1.2relating to health; changing licensing requirements for businesses regulated by the
1.3Board of Pharmacy; clarifying requirements for compounding; making changes
1.4to the prescription monitoring program;amending Minnesota Statutes 2012,
1.5sections 151.01, subdivisions 14, 16, 17, 27, 28, 29, 30, by adding subdivisions;
1.6151.19, subdivisions 1, 3; 151.211; 151.361, subdivision 2; 151.37, subdivision 2,
1.7by adding subdivisions; 151.44; 151.47, subdivision 1, by adding a subdivision;
1.8151.49; 152.126; proposing coding for new law in Minnesota Statutes, chapter
1.9151; repealing Minnesota Statutes 2012, sections 151.19, subdivision 2; 151.25;
1.10151.37, subdivision 11; 151.45; 151.47, subdivision 2; 151.48.
1.11BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF MINNESOTA:

1.12    Section 1. Minnesota Statutes 2012, section 151.01, subdivision 14, is amended to read:
1.13    Subd. 14. Manufacturing. The term "Manufacturing" except in the case of bulk
1.14compounding, prepackaging or extemporaneous compounding within a pharmacy, means
1.15and includes the production, quality control and standardization by mechanical, physical,
1.16chemical, or pharmaceutical means, packing, repacking, tableting, encapsulating, labeling,
1.17relabeling, filling or by any other process, of all drugs, medicines, chemicals, or poisons,
1.18without exception, for medicinal purposes preparation, propagation, conversion, or
1.19processing of a drug, either directly or indirectly, by extraction from substances of natural
1.20origin or independently by means of chemical or biological synthesis. Manufacturing
1.21includes the packaging or repackaging of a drug, or the labeling or relabeling of
1.22the container of a drug, for resale by pharmacies, practitioners, or other persons.
1.23Manufacturing does not include the prepackaging, extemporaneous compounding, or bulk
1.24compounding of a drug within a licensed pharmacy, nor the labeling of a container within
1.25a pharmacy for the purpose of dispensing a drug to a patient with a valid prescription.

2.1    Sec. 2. Minnesota Statutes 2012, section 151.01, is amended by adding a subdivision
2.2to read:
2.3    Subd. 13a. Manufacturer. "Manufacturer" means anyone engaged in
2.4manufacturing.

2.5    Sec. 3. Minnesota Statutes 2012, section 151.01, subdivision 16, is amended to read:
2.6    Subd. 16. Prescription drug order. The term "prescription drug order" means a
2.7signed lawful written order, or an oral, or electronic order reduced to writing, given by of
2.8 a practitioner licensed to prescribe drugs for patients in the course of the practitioner's
2.9practice, issued for an individual patient and containing the following: the date of issue,
2.10name and address of the patient, name and quantity of the drug prescribed, directions for
2.11use, and the name and address of the prescriber for a drug for a specific patient.

2.12    Sec. 4. Minnesota Statutes 2012, section 151.01, is amended by adding a subdivision
2.13to read:
2.14    Subd. 16a. Prescription. The term "prescription" means a prescription drug order
2.15that is written or printed on paper, an oral order reduced to writing by a pharmacist, or
2.16an electronic order. To be valid, a prescription must be issued for an individual patient
2.17by a practitioner within the scope and usual course of the practitioner's practice, and
2.18must contain the date of issue, name and address of the patient, name and quality of the
2.19drug prescribed, directions for use, name and address of the practitioner, and telephone
2.20number at which the practitioner can be reached. A prescription written or printed on
2.21paper that is given to the patient or an agent of the patient or transmitted via facsimile
2.22must contain the practitioner's manual signature. An electronic prescription must contain
2.23the practitioner's electronic signature.

2.24    Sec. 5. Minnesota Statutes 2012, section 151.01, is amended by adding a subdivision
2.25to read:
2.26    Subd. 16b. Chart order. The term "chart order" means a prescription drug order
2.27for a drug that is to be dispensed by a pharmacist or pharmacist intern under the direct
2.28supervision of a pharmacist and administered by an authorized person only during the
2.29patient's stay in a hospital or long-term care facility. The chart order shall contain the name
2.30of the patient, another patient identifier such as a birth date or medical record number,
2.31the drug ordered, and any directions the practitioner may prescribe concerning strength,
2.32dosage, frequency, and route of administration. The manual or electronic signature of the
3.1practitioner must be affixed to the chart order at the time it is written, or at a later date in
3.2the case of verbal chart orders.

3.3    Sec. 6. Minnesota Statutes 2012, section 151.01, subdivision 17, is amended to read:
3.4    Subd. 17. Legend drug. "Legend drug" means a drug which that is required by
3.5federal law to bear the following statement, "Caution: Federal law prohibits dispensing
3.6without prescription." be dispensed only pursuant to the prescription of a licensed
3.7practitioner.

3.8    Sec. 7. Minnesota Statutes 2012, section 151.01, subdivision 27, is amended to read:
3.9    Subd. 27. Practice of pharmacy. "Practice of pharmacy" means:
3.10    (1) interpretation and evaluation of prescription drug orders;
3.11    (2) compounding, labeling, and dispensing drugs and devices (except labeling by
3.12a manufacturer or packager of nonprescription drugs or commercially packaged legend
3.13drugs and devices);
3.14    (3) participation in clinical interpretations and monitoring of drug therapy for
3.15assurance of safe and effective use of drugs;
3.16    (4) participation in drug and therapeutic device selection; drug administration for first
3.17dosage and medical emergencies; drug regimen reviews; and drug or drug-related research;
3.18    (5) participation in administration of influenza vaccines to all eligible individuals ten
3.19years of age and older and all other vaccines to patients 18 years of age and older under
3.20standing orders from a physician licensed under chapter 147 or by written protocol with a
3.21physician licensed under chapter 147 provided that:
3.22    (i) the standing orders or protocol include, at a minimum, the name, dosage, and
3.23route of each vaccine that may be given, the patient population for whom the vaccine may
3.24be given, contraindications and precautions to the vaccine, the procedure for handling an
3.25adverse reaction, the name and signature of the physician, the address of the physician, a
3.26phone number at which the physician can be contacted, and the date and time period for
3.27which the standing orders or protocol are valid;
3.28    (i) (ii) the pharmacist is trained in has successfully completed a program approved
3.29by the American Accreditation Council of Pharmaceutical for Pharmacy Education,
3.30specifically for the administration of immunizations, or graduated from a college of
3.31pharmacy in 2001 or thereafter; and a program approved according to rules adopted by
3.32the board;
3.33    (iii) the pharmacist completes continuing education concerning the administration of
3.34immunizations, as required by Minnesota Rules;
4.1    (iv) the pharmacist has a current cardiopulmonary resuscitation certificate;
4.2    (ii) (v) the pharmacist reports the administration of the immunization to the patient's
4.3primary physician or clinic or to the Minnesota Immunization Information Connection;
4.4    (vi) the pharmacist complies with guidelines for vaccines and immunizations
4.5established by the federal Advisory Committee on Immunization Practices (ACIP), except
4.6that a pharmacist does not need to comply with those guidelines if administering a vaccine
4.7pursuant to a valid, patient-specific order issued by a physician licensed under chapter 147
4.8when the order is consistent with United States Food and Drug Administration approved
4.9labeling of the vaccine; and
4.10    (vii) the pharmacist complies with Centers for Disease Control and Prevention
4.11guidelines relating to immunization schedules, vaccine storage and handling, and vaccine
4.12administration and documentation;
4.13    (6) participation in the practice of managing drug therapy and modifying drug
4.14therapy, according to section 151.21, subdivision 1, according to a written protocol
4.15between the specific pharmacist and the individual dentist, optometrist, physician,
4.16podiatrist, or veterinarian who is responsible for the patient's care and authorized to
4.17independently prescribe drugs. Any significant changes in drug therapy must be reported
4.18by the pharmacist to the patient's medical record;
4.19    (7) participation in the storage of drugs and the maintenance of records;
4.20    (8) responsibility for participation in patient counseling on therapeutic values,
4.21content, hazards, and uses of drugs and devices; and
4.22    (9) offering or performing those acts, services, operations, or transactions necessary
4.23in the conduct, operation, management, and control of a pharmacy.

