hydroxyfentanyl;
43.26(33) beta-hydroxy-3-methylfentanyl;
43.27(34) 3-methylthiofentanyl;
43.28(35) thenylfentanyl;
43.29(36) thiofentanyl;
43.30(37) para-fluorofentanyl;
43.31(38) morpheridine;
43.32(39) 1-methyl-4-phenyl-4-propionoxypiperidine;
43.33(40) noracymethadol;
43.34(41) norlevorphanol;
43.35(42) normethadone;
43.36(43) norpipanone;
44.1(44) 1-(2-phenylethyl)-4-phenyl-4-acetoxypiperidine (PEPAP);
44.2(45) phenadoxone;
44.3(46) phenampromide;
44.4(47) phenomorphan;
44.5(48) phenoperidine;
44.6(49) piritramide;
44.7(50) proheptazine;
44.8(51) properidine;
44.9(52) propiram;
44.10(53) racemoramide;
44.11(54) tilidine;
44.12(55) trimeperidine.
44.13(56) N-(1-Phenethylpiperidin-4-yl)-N-phenylacetamide (acetyl fentanyl).
44.14(c) Opium derivatives. Any of the following substances, their analogs, salts, isomers,
44.15and salts of isomers, unless specifically excepted or unless listed in another schedule,
44.16whenever the existence of the analogs, salts, isomers, and salts of isomers is possible:
44.17(1) acetorphine;
44.18(2) acetyldihydrocodeine;
44.19(3) benzylmorphine;
44.20(4) codeine methylbromide;
44.21(5) codeine-n-oxide;
44.22(6) cyprenorphine;
44.23(7) desomorphine;
44.24(8) dihydromorphine;
44.25(9) drotebanol;
44.26(10) etorphine;
44.27(11) heroin;
44.28(12) hydromorphinol;
44.29(13) methyldesorphine;
44.30(14) methyldihydromorphine;
44.31(15) morphine methylbromide;
44.32(16) morphine methylsulfonate;
44.33(17) morphine-n-oxide;
44.34(18) myrophine;
44.35(19) nicocodeine;
44.36(20) nicomorphine;
45.1(21) normorphine;
45.2(22) pholcodine;
45.3(23) thebacon.
45.4(d) Hallucinogens. Any material, compound, mixture or preparation which contains
45.5any quantity of the following substances, their analogs, salts, isomers (whether optical,
45.6positional, or geometric), and salts of isomers, unless specifically excepted or unless listed
45.7in another schedule, whenever the existence of the analogs, salts, isomers, and salts of
45.8isomers is possible:
45.9(1) methylenedioxy amphetamine;
45.10(2) methylenedioxymethamphetamine;
45.11(3) methylenedioxy-N-ethylamphetamine (MDEA);
45.12(4) n-hydroxy-methylenedioxyamphetamine;
45.13(5) 4-bromo-2,5-dimethoxyamphetamine (DOB);
45.14(6) 2,5-dimethoxyamphetamine (2,5-DMA);
45.15(7) 4-methoxyamphetamine;
45.16(8) 5-methoxy-3, 4-methylenedioxy amphetamine;
45.17(9) alpha-ethyltryptamine;
45.18(10) bufotenine;
45.19(11) diethyltryptamine;
45.20(12) dimethyltryptamine;
45.21(13) 3,4,5-trimethoxy amphetamine;
45.22(14) 4-methyl-2, 5-dimethoxyamphetamine (DOM);
45.23(15) ibogaine;
45.24(16) lysergic acid diethylamide (LSD);
45.25(17) mescaline;
45.26(18) parahexyl;
45.27(19) N-ethyl-3-piperidyl benzilate;
45.28(20) N-methyl-3-piperidyl benzilate;
45.29(21) psilocybin;
45.30(22) psilocyn;
45.31(23) tenocyclidine (TPCP or TCP);
45.32(24) N-ethyl-1-phenyl-cyclohexylamine (PCE);
45.33(25) 1-(1-phenylcyclohexyl) pyrrolidine (PCPy);
45.34(26) 1-[1-(2-thienyl)cyclohexyl]-pyrrolidine (TCPy);
45.35(27) 4-chloro-2,5-dimethoxyamphetamine (DOC);
45.36(28) 4-ethyl-2,5-dimethoxyamphetamine (DOET);
46.1(29) 4-iodo-2,5-dimethoxyamphetamine (DOI);
46.2(30) 4-bromo-2,5-dimethoxyphenethylamine (2C-B);
46.3(31) 4-chloro-2,5-dimethoxyphenethylamine (2C-C);
46.4(32) 4-methyl-2,5-dimethoxyphenethylamine (2-CD);
46.5(33) 4-ethyl-2,5-dimethoxyphenethylamine (2C-E);
46.6(34) 4-iodo-2,5-dimethoxyphenethylamine (2C-I);
46.7(35) 4-propyl-2,5-dimethoxyphenethylamine (2C-P);
46.8(36) 4-isopropylthio-2,5-dimethoxyphenethylamine (2C-T-4);
46.9(37) 4-propylthio-2,5-dimethoxyphenethylamine (2C-T-7);
46.10(38) 2-(8-bromo-2,3,6,7-tetrahydrofuro [2,3-f][1]benzofuran-4-yl)ethanamine
46.11(2-CB-FLY);
46.12(39) bromo-benzodifuranyl-isopropylamine (Bromo-DragonFLY);
46.13(40) alpha-methyltryptamine (AMT);
46.14(41) N,N-diisopropyltryptamine (DiPT);
46.15(42) 4-acetoxy-N,N-dimethyltryptamine (4-AcO-DMT);
46.16(43) 4-acetoxy-N,N-diethyltryptamine (4-AcO-DET);
46.17(44) 4-hydroxy-N-methyl-N-propyltryptamine (4-HO-MPT);
46.18(45) 4-hydroxy-N,N-dipropyltryptamine (4-HO-DPT);
46.19(46) 4-hydroxy-N,N-diallyltryptamine (4-HO-DALT);
46.20(47) 4-hydroxy-N,N-diisopropyltryptamine (4-HO-DiPT);
46.21(48) 5-methoxy-N,N-diisopropyltryptamine (5-MeO-DiPT);
46.22(49) 5-methoxy-α-methyltryptamine (5-MeO-AMT);
46.23(50) 5-methoxy-N,N-dimethyltryptamine (5-MeO-DMT);
46.24(51) 5-methylthio-N,N-dimethyltryptamine (5-MeS-DMT);
46.25(52) 5-methoxy-N-methyl-N-propyltryptamine (5-MeO-MiPT);
46.26(53) 5-methoxy-α-ethyltryptamine (5-MeO-AET);
46.27(54) 5-methoxy-N,N-dipropyltryptamine (5-MeO-DPT);
46.28(55) 5-methoxy-N,N-diethyltryptamine (5-MeO-DET);
46.29(56) 5-methoxy-N,N-diallytryptamine (5-MeO-DALT);
46.30(57) methoxetamine (MXE);
46.31(58) 5-iodo-2-aminoindane (5-IAI);
46.32(59) 5,6-methylenedioxy-2-aminoindane (MDAI);
46.33(60) 2-(4-iodo-2,5-dimethoxyphenyl)-N-[(2-methoxyphenyl)methyl]ethanamine
46.34(25I-NBOMe).
46.35(e) Peyote. All parts of the plant presently classified botanically as Lophophora
46.36williamsii Lemaire, whether growing or not, the seeds thereof, any extract from any part
47.1of the plant, and every compound, manufacture, salts, derivative, mixture, or preparation
47.2of the plant, its seeds or extracts. The listing of peyote as a controlled substance in
47.3Schedule I does not apply to the nondrug use of peyote in bona fide religious ceremonies
47.4of the American Indian Church, and members of the American Indian Church are exempt
47.5from registration. Any person who manufactures peyote for or distributes peyote to the
47.6American Indian Church, however, is required to obtain federal registration annually and
47.7to comply with all other requirements of law.
47.8(f) Central nervous system depressants. Unless specifically excepted or unless listed
47.9in another schedule, any material compound, mixture, or preparation which contains any
47.10quantity of the following substances, their analogs, salts, isomers, and salts of isomers
47.11whenever the existence of the analogs, salts, isomers, and salts of isomers is possible:
47.12(1) mecloqualone;
47.13(2) methaqualone;
47.14(3) gamma-hydroxybutyric acid (GHB), including its esters and ethers;
47.15(4) flunitrazepam.
47.16(g) Stimulants. Unless specifically excepted or unless listed in another schedule, any
47.17material compound, mixture, or preparation which contains any quantity of the following
47.18substances, their analogs, salts, isomers, and salts of isomers whenever the existence of
47.19the analogs, salts, isomers, and salts of isomers is possible:
47.20 (1) aminorex;
47.21(2) cathinone;
47.22(3) fenethylline;
47.23 (4) methcathinone;
47.24(5) methylaminorex;
47.25(6) N,N-dimethylamphetamine;
47.26(7) N-benzylpiperazine (BZP);
47.27(8) methylmethcathinone (mephedrone);
47.28(9) 3,4-methylenedioxy-N-methylcathinone (methylone);
47.29(10) methoxymethcathinone (methedrone);
47.30(11) methylenedioxypyrovalerone (MDPV);
47.31(12) fluoromethcathinone;
47.32(13) methylethcathinone (MEC);
47.33(14) 1-benzofuran-6-ylpropan-2-amine (6-APB);
47.34(15) dimethylmethcathinone (DMMC);
47.35(16) fluoroamphetamine;
47.36(17) fluoromethamphetamine;
48.1(18) α-methylaminobutyrophenone (MABP or buphedrone);
48.2(19) β-keto-N-methylbenzodioxolylpropylamine (bk-MBDB or butylone);
48.3(20) 2-(methylamino)-1-(4-methylphenyl)butan-1-one (4-MEMABP or BZ-6378);
48.4(21) naphthylpyrovalerone (naphyrone);and
48.5(22) (RS)-1-phenyl-2-(1-pyrrolidinyl)-1-pentanone (alpha-PVP or
48.6alpha-pyrrolidinovalerophenone;
48.7(23) (RS)-1-(4-methylphenyl)-2-(1-pyrrolidinyl)-1-hexanone (4-Me-PHP oe
48.8MPHP); and
48.9(22) (24) any other substance, except bupropion or compounds listed under a
48.10different schedule, that is structurally derived from 2-aminopropan-1-one by substitution
48.11at the 1-position with either phenyl, naphthyl, or thiophene ring systems, whether or not
48.12the compound is further modified in any of the following ways:
48.13(i) by substitution in the ring system to any extent with alkyl, alkylenedioxy, alkoxy,
48.14haloalkyl, hydroxyl, or halide substituents, whether or not further substituted in the ring
48.15system by one or more other univalent substituents;
48.16(ii) by substitution at the 3-position with an acyclic alkyl substituent;
48.17(iii) by substitution at the 2-amino nitrogen atom with alkyl, dialkyl, benzyl, or
48.18methoxybenzyl groups; or
48.19(iv) by inclusion of the 2-amino nitrogen atom in a cyclic structure.
48.20(h) Marijuana, tetrahydrocannabinols, and synthetic cannabinoids. Unless
48.21specifically excepted or unless listed in another schedule, any natural or synthetic material,
48.22compound, mixture, or preparation that contains any quantity of the following substances,
48.23their analogs, isomers, esters, ethers, salts, and salts of isomers, esters, and ethers,
48.24whenever the existence of the isomers, esters, ethers, or salts is possible:
48.25(1) marijuana;
48.26(2) tetrahydrocannabinols naturally contained in a plant of the genus Cannabis,
48.27synthetic equivalents of the substances contained in the cannabis plant or in the
48.28resinous extractives of the plant, or synthetic substances with similar chemical structure
48.29and pharmacological activity to those substances contained in the plant or resinous
48.30extract, including, but not limited to, 1 cis or trans tetrahydrocannabinol, 6 cis or trans
48.31tetrahydrocannabinol, and 3,4 cis or trans tetrahydrocannabinol;
48.32(3) synthetic cannabinoids, including the following substances:
48.33(i) Naphthoylindoles, which are any compounds containing a 3-(1-napthoyl)indole
48.34structure with substitution at the nitrogen atom of the indole ring by an alkyl, haloalkyl,
48.35alkenyl, cycloalkylmethyl, cycloalkylethyl, 1-(N-methyl-2-piperidinyl)methyl or
48.362-(4-morpholinyl)ethyl group, whether or not further substituted in the indole ring to any
49.1extent and whether or not substituted in the naphthyl ring to any extent. Examples of
49.2naphthoylindoles include, but are not limited to:
49.3(A) 1-Pentyl-3-(1-naphthoyl)indole (JWH-018 and AM-678);
49.4(B) 1-Butul-3-(1-naphthoyl)indole (JWH-073);
49.5(C) 1-Pentyl-3-(4-methoxy-1-naphthoyl)indole (JWH-081);
49.6(D) 1-[2-(4-morpholinyl)ethyl]-3-(1-naphthoyl)indole (JWH-200);
49.7(E) 1-Propyl-2-methyl-3-(1-naphthoyl)indole (JWH-015);
49.8(F) 1-Hexyl-3-(1-naphthoyl)indole (JWH-019);
49.9(G) 1-Pentyl-3-(4-methyl-1-naphthoyl)indole (JWH-122);
49.10(H) 1-Pentyl-3-(4-ethyl-1-naphthoyl)indole (JWH-210);
49.11(I) 1-Pentyl-3-(4-chloro-1-naphthoyl)indole (JWH-398);
49.12(J) 1-(5-fluoropentyl)-3-(1-naphthoyl)indole (AM-2201).
49.13(ii) Napthylmethylindoles, which are any compounds containing a
49.141H-indol-3-yl-(1-naphthyl)methane structure with substitution at the nitrogen atom
49.15of the indole ring by an alkyl, haloalkyl, alkenyl, cycloalkylmethyl, cycloalkylethyl,
49.161-(N-methyl-2-piperidinyl)methyl or 2-(4-morpholinyl)ethyl group, whether or not further
49.17substituted in the indole ring to any extent and whether or not substituted in the naphthyl
49.18ring to any extent. Examples of naphthylmethylindoles include, but are not limited to:
49.19(A) 1-Pentyl-1H-indol-3-yl-(1-naphthyl)methane (JWH-175);
49.20(B) 1-Pentyl-1H-indol-3-yl-(4-methyl-1-naphthyl)methan (JWH-184).
49.21(iii) Naphthoylpyrroles, which are any compounds containing a
49.223-(1-naphthoyl)pyrrole structure with substitution at the nitrogen atom of the
49.23pyrrole ring by an alkyl, haloalkyl, alkenyl, cycloalkylmethyl, cycloalkylethyl,
49.241-(N-methyl-2-piperidinyl)methyl or 2-(4-morpholinyl)ethyl group whether or not
49.25further substituted in the pyrrole ring to any extent, whether or not substituted in the
49.26naphthyl ring to any extent. Examples of naphthoylpyrroles include, but are not limited to,
49.27(5-(2-fluorophenyl)-1-pentylpyrrol-3-yl)-naphthalen-1-ylmethanone (JWH-307).
49.28(iv) Naphthylmethylindenes, which are any compounds containing a
49.29naphthylideneindene structure with substitution at the 3-position of the indene
49.30ring by an allkyl, haloalkyl, alkenyl, cycloalkylmethyl, cycloalkylethyl,
49.311-(N-methyl-2-piperidinyl)methyl or 2-(4-morpholinyl)ethyl group whether or not further
49.32substituted in the indene ring to any extent, whether or not substituted in the naphthyl
49.33ring to any extent. Examples of naphthylemethylindenes include, but are not limited to,
49.34E-1-[1-(1-naphthalenylmethylene)-1H-inden-3-yl]pentane (JWH-176).
49.35(v) Phenylacetylindoles, which are any compounds containing a 3-phenylacetylindole
49.36structure with substitution at the nitrogen atom of the indole ring by an alkyl, haloalkyl,
50.1alkenyl, cycloalkylmethyl, cycloalkylethyl, 1-(N-methyl-2-piperidinyl)methyl or
50.22-(4-morpholinyl)ethyl group whether or not further substituted in the indole ring to
50.3any extent, whether or not substituted in the phenyl ring to any extent. Examples of
50.4phenylacetylindoles include, but are not limited to:
50.5(A) 1-(2-cyclohexylethyl)-3-(2-methoxyphenylacetyl)indole (RCS-8);
50.6(B) 1-pentyl-3-(2-methoxyphenylacetyl)indole (JWH-250);
50.7(C) 1-pentyl-3-(2-methylphenylacetyl)indole (JWH-251);
50.8(D) 1-pentyl-3-(2-chlorophenylacetyl)indole (JWH-203).