4.24    Sec. 8. Minnesota Statutes 2012, section 151.01, subdivision 28, is amended to read:
4.25    Subd. 28. Veterinary legend drug. "Veterinary legend drug" means a drug that is
4.26required by federal law to bear the following statement: "Caution: Federal law restricts
4.27this drug to use by or on the order of a licensed veterinarian." be dispensed only pursuant
4.28to the prescription of a licensed veterinarian.

4.29    Sec. 9. Minnesota Statutes 2012, section 151.01, subdivision 29, is amended to read:
4.30    Subd. 29. Legend medical gas. "Legend medical gas" means a liquid or gaseous
4.31substance used for medical purposes and that is required by federal law to bear the
4.32following statement: "Caution: Federal law prohibits dispensing without a prescription."
4.33 be dispensed only pursuant to the prescription of a licensed practitioner.

5.1    Sec. 10. Minnesota Statutes 2012, section 151.01, subdivision 30, is amended to read:
5.2    Subd. 30. Dispense or dispensing. "Dispense or dispensing" means the preparation
5.3or delivery of a drug pursuant to a lawful order of a practitioner in a suitable container
5.4appropriately labeled for subsequent administration to or use by a patient or other
5.5individual entitled to receive the drug interpretation, evaluation, and processing of a
5.6prescription drug order, including the preparation and delivery of a drug to a patient or
5.7patient's agent in a suitable container appropriately labeled for subsequent administration
5.8to, or use by, a patient.

5.9    Sec. 11. Minnesota Statutes 2012, section 151.01, is amended by adding a subdivision
5.10to read:
5.11    Subd. 35. Compounding. The term "compounding" means preparing, mixing,
5.12assembling, packaging, and labeling a drug for an identified individual patient as a
5.13result of a practitioner's prescription drug order, or for the purpose of, or incident to,
5.14research, teaching, or chemical analysis, and not for sale or dispensing. All compounding,
5.15regardless of the type of product, shall be done pursuant to a prescription drug order
5.16unless otherwise permitted in this chapter. Compounding also includes the preparation of
5.17drugs in which all bulk drug substances and components are nonprescription substances.
5.18Compounding does not include mixing or reconstituting a drug according to the product's
5.19labeling or the manufacturer's directions.

5.20    Sec. 12. Minnesota Statutes 2012, section 151.01, is amended by adding a subdivision
5.21to read:
5.22    Subd. 36. Anticipatory compounding. The term "anticipatory compounding"
5.23means the preparation by a pharmacy of a supply of a compounded drug product that is
5.24sufficient to meet the short-term anticipated need of the pharmacy for filling prescription
5.25drug orders. In the case of practitioners only, bulk compounding means the preparation
5.26of a supply of a compounded drug product that is sufficient to meet the practitioner's
5.27short-term anticipated need for dispensing or administering the drug to patients treated
5.28by the practitioner. Bulk compounding is not the preparation of a compounded drug
5.29product for wholesale distribution.

5.30    Sec. 13. Minnesota Statutes 2012, section 151.01, is amended by adding a subdivision
5.31to read:
6.1    Subd. 37. Extemporaneous compounding. The term "extemporaneous
6.2compounding" means compounding a drug product upon receipt of a prescription drug
6.3order for a specific patient.

6.4    Sec. 14. Minnesota Statutes 2012, section 151.01, is amended by adding a subdivision
6.5to read:
6.6    Subd. 38. Compounded positron emission tomography drug. (a) The term
6.7"compounded positron emission tomography drug" means a drug that:
6.8(1) exhibits spontaneous disintegration of unstable nuclei by the emission of
6.9positrons and is used for the purpose of providing dual photon positron emission
6.10tomographic diagnostic images; and
6.11(2) has been compounded by or on the order of a practitioner according to Minnesota
6.12Rules, chapters 4731 and 6800, for a patient or for research, teaching, or quality control.
6.13    (b) Compounded positron emission tomography drug includes any nonradioactive
6.14reagent, reagent kit, ingredient, nuclide generator, accelerator, target material, electronic
6.15synthesizer, or other apparatus or computer program used in the preparation of a drug.

6.16    Sec. 15. Minnesota Statutes 2012, section 151.19, subdivision 1, is amended to read:
6.17    Subdivision 1. Pharmacy registration licensure requirements. The board shall
6.18require and provide for the annual registration of every pharmacy now or hereafter doing
6.19business within this state. Upon the payment of any applicable fee specified in section
6.20151.065, the board shall issue a registration certificate in such form as it may prescribe to
6.21such persons as may be qualified by law to conduct a pharmacy. Such certificate shall
6.22be displayed in a conspicuous place in the pharmacy for which it is issued and expire on
6.23the 30th day of June following the date of issue. It shall be unlawful for any person to
6.24conduct a pharmacy unless such certificate has been issued to the person by the board. (a)
6.25No person shall operate a pharmacy without first obtaining a license from the board and
6.26paying any applicable fee specified in section 151.065. The license shall be displayed in a
6.27conspicuous place in the pharmacy for which it is issued and expires on June 30 following
6.28the date of issue. It is unlawful for any person to operate a pharmacy unless the license
6.29has been issued to the person by the board.
6.30(b) Application for a pharmacy license under this section shall be made in a manner
6.31specified by the board.
6.32(c) No license shall be issued or renewed for a pharmacy located within the state
6.33unless the applicant agrees to operate the pharmacy in a manner prescribed by federal and
6.34state law and according to rules adopted by the board. No license shall be issued for a
7.1pharmacy located outside of the state unless the applicant agrees to operate the pharmacy
7.2in a manner prescribed by federal law and, when dispensing medications for residents of
7.3this state, the laws of this state and Minnesota Rules.
7.4(d) No license shall be issued or renewed for a pharmacy that is required to be
7.5licensed or registered by the state in which it is physically located unless the applicant
7.6supplies the board with proof of such licensure or registration.
7.7(e) The board shall require a separate license for each pharmacy located within
7.8the state and for each pharmacy located outside of the state at which any portion of the
7.9dispensing process occurs for drugs dispensed to residents of this state.
7.10(f) The board shall not issue an initial or renewed license for a pharmacy unless the
7.11pharmacy passes an inspection conducted by an authorized representative of the board. In
7.12the case of a pharmacy located outside of the state, the board may require the applicant to
7.13pay the cost of the inspection, in addition to the license fee in section 151.065, unless the
7.14applicant furnishes the board with a report, issued by the appropriate regulatory agency of
7.15the state in which the facility is located, of an inspection that has occurred within the 24
7.16months immediately preceding receipt of the license application by the board. The board
7.17may deny licensure unless the applicant submits documentation satisfactory to the board
7.18that any deficiencies noted in an inspection report have been corrected.
7.19(g) The board shall not issue an initial or renewed license for a pharmacy located
7.20outside of the state unless the applicant discloses and certifies:
7.21(1) the location, names, and titles of all principal corporate officers and all
7.22pharmacists who are involved in dispensing drugs to residents of this state;
7.23(2) that it maintains its records of drugs dispensed to residents of this state so that the
7.24records are readily retrievable from the records of other drugs dispensed;
7.25(3) that it agrees to cooperate with, and provide information to, the board concerning
7.26matters related to dispensing drugs to residents of this state;
7.27(4) that, during its regular hours of operation, but no less than six days per week, for
7.28a minimum of 40 hours per week, a toll-free telephone service is provided to facilitate
7.29communication between patients in this state and a pharmacist at the pharmacy who has
7.30access to the patients' records; the toll-free number must be disclosed on the label affixed
7.31to each container of drugs dispensed to residents of this state; and
7.32(5) that, upon request of a resident of a long-term care facility located in this
7.33state, the resident's authorized representative, or a contract pharmacy or licensed health
7.34care facility acting on behalf of the resident, the pharmacy will dispense medications
7.35prescribed for the resident in unit-dose packaging or, alternatively, comply with section
7.36151.415, subdivision 5.

8.1    Sec. 16. Minnesota Statutes 2012, section 151.19, subdivision 3, is amended to read:
8.2    Subd. 3. Sale of federally restricted medical gases. The board shall require and
8.3provide for the annual registration of every person or establishment not licensed as a
8.4pharmacy or a practitioner engaged in the retail sale or distribution of federally restricted
8.5medical gases. Upon the payment of any applicable fee specified in section 151.065, the
8.6board shall issue a registration certificate in such form as it may prescribe to those persons
8.7or places that may be qualified to sell or distribute federally restricted medical gases. The
8.8certificate shall be displayed in a conspicuous place in the business for which it is issued
8.9and expire on the date set by the board. It is unlawful for a person to sell or distribute
8.10federally restricted medical gases unless a certificate has been issued to that person by the
8.11board. (a) A person or establishment not licensed as a pharmacy or a practitioner shall not
8.12engage in the retail sale or distribution of federally restricted medical gases without first
8.13obtaining a registration from the board and paying the applicable fee specified in section
8.14151.065. The registration shall be displayed in a conspicuous place in the business for
8.15which it is issued and expires on the date set by the board. It is unlawful for a person to
8.16sell or distribute federally restricted medical gases unless a certificate has been issued to
8.17that person by the board.
8.18(b) Application for a medical gas distributor registration under this section shall be
8.19made in a manner specified by the board.
8.20(c) No registration shall be issued or renewed for a medical gas distributor located
8.21within the state unless the applicant agrees to operate in a manner prescribed by federal
8.22and state law and according to the rules adopted by the board. No license shall be issued
8.23for a medical gas distributor located outside of the state unless the applicant agrees to
8.24operate in a manner prescribed by federal law and, when distributing medical gases for
8.25residents of this state, the laws of this state and Minnesota Rules.
8.26(d) No registration shall be issued or renewed for a medical gas distributor that is
8.27required to be licensed or registered by the state in which it is physically located unless the
8.28applicant supplies the board with proof of the licensure or registration. The board may, by
8.29rule, establish standards for the registration of a medical gas distributor that is not required
8.30to be licensed or registered by the state in which it is physically located.
8.31(e) The board shall require a separate registration for each medical gas distributor
8.32located within the state and for each facility located outside of the state from which
8.33medical gases are distributed to residents of this state.
8.34(f) The board shall not issue an initial or renewed registration for a medical gas
8.35distributor unless the medical gas distributor passes an inspection conducted by an
8.36authorized representative of the board. In the case of a medical gas distributor located
9.1outside of the state, the board may require the applicant to pay the cost of the inspection,
9.2in addition to the license fee in section 151.065, unless the applicant furnishes the board
9.3with a report, issued by the appropriate regulatory agency of the state in which the facility
9.4is located, of an inspection that has occurred within the 24 months immediately preceding
9.5receipt of the license application by the board. The board may deny licensure unless the
9.6applicant submits documentation satisfactory to the board that any deficiencies noted in
9.7an inspection report have been corrected.

9.8    Sec. 17. Minnesota Statutes 2012, section 151.211, is amended to read:
9.9151.211 RECORDS OF PRESCRIPTIONS.
9.10    Subdivision 1. Retention of prescription drug orders. All prescriptions dispensed
9.11 prescription drug orders shall be kept on file at the location in from which such dispensing
9.12occurred of the ordered drug occurs for a period of at least two years. Prescription drug
9.13orders that are electronically prescribed must be kept on file in the format in which
9.14they were originally received. Written or printed prescription drug orders and verbal
9.15prescription drug orders reduced to writing must be kept on file as received or transcribed
9.16unless they are converted to an electronic format that produces an exact and legible copy
9.17of the original document. Electronic systems used to process and store prescription drug
9.18orders must be compliant with the requirements of this chapter and Minnesota Rules.
9.19    Subd. 2. Refill requirements. No A prescription shall drug order may be refilled
9.20except only with the written, electronic, or verbal consent of the prescriber and in
9.21accordance with the requirements of this chapter, section 152.11, and the rules of the board.
9.22The date of such the refill must be recorded and initialed upon the original prescription
9.23 drug order or within the electronically maintained record of the original prescription drug
9.24order by the pharmacist, pharmacist intern, or practitioner who refills the prescription.