50.9(vi) Cyclohexylphenols, which are compounds containing a
50.102-(3-hydroxycyclohexyl)phenol structure with substitution at the 5-position
50.11of the phenolic ring by an alkyl, haloalkyl, alkenyl, cycloalkylmethyl, cycloalkylethyl,
50.121-(N-methyl-2-piperidinyl)methyl or 2-(4-morpholinyl)ethyl group whether or not
50.13substituted in the cyclohexyl ring to any extent. Examples of cyclohexylphenols include,
50.14but are not limited to:
50.15(A) 5-(1,1-dimethylheptyl)-2-[(1R,3S)-3-hydroxycyclohexyl]-phenol (CP 47,497);
50.16(B) 5-(1,1-dimethyloctyl)-2-[(1R,3S)-3-hydroxycyclohexyl]-phenol
50.17(Cannabicyclohexanol or CP 47,497 C8 homologue);
50.18(C) 5-(1,1-dimethylheptyl)-2-[(1R,2R)-5-hydroxy-2-(3-hydroxypropyl)cyclohexyl]
50.19-phenol (CP 55,940).
50.20(vii) Benzoylindoles, which are any compounds containing a 3-(benzoyl)indole
50.21structure with substitution at the nitrogen atom of the indole ring by an alkyl, haloalkyl,
50.22alkenyl, cycloalkylmethyl, cycloalkylethyl, 1-(N-methyl-2-piperidinyl)methyl or
50.232-(4-morpholinyl)ethyl group whether or not further substituted in the indole ring to
50.24any extent and whether or not substituted in the phenyl ring to any extent. Examples of
50.25benzoylindoles include, but are not limited to:
50.26(A) 1-Pentyl-3-(4-methoxybenzoyl)indole (RCS-4);
50.27(B) 1-(5-fluoropentyl)-3-(2-iodobenzoyl)indole (AM-694);
50.28(C) (4-methoxyphenyl-[2-methyl-1-(2-(4-morpholinyl)ethyl)indol-3-yl]methanone
50.29(WIN 48,098 or Pravadoline).
50.30(viii) Others specifically named:
50.31(A) (6aR,10aR)-9-(hydroxymethyl)-6,6-dimethyl-3-(2-methyloctan-2-yl)
50.32-6a,7,10,10a-tetrahydrobenzo[c]chromen-1-ol (HU-210);
50.33(B) (6aS,10aS)-9-(hydroxymethyl)-6,6-dimethyl-3-(2-methyloctan-2-yl)
50.34-6a,7,10,10a-tetrahydrobenzo[c]chromen-1-ol (Dexanabinol or HU-211);
50.35(C) 2,3-dihydro-5-methyl-3-(4-morpholinylmethyl)pyrrolo[1,2,3-de]
50.36-1,4-benzoxazin-6-yl-1-naphthalenylmethanone (WIN 55,212-2);
51.1(D) (1-pentylindol-3-yl)-(2,2,3,3-tetramethylcyclopropyl)methanone (UR-144);
51.2(E) (1-(5-fluoropentyl)-1H-indol-3-yl)(2,2,3,3-tetramethylcyclopropyl)methanone
51.3(XLR-11);
51.4(F) 1-pentyl-N-tricyclo[3.3.1.13,7]dec-1-yl-1H-indazole-3-carboxamide
51.5(AKB-48(APINACA));
51.6(G) N-((3s,5s,7s)-adamantan-1-yl)-1-(5-fluoropentyl)-1H-indazole-3-carboxamide
51.7(5-Fluoro-AKB-48);
51.8(H) 1-pentyl-8-quinolinyl ester-1H-indole-3-carboxylic acid (PB-22);
51.9(I) 8-quinolinyl ester-1-(5-fluoropentyl)-1H-indole-3-carboxylic acid (5-Fluoro
51.10PB-22).;
51.11(J) N-[(1S)-1-(aminocarbonyl)-2-methylpropyl]-1-pentyl-1H-indazole-
51.123-carboxamide (AB-PINACA);
51.13(K) N-[(1S)-1-(aminocarbonyl)-2-methylpropyl]-1-[(4-fluorophenyl)methyl]-
51.141H-indazole-3-carboxamide (AB-FUBINACA).
51.15(i) A controlled substance analog, to the extent that it is implicitly or explicitly
51.16intended for human consumption.
51.17 Sec. 21. Minnesota Statutes 2012, section 152.02, subdivision 8b, is amended to read:
51.18 Subd. 8b. Board of Pharmacy; expedited scheduling of additional substances.
51.19(a) The state Board of Pharmacy may, by rule, add a substance to Schedule I provided that
51.20it finds that the substance has a high potential for abuse, has no currently accepted medical
51.21use in the United States, has a lack of accepted safety for use under medical supervision,
51.22has known adverse health effects, and is currently available for use within the state. For
51.23the purposes of this subdivision only, the board may use the expedited rulemaking process
51.24under section14.389 . The scheduling of a substance under this subdivision expires the
51.25day after the adjournment of the legislative session immediately following the substance's
51.26scheduling unless the legislature by law ratifies the action.
51.27(b) If the board schedules a substance under this subdivision, the board shall notify
51.28in a timely manner the chairs and ranking minority members of the senate and house of
51.29representatives committees having jurisdiction over criminal justice and health policy
51.30and finance of the action and the reasons for it. The notice must include a copy of the
51.31administrative law judge's decision on the matter.
51.32(c) This subdivision expires August 1, 2014.
1.3for pharmacist participation in immunizations; changing the powers and duties of
1.4the Board of Pharmacy; changing licensing requirements for businesses regulated
1.5by the Board of Pharmacy; clarifying requirements for compounding; allowing
1.6certain educational institutions to purchase legend drugs in limited circumstances;
1.7allowing certain entities to handle drugs in preparation for emergency use;
1.8clarifying the requirement that drug manufacturers report certain payments to the
1.9Board of Pharmacy; adding certain substances to the schedules for controlled
1.10substances;amending Minnesota Statutes 2012, sections 151.01; 151.06;
1.11151.211; 151.26; 151.34; 151.35; 151.361, subdivision 2; 151.37, as amended;
1.12151.44; 151.58, subdivisions 2, 3, 5; 152.02, subdivision 8b; Minnesota Statutes
1.132013 Supplement, sections 151.252, by adding a subdivision; 152.02, subdivision
1.142; proposing coding for new law in Minnesota Statutes, chapter 151.
1.15BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF MINNESOTA:
1.16 Section 1. Minnesota Statutes 2012, section 151.01, is amended to read:
1.17151.01 DEFINITIONS.
1.18 Subdivision 1. Words, terms, and phrases. Unless the language or context clearly
1.19indicates that a different meaning is intended, the following words, terms, and phrases, for
1.20the purposes of this chapter, shall be given the meanings subjoined to them.
1.21 Subd. 2. Pharmacy. "Pharmacy" means
1.22which
1.23compounded, or dispensed
1.24the supervision of a pharmacist and from which related clinical pharmacy services are
1.25delivered.
1.26 Subd. 2a. Limited service pharmacy. "Limited service pharmacy" means a
1.27pharmacy that has been issued a restricted license by the board to perform a limited range
1.28of the activities that constitute the practice of pharmacy.
2.1 Subd. 3. Pharmacist. The term "pharmacist" means an individual with a currently
2.2valid license issued by the Board of Pharmacy to practice pharmacy.
2.3 Subd. 5. Drug. The term "drug" means all medicinal substances and preparations
2.4recognized by the United States Pharmacopoeia and National Formulary, or any revision
2.5thereof, vaccines and biologicals, and all substances and preparations intended for external
2.6and internal use in the diagnosis, cure, mitigation, treatment, or prevention of disease in
2.7humans or other animals, and all substances and preparations, other than food, intended to
2.8affect the structure or any function of the bodies of humans or other animals. The term drug
2.9shall also mean any compound, substance, or derivative that is not approved for human
2.10consumption by the United States Food and Drug Administration or specifically permitted
2.11for human consumption under Minnesota law that, when introduced into the body, induces
2.12an effect similar to that of a Schedule I or Schedule II controlled substance listed in
2.13section 152.02, subdivisions 2 and 3, or Minnesota Rules, parts 6800.4210 and 6800.4220,
2.14regardless of whether the substance is marketed for the purpose of human consumption.
2.15 Subd. 6. Medicine. The term "medicine" means any remedial agent that has the
2.16property of curing, preventing, treating, or mitigating diseases, or that is used for that
2.17purpose.
2.18 Subd. 7. Poisons. The term "poisons" means any substance
2.19introduced into the system, directly or by absorption, produces violent, morbid, or fatal
2.20changes, or
2.21 Subd. 8. Chemical. The term "chemical" means all medicinal or industrial
2.22substances, whether simple or compound, or obtained through the process of the science
2.23and art of chemistry, whether of organic or inorganic origin.
2.24 Subd. 9. Board or
2.25Pharmacy" means the Minnesota
2.26 Subd. 10. Director. The term "director" means the executive director of the
2.27Minnesota
2.28 Subd. 11. Person. The term "person" means an individual, firm, partnership,
2.29company, corporation, trustee, association, agency, or other public or private entity.
2.30 Subd. 12. Wholesale. The term "wholesale" means and includes any sale for the
2.31purpose of resale.
2.32 Subd. 13. Commercial purposes. The phrase "commercial purposes" means the
2.33ordinary purposes of trade, agriculture, industry, and commerce, exclusive of the practices
2.34of medicine
2.35 Subd. 14. Manufacturing. The term "manufacturing"
2.36
3.1
3.2
3.3
3.4
3.5processing of a drug, either directly or indirectly, by extraction from substances of natural
3.6origin or independently by means of chemical or biological synthesis. Manufacturing
3.7includes the packaging or repackaging of a drug, or the labeling or relabeling of
3.8the container of a drug, for resale by pharmacies, practitioners, or other persons.
3.9Manufacturing does not include the prepackaging, extemporaneous compounding, or
3.10anticipatory compounding of a drug within a licensed pharmacy or by a practitioner,
3.11nor the labeling of a container within a pharmacy or by a practitioner for the purpose of
3.12dispensing a drug to a patient pursuant to a valid prescription.
3.13 Subd. 14a. Manufacturer. The term "manufacturer" means any person engaged
3.14in manufacturing.
3.15 Subd. 14b. Outsourcing facility. "Outsourcing facility" means a facility that is
3.16registered by the United States Food and Drug Administration pursuant to United States
3.17Code, title 21, section 353b.
3.18 Subd. 15. Pharmacist intern. The term "pharmacist intern" means (1) a natural
3.19person satisfactorily progressing toward the degree in pharmacy required for licensure, or
3.20(2) a graduate of the University of Minnesota College of Pharmacy, or other pharmacy
3.21college approved by the board, who is registered by the
3.22purpose of obtaining practical experience as a requirement for licensure as a pharmacist,
3.23or (3) a qualified applicant awaiting examination for licensure.
3.24 Subd. 15a. Pharmacy technician. The term "pharmacy technician" means a person
3.25not licensed as a pharmacist or a pharmacist intern, who assists the pharmacist in the
3.26preparation and dispensing of medications by performing computer entry of prescription
3.27data and other manipulative tasks. A pharmacy technician shall not perform tasks
3.28specifically reserved to a licensed pharmacist or requiring professional judgment.
3.29 Subd. 16. Prescription drug order. The term "prescription drug order" means a
3.30
3.31 a practitioner
3.32
3.33
3.34
3.35Prescription drug orders for controlled substances must be prepared in accordance with the
4.1provisions of section 152.11 and the federal Controlled Substances Act and the regulations
4.2promulgated thereunder.
4.3 Subd. 16a. Prescription. The term "prescription" means a prescription drug order
4.4that is written or printed on paper, an oral order reduced to writing by a pharmacist, or an
4.5electronic order. To be valid, a prescription must be issued for an individual patient by
4.6a practitioner within the scope and usual course of the practitioner's practice, and must
4.7contain the date of issue, name and address of the patient, name and quantity of the drug
4.8prescribed, directions for use, the name and address of the practitioner, and a telephone
4.9number at which the practitioner can be reached. A prescription written or printed on
4.10paper that is given to the patient or an agent of the patient or that is transmitted by fax
4.11must contain the practitioner's manual signature. An electronic prescription must contain
4.12the practitioner's electronic signature.
4.13 Subd. 16b. Chart order. The term "chart order" means a prescription drug order for
4.14a drug that is to be dispensed by a pharmacist, or by a pharmacist intern under the direct
4.15supervision of a pharmacist, and administered by an authorized person only during the
4.16patient's stay in a hospital or long-term care facility. The chart order shall contain the name
4.17of the patient, another patient identifier such as birth date or medical record number, the
4.18drug ordered, and any directions that the practitioner may prescribe concerning strength,
4.19dosage, frequency, and route of administration. The manual or electronic signature of the
4.20practitioner must be affixed to the chart order at the time it is written or at a later date in
4.21the case of verbal chart orders.
4.22 Subd. 17. Legend drug. "Legend drug" means a drug
4.23federal law to
4.24
4.25practitioner.
4.26 Subd. 18. Label. "Label" means a display of written, printed, or graphic matter
4.27upon the immediate container of any drug or medicine
4.28
4.29
4.30
4.31
4.32such drug or medicine, or
4.33 Subd. 19. Package. "Package" means any container or wrapping in which any
4.34drug or medicine is enclosed for use in the delivery or display of that article to retail
4.35purchasers, but does not include:
5.1(a) shipping containers or wrappings used solely for the transportation of any such
5.2article in bulk or in quantity to manufacturers, packers, processors, or wholesale or
5.3retail distributors;
5.4(b) shipping containers or outer wrappings used by retailers to ship or deliver any
5.5such article to retail customers if such containers and wrappings bear no printed matter
5.6pertaining to any particular drug or medicine.
5.7 Subd. 20. Labeling. "Labeling" means all labels and other written, printed, or
5.8graphic matter (a) upon a drug or medicine or any of its containers or wrappers, or (b)
5.9accompanying such article.
5.10 Subd. 21. Federal act. "Federal act" means the Federal Food, Drug, and Cosmetic
5.11Act, United States Code, title 21, section 301, et seq., as amended.
5.12 Subd. 22. Pharmacist in charge. "Pharmacist in charge" means a duly licensed
5.13pharmacist in the state of Minnesota who has been designated in accordance with the rules
5.14of the
5.15of the pharmacy in compliance with the requirements and duties as established by the
5.16board in its rules.
5.17 Subd. 23. Practitioner. "Practitioner" means a licensed doctor of medicine, licensed
5.18doctor of osteopathy duly licensed to practice medicine, licensed doctor of dentistry,
5.19licensed doctor of optometry, licensed podiatrist, or licensed veterinarian. For purposes of
5.20sections
5.21(b), (e), and (f); and
5.22prescribe, dispense, and administer under chapter 147A, or an advanced practice nurse
5.23authorized to prescribe, dispense, and administer under section
5.24sections
5.25(b); and
5.26administer under chapter 150A.
5.27 Subd. 24. Brand name. "Brand name" means the registered trademark name given
5.28to a drug product by its manufacturer, labeler or distributor.
5.29 Subd. 25. Generic name. "Generic name" means the established name or official
5.30name of a drug or drug product.
5.31 Subd. 26. Finished dosage form. "Finished dosage form" means that form of a
5.32drug
5.33no further manufacturing or processing other than packaging, reconstitution, or labeling.
5.34 Subd. 27. Practice of pharmacy. "Practice of pharmacy" means:
5.35 (1) interpretation and evaluation of prescription drug orders;
6.1 (2) compounding, labeling, and dispensing drugs and devices (except labeling by
6.2a manufacturer or packager of nonprescription drugs or commercially packaged legend
6.3drugs and devices);
6.4 (3) participation in clinical interpretations and monitoring of drug therapy for
6.5assurance of safe and effective use of drugs, including the performance of laboratory tests
6.6that are waived under the federal Clinical Laboratory Improvement Act of 1988, United
6.7States Code, title 42, section 263a et seq., provided that a pharmacist may interpret the
6.8results of laboratory tests but may modify drug therapy only pursuant to a protocol or
6.9collaborative practice agreement;
6.10 (4) participation in drug and therapeutic device selection; drug administration for first
6.11dosage and medical emergencies; drug regimen reviews; and drug or drug-related research;
6.12 (5) participation in administration of influenza vaccines to all eligible individuals ten
6.13years of age and older and all other vaccines to patients 18 years of age and older
6.14
6.15physician licensed under chapter 147, a physician assistant authorized to prescribe drugs
6.16under chapter 147A, or an advanced practice nurse authorized to prescribe drugs under
6.17section 148.235, provided that:
6.18(i) the protocol includes, at a minimum:
6.19(A) the name, dose, and route of each vaccine that may be given;
6.20(B) the patient population for whom the vaccine may be given;
6.21(C) contraindications and precautions to the vaccine;
6.22(D) the procedure for handling an adverse reaction;
6.23(E) the name, signature, and address of the physician, physician assistant, or
6.24advanced nurse practitioner;
6.25(F) a telephone number at which the physician, physician assistant, or advanced
6.26nurse practitioner can be contacted; and
6.27(G) the date and time period for which the protocol is valid;
6.28
6.29by the
6.30specifically for the administration of immunizations or
6.31
6.32
6.33primary physician or clinic or to the Minnesota Immunization Information Connection; and
6.34(iv) the pharmacist complies with guidelines for vaccines and immunizations
6.35established by the federal Advisory Committee on Immunization Practices, except that a
6.36pharmacist does not need to comply with those portions of the guidelines that establish
7.1immunization schedules when administering a vaccine pursuant to a valid, patient-specific
7.2order issued by a physician licensed under chapter 147, a physician assistant authorized to
7.3prescribe drugs under chapter 147A, or an advanced practice nurse authorized to prescribe
7.4drugs under section 148.235, provided that the order is consistent with the United States
7.5Food and Drug Administration approved labeling of the vaccine;
7.6 (6) participation in the
7.7management, modification, and discontinuation of drug therapy
7.8
7.9between
7.10
7.11
7.12physicians, podiatrists, or veterinarians; or (ii) one or more pharmacists and one or more
7.13physician assistants authorized to prescribe, dispense, and administer under chapter 147A,
7.14or advanced practice nurses authorized to prescribe, dispense, and administer under
7.15section 148.235. Any
7.16collaborative practice agreement must be
7.17 the patient's medical record or reported by the pharmacist to a practitioner responsible
7.18for the patient's care;
7.19 (7) participation in the storage of drugs and the maintenance of records;
7.20 (8)
7.21content, hazards, and uses of drugs and devices; and
7.22 (9) offering or performing those acts, services, operations, or transactions necessary
7.23in the conduct, operation, management, and control of a pharmacy.