9.25    Sec. 18. [151.251] PHARMACY COMPOUNDING.
9.26    Subdivision 1. Exemption from manufacturing licensure requirement. Section
9.27151.25 shall not apply to a pharmacy or a practitioner that compounds a drug product if
9.28the drug product is compounded for an identified individual patient based on receipt of a
9.29valid prescription drug order, as defined in section 151.01, subdivision 16a, on which the
9.30prescribing practitioner has indicated that compounding of the drug product is medically
9.31necessary for the patient, if the drug product meets the requirements of this section and is
9.32not sold at wholesale and if the compounding:
9.33(1) is by a licensed pharmacist or a licensed practitioner, on the prescription order
9.34for the individual patient made by a licensed practitioner authorized to prescribe drugs; or
10.1(2) is by a licensed pharmacist or licensed practitioner in limited quantities before
10.2the receipt of a valid prescription order for the individual patient and:
10.3(i) is not dispensed or otherwise distributed in any manner prior to receipt of a
10.4valid prescription order; and
10.5(ii) is based on a history of the licensed pharmacist or licensed practitioner receiving
10.6valid prescription orders for the compounding of the drug product, and those orders have
10.7been generated solely within an established relationship between the licensed pharmacist
10.8or licensed practitioner and the individual patient for whom the prescription order will be
10.9provided or the licensed practitioner who will write the prescription order.
10.10    Subd. 2. Compounded drug. (a) A drug product may be compounded under this
10.11section if the licensed pharmacist or licensed practitioner:
10.12(1) compounds the drug product using bulk drug substances, as defined in Code of
10.13Federal Regulations, title 21, section 207.3, subsection (a), paragraph (4), that:
10.14(i) complies with the standards of an applicable United States Pharmacopoeia
10.15or National Formulary monograph, if a monograph exists, and the United States
10.16Pharmacopoeia chapter on pharmacy compounding;
10.17(ii) if a monograph does not exist, are drug substances that are components of drugs
10.18approved for use in this country by the United States Food and Drug Administration; or
10.19(iii) if a monograph does not exist and the drug substance is not a component of a
10.20drug approved for use in this country by the United States Food and Drug Administration,
10.21appears on a list developed by the United States Food and Drug Administration through
10.22regulations issued by the Secretary of the United States Department of Health and Human
10.23Services pursuant to the Food, Drugs, and Cosmetic Act, section 503a, subsection (d) and:
10.24(A) are manufactured by an establishment that is registered under the federal Food,
10.25Drug, and Cosmetic Act, section 360, including a foreign establishment registered under
10.26section 360, subsection (i) of the act; and
10.27(B) are accompanied by valid certificates of analysis for each bulk drug substance; and
10.28(2) compounds the drug product using ingredients, other than bulk drug substances,
10.29that comply with the standards of an applicable United States Pharmacopoeia or National
10.30Formulary monograph, if a monograph exists, and the United States Pharmacopoeia
10.31chapters on pharmacy compounding.
10.32(b) A licensed pharmacist or licensed practitioner, when compounding a drug product,
10.33is prohibited from using any product that appears on a list published by the secretary of the
10.34United States Department of Health and Human Services in the Federal Register of drug
10.35products that have been withdrawn or removed from the market because the drug products
10.36or components of the drug products have been found to be unsafe or not effective.
11.1(c) A licensed pharmacist or licensed practitioner shall not compound any drug
11.2product that is essentially a copy of a commercially available drug product. For purposes
11.3of this paragraph, "essentially a copy of a commercially available drug product" does
11.4not include a drug product in which there is a change, made for an identified individual
11.5patient, that produces for that patient a sufficient difference between the compounded
11.6drug and the comparable commercially available drug product, as determined by the
11.7prescribing practitioner.
11.8    Subd. 3. Exceptions. (a) This section does not apply to:
11.9(1) drugs compounded by a pharmacy licensed by the board for use by, or
11.10administration to, patients enrolled in a bona fide research study that is being conducted
11.11pursuant to either an investigational new drug application approved by the United States
11.12Food and Drug Administration or that has been approved by an institutional review board;
11.13(2) compounded positron emission tomography drugs as defined in section 151.01,
11.14subdivision 38; or
11.15(3) radiopharmaceuticals.
11.16(b) As used in this section, "compounding" does not include mixing, reconstituting,
11.17or other acts performed according to directions contained in approved labeling provided by
11.18the product's manufacturer and other manufacturer directions consistent with that labeling.

11.19    Sec. 19. [151.252] LICENSING OF DRUG MANUFACTURERS; FEES;
11.20PROHIBITIONS.
11.21    Subdivision 1. Requirements. (a) No person shall act as a manufacturer without
11.22first obtaining a license from the board and paying any applicable fee specified in section
11.23151.065.
11.24(b) Application for a manufacturer license under this section shall be made in a
11.25manner specified by the board.
11.26(c) No license shall be issued or renewed for a manufacturer unless the applicant
11.27agrees to operate in a manner prescribed by federal and state law and according to
11.28Minnesota Rules.
11.29(d) No license shall be issued or renewed for a manufacturer that is required to
11.30be registered pursuant to United State Code, title 21, section 360, unless the applicant
11.31supplies the board with proof of registration. The board may establish by rule the
11.32standards for licensure of manufacturers that are not required to be registered under United
11.33States Code, title 21, section 360.
11.34(e) No license shall be issued or renewed for a manufacturer that is required to be
11.35licensed or registered by the state in which it is physically located unless the applicant
12.1supplies the board with proof of licensure or registration. The board may establish, by
12.2rule, standards for the licensure of a manufacturer that is not required to be licensed or
12.3registered by the state in which it is physically located.
12.4(f) The board shall require a separate license for each facility located within the state
12.5at which manufacturing occurs and for each facility located outside of the state at which
12.6drugs that are shipped into the state are manufactured.
12.7(g) The board shall not issue an initial or renewed license for a manufacturing
12.8facility unless the facility passes an inspection conducted by an authorized representative
12.9of the board. In the case of a manufacturing facility located outside of the state, the board
12.10may require the applicant to pay the cost of the inspection, in addition to the license fee
12.11in section 151.065, unless the applicant furnishes the board with a report, issued by the
12.12appropriate regulatory agency of the state in which the facility is located or by the United
12.13States Food and Drug Administration, of an inspection that has occurred within the 24
12.14months immediately preceding receipt of the license application by the board. The board
12.15may deny licensure unless the applicant submits documentation satisfactory to the board
12.16that any deficiencies noted in an inspection report have been corrected.
12.17    Subd. 2. Prohibition. It is unlawful for any person engaged in manufacturing to sell
12.18legend drugs to anyone located in this state except as provided in this chapter.

12.19    Sec. 20. Minnesota Statutes 2012, section 151.361, subdivision 2, is amended to read:
12.20    Subd. 2. After January 1, 1983. (a) No legend drug in solid oral dosage form may
12.21be manufactured, packaged or distributed for sale in this state after January 1, 1983 unless
12.22it is clearly marked or imprinted with a symbol, number, company name, words, letters,
12.23national drug code or other mark uniquely identifiable to that drug product. An identifying
12.24mark or imprint made as required by federal law or by the federal United States Food and
12.25Drug Administration shall be deemed to be in compliance with this section.
12.26(b) The Board of Pharmacy may grant exemptions from the requirements of this
12.27section on its own initiative or upon application of a manufacturer, packager, or distributor
12.28indicating size or other characteristics which render the product impractical for the
12.29imprinting required by this section.
12.30(c) The provisions of clauses Paragraphs (a) and (b) shall not apply to any of the
12.31following:
12.32(1) drugs purchased by a pharmacy, pharmacist, or licensed wholesaler prior to
12.33January 1, 1983, and held in stock for resale.; and
13.1(2) drugs which that are manufactured compounded by or upon the order of a
13.2practitioner licensed by law to prescribe or administer drugs and which are to be used
13.3solely by the patient for whom prescribed.

13.4    Sec. 21. Minnesota Statutes 2012, section 151.37, subdivision 2, is amended to read:
13.5    Subd. 2. Prescribing and filing. (a) A licensed practitioner in the course of
13.6professional practice only, may prescribe, administer, and dispense a legend drug, and may
13.7cause the same to be administered by a nurse, a physician assistant, or medical student or
13.8resident under the practitioner's direction and supervision, and may cause a person who
13.9is an appropriately certified, registered, or licensed health care professional to prescribe,
13.10dispense, and administer the same within the expressed legal scope of the person's practice
13.11as defined in Minnesota Statutes. A licensed practitioner may prescribe a legend drug,
13.12without reference to a specific patient, by directing a nurse, pursuant to section 148.235,
13.13subdivisions 8 and 9, physician assistant, medical student or resident, or pharmacist
13.14according to section 151.01, subdivision 27, to adhere to a particular practice guideline or
13.15protocol when treating patients whose condition falls within such guideline or protocol,
13.16and when such guideline or protocol specifies the circumstances under which the legend
13.17drug is to be prescribed and administered. An individual who verbally, electronically, or
13.18otherwise transmits a written, oral, or electronic order, as an agent of a prescriber, shall
13.19not be deemed to have prescribed the legend drug. This paragraph applies to a physician
13.20assistant only if the physician assistant meets the requirements of section 147A.18.
13.21(b) The commissioner of health, if a licensed practitioner, or a person designated
13.22by the commissioner who is a licensed practitioner, may prescribe a legend drug to an
13.23individual or by protocol for mass dispensing purposes where the commissioner finds that
13.24the conditions triggering section 144.4197 or 144.4198, subdivision 2, paragraph (b), exist.
13.25The commissioner, if a licensed practitioner, or a designated licensed practitioner, may
13.26prescribe, dispense, or administer a legend drug or other substance listed in subdivision 10
13.27to control tuberculosis and other communicable diseases. The commissioner may modify
13.28state drug labeling requirements, and medical screening criteria and documentation, where
13.29time is critical and limited labeling and screening are most likely to ensure legend drugs
13.30reach the maximum number of persons in a timely fashion so as to reduce morbidity
13.31and mortality.
13.32    (c) A licensed practitioner that dispenses for profit a legend drug that is to be
13.33administered orally, is ordinarily dispensed by a pharmacist, and is not a vaccine, must
13.34file with the practitioner's licensing board a statement indicating that the practitioner
13.35dispenses legend drugs for profit, the general circumstances under which the practitioner
14.1dispenses for profit, and the types of legend drugs generally dispensed. It is unlawful to
14.2dispense legend drugs for profit after July 31, 1990, unless the statement has been filed
14.3with the appropriate licensing board. For purposes of this paragraph, "profit" means (1)
14.4any amount received by the practitioner in excess of the acquisition cost of a legend drug
14.5for legend drugs that are purchased in prepackaged form, or (2) any amount received
14.6by the practitioner in excess of the acquisition cost of a legend drug plus the cost of
14.7making the drug available if the legend drug requires compounding, packaging, or other
14.8treatment. The statement filed under this paragraph is public data under section 13.03.
14.9This paragraph does not apply to a licensed doctor of veterinary medicine or a registered
14.10pharmacist. Any person other than a licensed practitioner with the authority to prescribe,
14.11dispense, and administer a legend drug under paragraph (a) shall not dispense for profit.
14.12To dispense for profit does not include dispensing by a community health clinic when the
14.13profit from dispensing is used to meet operating expenses.
14.14    (d) A prescription or drug order for the following drugs is not valid, unless it can
14.15be established that the prescription or drug order was based on a documented patient
14.16evaluation, including an examination, adequate to establish a diagnosis and identify
14.17underlying conditions and contraindications to treatment:
14.18    (1) controlled substance drugs listed in section 152.02, subdivisions 3 to 5;
14.19    (2) drugs defined by the Board of Pharmacy as controlled substances under section
14.20152.02, subdivisions 7 , 8, and 12;
14.21    (3) muscle relaxants;
14.22    (4) centrally acting analgesics with opioid activity;
14.23    (5) drugs containing butalbital; or
14.24    (6) phoshodiesterase type 5 inhibitors when used to treat erectile dysfunction.
14.25    (e) For the purposes of paragraph (d), the requirement for an examination shall be
14.26met if an in-person examination has been completed in any of the following circumstances:
14.27    (1) the prescribing practitioner examines the patient at the time the prescription
14.28or drug order is issued;
14.29    (2) the prescribing practitioner has performed a prior examination of the patient;
14.30    (3) another prescribing practitioner practicing within the same group or clinic as the
14.31prescribing practitioner has examined the patient;
14.32    (4) a consulting practitioner to whom the prescribing practitioner has referred the
14.33patient has examined the patient; or
14.34    (5) the referring practitioner has performed an examination in the case of a
14.35consultant practitioner issuing a prescription or drug order when providing services by
14.36means of telemedicine.
15.1    (f) Nothing in paragraph (d) or (e) prohibits a licensed practitioner from prescribing
15.2a drug through the use of a guideline or protocol pursuant to paragraph (a).
15.3    (g) Nothing in this chapter prohibits a licensed practitioner from issuing a
15.4prescription or dispensing a legend drug in accordance with the Expedited Partner Therapy
15.5in the Management of Sexually Transmitted Diseases guidance document issued by the
15.6United States Centers for Disease Control.
15.7    (h) Nothing in paragraph (d) or (e) limits prescription, administration, or dispensing
15.8of legend drugs through a public health clinic or other distribution mechanism approved
15.9by the commissioner of health or a board of health in order to prevent, mitigate, or treat
15.10a pandemic illness, infectious disease outbreak, or intentional or accidental release of a
15.11biological, chemical, or radiological agent.
15.12    (i) No pharmacist employed by, under contract to, or working for a pharmacy
15.13licensed under section 151.19, subdivision 1, may dispense a legend drug based on a
15.14prescription that the pharmacist knows, or would reasonably be expected to know, is not
15.15valid under paragraph (d).
15.16    (j) No pharmacist employed by, under contract to, or working for a pharmacy
15.17licensed under section 151.19, subdivision 2, may dispense a legend drug to a resident
15.18of this state based on a prescription that the pharmacist knows, or would reasonably be
15.19expected to know, is not valid under paragraph (d).