7.24 Subd. 27a. Protocol. "Protocol" means:
7.25(1) a specific written plan that describes the nature and scope of activities that a
7.26pharmacist may engage in when initiating, managing, modifying, or discontinuing drug
7.27therapy as allowed in subdivision 27, clause (6); or
7.28(2) a specific written plan that authorizes a pharmacist to administer vaccines and
7.29that complies with subdivision 27, clause (5).
7.30 Subd. 27b. Collaborative practice. "Collaborative practice" means patient care
7.31activities, consistent with subdivision 27, engaged in by one or more pharmacists who
7.32have agreed to work in collaboration with one or more practitioners to initiate, manage,
7.33and modify drug therapy under specified conditions mutually agreed to by the pharmacists
7.34and practitioners.
8.1 Subd. 27c. Collaborative practice agreement. "Collaborative practice agreement"
8.2means a written and signed agreement between one or more pharmacists and one or more
8.3practitioners that allows the pharmacist or pharmacists to engage in collaborative practice.
8.4 Subd. 28. Veterinary legend drug. "Veterinary legend drug" means a drug that is
8.5required by federal law to
8.6
8.7to the prescription of a licensed veterinarian.
8.8 Subd. 29. Legend medical gas. "Legend medical gas" means a liquid or gaseous
8.9substance used for medical purposes and that is required by federal law to
8.10
8.11 be dispensed only pursuant to the prescription of a licensed practitioner.
8.12 Subd. 30. Dispense or dispensing. "Dispense or dispensing" means the
8.13
8.14
8.15
8.16drug order and includes those processes specified by the board in rule that are necessary
8.17for the preparation and provision of a drug to a patient or patient's agent in a suitable
8.18container appropriately labeled for subsequent administration to, or use by, a patient.
8.19 Subd. 31. Central service pharmacy. "Central service pharmacy" means a
8.20pharmacy that may provide dispensing functions, drug utilization review, packaging,
8.21labeling, or delivery of a prescription product to another pharmacy for the purpose of
8.22filling a prescription.
8.23 Subd. 32. Electronic signature. "Electronic signature" means an electronic sound,
8.24symbol, or process attached to or associated with a record and executed or adopted by a
8.25person with the intent to sign the record.
8.26 Subd. 33. Electronic transmission. "Electronic transmission" means transmission
8.27of information in electronic form.
8.28 Subd. 34. Health professional shortage area. "Health professional shortage area"
8.29means an area designated as such by the federal Secretary of Health and Human Services,
8.30as provided under Code of Federal Regulations, title 42, part 5, and United States Code,
8.31title 42, section 254E.
8.32 Subd. 35. Compounding. "Compounding" means preparing, mixing, assembling,
8.33packaging, and labeling a drug for an identified individual patient as a result of
8.34a practitioner's prescription drug order. Compounding also includes anticipatory
8.35compounding, as defined in this section, and the preparation of drugs in which all bulk
8.36drug substances and components are nonprescription substances. Compounding does
9.1not include mixing or reconstituting a drug according to the product's labeling or to the
9.2manufacturer's directions. Compounding does not include the preparation of a drug for the
9.3purpose of, or incident to, research, teaching, or chemical analysis, provided that the drug
9.4is not prepared for dispensing or administration to patients. All compounding, regardless
9.5of the type of product, must be done pursuant to a prescription drug order unless otherwise
9.6permitted in this chapter or by the rules of the board.
9.7 Subd. 36. Anticipatory compounding. "Anticipatory compounding" means the
9.8preparation by a pharmacy of a supply of a compounded drug product that is sufficient to
9.9meet the short-term anticipated need of the pharmacy for the filling of prescription drug
9.10orders. In the case of practitioners only, anticipatory compounding means the preparation
9.11of a supply of a compounded drug product that is sufficient to meet the practitioner's
9.12short-term anticipated need for dispensing or administering the drug to patients treated
9.13by the practitioner. Anticipatory compounding is not the preparation of a compounded
9.14drug product for wholesale distribution.
9.15 Subd. 37. Extemporaneous compounding. "Extemporaneous compounding"
9.16means the compounding of a drug product pursuant to a prescription drug order for a specific
9.17patient that is issued in advance of the compounding. Extemporaneous compounding is
9.18not the preparation of a compounded drug product for wholesale distribution.
9.19 Subd. 38. Compounded positron emission tomography drug. "Compounded
9.20positron emission tomography drug" means a drug that:
9.21(1) exhibits spontaneous disintegration of unstable nuclei by the emission of
9.22positrons and is used for the purpose of providing dual photon positron emission
9.23tomographic diagnostic images;
9.24(2) has been compounded by or on the order of a practitioner in accordance with the
9.25relevant parts of Minnesota Rules, chapters 4731 and 6800, for a patient or for research,
9.26teaching, or quality control; and
9.27(3) includes any nonradioactive reagent, reagent kit, ingredient, nuclide generator,
9.28accelerator, target material, electronic synthesizer, or other apparatus or computer program
9.29to be used in the preparation of such a drug.
9.30 Sec. 2. Minnesota Statutes 2012, section 151.06, is amended to read:
9.31151.06 POWERS AND DUTIES.
9.32 Subdivision 1. Generally; rules. (a) Powers and duties. The Board of Pharmacy
9.33shall have the power and it shall be its duty:
9.34 (1) to regulate the practice of pharmacy;
9.35 (2) to regulate the manufacture, wholesale, and retail sale of drugs within this state;
10.1 (3) to regulate the identity, labeling, purity, and quality of all drugs and medicines
10.2dispensed in this state, using the United States Pharmacopeia and the National Formulary,
10.3or any revisions thereof, or standards adopted under the federal act as the standard;
10.4 (4) to enter and inspect by its authorized representative any and all places where
10.5drugs, medicines, medical gases, or veterinary drugs or devices are sold, vended, given
10.6away, compounded, dispensed, manufactured, wholesaled, or held; it may secure samples
10.7or specimens of any drugs, medicines, medical gases, or veterinary drugs or devices
10.8after paying or offering to pay for such sample; it shall be entitled to inspect and make
10.9copies of any and all records of shipment, purchase, manufacture, quality control, and
10.10sale of these items provided, however, that such inspection shall not extend to financial
10.11data, sales data, or pricing data;
10.12 (5) to examine and license as pharmacists all applicants whom it shall deem qualified
10.13to be such;
10.14 (6) to license wholesale drug distributors;
10.15 (7) to
10.16registration or license required under this chapter
10.17 upon any of the
10.18the provisions of section 151.071;
10.19
10.20
10.21
10.22
10.23
10.24
10.25
10.26
10.27
10.28
10.29
10.30
10.31
10.32
10.33
10.34
10.35
10.36
11.1
11.2
11.3
11.4
11.5
11.6
11.7
11.8
11.9
11.10
11.11
11.12
11.13
11.14 (8) to employ necessary assistants and adopt rules for the conduct of its business;
11.15 (9) to register as pharmacy technicians all applicants who the board determines are
11.16qualified to carry out the duties of a pharmacy technician;
11.17 (10) to perform such other duties and exercise such other powers as the provisions of
11.18the act may require
11.19(11) to enter and inspect any business to which it issues a license or registration.
11.20
11.21
11.22
11.23
11.24
11.25
11.26
11.27
11.28
11.29and publish uniform rules not inconsistent herewith for carrying out and enforcing
11.30the provisions of this chapter. The board shall adopt rules regarding prospective drug
11.31utilization review and patient counseling by pharmacists. A pharmacist in the exercise of
11.32the pharmacist's professional judgment, upon the presentation of a
11.33patient or the patient's caregiver or agent, shall perform the prospective drug utilization
11.34review required by rules issued under this subdivision.
11.35
11.36(FDA) determines that the substitution of drugs used for the treatment of epilepsy or
12.1seizures poses a health risk to patients, the board shall adopt rules in accordance with
12.2accompanying FDA interchangeability standards regarding the use of substitution for
12.3these drugs. If the board adopts a rule regarding the substitution of drugs used for the
12.4treatment of epilepsy or seizures that conflicts with the substitution requirements of
12.5section
12.6proposed by the board would increase state costs for state public health care programs,
12.7the board shall report to the chairs and ranking minority members of the senate Health
12.8and Human Services Budget Division and the house of representatives Health Care and
12.9Human Services Finance Division the proposed rule and the increased cost associated
12.10with the proposed rule before the board may adopt the rule.
12.11 Subd. 1a.
12.12
12.13
12.14
12.15
12.16
12.17
12.18an act or practice constituting a violation of a law, rule, or other order related to the duties
12.19and responsibilities entrusted to the board, the board may issue and cause to be served
12.20upon the person an order requiring the person to cease and desist from violations.
12.21(b) The cease and desist order must state the reasons for the issuance of the order
12.22and must give reasonable notice of the rights of the person to request a hearing before
12.23an administrative law judge. A hearing must be held not later than ten days after the
12.24request for the hearing is received by the board. After the completion of the hearing,
12.25the administrative law judge shall issue a report within ten days. Within 15 days after
12.26receiving the report of the administrative law judge, the board shall issue a further order
12.27vacating or making permanent the cease and desist order. The time periods provided in
12.28this provision may be waived by agreement of the executive director of the board and the
12.29person against whom the cease and desist order was issued. If the person to whom a cease
12.30and desist order is issued fails to appear at the hearing after being duly notified, the person
12.31is in default, and the proceeding may be determined against that person upon consideration
12.32of the cease and desist order, the allegations of which may be considered to be true. Unless
12.33otherwise provided, all hearings must be conducted according to chapter 14. The board
12.34may adopt rules of procedure concerning all proceedings conducted under this subdivision.
12.35(c) If no hearing is requested within 30 days of service of the order, the cease and
12.36desist order will become permanent.
13.1(d) A cease and desist order issued under this subdivision remains in effect until
13.2it is modified or vacated by the board. The administrative proceeding provided by this
13.3subdivision, and subsequent appellate judicial review of that administrative proceeding,
13.4constitutes the exclusive remedy for determining whether the board properly issued the
13.5cease and desist order and whether the cease and desist order should be vacated or made
13.6permanent.
13.7 Subd. 1b. Enforcement of violations of cease and desist orders. (a) Whenever
13.8the board under subdivision 1a seeks to enforce compliance with a cease and desist
13.9order that has been made permanent, the allegations of the cease and desist order are
13.10considered conclusively established for purposes of proceeding under subdivision 1a for
13.11permanent or temporary relief to enforce the cease and desist order. Whenever the board
13.12under subdivision 1a seeks to enforce compliance with a cease and desist order when a
13.13hearing or hearing request on the cease and desist order is pending, or the time has not
13.14yet expired to request a hearing on whether a cease and desist order should be vacated or
13.15made permanent, the allegations in the cease and desist order are considered conclusively
13.16established for the purposes of proceeding under subdivision 1a for temporary relief to
13.17enforce the cease and desist order.
13.18(b) Notwithstanding this subdivision or subdivision 1a, the person against whom
13.19the cease and desist order is issued and who has requested a hearing under subdivision 1a
13.20may, within 15 days after service of the cease and desist order, bring an action in Ramsey
13.21County District Court for issuance of an injunction to suspend enforcement of the cease
13.22and desist order pending a final decision of the board under subdivision 1a to vacate or
13.23make permanent the cease and desist order. The court shall determine whether to issue
13.24such an injunction based on traditional principles of temporary relief.
13.25 Subd. 2. Application. In the case of a facility licensed or registered by the board,
13.26the provisions of subdivision 1 shall apply to an individual owner or sole proprietor and
13.27shall also apply to the following:
13.28(1) In the case of a partnership, each partner thereof;
13.29(2) In the case of an association, each member thereof;
13.30(3) In the case of a corporation, each officer or director thereof and each shareholder
13.31owning 30 percent or more of the voting stock of such corporation.
13.32
13.33
13.34
13.35
13.36
14.1
14.2
14.3
14.4
14.5
14.6
14.7
14.8
14.9
14.10
14.11
14.12
14.13 Sec. 3. [151.071] DISCIPLINARY ACTION.
14.14 Subdivision 1. Forms of disciplinary action. When the board finds that a licensee,
14.15registrant, or applicant has engaged in conduct prohibited under subdivision 2, it may
14.16do one or more of the following:
14.17(1) deny the issuance of a license or registration;
14.18(2) refuse to renew a license or registration;
14.19(3) revoke the license or registration;
14.20(4) suspend the license or registration;
14.21(5) impose limitations, conditions, or both on the license or registration, including
14.22but not limited to: the limitation of practice designated settings; the imposition of
14.23retraining or rehabilitation requirements; the requirement of practice under supervision;
14.24the requirement of participation in a diversion program such as that established pursuant to
14.25section 214.31 or the conditioning of continued practice on demonstration of knowledge
14.26or skills by appropriate examination or other review of skill and competence;
14.27(6) impose a civil penalty not exceeding $10,000 for each separate violation, the
14.28amount of the civil penalty to be fixed so as to deprive a licensee or registrant of any
14.29economic advantage gained by reason of the violation, to discourage similar violations
14.30by the licensee or registrant or any other licensee or registrant, or to reimburse the board
14.31for the cost of the investigation and proceeding, including but not limited to, fees paid
14.32for services provided by the Office of Administrative Hearings, legal and investigative
14.33services provided by the Office of the Attorney General, court reporters, witnesses,
14.34reproduction of records, board members' per diem compensation, board staff time, and
14.35travel costs and expenses incurred by board staff and board members; and
15.1(7) reprimand the licensee or registrant.
15.2 Subd. 2. Grounds for disciplinary action. The following conduct is prohibited and
15.3is grounds for disciplinary action:
15.4(1) failure to demonstrate the qualifications or satisfy the requirements for a license
15.5or registration contained in this chapter or the rules of the board. The burden of proof is on
15.6the applicant to demonstrate such qualifications or satisfaction of such requirements;
15.7(2) obtaining a license by fraud or by misleading the board in any way during
15.8the application process or obtaining a license by cheating, or attempting to subvert
15.9the licensing examination process. Conduct that subverts or attempts to subvert the
15.10licensing examination process includes, but is not limited to: (i) conduct that violates the
15.11security of the examination materials, such as removing examination materials from the
15.12examination room or having unauthorized possession of any portion of a future, current,
15.13or previously administered licensing examination; (ii) conduct that violates the standard of
15.14test administration, such as communicating with another examinee during administration
15.15of the examination, copying another examinee's answers, permitting another examinee
15.16to copy one's answers, or possessing unauthorized materials; or (iii) impersonating an
15.17examinee or permitting an impersonator to take the examination on one's own behalf;
15.18(3) for a pharmacist, pharmacy technician, pharmacist intern, applicant for a
15.19pharmacist or pharmacy license, or applicant for a pharmacy technician or pharmacist
15.20intern registration, conviction of a felony reasonably related to the practice of pharmacy.
15.21Conviction as used in this subdivision includes a conviction of an offense that if committed
15.22in this state would be deemed a felony without regard to its designation elsewhere, or
15.23a criminal proceeding where a finding or verdict of guilt is made or returned but the
15.24adjudication of guilt is either withheld or not entered thereon. The board may delay the
15.25issuance of a new license or registration if the applicant has been charged with a felony
15.26until the matter has been adjudicated;
15.27(4) for a facility, other than a pharmacy, licensed or registered by the board, if an
15.28owner or applicant is convicted of a felony reasonably related to the operation of the
15.29facility. The board may delay the issuance of a new license or registration if the owner or
15.30applicant has been charged with a felony until the matter has been adjudicated;
15.31(5) for a controlled substance researcher, conviction of a felony reasonably related
15.32to controlled substances or to the practice of the researcher's profession. The board may
15.33delay the issuance of a registration if the applicant has been charged with a felony until
15.34the matter has been adjudicated;
15.35(6) disciplinary action taken by another state or by one of this state's health licensing
15.36agencies:
16.1(i) revocation, suspension, restriction, limitation, or other disciplinary action against
16.2a license or registration in another state or jurisdiction, failure to report to the board that
16.3charges or allegations regarding the person's license or registration have been brought in
16.4another state or jurisdiction, or having been refused a license or registration by any other
16.5state or jurisdiction. The board may delay the issuance of a new license or registration if
16.6an investigation or disciplinary action is pending in another state or jurisdiction until the
16.7investigation or action has been dismissed or otherwise resolved; and
16.8(ii) revocation, suspension, restriction, limitation, or other disciplinary action against
16.9a license or registration issued by another of this state's health licensing agencies, failure
16.10to report to the board that charges regarding the person's license or registration have been
16.11brought by another of this state's health licensing agencies, or having been refused a
16.12license or registration by another of this state's health licensing agencies. The board may
16.13delay the issuance of a new license or registration if a disciplinary action is pending before
16.14another of this state's health licensing agencies until the action has been dismissed or
16.15otherwise resolved;
16.16(7) for a pharmacist, pharmacy, pharmacy technician, or pharmacist intern, violation
16.17of any order of the board, of any of the provisions of this chapter or any rules of the
16.18board or violation of any federal, state, or local law or rule reasonably pertaining to the
16.19practice of pharmacy;
16.20(8) for a facility, other than a pharmacy, licensed by the board, violations of any
16.21order of the board, of any of the provisions of this chapter or the rules of the board or
16.22violation of any federal, state, or local law relating to the operation of the facility;
16.23(9) engaging in any unethical conduct; conduct likely to deceive, defraud, or harm
16.24the public, or demonstrating a willful or careless disregard for the health, welfare, or safety
16.25of a patient; or pharmacy practice that is professionally incompetent, in that it may create
16.26unnecessary danger to any patient's life, health, or safety, in any of which cases, proof
16.27of actual injury need not be established;
16.28(10) aiding or abetting an unlicensed person in the practice of pharmacy, except
16.29that it is not a violation of this clause for a pharmacist to supervise a properly registered
16.30pharmacy technician or pharmacist intern if that person is performing duties allowed
16.31by this chapter or the rules of the board;
16.32(11) for an individual licensed or registered by the board, adjudication as mentally ill
16.33or developmentally disabled, or as a chemically dependent person, a person dangerous
16.34to the public, a sexually dangerous person, or a person who has a sexual psychopathic
16.35personality, by a court of competent jurisdiction, within or without this state. Such
17.1adjudication shall automatically suspend a license for the duration thereof unless the
17.2board orders otherwise;
17.3(12) for a pharmacist or pharmacy intern, engaging in unprofessional conduct as
17.4specified in the board's rules. In the case of a pharmacy technician, engaging in conduct
17.5specified in board rules that would be unprofessional if it were engaged in by a pharmacist
17.6or pharmacist intern or performing duties specifically reserved for pharmacists under this
17.7chapter or the rules of the board;
17.8(13) for a pharmacy, operation of the pharmacy without a pharmacist present and on
17.9duty except as allowed by a variance approved by the board;
17.10(14) for a pharmacist, the inability to practice pharmacy with reasonable skill and
17.11safety to patients by reason of illness, drunkenness, use of drugs, narcotics, chemicals, or
17.12any other type of material or as a result of any mental or physical condition, including
17.13deterioration through the aging process or loss of motor skills. In the case of registered
17.14pharmacy technicians, pharmacist interns, or controlled substance researchers, the
17.15inability to carry out duties allowed under this chapter or the rules of the board with
17.16reasonable skill and safety to patients by reason of illness, drunkenness, use of drugs,
17.17narcotics, chemicals, or any other type of material or as a result of any mental or physical
17.18condition, including deterioration through the aging process or loss of motor skills;
17.19(15) for a pharmacist, pharmacy, pharmacist intern, pharmacy technician, medical
17.20gas distributor, or controlled substance researcher, revealing a privileged communication
17.21from or relating to a patient except when otherwise required or permitted by law;
17.22(16) for a pharmacist or pharmacy, improper management of patient records,
17.23including failure to maintain adequate patient records, to comply with a patient's request
17.24made pursuant to sections 144.291 to 144.298, or to furnish a patient record or report
17.25required by law;
17.26(17) paying, offering to pay, receiving, or agreeing to receive, a commission, rebate,
17.27kickback, or other form of remuneration, directly or indirectly, for the referral of patients
17.28or the dispensing of drugs or devices;
17.29(18) engaging in abusive or fraudulent billing practices, including violations of the
17.30federal Medicare and Medicaid laws or state medical assistance laws or rules;
17.31(19) engaging in conduct with a patient that is sexual or may reasonably be
17.32interpreted by the patient as sexual, or in any verbal behavior that is seductive or sexually
17.33demeaning to a patient;
17.34(20) failure to make reports as required by section 151.072 or to cooperate with an
17.35investigation of the board as required by section 151.074;
18.1(21) knowingly providing false or misleading information that is directly related
18.2to the care of a patient unless done for an accepted therapeutic purpose such as the
18.3dispensing and administration of a placebo;
18.4(22) aiding suicide or aiding attempted suicide in violation of section 609.215 as
18.5established by any of the following:
18.6(i) a copy of the record of criminal conviction or plea of guilty for a felony in
18.7violation of section 609.215, subdivision 1 or 2;
18.8(ii) a copy of the record of a judgment of contempt of court for violating an
18.9injunction issued under section 609.215, subdivision 4;
18.10(iii) a copy of the record of a judgment assessing damages under section 609.215,
18.11subdivision 5; or
18.12(iv) a finding by the board that the person violated section 609.215, subdivision
18.131 or 2. The board shall investigate any complaint of a violation of section 609.215,
18.14subdivision 1 or 2;
18.15(23) for a pharmacist, practice of pharmacy under a lapsed or nonrenewed license.
18.16For a pharmacist intern, pharmacy technician, or controlled substance researcher,
18.17performing duties permitted to such individuals by this chapter or the rules of the board
18.18under a lapsed or nonrenewed registration. For a facility required to be licensed under this
18.19chapter, operation of the facility under a lapsed or nonrenewed license or registration; and
18.20(24) for a pharmacist, pharmacist intern, or pharmacy technician, termination
18.21or discharge from the health professional services program for reasons other than the
18.22satisfactory completion of the program.
18.23 Subd. 3. Automatic suspension. (a) A license or registration issued under this
18.24chapter to a pharmacist, pharmacist intern, pharmacy technician, or controlled substance
18.25researcher is automatically suspended if: (1) a guardian of a licensee or registrant is
18.26appointed by order of a court pursuant to sections 524.5-101 to 524.5-502, for reasons
18.27other than the minority of the licensee or registrant; or (2) the licensee or registrant is
18.28committed by order of a court pursuant to chapter 253B. The license or registration
18.29remains suspended until the licensee is restored to capacity by a court and, upon petition
18.30by the licensee or registrant, the suspension is terminated by the board after a hearing.
18.31(b) For a pharmacist, pharmacy intern, or pharmacy technician, upon notice to the
18.32board of a judgment of, or a plea of guilty to, a felony reasonably related to the practice
18.33of pharmacy, the license or registration of the regulated person may be automatically
18.34suspended by the board. The license or registration will remain suspended until, upon
18.35petition by the regulated individual and after a hearing, the suspension is terminated by
18.36the board. The board may indefinitely suspend or revoke the license or registration of the
19.1regulated individual if, after a hearing before the board, the board finds that the felonious
19.2conduct would cause a serious risk of harm to the public.
19.3(c) For a facility that is licensed or registered by the board, upon notice to the
19.4board that an owner of the facility is subject to a judgment of, or a plea of guilty to,
19.5a felony reasonably related to the operation of the facility, the license or registration of
19.6the facility may be automatically suspended by the board. The license or registration will
19.7remain suspended until, upon petition by the facility and after a hearing, the suspension
19.8is terminated by the board. The board may indefinitely suspend or revoke the license or
19.9registration of the facility if, after a hearing before the board, the board finds that the
19.10felonious conduct would cause a serious risk of harm to the public.
19.11(d) For licenses and registrations that have been suspended or revoked pursuant
19.12to paragraphs (a) and (b), the regulated individual may have a license or registration
19.13reinstated, either with or without restrictions, by demonstrating clear and convincing
19.14evidence of rehabilitation, as provided in section 364.03. If the regulated individual has
19.15the conviction subsequently overturned by court decision, the board shall conduct a
19.16hearing to review the suspension within 30 days after the receipt of the court decision.
19.17The regulated individual is not required to prove rehabilitation if the subsequent court
19.18decision overturns previous court findings of public risk.
19.19(e) For licenses and registrations that have been suspended or revoked pursuant to
19.20paragraph (c), the regulated facility may have a license or registration reinstated, either with
19.21or without restrictions, conditions, or limitations, by demonstrating clear and convincing
19.22evidence of rehabilitation of the convicted owner, as provided in section 364.03. If the
19.23convicted owner has the conviction subsequently overturned by court decision, the board
19.24shall conduct a hearing to review the suspension within 30 days after receipt of the court
19.25decision. The regulated facility is not required to prove rehabilitation of the convicted
19.26owner if the subsequent court decision overturns previous court findings of public risk.
19.27(f) The board may, upon majority vote of a quorum of its appointed members,
19.28suspend the license or registration of a regulated individual without a hearing if the
19.29regulated individual fails to maintain a current name and address with the board, as
19.30described in paragraphs (h) and (i), while the regulated individual is: (1) under board
19.31investigation, and a notice of conference has been issued by the board; (2) party to a
19.32contested case with the board; (3) party to an agreement for corrective action with the
19.33board; or (4) under a board order for disciplinary action. The suspension shall remain
19.34in effect until lifted by the board to the board's receipt of a petition from the regulated
19.35individual, along with the current name and address of the regulated individual.
20.1(g) The board may, upon majority vote of a quorum of its appointed members,
20.2suspend the license or registration of a regulated facility without a hearing if the regulated
20.3facility fails to maintain a current name and address of the owner of the facility with the
20.4board, as described in paragraphs (h) and (i), while the regulated facility is: (1) under
20.5board investigation, and a notice of conference has been issued by the board; (2) party
20.6to a contested case with the board; (3) party to an agreement for corrective action with
20.7the board; or (4) under a board order for disciplinary action. The suspension shall remain
20.8in effect until lifted by the board pursuant to the board's receipt of a petition from the
20.9regulated facility, along with the current name and address of the owner of the facility.
20.10(h) An individual licensed or registered by the board shall maintain a current name
20.11and home address with the board and shall notify the board in writing within 30 days of
20.12any change in name or home address. An individual regulated by the board shall also
20.13maintain a current business address with the board as required by section 214.073. For
20.14an individual, if a name change only is requested, the regulated individual must request
20.15a revised license or registration. The board may require the individual to substantiate
20.16the name change by submitting official documentation from a court of law or agency
20.17authorized under law to receive and officially record a name change. In the case of an
20.18individual, if an address change only is requested, no request for a revised license or
20.19registration is required. If the current license or registration of an individual has been lost,
20.20stolen, or destroyed, the individual shall provide a written explanation to the board.
20.21(i) A facility licensed or registered by the board shall maintain a current name and
20.22address with the board. A facility shall notify the board in writing within 30 days of any
20.23change in name. A facility licensed or registered by the board but located outside of the
20.24state must notify the board within 30 days of an address change. A facility licensed or
20.25registered by the board and located within the state must notify the board at least 60
20.26days in advance of a change of address that will result from the move of the facility to a
20.27different location and must pass an inspection at the new location as required by the board.
20.28If the current license or registration of a facility has been lost, stolen, or destroyed, the
20.29facility shall provide a written explanation to the board.
20.30 Subd. 4. Effective dates. A suspension, revocation, condition, limitation,
20.31qualification, or restriction of a license or registration shall be in effect pending
20.32determination of an appeal. A revocation of a license pursuant to subdivision 1a is not
20.33appealable and shall remain in effect indefinitely.
20.34 Subd. 5. Conditions on reissued license. In its discretion, the board may restore
20.35and reissue a license or registration issued under this chapter, but as a condition thereof
20.36may impose any disciplinary or corrective measure that it might originally have imposed.
21.1 Subd. 6. Temporary suspension of license for pharmacists. In addition to any
21.2other remedy provided by law, the board may, without a hearing, temporarily suspend the
21.3license of a pharmacist if the board finds that the pharmacist has violated a statute or rule
21.4that the board is empowered to enforce and continued practice by the pharmacist would
21.5create a serious risk of harm to the public. The suspension shall take effect upon written
21.6notice to the pharmacist, specifying the statute or rule violated. The suspension shall
21.7remain in effect until the board issues a final order in the matter after a hearing. At the
21.8time it issues the suspension notice, the board shall schedule a disciplinary hearing to be
21.9held pursuant to the Administrative Procedure Act. The pharmacist shall be provided with
21.10at least 20 days' notice of any hearing held pursuant to this subdivision. The hearing shall
21.11be scheduled to begin no later than 30 days after the issuance of the suspension order.
21.12 Subd. 7. Temporary suspension of license for pharmacist interns, pharmacy
21.13technicians, and controlled substance researchers. In addition to any other remedy
21.14provided by law, the board may, without a hearing, temporarily suspend the registration of
21.15a pharmacist intern, pharmacy technician, or controlled substance researcher if the board
21.16finds that the registrant has violated a statute or rule that the board is empowered to enforce
21.17and continued registration of the registrant would create a serious risk of harm to the
21.18public. The suspension shall take effect upon written notice to the registrant, specifying
21.19the statute or rule violated. The suspension shall remain in effect until the board issues a
21.20final order in the matter after a hearing. At the time it issues the suspension notice, the
21.21board shall schedule a disciplinary hearing to be held pursuant to the Administrative
21.22Procedure Act. The licensee or registrant shall be provided with at least 20 days' notice of
21.23any hearing held pursuant to this subdivision. The hearing shall be scheduled to begin no
21.24later than 30 days after the issuance of the suspension order.
21.25 Subd. 8. Temporary suspension of license for pharmacies, drug wholesalers,
21.26drug manufacturers, medical gas manufacturers, and medical gas distributors.
21.27In addition to any other remedy provided by law, the board may, without a hearing,
21.28temporarily suspend the license or registration of a pharmacy, drug wholesaler, drug
21.29manufacturer, medical gas manufacturer, or medical gas distributor if the board finds
21.30that the licensee or registrant has violated a statute or rule that the board is empowered
21.31to enforce and continued operation of the licensed facility would create a serious risk of
21.32harm to the public. The suspension shall take effect upon written notice to the licensee or
21.33registrant, specifying the statute or rule violated. The suspension shall remain in effect
21.34until the board issues a final order in the matter after a hearing. At the time it issues the
21.35suspension notice, the board shall schedule a disciplinary hearing to be held pursuant to
21.36the Administrative Procedure Act. The licensee or registrant shall be provided with at
22.1least 20 days' notice of any hearing held pursuant to this subdivision. The hearing shall be
22.2scheduled to begin no later than 30 days after the issuance of the suspension order.
22.3 Subd. 9. Evidence. In disciplinary actions alleging a violation of subdivision 2,
22.4clause (4), (5), (6), or (7), a copy of the judgment or proceeding under the seal of the court
22.5administrator or of the administrative agency that entered the same shall be admissible
22.6into evidence without further authentication and shall constitute prima facie evidence
22.7of the contents thereof.
22.8 Subd. 10. Mental examination; access to medical data. (a) If the board has
22.9probable cause to believe that an individual licensed or registered by the board falls under
22.10subdivision 2, clause (14), it may direct the individual to submit to a mental or physical
22.11examination. For the purpose of this subdivision, every licensed or registered individual is
22.12deemed to have consented to submit to a mental or physical examination when directed in
22.13writing by the board and further to have waived all objections to the admissibility of the
22.14examining practitioner's testimony or examination reports on the grounds that the same
22.15constitute a privileged communication. Failure of a licensed or registered individual to
22.16submit to an examination when directed constitutes an admission of the allegations against
22.17the individual, unless the failure was due to circumstances beyond the individual's control,
22.18in which case a default and final order may be entered without the taking of testimony or
22.19presentation of evidence. Pharmacists affected under this paragraph shall at reasonable
22.20intervals be given an opportunity to demonstrate that they can resume the competent
22.21practice of the profession of pharmacy with reasonable skill and safety to the public.
22.22Pharmacist interns, pharmacy technicians, or controlled substance researchers affected
22.23under this paragraph shall at reasonable intervals be given an opportunity to demonstrate
22.24that they can competently resume the duties that can be performed, under this chapter or
22.25the rules of the board, by similarly registered persons with reasonable skill and safety to
22.26the public. In any proceeding under this paragraph, neither the record of proceedings nor
22.27the orders entered by the board shall be used against a licensed or registered individual
22.28in any other proceeding.
22.29(b) In addition to ordering a physical or mental examination, the board may,
22.30notwithstanding section 13.384, 144.651, or any other law limiting access to medical or
22.31other health data, obtain medical data and health records relating to an individual licensed
22.32or registered by the board, or to an applicant for licensure or registration, without the
22.33individual's consent, if the board has probable cause to believe that the individual falls
22.34under subdivision 2, clause (14). The medical data may be requested from a provider,
22.35as defined in section 144.291, subdivision 2, paragraph (h), an insurance company, or a
22.36government agency, including the Department of Human Services. A provider, insurance
23.1company, or government agency shall comply with any written request of the board under
23.2this subdivision and is not liable in any action for damages for releasing the data requested
23.3by the board if the data are released pursuant to a written request under this subdivision,
23.4unless the information is false and the provider giving the information knew, or had reason
23.5to believe, the information was false. Information obtained under this subdivision is
23.6classified as private under sections 13.01 to 13.87.