15.20    Sec. 22. Minnesota Statutes 2012, section 151.37, is amended by adding a subdivision
15.21to read:
15.22    Subd. 10a. Emergency use authorizations. Nothing in this chapter prohibits the
15.23purchase, possession, or use of a legend drug by an entity authorized by an emergency
15.24use authorization issued by the United States Food and Drug Administration pursuant to
15.25United States Code, title 21, section 360.bbb-3. The entity must be specifically tasked
15.26in a public health response plan to perform critical functions necessary to support the
15.27response to a public health incident or event.

15.28    Sec. 23. Minnesota Statutes 2012, section 151.37, is amended by adding a subdivision
15.29to read:
15.30    Subd. 10b. Exclusion for health care educational programs. (a) Nothing in this
15.31chapter prohibits an accredited public or private postsecondary school from possessing a
15.32legend drug that is not a controlled substance listed in section 152.02, provided that:
16.1(1) the school is approved by the United States Secretary of Education according
16.2to the Higher Education Act of 1965, as amended, published in United States Code, title
16.320, chapter 28;
16.4(2) the school provides a course of instruction that prepares individuals for
16.5employment in a health care occupation or profession;
16.6(3) the school only possesses those drugs necessary for instruction of individuals; and
16.7(4) the drugs may only be used in the course of providing such instruction and are
16.8labeled by the purchaser to indicate that they are not to be administered to patients.
16.9    (b) Those areas of the school in which legend drugs are stored are subject to section
16.10151.06, subdivision 1, paragraph (a), clause (4).

16.11    Sec. 24. Minnesota Statutes 2012, section 151.44, is amended to read:
16.12151.44 DEFINITIONS.
16.13As used in sections 151.43 to 151.51, the following terms have the meanings given
16.14in paragraphs (a) to (h):
16.15(a) "Wholesale drug distribution" means distribution of prescription or
16.16nonprescription drugs to persons other than a consumer or patient or reverse distribution
16.17of such drugs, but does not include:
16.18(1) a sale between a division, subsidiary, parent, affiliated, or related company under
16.19the common ownership and control of a corporate entity;
16.20(2) the purchase or other acquisition, by a hospital or other health care entity that is a
16.21member of a group purchasing organization, of a drug for its own use from the organization
16.22or from other hospitals or health care entities that are members of such organizations;
16.23(3) the sale, purchase, or trade of a drug or an offer to sell, purchase, or trade a
16.24drug by a charitable organization described in section 501(c)(3) of the Internal Revenue
16.25Code of 1986, as amended through December 31, 1988, to a nonprofit affiliate of the
16.26organization to the extent otherwise permitted by law;
16.27(4) the sale, purchase, or trade of a drug or offer to sell, purchase, or trade a drug
16.28among hospitals or other health care entities that are under common control;
16.29(5) the sale, purchase, or trade of a drug or offer to sell, purchase, or trade a drug
16.30for emergency medical reasons;
16.31(6) the sale, purchase, or trade of a drug, an offer to sell, purchase, or trade a drug, or
16.32the dispensing of a drug pursuant to a prescription;
16.33(7) the transfer of prescription or nonprescription drugs by a retail pharmacy to
16.34another retail pharmacy to alleviate a temporary shortage;
17.1(8) the distribution of prescription or nonprescription drug samples by manufacturers
17.2representatives; or
17.3(9) the sale, purchase, or trade of blood and blood components.
17.4(b) "Wholesale drug distributor" means anyone engaged in wholesale drug
17.5distribution including, but not limited to, manufacturers; repackers repackagers; own-label
17.6distributors; jobbers; brokers; warehouses, including manufacturers' and distributors'
17.7warehouses, chain drug warehouses, and wholesale drug warehouses; independent
17.8wholesale drug traders; and pharmacies that conduct wholesale drug distribution. A
17.9wholesale drug distributor does not include a common carrier or individual hired primarily
17.10to transport prescription or nonprescription drugs.
17.11(c) "Manufacturer" means anyone who is engaged in the manufacturing, preparing,
17.12propagating, compounding, processing, packaging, repackaging, or labeling of a
17.13prescription drug has the meaning provided in section 151.01, subdivision 13a.
17.14(d) "Prescription drug" means a drug required by federal or state law or regulation
17.15to be dispensed only by a prescription, including finished dosage forms and active
17.16ingredients subject to United States Code, title 21, sections 811 and 812.
17.17(e) "Blood" means whole blood collected from a single donor and processed either
17.18for transfusion or further manufacturing.
17.19(f) "Blood components" means that part of blood separated by physical or
17.20mechanical means.
17.21(g) "Reverse distribution" means the receipt of prescription or nonprescription drugs
17.22received from or shipped to Minnesota locations for the purpose of returning the drugs
17.23to their producers or distributors.
17.24(h) "Reverse distributor" means a person engaged in the reverse distribution of drugs.

17.25    Sec. 25. Minnesota Statutes 2012, section 151.47, subdivision 1, is amended to read:
17.26    Subdivision 1. Requirements. (a) All wholesale drug distributors are subject to the
17.27requirements in paragraphs (a) to (f) of this subdivision.
17.28(a) (b) No person or distribution outlet shall act as a wholesale drug distributor
17.29without first obtaining a license from the board and paying any applicable fee specified
17.30in section 151.065.
17.31(c) Application for a wholesale drug distributor license under this section shall be
17.32made in a manner specified by the board.
17.33(b) (d) No license shall be issued or renewed for a wholesale drug distributor to
17.34operate unless the applicant agrees to operate in a manner prescribed by federal and state
17.35law and according to the rules adopted by the board.
18.1(c) The board may require a separate license for each facility directly or indirectly
18.2owned or operated by the same business entity within the state, or for a parent entity
18.3with divisions, subsidiaries, or affiliate companies within the state, when operations
18.4are conducted at more than one location and joint ownership and control exists among
18.5all the entities.
18.6(e) No license may be issued or renewed for a drug wholesale distributor that is
18.7required to be licensed or registered by the state in which it is physically located unless
18.8the applicant supplies the board with proof of licensure or registration. The board may
18.9establish, by rule, standards for the licensure of a drug wholesale distributor that is not
18.10required to be licensed or registered by the state in which it is physically located.
18.11(f) The board shall require a separate license for each drug wholesale distributor
18.12facility located within the state and for each drug wholesale distributor facility located
18.13outside of the state from which drugs are shipped into the state or to which drugs are
18.14reverse distributed.
18.15(g) The board shall not issue an initial or renewed license for a drug wholesale
18.16distributor facility unless the facility passes an inspection conducted by an authorized
18.17representative of the board. In the case of a drug wholesale distributor facility located
18.18outside of the state, the board may require the applicant to pay the cost of the inspection,
18.19in addition to the license fee in section 151.065, unless the applicant furnishes the board
18.20with a report, issued by the appropriate regulatory agency of the state in which the facility
18.21is located, of an inspection that has occurred within the 24 months immediately preceding
18.22receipt of the license application by the board. The board may deny licensure unless the
18.23applicant submits documentation satisfactory to the board that any deficiencies noted in
18.24an inspection report have been corrected.
18.25(d) (h) As a condition for receiving and retaining a wholesale drug distributor license
18.26issued under sections 151.42 to 151.51, an applicant shall satisfy the board that it has
18.27and will continuously maintain:
18.28(1) adequate storage conditions and facilities;
18.29(2) minimum liability and other insurance as may be required under any applicable
18.30federal or state law;
18.31(3) a viable security system that includes an after hours central alarm, or comparable
18.32entry detection capability; restricted access to the premises; comprehensive employment
18.33applicant screening; and safeguards against all forms of employee theft;
18.34(4) a system of records describing all wholesale drug distributor activities set forth
18.35in section 151.44 for at least the most recent two-year period, which shall be reasonably
18.36accessible as defined by board regulations in any inspection authorized by the board;
19.1(5) principals and persons, including officers, directors, primary shareholders,
19.2and key management executives, who must at all times demonstrate and maintain their
19.3capability of conducting business in conformity with sound financial practices as well
19.4as state and federal law;
19.5(6) complete, updated information, to be provided to the board as a condition for
19.6obtaining and retaining a license, about each wholesale drug distributor to be licensed,
19.7including all pertinent corporate licensee information, if applicable, or other ownership,
19.8principal, key personnel, and facilities information found to be necessary by the board;
19.9(7) written policies and procedures that assure reasonable wholesale drug distributor
19.10preparation for, protection against, and handling of any facility security or operation
19.11problems, including, but not limited to, those caused by natural disaster or government
19.12emergency, inventory inaccuracies or product shipping and receiving, outdated product
19.13or other unauthorized product control, appropriate disposition of returned goods, and
19.14product recalls;
19.15(8) sufficient inspection procedures for all incoming and outgoing product
19.16shipments; and
19.17(9) operations in compliance with all federal requirements applicable to wholesale
19.18drug distribution.
19.19(e) (i) An agent or employee of any licensed wholesale drug distributor need not
19.20seek licensure under this section.
19.21(f) A wholesale drug distributor shall file with the board an annual report, in a
19.22form and on the date prescribed by the board, identifying all payments, honoraria,
19.23reimbursement or other compensation authorized under section 151.461, clauses (3) to
19.24(5), paid to practitioners in Minnesota during the preceding calendar year. The report
19.25shall identify the nature and value of any payments totaling $100 or more, to a particular
19.26practitioner during the year, and shall identify the practitioner. Reports filed under this
19.27provision are public data.

19.28    Sec. 26. Minnesota Statutes 2012, section 151.47, is amended by adding a subdivision
19.29to read:
19.30    Subd. 3. Prohibition. It is unlawful for any person engaged in wholesale drug
19.31distribution to sell drugs to anyone located within the state or to receive drugs in reverse
19.32distribution from anyone located within the state except as provided in this chapter.

19.33    Sec. 27. Minnesota Statutes 2012, section 151.49, is amended to read:
19.34151.49 LICENSE RENEWAL APPLICATION PROCEDURES.
20.1Application blanks or notices for renewal of a license required by sections 151.42
20.2to 151.51 shall be mailed or otherwise provided to each licensee on or before the first
20.3day of the month prior to the month in which the license expires and, if application for
20.4renewal of the license with the required fee and supporting documents is not made before
20.5the expiration date, the existing license or renewal shall lapse and become null and void
20.6upon the date of expiration.