23.7 Subd. 11. Tax clearance certificate. (a) In addition to the provisions of subdivision
23.81, the board may not issue or renew a license or registration if the commissioner of
23.9revenue notifies the board and the licensee or applicant for a license that the licensee or
23.10applicant owes the state delinquent taxes in the amount of $500 or more. The board may
23.11issue or renew the license or registration only if (1) the commissioner of revenue issues a
23.12tax clearance certificate, and (2) the commissioner of revenue or the licensee, registrant, or
23.13applicant forwards a copy of the clearance to the board. The commissioner of revenue
23.14may issue a clearance certificate only if the licensee, registrant, or applicant does not owe
23.15the state any uncontested delinquent taxes.
23.16(b) For purposes of this subdivision, the following terms have the meanings given.
23.17(1) "Taxes" are all taxes payable to the commissioner of revenue, including penalties
23.18and interest due on those taxes.
23.19(2) "Delinquent taxes" do not include a tax liability if (i) an administrative or court
23.20action that contests the amount or validity of the liability has been filed or served, (ii) the
23.21appeal period to contest the tax liability has not expired, or (iii) the licensee or applicant
23.22has entered into a payment agreement to pay the liability and is current with the payments.
23.23(c) In lieu of the notice and hearing requirements of subdivision 1, when a licensee,
23.24registrant, or applicant is required to obtain a clearance certificate under this subdivision,
23.25a contested case hearing must be held if the licensee or applicant requests a hearing in
23.26writing to the commissioner of revenue within 30 days of the date of the notice provided
23.27in paragraph (a). The hearing must be held within 45 days of the date the commissioner of
23.28revenue refers the case to the Office of Administrative Hearings. Notwithstanding any law
23.29to the contrary, the licensee or applicant must be served with 20 days' notice in writing
23.30specifying the time and place of the hearing and the allegations against the licensee or
23.31applicant. The notice may be served personally or by mail.
23.32(d) A licensee or applicant must provide the licensee's or applicant's Social Security
23.33number and Minnesota business identification number on all license applications. Upon
23.34request of the commissioner of revenue, the board must provide to the commissioner of
23.35revenue a list of all licensees and applicants that includes the licensee's or applicant's
23.36name, address, Social Security number, and business identification number. The
24.1commissioner of revenue may request a list of the licensees and applicants no more than
24.2once each calendar year.
24.3 Subd. 12. Limitation. No board proceeding against a regulated person or facility
24.4shall be instituted unless commenced within seven years from the date of the commission
24.5of some portion of the offense or misconduct complained of except for alleged violations
24.6of subdivision 2, clause (21).
24.7 Sec. 4. [151.072] REPORTING OBLIGATIONS.
24.8 Subdivision 1. Permission to report. A person who has knowledge of any conduct
24.9constituting grounds for discipline under the provisions of this chapter or the rules of the
24.10board may report the violation to the board.
24.11 Subd. 2. Pharmacies. A pharmacy located in this state must report to the board any
24.12discipline that is related to an incident involving conduct that would constitute grounds
24.13for discipline under the provisions of this chapter or the rules of the board, that is taken
24.14by the pharmacy or any of its administrators against a pharmacist, pharmacist intern, or
24.15pharmacy technician, including the termination of employment of the individual or the
24.16revocation, suspension, restriction, limitation, or conditioning of an individual's ability
24.17to practice or work at or on behalf of the pharmacy. The pharmacy shall also report the
24.18resignation of any pharmacist, pharmacist intern, or technician prior to the conclusion of
24.19any disciplinary proceeding, or prior to the commencement of formal charges but after the
24.20individual had knowledge that formal charges were contemplated or in preparation. Each
24.21report made under this subdivision must state the nature of the action taken and state in
24.22detail the reasons for the action. Failure to report violations as required by this subdivision
24.23is a basis for discipline pursuant to section 151.071, subdivision 2, clause (8).
24.24 Subd. 3. Licensees and registrants of the board. A licensee or registrant of
24.25the board shall report to the board personal knowledge of any conduct that the person
24.26reasonably believes constitutes grounds for disciplinary action under this chapter or
24.27the rules of the board by any pharmacist, pharmacist intern, pharmacy technician, or
24.28controlled substance researcher, including any conduct indicating that the person may be
24.29professionally incompetent, or may have engaged in unprofessional conduct or may be
24.30medically or physically unable to engage safely in the practice of pharmacy or to carry
24.31out the duties permitted to the person by this chapter or the rules of the board. Failure
24.32to report violations as required by this subdivision is a basis for discipline pursuant to
24.33section 151.071, subdivision 2, clause (20).
24.34 Subd. 4. Courts. The court administrator of a district court or any other court of
24.35competent jurisdiction shall report to the board any judgment or other determination of
25.1the court that: adjudges or includes a finding that a licensee or registrant of the board is
25.2mentally ill, mentally incompetent, guilty of a felony, or guilty of a violation of federal
25.3or state narcotics laws or controlled substances act, guilty of an abuse or fraud under
25.4Medicare or Medicaid; appoints a guardian of the licensee or registrant pursuant to sections
25.5524.5-101 to 524.5-502; or commits a licensee or registrant pursuant to chapter 253B.
25.6 Subd. 5. Self-reporting. A licensee or registrant of the board shall report to the
25.7board any personal action that would require that a report be filed with the board pursuant
25.8to subdivision 2 or 4.
25.9 Subd. 6. Deadlines; forms. Reports required by subdivisions 2 to 5 must be
25.10submitted not later than 30 days after the occurrence of the reportable event or transaction.
25.11The board may provide forms for the submission of reports required by this section, may
25.12require that reports be submitted on the forms provided, and may adopt rules necessary
25.13to assure prompt and accurate reporting.
25.14 Subd. 7. Subpoenas. The board may issue subpoenas for the production of any
25.15reports required by subdivisions 2 to 5 or any related documents.
25.16 Sec. 5. [151.073] IMMUNITY.
25.17 Subdivision 1. Reporting. Any person, health care facility, business, or organization
25.18is immune from civil liability or criminal prosecution for submitting in good faith a report
25.19to the board under section 151.072 or for otherwise reporting in good faith to the board
25.20violations or alleged violations of this chapter or the rules of the board. All such reports
25.21are investigative data as defined in chapter 13.
25.22 Subd. 2. Investigation. (a) Members of the board and persons employed by the board
25.23or engaged on behalf of the board in the investigation of violations and in the preparation
25.24and management of charges or violations of this chapter of the rules of the board, or persons
25.25participating in the investigation or testifying regarding charges of violations, are immune
25.26from civil liability and criminal prosecution for any actions, transactions, or publications
25.27in the execution of, or relating to, their duties under this chapter or the rules of the board.
25.28(b) Members of the board and persons employed by the board or engaged in
25.29maintaining records and making reports regarding adverse health care events are immune
25.30from civil liability and criminal prosecution for any actions, transactions, or publications
25.31in the execution of, or relating to, their duties under section 151.301.
25.32 Sec. 6. [151.074] LICENSEE OR REGISTRANT COOPERATION.
25.33An individual who is licensed or registered by the board, who is the subject of an
25.34investigation by or on behalf of the board, shall cooperate fully with the investigation.
26.1An owner or employee of a facility that is licensed or registered by the board, when the
26.2facility is the subject of an investigation by or on behalf of the board, shall cooperate
26.3fully with the investigation. Cooperation includes responding fully and promptly to any
26.4question raised by, or on behalf of, the board relating to the subject of the investigation and
26.5providing copies of patient pharmacy records and other relevant records, as reasonably
26.6requested by the board, to assist the board in its investigation. The board shall maintain
26.7any records obtained pursuant to this section as investigative data pursuant to chapter 13.
26.8 Sec. 7. [151.075] DISCIPLINARY RECORD ON JUDICIAL REVIEW.
26.9Upon judicial review of any board disciplinary action taken under this chapter, the
26.10reviewing court shall seal the administrative record, except for the board's final decision,
26.11and shall not make the administrative record available to the public.
26.12 Sec. 8. Minnesota Statutes 2012, section 151.211, is amended to read:
26.13151.211 RECORDS OF PRESCRIPTIONS.
26.14 Subdivision 1. Retention of prescription drug orders. All
26.15 prescription drug orders shall be kept on file at the location
26.16
26.17orders that are electronically prescribed must be kept on file in the format in which
26.18they were originally received. Written or printed prescription drug orders and verbal
26.19prescription drug orders reduced to writing, must be kept on file as received or transcribed,
26.20except that such orders may be kept in an electronic format as allowed by the board.
26.21Electronic systems used to process and store prescription drug orders must be compliant
26.22with the requirements of this chapter and the rules of the board. Prescription drug orders
26.23that are stored in an electronic format, as permitted by this subdivision, may be kept on
26.24file at a remote location provided that they are readily and securely accessible from the
26.25location at which dispensing of the ordered drug occurred.
26.26 Subd. 2. Refill requirements.
26.27
26.28accordance with the requirements of this chapter, the rules of the board, and where
26.29applicable, section 152.11. The date of such refill must be recorded and initialed upon
26.30the original prescription drug order, or within the electronically maintained record of the
26.31original prescription drug order, by the pharmacist, pharmacist intern, or practitioner
26.32who refills the prescription.
26.33 Sec. 9. [151.251] COMPOUNDING.
27.1 Subdivision 1. Exemption from manufacturing licensure requirement. Section
27.2151.252 shall not apply to:
27.3(1) a practitioner engaged in extemporaneous compounding, anticipatory
27.4compounding, or compounding not done pursuant to a prescription drug order when
27.5permitted by this chapter or the rules of the board; and
27.6(2) a pharmacy in which a pharmacist is engaged in extemporaneous compounding,
27.7anticipatory compounding, or compounding not done pursuant to a prescription drug order
27.8when permitted by this chapter or the rules of the board.
27.9 Subd. 2. Compounded drug. A drug product may be compounded under this
27.10section if a pharmacist or practitioner:
27.11(a) compounds the drug product using bulk drug substances, as defined in the federal
27.12regulations published in Code of Federal Regulations, title 21, section 207.3(a)(4):
27.13(1) that:
27.14(i) comply with the standards of an applicable United States Pharmacopoeia
27.15or National Formulary monograph, if a monograph exists, and the United States
27.16Pharmacopoeia chapter on pharmacy compounding;
27.17(ii) if such a monograph does not exist, are drug substances that are components of
27.18drugs approved for use in this country by the United States Food and Drug Administration;
27.19or
27.20(iii) if such a monograph does not exist and the drug substance is not a component of
27.21a drug approved for use in this country by the United States Food and Drug Administration,
27.22that appear on a list developed by the United States Food and Drug Administration through
27.23regulations issued by the secretary of the federal Department of Health and Human
27.24Services pursuant to section 503a of the Food, Drug and Cosmetic Act under paragraph (d);
27.25(2) that are manufactured by an establishment that is registered under section 360
27.26of the federal Food, Drug and Cosmetic Act, including a foreign establishment that is
27.27registered under section 360(i) of that act; and
27.28(3) that are accompanied by valid certificates of analysis for each bulk drug substance;
27.29(b) compounds the drug product using ingredients, other than bulk drug substances,
27.30that comply with the standards of an applicable United States Pharmacopoeia or National
27.31Formulary monograph, if a monograph exists, and the United States Pharmacopoeia
27.32chapters on pharmacy compounding;
27.33(c) does not compound a drug product that appears on a list published by the secretary
27.34of the federal Department of Health and Human Services in the Federal Register of drug
27.35products that have been withdrawn or removed from the market because such drug products
27.36or components of such drug products have been found to be unsafe or not effective;
28.1(d) does not compound any drug products that are essentially copies of a
28.2commercially available drug product; and
28.3(e) does not compound any drug product that has been identified pursuant to
28.4United States Code, title 21, section 353a, as a drug product that presents demonstrable
28.5difficulties for compounding that reasonably demonstrate an adverse effect on the safety
28.6or effectiveness of that drug product.
28.7The term "essentially a copy of a commercially available drug product" does not
28.8include a drug product in which there is a change, made for an identified individual
28.9patient, that produces for that patient a significant difference, as determined by the
28.10prescribing practitioner, between the compounded drug and the comparable commercially
28.11available drug product.
28.12 Subd. 3. Exceptions. This section shall not apply to:
28.13(1) compounded positron emission tomography drugs as defined in section 151.01,
28.14subdivision 38; or
28.15(2) radiopharmaceuticals.
28.16 Sec. 10. Minnesota Statutes 2013 Supplement, section 151.252, is amended by adding
28.17a subdivision to read:
28.18 Subd. 1a. Outsourcing facility. (a) No person shall act as an outsourcing facility
28.19without first obtaining a license from the board and paying any applicable manufacturer
28.20licensing fee specified in section 151.065.
28.21(b) Application for an outsourcing facility license under this section shall be made
28.22in a manner specified by the board and may differ from the application required of other
28.23drug manufacturers.
28.24(c) No license shall be issued or renewed for an outsourcing facility unless the
28.25applicant agrees to operate in a manner prescribed for outsourcing facilities by federal and
28.26state law and according to Minnesota Rules.
28.27(d) No license shall be issued or renewed for an outsourcing facility unless the
28.28applicant supplies the board with proof of such registration by the United States Food and
28.29Drug Administration as required by United States Code, title 21, section 353b.
28.30(e) No license shall be issued or renewed for an outsourcing facility that is required
28.31to be licensed or registered by the state in which it is physically located unless the
28.32applicant supplies the board with proof of such licensure or registration. The board may
28.33establish, by rule, standards for the licensure of an outsourcing facility that is not required
28.34to be licensed or registered by the state in which it is physically located.
29.1(f) The board shall require a separate license for each outsourcing facility located
29.2within the state and for each outsourcing facility located outside of the state at which drugs
29.3that are shipped into the state are prepared.
29.4(g) The board shall not issue an initial or renewed license for an outsourcing facility
29.5unless the facility passes an inspection conducted by an authorized representative of the
29.6board. In the case of an outsourcing facility located outside of the state, the board may
29.7require the applicant to pay the cost of the inspection, in addition to the license fee in
29.8section 151.065, unless the applicant furnishes the board with a report, issued by the
29.9appropriate regulatory agency of the state in which the facility is located or by the United
29.10States Food and Drug Administration, of an inspection that has occurred within the 24
29.11months immediately preceding receipt of the license application by the board. The board
29.12may deny licensure unless the applicant submits documentation satisfactory to the board
29.13that any deficiencies noted in an inspection report have been corrected.
29.14 Sec. 11. Minnesota Statutes 2012, section 151.26, is amended to read:
29.15151.26 EXCEPTIONS.
29.16 Subdivision 1. Generally. Nothing in this chapter shall subject a person duly
29.17licensed in this state to practice medicine, dentistry, or veterinary medicine, to inspection
29.18by the State Board of Pharmacy, nor prevent the person from administering drugs,
29.19medicines, chemicals, or poisons in the person's practice, nor prevent a duly licensed
29.20practitioner from furnishing to a patient properly packaged and labeled drugs, medicines,
29.21chemicals, or poisons as may be considered appropriate in the treatment of such patient;
29.22unless the person is engaged in the dispensing, sale, or distribution of drugs and the board
29.23provides reasonable notice of an inspection.
29.24Except for the provisions of section
29.25interferes with the dispensing, in its original package and at no charge to the patient, of a
29.26legend drug, other than a controlled substance, that was packaged by a manufacturer and
29.27provided to the dispenser for distribution as a professional sample.
29.28Nothing in this chapter shall prevent the sale of drugs, medicines, chemicals, or
29.29poisons at wholesale to licensed physicians, dentists and veterinarians for use in their
29.30practice, nor to hospitals for use therein.
29.31Nothing in this chapter shall prevent the sale of drugs, chemicals, or poisons either
29.32at wholesale or retail for use for commercial purposes, or in the arts, nor interfere with the
29.33sale of insecticides, as defined in Minnesota Statutes 1974, section
29.34this chapter shall prevent the sale of common household preparations and other drugs,
29.35chemicals, and poisons sold exclusively for use for nonmedicinal purposes
30.1that this exception does not apply to any compound, substance, or derivative that is not
30.2approved for human consumption by the United States Food and Drug Administration
30.3or specifically permitted for human consumption under Minnesota law that, when
30.4introduced into the body, induces an effect similar to that of a Schedule I or Schedule II
30.5controlled substance listed in section 152.02, subdivisions 2 and 3, or Minnesota Rules,
30.6parts 6800.4210 and 6800.4220, regardless of whether the substance is marketed for the
30.7purpose of human consumption.
30.8Nothing in this chapter shall apply to or interfere with the vending or retailing of
30.9any nonprescription medicine or drug not otherwise prohibited by statute
30.10prepackaged, fully prepared by the manufacturer or producer for use by the consumer, and
30.11labeled in accordance with the requirements of the state or federal Food and Drug Act; nor
30.12to the manufacture, wholesaling, vending, or retailing of flavoring extracts, toilet articles,
30.13cosmetics, perfumes, spices, and other commonly used household articles of a chemical
30.14nature, for use for nonmedicinal purposes
30.15to any compound, substance, or derivative that is not approved for human consumption
30.16by the United States Food and Drug Administration or specifically permitted for human
30.17consumption under Minnesota law that, when introduced into the body, induces an effect
30.18similar to that of a Schedule I or Schedule II controlled substance listed in section 152.02,
30.19subdivisions 2 and 3, or Minnesota Rules, parts 6800.4210 and 6800.4220, regardless of
30.20whether the substance is marketed for the purpose of human consumption. Nothing in
30.21this chapter shall prevent the sale of drugs or medicines by licensed pharmacists at a
30.22discount to persons over 65 years of age.
30.23 Sec. 12. Minnesota Statutes 2012, section 151.34, is amended to read:
30.24151.34 PROHIBITED ACTS.
30.25It shall be unlawful to:
30.26(1) manufacture, sell or deliver, hold or offer for sale any drug that is adulterated
30.27or misbranded;
30.28(2) adulterate or misbrand any drug;
30.29(3) receive in commerce any drug that is adulterated or misbranded, and to deliver or
30.30proffer delivery thereof for pay or otherwise;
30.31(4) refuse to permit entry or inspection, or to permit the taking of a sample, or to
30.32permit access to or copying of any record as authorized by this chapter;
30.33(5) remove or dispose of a detained or embargoed article in violation of this chapter;
31.1(6) alter, mutilate, destroy, obliterate, or remove the whole or any part of the labeling
31.2of, or to do any other act with respect to a drug, if such act is done while such drug is held
31.3for sale and results in such drug being adulterated or misbranded;
31.4(7) use for a person's own advantage or to reveal other than to the board or its
31.5authorized representative or to the courts when required in any judicial proceeding under
31.6this chapter any information acquired under authority of this chapter concerning any
31.7method or process
31.8(8) use on the labeling of any drug any representation or suggestion that an
31.9application with respect to such drug is effective under the federal act or that such drug
31.10complies with such provisions;
31.11(9) in the case of a manufacturer, packer, or distributor offering legend drugs for sale
31.12within this state, fail to maintain for transmittal or to transmit, to any practitioner licensed
31.13by applicable law to administer such drug who makes written request for information as to
31.14such drug, true and correct copies of all printed matter
31.15in any package in which that drug is distributed or sold, or such other printed matter as is
31.16approved under the federal act. Nothing in this paragraph shall be construed to exempt
31.17any person from any labeling requirement imposed by or under provisions of this chapter;
31.18(10) conduct a pharmacy without a pharmacist in charge;
31.19(11) dispense a legend drug without first obtaining a valid prescription for that drug;
31.20(12) conduct a pharmacy without proper registration with the board;
31.21(13) practice pharmacy without being licensed to do so by the board;
31.22(14) sell at retail federally restricted medical gases without proper registration with
31.23the board except as provided in this chapter
31.24(15) sell any compound, substance, or derivative that is not approved for human
31.25consumption by the United States Food and Drug Administration or specifically permitted
31.26for human consumption under Minnesota law that, when introduced into the body, induces
31.27an effect similar to that of a Schedule I or Schedule II controlled substance listed in
31.28section 152.02, subdivisions 2 and 3, or Minnesota Rules, parts 6800.4210 and 6800.4220,
31.29regardless of whether the substance is marketed for the purpose of human consumption.
31.30 Sec. 13. Minnesota Statutes 2012, section 151.35, is amended to read:
31.31151.35 DRUGS, ADULTERATION.
31.32A drug shall be deemed to be adulterated:
31.33(1) if it consists in whole or in part of any filthy, putrid or decomposed substance; or
31.34if it has been produced, prepared, packed, or held under unsanitary conditions whereby it
31.35may have been rendered injurious to health, or whereby it may have been contaminated
32.1with filth; or if the methods used in, or the facilities or controls used for, its manufacture,
32.2processing, packing, or holding do not conform to or are not operated or administered
32.3in conformity with current good manufacturing practice as required under the federal
32.4act to assure that such drug is safe and has the identity, strength, quality, and purity
32.5characteristics, which it purports or is represented to possess; or the facility in which it
32.6was produced was not registered by the United States Food and Drug Administration or
32.7licensed by the board; or, its container is composed, in whole or in part, of any poisonous
32.8or deleterious substance which may render the contents injurious to health; or it bears
32.9or contains, for purposes of coloring only, a color additive which is unsafe within the
32.10meaning of the federal act, or it is a color additive, the intended use of which in or on drugs
32.11is for the purposes of coloring only, and is unsafe within the meaning of the federal act;
32.12(2) if it purports to be or is represented as a drug the name of which is recognized in
32.13the United States Pharmacopoeia or the National Formulary, and its strength differs from,
32.14or its quality or purity falls below, the standard set forth therein. Such determination as
32.15to strength, quality, or purity shall be made in accordance with the tests or methods of
32.16assay set forth in such compendium, or in the absence of or inadequacy of such tests or
32.17methods of assay, those prescribed under authority of the federal act. No drug defined
32.18in the United States Pharmacopoeia or the National Formulary shall be deemed to be
32.19adulterated under this paragraph because it differs from the standard of strength, quality,
32.20or purity therefor set forth in such compendium, if its difference in strength, quality, or
32.21purity from such standard is plainly stated on its label;
32.22(3) if it is not subject to the provisions of paragraph (2) of this section and its
32.23strength differs from, or its purity or quality differs from that which it purports or is
32.24represented to possess;
32.25(4) if any substance has been mixed or packed therewith so as to reduce its quality or
32.26strength, or substituted wholly or in part therefor.
32.27 Sec. 14. Minnesota Statutes 2012, section 151.361, subdivision 2, is amended to read:
32.28 Subd. 2. After January 1, 1983. (a) No legend drug in solid oral dosage form
32.29may be manufactured, packaged or distributed for sale in this state after January 1, 1983
32.30unless it is clearly marked or imprinted with a symbol, number, company name, words,
32.31letters, national drug code or other mark uniquely identifiable to that drug product. An
32.32identifying mark or imprint made as required by federal law or by the federal Food and
32.33Drug Administration shall be deemed to be in compliance with this section.
32.34(b) The Board of Pharmacy may grant exemptions from the requirements of this
32.35section on its own initiative or upon application of a manufacturer, packager, or distributor
33.1indicating size or other characteristics
33.2imprinting required by this section.
33.3
33.4
33.5
33.6
33.7
33.8
33.9 Sec. 15. Minnesota Statutes 2012, section 151.37, as amended by Laws 2013, chapter
33.1043, section 30, Laws 2013, chapter 55, section 2, and Laws 2013, chapter 108, article
33.1110, section 5, is amended to read:
33.12151.37 LEGEND DRUGS, WHO MAY PRESCRIBE, POSSESS.
33.13 Subdivision 1. Prohibition. Except as otherwise provided in this chapter, it shall be
33.14unlawful for any person to have in possession, or to sell, give away, barter, exchange, or
33.15distribute a legend drug.
33.16 Subd. 2. Prescribing and filing. (a) A licensed practitioner in the course of
33.17professional practice only, may prescribe, administer, and dispense a legend drug, and
33.18may cause the same to be administered by a nurse, a physician assistant, or medical
33.19student or resident under the practitioner's direction and supervision, and may cause a
33.20person who is an appropriately certified, registered, or licensed health care professional
33.21to prescribe, dispense, and administer the same within the expressed legal scope of the
33.22person's practice as defined in Minnesota Statutes. A licensed practitioner may prescribe a
33.23legend drug, without reference to a specific patient, by directing a licensed dietitian or
33.24licensed nutritionist, pursuant to section
33.25subdivisions 8 and 9; physician assistant; medical student or resident; or pharmacist
33.26according to section 151.01, subdivision 27, to adhere to a particular practice guideline or
33.27protocol when treating patients whose condition falls within such guideline or protocol,
33.28and when such guideline or protocol specifies the circumstances under which the legend
33.29drug is to be prescribed and administered. An individual who verbally, electronically, or
33.30otherwise transmits a written, oral, or electronic order, as an agent of a prescriber, shall
33.31not be deemed to have prescribed the legend drug. This paragraph applies to a physician
33.32assistant only if the physician assistant meets the requirements of section
33.33(b) The commissioner of health, if a licensed practitioner, or a person designated
33.34by the commissioner who is a licensed practitioner, may prescribe a legend drug to an
33.35individual or by protocol for mass dispensing purposes where the commissioner finds that
34.1the conditions triggering section
34.2The commissioner, if a licensed practitioner, or a designated licensed practitioner, may
34.3prescribe, dispense, or administer a legend drug or other substance listed in subdivision 10
34.4to control tuberculosis and other communicable diseases. The commissioner may modify
34.5state drug labeling requirements, and medical screening criteria and documentation, where
34.6time is critical and limited labeling and screening are most likely to ensure legend drugs
34.7reach the maximum number of persons in a timely fashion so as to reduce morbidity
34.8and mortality.
34.9 (c) A licensed practitioner that dispenses for profit a legend drug that is to be
34.10administered orally, is ordinarily dispensed by a pharmacist, and is not a vaccine, must
34.11file with the practitioner's licensing board a statement indicating that the practitioner
34.12dispenses legend drugs for profit, the general circumstances under which the practitioner
34.13dispenses for profit, and the types of legend drugs generally dispensed. It is unlawful to
34.14dispense legend drugs for profit after July 31, 1990, unless the statement has been filed
34.15with the appropriate licensing board. For purposes of this paragraph, "profit" means (1)
34.16any amount received by the practitioner in excess of the acquisition cost of a legend drug
34.17for legend drugs that are purchased in prepackaged form, or (2) any amount received
34.18by the practitioner in excess of the acquisition cost of a legend drug plus the cost of
34.19making the drug available if the legend drug requires compounding, packaging, or other
34.20treatment. The statement filed under this paragraph is public data under section
34.21This paragraph does not apply to a licensed doctor of veterinary medicine or a registered
34.22pharmacist. Any person other than a licensed practitioner with the authority to prescribe,
34.23dispense, and administer a legend drug under paragraph (a) shall not dispense for profit.
34.24To dispense for profit does not include dispensing by a community health clinic when the
34.25profit from dispensing is used to meet operating expenses.
34.26 (d) A prescription
34.27be established that the prescription
34.28evaluation, including an examination, adequate to establish a diagnosis and identify
34.29underlying conditions and contraindications to treatment:
34.30 (1) controlled substance drugs listed in section
34.31 (2) drugs defined by the Board of Pharmacy as controlled substances under section
34.33 (3) muscle relaxants;
34.34 (4) centrally acting analgesics with opioid activity;
34.35 (5) drugs containing butalbital; or
34.36 (6) phoshodiesterase type 5 inhibitors when used to treat erectile dysfunction.
35.1 (e) For the purposes of paragraph (d), the requirement for an examination shall be
35.2met if an in-person examination has been completed in any of the following circumstances:
35.3 (1) the prescribing practitioner examines the patient at the time the prescription
35.4or drug order is issued;
35.5 (2) the prescribing practitioner has performed a prior examination of the patient;
35.6 (3) another prescribing practitioner practicing within the same group or clinic as the
35.7prescribing practitioner has examined the patient;
35.8 (4) a consulting practitioner to whom the prescribing practitioner has referred the
35.9patient has examined the patient; or
35.10 (5) the referring practitioner has performed an examination in the case of a
35.11consultant practitioner issuing a prescription or drug order when providing services by
35.12means of telemedicine.
35.13 (f) Nothing in paragraph (d) or (e) prohibits a licensed practitioner from prescribing
35.14a drug through the use of a guideline or protocol pursuant to paragraph (a).
35.15 (g) Nothing in this chapter prohibits a licensed practitioner from issuing a
35.16prescription or dispensing a legend drug in accordance with the Expedited Partner Therapy
35.17in the Management of Sexually Transmitted Diseases guidance document issued by the
35.18United States Centers for Disease Control.
35.19 (h) Nothing in paragraph (d) or (e) limits prescription, administration, or dispensing
35.20of legend drugs through a public health clinic or other distribution mechanism approved
35.21by the commissioner of health or a board of health in order to prevent, mitigate, or treat
35.22a pandemic illness, infectious disease outbreak, or intentional or accidental release of a
35.23biological, chemical, or radiological agent.
35.24 (i) No pharmacist employed by, under contract to, or working for a pharmacy
35.25licensed under section
35.26prescription that the pharmacist knows, or would reasonably be expected to know, is not
35.27valid under paragraph (d).
35.28 (j) No pharmacist employed by, under contract to, or working for a pharmacy
35.29licensed under section
35.30of this state based on a prescription that the pharmacist knows, or would reasonably be
35.31expected to know, is not valid under paragraph (d).
35.32(k) Nothing in this chapter prohibits the commissioner of health, if a licensed
35.33practitioner, or, if not a licensed practitioner, a designee of the commissioner who is
35.34a licensed practitioner, from prescribing legend drugs for field-delivered therapy in the
35.35treatment of a communicable disease according to the Centers For Disease Control and
35.36Prevention Partner Services Guidelines.
36.1 Subd. 2a. Delegation. A supervising physician may delegate to a physician assistant
36.2who is registered with the Board of Medical Practice and certified by the National
36.3Commission on Certification of Physician Assistants and who is under the supervising
36.4physician's supervision, the authority to prescribe, dispense, and administer legend drugs
36.5and medical devices, subject to the requirements in chapter 147A and other requirements
36.6established by the Board of Medical Practice in rules.
36.7 Subd. 3. Veterinarians. A licensed doctor of veterinary medicine, in the course of
36.8professional practice only and not for use by a human being, may personally prescribe,
36.9administer, and dispense a legend drug, and may cause the same to be administered or
36.10dispensed by an assistant under the doctor's direction and supervision.
36.11 Subd. 4. Research. (a) Any qualified person may use legend drugs in the course
36.12of a bona fide research project, but cannot administer or dispense such drugs to human
36.13beings unless such drugs are prescribed, dispensed, and administered by a person lawfully
36.14authorized to do so.
36.15 (b) Drugs may be dispensed or distributed by a pharmacy licensed by the board for
36.16use by, or administration to, patients enrolled in a bona fide research study that is being
36.17conducted pursuant to either an investigational new drug application approved by the
36.18United States Food and Drug Administration or that has been approved by an institutional
36.19review board. For the purposes of this subdivision only:
36.20 (1) a prescription drug order is not required for a pharmacy to dispense a research
36.21drug, unless the study protocol requires the pharmacy to receive such an order;
36.22 (2) notwithstanding the prescription labeling requirements found in this chapter or
36.23the rules promulgated by the board, a research drug may be labeled as required by the
36.24study protocol;
36.25 (3) dispensing and distribution of research drugs by pharmacies shall not be
36.26considered
36.27(4) a pharmacy may compound drugs for research studies as provided in
36.28this subdivision but must follow applicable standards established by United States
36.29Pharmacopeia, chapter 795 or 797, for nonsterile and sterile compounding, respectively.
36.30 (c) An entity that is under contract to a federal agency for the purpose of distributing
36.31drugs for bona fide research studies is exempt from the drug wholesaler licensing
36.32requirements of this chapter. Any other entity is exempt from the drug wholesaler
36.33licensing requirements of this chapter if the board finds that the entity is licensed or
36.34registered according to the laws of the state in which it is physically located and it is
36.35distributing drugs for use by, or administration to, patients enrolled in a bona fide research
36.36study that is being conducted pursuant to either an investigational new drug application
37.1approved by the United States Food and Drug Administration or that has been approved
37.2by an institutional review board.
37.3 Subd. 5. Exclusion for course of practice. Nothing in this chapter shall prohibit
37.4the sale to, or the possession of, a legend drug by licensed drug wholesalers, licensed
37.5manufacturers, registered pharmacies, local detoxification centers, licensed hospitals,
37.6bona fide hospitals wherein animals are treated, or licensed pharmacists and licensed
37.7practitioners while acting within the course of their practice only.
37.8 Subd. 6. Exclusion for course of employment. (a) Nothing in this chapter shall
37.9prohibit the possession of a legend drug by an employee, agent, or sales representative of
37.10a registered drug manufacturer, or an employee or agent of a registered drug wholesaler,
37.11or registered pharmacy, while acting in the course of employment.
37.12(b) Nothing in this chapter shall prohibit the following entities from possessing a
37.13legend drug for the purpose of disposing of the legend drug as pharmaceutical waste:
37.14(1) a law enforcement officer;
37.15(2) a hazardous waste transporter licensed by the Department of Transportation;
37.16(3) a facility permitted by the Pollution Control Agency to treat, store, or dispose of
37.17hazardous waste, including household hazardous waste;
37.18(4) a facility licensed by the Pollution Control Agency or a metropolitan county as a
37.19very small quantity generator collection program or a minimal generator;
37.20(5) a county that collects, stores, transports, or disposes of a legend drug pursuant to
37.21a program in compliance with applicable federal law or a person authorized by the county
37.22to conduct one or more of these activities; or
37.23(6) a sanitary district organized under chapter 115, or a special law.
37.24 Subd. 7. Exclusion for prescriptions. (a) Nothing in this chapter shall prohibit the
37.25possession of a legend drug by a person for that person's use when it has been dispensed to
37.26the person in accordance with a valid prescription issued by a practitioner.
37.27(b) Nothing in this chapter shall prohibit a person, for whom a legend drug has
37.28been dispensed in accordance with a written or oral prescription by a practitioner, from
37.29designating a family member, caregiver, or other individual to handle the legend drug for
37.30the purpose of assisting the person in obtaining or administering the drug or sending
37.31the drug for destruction.
37.32(c) Nothing in this chapter shall prohibit a person for whom a prescription drug has
37.33been dispensed in accordance with a valid prescription issued by a practitioner from
37.34transferring the legend drug to a county that collects, stores, transports, or disposes of a
37.35legend drug pursuant to a program in compliance with applicable federal law or to a
37.36person authorized by the county to conduct one or more of these activities.
38.1 Subd. 8. Misrepresentation. It is unlawful for a person to procure, attempt to
38.2procure, possess, or control a legend drug by any of the following means:
38.3(1) deceit, misrepresentation, or subterfuge;
38.4(2) using a false name; or
38.5(3) falsely assuming the title of, or falsely representing a person to be a manufacturer,
38.6wholesaler, pharmacist, practitioner, or other authorized person for the purpose of
38.7obtaining a legend drug.
38.8 Subd. 9. Exclusion for course of laboratory employment. Nothing in this chapter
38.9shall prohibit the possession of a legend drug by an employee or agent of a registered
38.10analytical laboratory while acting in the course of laboratory employment.
38.11 Subd. 10. Purchase of drugs and other agents by commissioner of health. The
38.12commissioner of health, in preparation for and in carrying out the duties of sections
38.14drugs, biologics, vaccines, antitoxins, serums, immunizing agents, antibiotics, antivirals,
38.15antidotes, other pharmaceutical agents, and medical supplies to treat and prevent
38.16communicable disease.
38.17 Subd. 10a. Emergency use authorizations. Nothing in this chapter shall prohibit
38.18the purchase, possession, or use of a legend drug by an entity acting according to an
38.19emergency use authorization issued by the United States Food and Drug Administration
38.20pursuant to United States Code, title 21, section 360.bbb-3. The entity must be specifically
38.21tasked in a public health response plan to perform critical functions necessary to support
38.22the response to a public health incident or event.
38.23 Subd. 11.
38.24
38.25
38.26
38.27postsecondary school from possessing a legend drug that is not a controlled substance
38.28listed in section 152.02, provided that:
38.29(a) the school is approved by the United States secretary of education in accordance
38.30with requirements of the Higher Education Act of 1965, as amended;
38.31(b) the school provides a course of instruction that prepares individuals for
38.32employment in a health care occupation or profession;
38.33(c) the school may only possess those drugs necessary for the instruction of such
38.34individuals; and
38.35(d) the drugs may only be used in the course of providing such instruction and are
38.36labeled by the purchaser to indicate that they are not to be administered to patients.
39.1Those areas of the school in which legend drugs are stored are subject to section
39.2151.06, subdivision 1, paragraph (a), clause (4).
39.3 Sec. 16. Minnesota Statutes 2012, section 151.44, is amended to read:
39.4151.44 DEFINITIONS.
39.5As used in sections
39.6in paragraphs (a) to (h):
39.7(a) "Wholesale drug distribution" means distribution of prescription or
39.8nonprescription drugs to persons other than a consumer or patient or reverse distribution
39.9of such drugs, but does not include:
39.10(1) a sale between a division, subsidiary, parent, affiliated, or related company under
39.11the common ownership and control of a corporate entity;
39.12(2) the purchase or other acquisition, by a hospital or other health care entity that is a
39.13member of a group purchasing organization, of a drug for its own use from the organization
39.14or from other hospitals or health care entities that are members of such organizations;
39.15(3) the sale, purchase, or trade of a drug or an offer to sell, purchase, or trade a
39.16drug by a charitable organization described in section 501(c)(3) of the Internal Revenue
39.17Code of 1986, as amended through December 31, 1988, to a nonprofit affiliate of the
39.18organization to the extent otherwise permitted by law;
39.19(4) the sale, purchase, or trade of a drug or offer to sell, purchase, or trade a drug
39.20among hospitals or other health care entities that are under common control;
39.21(5) the sale, purchase, or trade of a drug or offer to sell, purchase, or trade a drug
39.22for emergency medical reasons;
39.23(6) the sale, purchase, or trade of a drug, an offer to sell, purchase, or trade a drug, or
39.24the dispensing of a drug pursuant to a prescription;
39.25(7) the transfer of prescription or nonprescription drugs by a retail pharmacy to
39.26another retail pharmacy to alleviate a temporary shortage;
39.27(8) the distribution of prescription or nonprescription drug samples by manufacturers
39.28representatives; or
39.29(9) the sale, purchase, or trade of blood and blood components.
39.30(b) "Wholesale drug distributor" means anyone engaged in wholesale drug
39.31distribution including, but not limited to, manufacturers;
39.32distributors; jobbers; brokers; warehouses, including manufacturers' and distributors'
39.33warehouses, chain drug warehouses, and wholesale drug warehouses; independent
39.34wholesale drug traders; and pharmacies that conduct wholesale drug distribution. A
40.1wholesale drug distributor does not include a common carrier or individual hired primarily
40.2to transport prescription or nonprescription drugs.
40.3(c) "Manufacturer"
40.4
40.5
40.6(d) "Prescription drug" means a drug required by federal or state law or regulation
40.7to be dispensed only by a prescription, including finished dosage forms and active
40.8ingredients subject to United States Code, title 21, sections 811 and 812.
40.9(e) "Blood" means whole blood collected from a single donor and processed either
40.10for transfusion or further manufacturing.
40.11(f) "Blood components" means that part of blood separated by physical or
40.12mechanical means.
40.13(g) "Reverse distribution" means the receipt of prescription or nonprescription drugs
40.14received from or shipped to Minnesota locations for the purpose of returning the drugs
40.15to their producers or distributors.
40.16(h) "Reverse distributor" means a person engaged in the reverse distribution of drugs.
40.17 Sec. 17. Minnesota Statutes 2012, section 151.58, subdivision 2, is amended to read:
40.18 Subd. 2. Definitions. For purposes of this section only, the terms defined in this
40.19subdivision have the meanings given.
40.20(a) "Automated drug distribution system" or "system" means a mechanical system
40.21approved by the board that performs operations or activities, other than compounding or
40.22administration, related to the storage, packaging, or dispensing of drugs, and collects,
40.23controls, and maintains all required transaction information and records.
40.24(b) "Health care facility" means a nursing home licensed under section
40.25a housing with services establishment registered under section
40.26in which a home provider licensed under chapter 144A is providing centralized storage
40.27of medications; or a
40.28program facility operated by the Department of Human Services.
40.29(c) "Managing pharmacy" means a pharmacy licensed by the board that controls and
40.30is responsible for the operation of an automated drug distribution system.
40.31 Sec. 18. Minnesota Statutes 2012, section 151.58, subdivision 3, is amended to read:
40.32 Subd. 3. Authorization. A pharmacy may use an automated drug distribution
40.33system to fill prescription drug orders for patients of a health care facility provided that the
40.34policies and procedures required by this section have been approved by the board. The
41.1automated drug distribution system may be located in a health care facility that is not at
41.2the same location as the managing pharmacy. When located within a health care facility,
41.3the system is considered to be an extension of the managing pharmacy.
41.4 Sec. 19. Minnesota Statutes 2012, section 151.58, subdivision 5, is amended to read:
41.5 Subd. 5. Operation of automated drug distribution systems. (a) The managing
41.6pharmacy and the pharmacist in charge are responsible for the operation of an automated
41.7drug distribution system.
41.8(b) Access to an automated drug distribution system must be limited to pharmacy
41.9and nonpharmacy personnel authorized to procure drugs from the system, except that field
41.10service technicians may access a system located in a health care facility for the purposes of
41.11servicing and maintaining it while being monitored either by the managing pharmacy, or a
41.12licensed nurse within the health care facility. In the case of an automated drug distribution
41.13system that is not physically located within a licensed pharmacy, access for the purpose
41.14of procuring drugs shall be limited to licensed nurses. Each person authorized to access
41.15the system must be assigned an individual specific access code. Alternatively, access to
41.16the system may be controlled through the use of biometric identification procedures. A
41.17policy specifying time access parameters, including time-outs, logoffs, and lockouts,
41.18must be in place.
41.19(c) For the purposes of this section only, the requirements of section
41.20if the following clauses are met:
41.21(1) a pharmacist employed by and working at the managing pharmacy, or at a
41.22pharmacy that is acting as a central services pharmacy for the managing pharmacy,
41.23pursuant to Minnesota Rules, part 6800.4075, must review, interpret, and approve all
41.24prescription drug orders before any drug is distributed from the system to be administered
41.25to a patient. A pharmacy technician may perform data entry of prescription drug orders
41.26provided that a pharmacist certifies the accuracy of the data entry before the drug can
41.27be released from the automated drug distribution system. A pharmacist employed by
41.28and working at the managing pharmacy must certify the accuracy of the filling of any
41.29cassettes, canisters, or other containers that contain drugs that will be loaded into the
41.30automated drug distribution system; and
41.31(2) when the automated drug dispensing system is located and used within the
41.32managing pharmacy, a pharmacist must personally supervise and take responsibility for all
41.33packaging and labeling associated with the use of an automated drug distribution system.
41.34(d) Access to drugs when a pharmacist has not reviewed and approved the
41.35prescription drug order is permitted only when a formal and written decision to allow such
42.1access is issued by the pharmacy and the therapeutics committee or its equivalent. The
42.2committee must specify the patient care circumstances in which such access is allowed,
42.3the drugs that can be accessed, and the staff that are allowed to access the drugs.
42.4(e) In the case of an automated drug distribution system that does not utilize bar
42.5coding in the loading process, the loading of a system located in a health care facility may
42.6be performed by a pharmacy technician, so long as the activity is continuously supervised,
42.7through a two-way audiovisual system by a pharmacist on duty within the managing
42.8pharmacy. In the case of an automated drug distribution system that utilizes bar coding
42.9in the loading process, the loading of a system located in a health care facility may be
42.10performed by a pharmacy technician or a licensed nurse, provided that the managing
42.11pharmacy retains an electronic record of loading activities.
42.12(f) The automated drug distribution system must be under the supervision of a
42.13pharmacist. The pharmacist is not required to be physically present at the site of the
42.14automated drug distribution system if the system is continuously monitored electronically
42.15by the managing pharmacy. A pharmacist on duty within a pharmacy licensed by the
42.16board must be continuously available to address any problems detected by the monitoring
42.17or to answer questions from the staff of the health care facility. The licensed pharmacy
42.18may be the managing pharmacy or a pharmacy which is acting as a central services
42.19pharmacy, pursuant to Minnesota Rules, part 6800.4075, for the managing pharmacy.
42.20 Sec. 20. Minnesota Statutes 2013 Supplement, section 152.02, subdivision 2, is
42.21amended to read:
42.22 Subd. 2. Schedule I. (a) Schedule I consists of the substances listed in this
42.23subdivision.
42.24(b) Opiates. Unless specifically excepted or unless listed in another schedule, any of
42.25the following substances, including their analogs, isomers, esters, ethers, salts, and salts
42.26of isomers, esters, and ethers, whenever the existence of the analogs, isomers, esters,
42.27ethers, and salts is possible:
42.28(1) acetylmethadol;
42.29(2) allylprodine;
42.30(3) alphacetylmethadol (except levo-alphacetylmethadol, also known as
42.31levomethadyl acetate);
42.32(4) alphameprodine;
42.33(5) alphamethadol;
42.34(6) alpha-methylfentanyl benzethidine;
42.35(7) betacetylmethadol;
43.1(8) betameprodine;
43.2(9) betamethadol;
43.3(10) betaprodine;
43.4(11) clonitazene;
43.5(12) dextromoramide;
43.6(13) diampromide;
43.7(14) diethyliambutene;
43.8(15) difenoxin;
43.9(16) dimenoxadol;
43.10(17) dimepheptanol;
43.11(18) dimethyliambutene;
43.12(19) dioxaphetyl butyrate;
43.13(20) dipipanone;
43.14(21) ethylmethylthiambutene;
43.15(22) etonitazene;
43.16(23) etoxeridine;
43.17(24) furethidine;
43.18(25) hydroxypethidine;
43.19(26) ketobemidone;
43.20(27) levomoramide;
43.21(28) levophenacylmorphan;
43.22(29) 3-methylfentanyl;
43.23(30) acetyl-alpha-methylfentanyl;
43.24(31) alpha-methylthiofentanyl;
43.25(32) benzylfentanyl beta-hydroxyfentanyl;
43.26(33) beta-hydroxy-3-methylfentanyl;
43.27(34) 3-methylthiofentanyl;
43.28(35) thenylfentanyl;
43.29(36) thiofentanyl;
43.30(37) para-fluorofentanyl;
43.31(38) morpheridine;
43.32(39) 1-methyl-4-phenyl-4-propionoxypiperidine;
43.33(40) noracymethadol;
43.34(41) norlevorphanol;
43.35(42) normethadone;
43.36(43) norpipanone;
44.1(44) 1-(2-phenylethyl)-4-phenyl-4-acetoxypiperidine (PEPAP);
44.2(45) phenadoxone;
44.3(46) phenampromide;
44.4(47) phenomorphan;
44.5(48) phenoperidine;
44.6(49) piritramide;
44.7(50) proheptazine;
44.8(51) properidine;
44.9(52) propiram;
44.10(53) racemoramide;
44.11(54) tilidine;
44.12(55) trimeperidine
44.13(56) N-(1-Phenethylpiperidin-4-yl)-N-phenylacetamide (acetyl fentanyl).
44.14(c) Opium derivatives. Any of the following substances, their analogs, salts, isomers,
44.15and salts of isomers, unless specifically excepted or unless listed in another schedule,
44.16whenever the existence of the analogs, salts, isomers, and salts of isomers is possible:
44.17(1) acetorphine;
44.18(2) acetyldihydrocodeine;
44.19(3) benzylmorphine;
44.20(4) codeine methylbromide;
44.21(5) codeine-n-oxide;
44.22(6) cyprenorphine;
44.23(7) desomorphine;
44.24(8) dihydromorphine;
44.25(9) drotebanol;
44.26(10) etorphine;
44.27(11) heroin;
44.28(12) hydromorphinol;
44.29(13) methyldesorphine;
44.30(14) methyldihydromorphine;
44.31(15) morphine methylbromide;
44.32(16) morphine methylsulfonate;
44.33(17) morphine-n-oxide;
44.34(18) myrophine;
44.35(19) nicocodeine;
44.36(20) nicomorphine;
45.1(21) normorphine;
45.2(22) pholcodine;
45.3(23) thebacon.
45.4(d) Hallucinogens. Any material, compound, mixture or preparation which contains
45.5any quantity of the following substances, their analogs, salts, isomers (whether optical,
45.6positional, or geometric), and salts of isomers, unless specifically excepted or unless listed
45.7in another schedule, whenever the existence of the analogs, salts, isomers, and salts of
45.8isomers is possible:
45.9(1) methylenedioxy amphetamine;
45.10(2) methylenedioxymethamphetamine;
45.11(3) methylenedioxy-N-ethylamphetamine (MDEA);
45.12(4) n-hydroxy-methylenedioxyamphetamine;
45.13(5) 4-bromo-2,5-dimethoxyamphetamine (DOB);
45.14(6) 2,5-dimethoxyamphetamine (2,5-DMA);
45.15(7) 4-methoxyamphetamine;
45.16(8) 5-methoxy-3, 4-methylenedioxy amphetamine;
45.17(9) alpha-ethyltryptamine;
45.18(10) bufotenine;
45.19(11) diethyltryptamine;
45.20(12) dimethyltryptamine;
45.21(13) 3,4,5-trimethoxy amphetamine;
45.22(14) 4-methyl-2, 5-dimethoxyamphetamine (DOM);
45.23(15) ibogaine;
45.24(16) lysergic acid diethylamide (LSD);
45.25(17) mescaline;
45.26(18) parahexyl;
45.27(19) N-ethyl-3-piperidyl benzilate;
45.28(20) N-methyl-3-piperidyl benzilate;
45.29(21) psilocybin;
45.30(22) psilocyn;
45.31(23) tenocyclidine (TPCP or TCP);
45.32(24) N-ethyl-1-phenyl-cyclohexylamine (PCE);
45.33(25) 1-(1-phenylcyclohexyl) pyrrolidine (PCPy);
45.34(26) 1-[1-(2-thienyl)cyclohexyl]-pyrrolidine (TCPy);
45.35(27) 4-chloro-2,5-dimethoxyamphetamine (DOC);
45.36(28) 4-ethyl-2,5-dimethoxyamphetamine (DOET);
46.1(29) 4-iodo-2,5-dimethoxyamphetamine (DOI);
46.2(30) 4-bromo-2,5-dimethoxyphenethylamine (2C-B);
46.3(31) 4-chloro-2,5-dimethoxyphenethylamine (2C-C);
46.4(32) 4-methyl-2,5-dimethoxyphenethylamine (2-CD);
46.5(33) 4-ethyl-2,5-dimethoxyphenethylamine (2C-E);
46.6(34) 4-iodo-2,5-dimethoxyphenethylamine (2C-I);
46.7(35) 4-propyl-2,5-dimethoxyphenethylamine (2C-P);
46.8(36) 4-isopropylthio-2,5-dimethoxyphenethylamine (2C-T-4);
46.9(37) 4-propylthio-2,5-dimethoxyphenethylamine (2C-T-7);
46.10(38) 2-(8-bromo-2,3,6,7-tetrahydrofuro [2,3-f][1]benzofuran-4-yl)ethanamine
46.11(2-CB-FLY);
46.12(39) bromo-benzodifuranyl-isopropylamine (Bromo-DragonFLY);
46.13(40) alpha-methyltryptamine (AMT);
46.14(41) N,N-diisopropyltryptamine (DiPT);
46.15(42) 4-acetoxy-N,N-dimethyltryptamine (4-AcO-DMT);
46.16(43) 4-acetoxy-N,N-diethyltryptamine (4-AcO-DET);
46.17(44) 4-hydroxy-N-methyl-N-propyltryptamine (4-HO-MPT);
46.18(45) 4-hydroxy-N,N-dipropyltryptamine (4-HO-DPT);
46.19(46) 4-hydroxy-N,N-diallyltryptamine (4-HO-DALT);
46.20(47) 4-hydroxy-N,N-diisopropyltryptamine (4-HO-DiPT);
46.21(48) 5-methoxy-N,N-diisopropyltryptamine (5-MeO-DiPT);
46.22(49) 5-methoxy-α-methyltryptamine (5-MeO-AMT);
46.23(50) 5-methoxy-N,N-dimethyltryptamine (5-MeO-DMT);
46.24(51) 5-methylthio-N,N-dimethyltryptamine (5-MeS-DMT);
46.25(52) 5-methoxy-N-methyl-N-propyltryptamine (5-MeO-MiPT);
46.26(53) 5-methoxy-α-ethyltryptamine (5-MeO-AET);
46.27(54) 5-methoxy-N,N-dipropyltryptamine (5-MeO-DPT);
46.28(55) 5-methoxy-N,N-diethyltryptamine (5-MeO-DET);
46.29(56) 5-methoxy-N,N-diallytryptamine (5-MeO-DALT);
46.30(57) methoxetamine (MXE);
46.31(58) 5-iodo-2-aminoindane (5-IAI);
46.32(59) 5,6-methylenedioxy-2-aminoindane (MDAI);
46.33(60) 2-(4-iodo-2,5-dimethoxyphenyl)-N-[(2-methoxyphenyl)methyl]ethanamine
46.34(25I-NBOMe).
46.35(e) Peyote. All parts of the plant presently classified botanically as Lophophora
46.36williamsii Lemaire, whether growing or not, the seeds thereof, any extract from any part
47.1of the plant, and every compound, manufacture, salts, derivative, mixture, or preparation
47.2of the plant, its seeds or extracts. The listing of peyote as a controlled substance in
47.3Schedule I does not apply to the nondrug use of peyote in bona fide religious ceremonies
47.4of the American Indian Church, and members of the American Indian Church are exempt
47.5from registration. Any person who manufactures peyote for or distributes peyote to the
47.6American Indian Church, however, is required to obtain federal registration annually and
47.7to comply with all other requirements of law.
47.8(f) Central nervous system depressants. Unless specifically excepted or unless listed
47.9in another schedule, any material compound, mixture, or preparation which contains any
47.10quantity of the following substances, their analogs, salts, isomers, and salts of isomers
47.11whenever the existence of the analogs, salts, isomers, and salts of isomers is possible:
47.12(1) mecloqualone;
47.13(2) methaqualone;
47.14(3) gamma-hydroxybutyric acid (GHB), including its esters and ethers;
47.15(4) flunitrazepam.
47.16(g) Stimulants. Unless specifically excepted or unless listed in another schedule, any
47.17material compound, mixture, or preparation which contains any quantity of the following
47.18substances, their analogs, salts, isomers, and salts of isomers whenever the existence of
47.19the analogs, salts, isomers, and salts of isomers is possible:
47.20 (1) aminorex;
47.21(2) cathinone;
47.22(3) fenethylline;
47.23 (4) methcathinone;
47.24(5) methylaminorex;
47.25(6) N,N-dimethylamphetamine;
47.26(7) N-benzylpiperazine (BZP);
47.27(8) methylmethcathinone (mephedrone);
47.28(9) 3,4-methylenedioxy-N-methylcathinone (methylone);
47.29(10) methoxymethcathinone (methedrone);
47.30(11) methylenedioxypyrovalerone (MDPV);
47.31(12) fluoromethcathinone;
47.32(13) methylethcathinone (MEC);
47.33(14) 1-benzofuran-6-ylpropan-2-amine (6-APB);
47.34(15) dimethylmethcathinone (DMMC);
47.35(16) fluoroamphetamine;
47.36(17) fluoromethamphetamine;
48.1(18) α-methylaminobutyrophenone (MABP or buphedrone);
48.2(19) β-keto-N-methylbenzodioxolylpropylamine (bk-MBDB or butylone);
48.3(20) 2-(methylamino)-1-(4-methylphenyl)butan-1-one (4-MEMABP or BZ-6378);
48.4(21) naphthylpyrovalerone (naphyrone);
48.5(22) (RS)-1-phenyl-2-(1-pyrrolidinyl)-1-pentanone (alpha-PVP or
48.6alpha-pyrrolidinovalerophenone;
48.7(23) (RS)-1-(4-methylphenyl)-2-(1-pyrrolidinyl)-1-hexanone (4-Me-PHP oe
48.8MPHP); and
48.9
48.10different schedule, that is structurally derived from 2-aminopropan-1-one by substitution
48.11at the 1-position with either phenyl, naphthyl, or thiophene ring systems, whether or not
48.12the compound is further modified in any of the following ways:
48.13(i) by substitution in the ring system to any extent with alkyl, alkylenedioxy, alkoxy,
48.14haloalkyl, hydroxyl, or halide substituents, whether or not further substituted in the ring
48.15system by one or more other univalent substituents;
48.16(ii) by substitution at the 3-position with an acyclic alkyl substituent;
48.17(iii) by substitution at the 2-amino nitrogen atom with alkyl, dialkyl, benzyl, or
48.18methoxybenzyl groups; or
48.19(iv) by inclusion of the 2-amino nitrogen atom in a cyclic structure.
48.20(h) Marijuana, tetrahydrocannabinols, and synthetic cannabinoids. Unless
48.21specifically excepted or unless listed in another schedule, any natural or synthetic material,
48.22compound, mixture, or preparation that contains any quantity of the following substances,
48.23their analogs, isomers, esters, ethers, salts, and salts of isomers, esters, and ethers,
48.24whenever the existence of the isomers, esters, ethers, or salts is possible:
48.25(1) marijuana;
48.26(2) tetrahydrocannabinols naturally contained in a plant of the genus Cannabis,
48.27synthetic equivalents of the substances contained in the cannabis plant or in the
48.28resinous extractives of the plant, or synthetic substances with similar chemical structure
48.29and pharmacological activity to those substances contained in the plant or resinous
48.30extract, including, but not limited to, 1 cis or trans tetrahydrocannabinol, 6 cis or trans
48.31tetrahydrocannabinol, and 3,4 cis or trans tetrahydrocannabinol;
48.32(3) synthetic cannabinoids, including the following substances:
48.33(i) Naphthoylindoles, which are any compounds containing a 3-(1-napthoyl)indole
48.34structure with substitution at the nitrogen atom of the indole ring by an alkyl, haloalkyl,
48.35alkenyl, cycloalkylmethyl, cycloalkylethyl, 1-(N-methyl-2-piperidinyl)methyl or
48.362-(4-morpholinyl)ethyl group, whether or not further substituted in the indole ring to any
49.1extent and whether or not substituted in the naphthyl ring to any extent. Examples of
49.2naphthoylindoles include, but are not limited to:
49.3(A) 1-Pentyl-3-(1-naphthoyl)indole (JWH-018 and AM-678);
49.4(B) 1-Butul-3-(1-naphthoyl)indole (JWH-073);
49.5(C) 1-Pentyl-3-(4-methoxy-1-naphthoyl)indole (JWH-081);
49.6(D) 1-[2-(4-morpholinyl)ethyl]-3-(1-naphthoyl)indole (JWH-200);
49.7(E) 1-Propyl-2-methyl-3-(1-naphthoyl)indole (JWH-015);
49.8(F) 1-Hexyl-3-(1-naphthoyl)indole (JWH-019);
49.9(G) 1-Pentyl-3-(4-methyl-1-naphthoyl)indole (JWH-122);
49.10(H) 1-Pentyl-3-(4-ethyl-1-naphthoyl)indole (JWH-210);
49.11(I) 1-Pentyl-3-(4-chloro-1-naphthoyl)indole (JWH-398);
49.12(J) 1-(5-fluoropentyl)-3-(1-naphthoyl)indole (AM-2201).
49.13(ii) Napthylmethylindoles, which are any compounds containing a
49.141H-indol-3-yl-(1-naphthyl)methane structure with substitution at the nitrogen atom
49.15of the indole ring by an alkyl, haloalkyl, alkenyl, cycloalkylmethyl, cycloalkylethyl,
49.161-(N-methyl-2-piperidinyl)methyl or 2-(4-morpholinyl)ethyl group, whether or not further
49.17substituted in the indole ring to any extent and whether or not substituted in the naphthyl
49.18ring to any extent. Examples of naphthylmethylindoles include, but are not limited to:
49.19(A) 1-Pentyl-1H-indol-3-yl-(1-naphthyl)methane (JWH-175);
49.20(B) 1-Pentyl-1H-indol-3-yl-(4-methyl-1-naphthyl)methan (JWH-184).
49.21(iii) Naphthoylpyrroles, which are any compounds containing a
49.223-(1-naphthoyl)pyrrole structure with substitution at the nitrogen atom of the
49.23pyrrole ring by an alkyl, haloalkyl, alkenyl, cycloalkylmethyl, cycloalkylethyl,
49.241-(N-methyl-2-piperidinyl)methyl or 2-(4-morpholinyl)ethyl group whether or not
49.25further substituted in the pyrrole ring to any extent, whether or not substituted in the
49.26naphthyl ring to any extent. Examples of naphthoylpyrroles include, but are not limited to,
49.27(5-(2-fluorophenyl)-1-pentylpyrrol-3-yl)-naphthalen-1-ylmethanone (JWH-307).
49.28(iv) Naphthylmethylindenes, which are any compounds containing a
49.29naphthylideneindene structure with substitution at the 3-position of the indene
49.30ring by an allkyl, haloalkyl, alkenyl, cycloalkylmethyl, cycloalkylethyl,
49.311-(N-methyl-2-piperidinyl)methyl or 2-(4-morpholinyl)ethyl group whether or not further
49.32substituted in the indene ring to any extent, whether or not substituted in the naphthyl
49.33ring to any extent. Examples of naphthylemethylindenes include, but are not limited to,
49.34E-1-[1-(1-naphthalenylmethylene)-1H-inden-3-yl]pentane (JWH-176).
49.35(v) Phenylacetylindoles, which are any compounds containing a 3-phenylacetylindole
49.36structure with substitution at the nitrogen atom of the indole ring by an alkyl, haloalkyl,
50.1alkenyl, cycloalkylmethyl, cycloalkylethyl, 1-(N-methyl-2-piperidinyl)methyl or
50.22-(4-morpholinyl)ethyl group whether or not further substituted in the indole ring to
50.3any extent, whether or not substituted in the phenyl ring to any extent. Examples of
50.4phenylacetylindoles include, but are not limited to:
50.5(A) 1-(2-cyclohexylethyl)-3-(2-methoxyphenylacetyl)indole (RCS-8);
50.6(B) 1-pentyl-3-(2-methoxyphenylacetyl)indole (JWH-250);
50.7(C) 1-pentyl-3-(2-methylphenylacetyl)indole (JWH-251);
50.8(D) 1-pentyl-3-(2-chlorophenylacetyl)indole (JWH-203).
50.9(vi) Cyclohexylphenols, which are compounds containing a
50.102-(3-hydroxycyclohexyl)phenol structure with substitution at the 5-position
50.11of the phenolic ring by an alkyl, haloalkyl, alkenyl, cycloalkylmethyl, cycloalkylethyl,
50.121-(N-methyl-2-piperidinyl)methyl or 2-(4-morpholinyl)ethyl group whether or not
50.13substituted in the cyclohexyl ring to any extent. Examples of cyclohexylphenols include,
50.14but are not limited to:
50.15(A) 5-(1,1-dimethylheptyl)-2-[(1R,3S)-3-hydroxycyclohexyl]-phenol (CP 47,497);
50.16(B) 5-(1,1-dimethyloctyl)-2-[(1R,3S)-3-hydroxycyclohexyl]-phenol
50.17(Cannabicyclohexanol or CP 47,497 C8 homologue);
50.18(C) 5-(1,1-dimethylheptyl)-2-[(1R,2R)-5-hydroxy-2-(3-hydroxypropyl)cyclohexyl]
50.19-phenol (CP 55,940).
50.20(vii) Benzoylindoles, which are any compounds containing a 3-(benzoyl)indole
50.21structure with substitution at the nitrogen atom of the indole ring by an alkyl, haloalkyl,
50.22alkenyl, cycloalkylmethyl, cycloalkylethyl, 1-(N-methyl-2-piperidinyl)methyl or
50.232-(4-morpholinyl)ethyl group whether or not further substituted in the indole ring to
50.24any extent and whether or not substituted in the phenyl ring to any extent. Examples of
50.25benzoylindoles include, but are not limited to:
50.26(A) 1-Pentyl-3-(4-methoxybenzoyl)indole (RCS-4);
50.27(B) 1-(5-fluoropentyl)-3-(2-iodobenzoyl)indole (AM-694);
50.28(C) (4-methoxyphenyl-[2-methyl-1-(2-(4-morpholinyl)ethyl)indol-3-yl]methanone
50.29(WIN 48,098 or Pravadoline).
50.30(viii) Others specifically named:
50.31(A) (6aR,10aR)-9-(hydroxymethyl)-6,6-dimethyl-3-(2-methyloctan-2-yl)
50.32-6a,7,10,10a-tetrahydrobenzo[c]chromen-1-ol (HU-210);
50.33(B) (6aS,10aS)-9-(hydroxymethyl)-6,6-dimethyl-3-(2-methyloctan-2-yl)
50.34-6a,7,10,10a-tetrahydrobenzo[c]chromen-1-ol (Dexanabinol or HU-211);
50.35(C) 2,3-dihydro-5-methyl-3-(4-morpholinylmethyl)pyrrolo[1,2,3-de]
50.36-1,4-benzoxazin-6-yl-1-naphthalenylmethanone (WIN 55,212-2);
51.1(D) (1-pentylindol-3-yl)-(2,2,3,3-tetramethylcyclopropyl)methanone (UR-144);
51.2(E) (1-(5-fluoropentyl)-1H-indol-3-yl)(2,2,3,3-tetramethylcyclopropyl)methanone
51.3(XLR-11);
51.4(F) 1-pentyl-N-tricyclo[3.3.1.13,7]dec-1-yl-1H-indazole-3-carboxamide
51.5(AKB-48(APINACA));
51.6(G) N-((3s,5s,7s)-adamantan-1-yl)-1-(5-fluoropentyl)-1H-indazole-3-carboxamide
51.7(5-Fluoro-AKB-48);
51.8(H) 1-pentyl-8-quinolinyl ester-1H-indole-3-carboxylic acid (PB-22);
51.9(I) 8-quinolinyl ester-1-(5-fluoropentyl)-1H-indole-3-carboxylic acid (5-Fluoro
51.10PB-22)
51.11(J) N-[(1S)-1-(aminocarbonyl)-2-methylpropyl]-1-pentyl-1H-indazole-
51.123-carboxamide (AB-PINACA);
51.13(K) N-[(1S)-1-(aminocarbonyl)-2-methylpropyl]-1-[(4-fluorophenyl)methyl]-
51.141H-indazole-3-carboxamide (AB-FUBINACA).
51.15(i) A controlled substance analog, to the extent that it is implicitly or explicitly
51.16intended for human consumption.
51.17 Sec. 21. Minnesota Statutes 2012, section 152.02, subdivision 8b, is amended to read:
51.18 Subd. 8b. Board of Pharmacy; expedited scheduling of additional substances.
51.19
51.20it finds that the substance has a high potential for abuse, has no currently accepted medical
51.21use in the United States, has a lack of accepted safety for use under medical supervision,
51.22has known adverse health effects, and is currently available for use within the state. For
51.23the purposes of this subdivision only, the board may use the expedited rulemaking process
51.24under section
51.25
51.26
51.27
51.28
51.29
51.30
51.31
51.32