20.7    Sec. 28. Minnesota Statutes 2012, section 152.126, is amended to read:
20.8152.126 CONTROLLED SUBSTANCES PRESCRIPTION ELECTRONIC
20.9REPORTING SYSTEM PRESCRIPTION MONITORING PROGRAM.
20.10    Subdivision 1. Definitions. (a) For purposes of this section, the terms defined in
20.11this subdivision have the meanings given.
20.12    (a) (b) "Board" means the Minnesota State Board of Pharmacy established under
20.13chapter 151.
20.14    (b) (c) "Controlled substances" means those substances listed in section 152.02,
20.15subdivisions 3 to 5 6, and those substances defined by the board pursuant to section
20.16152.02, subdivisions 7 , 8, and 12. For the purpose of this section only, "controlled
20.17substances" includes tramadol and butalbital.
20.18    (c) (d) "Dispense" or "dispensing" has the meaning given in section 151.01,
20.19subdivision 30 . Dispensing does not include the direct administering of a controlled
20.20substance to a patient by a licensed health care professional.
20.21    (d) (e) "Dispenser" means a person authorized by law to dispense a controlled
20.22substance, pursuant to a valid prescription. For the purposes of this section, a dispenser does
20.23not include a licensed hospital pharmacy that distributes controlled substances for inpatient
20.24hospital care or a veterinarian who is dispensing prescriptions under section 156.18.
20.25    (e) (f) "Prescriber" means a licensed health care professional who is authorized to
20.26prescribe a controlled substance under section 152.12, subdivision 1.
20.27    (f) (g) "Prescription" has the meaning given in section 151.01, subdivision 16.
20.28    Subd. 1a. Treatment of intractable pain. This section is not intended to limit or
20.29interfere with the legitimate prescribing of controlled substances for pain. No prescriber
20.30shall be subject to disciplinary action by a health-related licensing board for prescribing a
20.31controlled substance according to the provisions of section 152.125.
20.32    Subd. 2. Prescription electronic reporting system. (a) The board shall establish
20.33by January 1, 2010, an electronic system for reporting the information required under
20.34subdivision 4 for all controlled substances dispensed within the state.
21.1    (b) The board may contract with a vendor for the purpose of obtaining technical
21.2assistance in the design, implementation, operation, and maintenance of the electronic
21.3reporting system.
21.4    Subd. 3. Prescription Electronic Reporting Monitoring Program Advisory
21.5Committee. (a) The board shall convene an advisory committee. The committee must
21.6include at least one representative of:
21.7    (1) the Department of Health;
21.8    (2) the Department of Human Services;
21.9    (3) each health-related licensing board that licenses prescribers;
21.10    (4) a professional medical association, which may include an association of pain
21.11management and chemical dependency specialists;
21.12    (5) a professional pharmacy association;
21.13    (6) a professional nursing association;
21.14    (7) a professional dental association;
21.15    (8) a consumer privacy or security advocate; and
21.16    (9) a consumer or patient rights organization; and
21.17    (10) an association of medical examiners and coroners.
21.18    (b) The advisory committee shall advise the board on the development and operation
21.19of the electronic reporting system prescription monitoring program, including, but not
21.20limited to:
21.21    (1) technical standards for electronic prescription drug reporting;
21.22    (2) proper analysis and interpretation of prescription monitoring data; and
21.23    (3) an evaluation process for the program.
21.24    Subd. 4. Reporting requirements; notice. (a) Each dispenser must submit the
21.25following data to the board or its designated vendor, subject to the notice required under
21.26paragraph (d):
21.27    (1) name of the prescriber;
21.28    (2) national provider identifier of the prescriber;
21.29    (3) name of the dispenser;
21.30    (4) national provider identifier of the dispenser;
21.31    (5) prescription number;
21.32    (6) name of the patient for whom the prescription was written;
21.33    (7) address of the patient for whom the prescription was written;
21.34    (8) date of birth of the patient for whom the prescription was written;
21.35    (9) date the prescription was written;
21.36    (10) date the prescription was filled;
22.1    (11) name and strength of the controlled substance;
22.2    (12) quantity of controlled substance prescribed;
22.3    (13) quantity of controlled substance dispensed; and
22.4    (14) number of days supply.
22.5    (b) The dispenser must submit the required information by a procedure and in a
22.6format established by the board. The board may allow dispensers to omit data listed in this
22.7subdivision or may require the submission of data not listed in this subdivision provided
22.8the omission or submission is necessary for the purpose of complying with the electronic
22.9reporting or data transmission standards of the American Society for Automation in
22.10Pharmacy, the National Council on Prescription Drug Programs, or other relevant national
22.11standard-setting body.
22.12    (c) A dispenser is not required to submit this data for those controlled substance
22.13prescriptions dispensed for:
22.14    (1) individuals residing in licensed skilled nursing or intermediate care facilities;
22.15    (2) individuals receiving assisted living services under chapter 144G or through a
22.16medical assistance home and community-based waiver;
22.17    (3) individuals receiving medication intravenously;
22.18    (4) individuals receiving hospice and other palliative or end-of-life care; and
22.19    (5) individuals receiving services from a home care provider regulated under
22.20chapter 144A. individuals residing in a health care facility as defined in section 151.58,
22.21subdivision 2, paragraph (b), when a drug is distributed through the use of an automated
22.22drug distribution system according to section 151.58.
22.23    (d) A dispenser must not submit data under this subdivision unless provide a
22.24conspicuous notice of the reporting requirements of this section is given to the patient for
22.25whom the prescription was written.
22.26    Subd. 5. Use of data by board. (a) The board shall develop and maintain a database
22.27of the data reported under subdivision 4. The board shall maintain data that could identify
22.28an individual prescriber or dispenser in encrypted form. The database may be used by
22.29permissible users identified under subdivision 6 for the identification of:
22.30    (1) individuals receiving prescriptions for controlled substances from prescribers
22.31who subsequently obtain controlled substances from dispensers in quantities or with a
22.32frequency inconsistent with generally recognized standards of use for those controlled
22.33substances, including standards accepted by national and international pain management
22.34associations; and
22.35    (2) individuals presenting forged or otherwise false or altered prescriptions for
22.36controlled substances to dispensers.
23.1    (b) No permissible user identified under subdivision 6 may access the database
23.2for the sole purpose of identifying prescribers of controlled substances for unusual or
23.3excessive prescribing patterns without a valid search warrant or court order.
23.4    (c) No personnel of a state or federal occupational licensing board or agency may
23.5access the database for the purpose of obtaining information to be used to initiate or
23.6substantiate a disciplinary action against a prescriber when the disciplinary action relates
23.7to allegations involving unusual or excessive prescribing of the drugs for which data
23.8is collected under subdivision 4.
23.9    (d) Data reported under subdivision 4 shall be retained by the board in the an active
23.10 database for a 12-month period, and shall be removed from the active database no later
23.11than 12 months from the last day of the month during which the data was received. The
23.12board may transfer data into an inactive database provided that the data thus transferred
23.13may only be used by the authorized staff of the board for the purposes of administering,
23.14operating, and maintaining the prescription monitoring program and conducting trend
23.15analyses and other studies as necessary to evaluate the effectiveness of the program. Data
23.16in the inactive database shall not be accessible to any other persons for any reason.
23.17    Subd. 6. Access to reporting system data. (a) Except as indicated in this
23.18subdivision, the data submitted to the board under subdivision 4 is private data on
23.19individuals as defined in section 13.02, subdivision 12, and not subject to public disclosure.
23.20    (b) Except as specified in subdivision 5, the following persons shall be considered
23.21permissible users and may access the data submitted under subdivision 4 in the same or
23.22similar manner, and for the same or similar purposes, as those persons who are authorized
23.23to access similar private data on individuals under federal and state law:
23.24    (1) a prescriber or an agent or employee of the prescriber to whom the prescriber has
23.25delegated the task of accessing the data, to the extent the information relates specifically to
23.26a current patient, to whom the prescriber is prescribing or considering prescribing any
23.27controlled substance or to whom the prescriber is providing other medical treatment for
23.28which access to the data may be necessary and with the provision that the prescriber remains
23.29responsible for the use or misuse of data accessed by a delegated agent or employee;
23.30    (2) a dispenser or an agent or employee of the dispenser to whom the dispenser has
23.31delegated the task of accessing the data, to the extent the information relates specifically
23.32to a current patient to whom that dispenser is dispensing or considering dispensing any
23.33controlled substance or to whom the dispenser is providing other pharmaceutical care for
23.34which access to the data may be necessary and with the provision that the dispenser remains
23.35responsible for the use or misuse of data accessed by a delegated agent or employee;
24.1    (3) an individual who is the recipient of a controlled substance prescription for
24.2which data was submitted under subdivision 4, or a guardian of the individual, parent or
24.3guardian of a minor, or health care agent of the individual acting under a health care
24.4directive under chapter 145C;
24.5    (4) personnel of the a health-related licensing board specifically listed in section
24.6214.01, subdivision 2, or of the Emergency Medical Services Regulatory Board assigned
24.7to conduct a bona fide investigation of a complaint received by that board alleging that
24.8a specific licensee is chemically dependent, has diverted controlled substances, or has
24.9engaged in the behavior specified in subdivision 5, paragraph (a);
24.10    (5) personnel of the board engaged in the collection of controlled substance
24.11prescription information as part of the assigned duties and responsibilities under this
24.12section;
24.13    (6) authorized personnel of a vendor under contract with the board who are engaged
24.14in the design, implementation, operation, and maintenance of the electronic reporting
24.15system prescription monitoring program as part of the assigned duties and responsibilities
24.16of their employment, provided that access to data is limited to the minimum amount
24.17necessary to carry out such duties and responsibilities;
24.18    (7) federal, state, and local law enforcement authorities acting pursuant to a valid
24.19search warrant; and
24.20    (8) personnel of the medical assistance program Minnesota health care programs
24.21 assigned to use the data collected under this section to identify and manage recipients
24.22whose usage of controlled substances may warrant restriction to a single primary care
24.23physician provider, a single outpatient pharmacy, or and a single hospital;
24.24    (9) a coroner or medical examiner, or an agent or employee of the coroner or medical
24.25examiner to whom the coroner or medical examiner has delegated the task of accessing
24.26the data, conducting an investigation pursuant to section 390.11, and with the provision
24.27that the coroner or medical examiner remains responsible for the use or misuse of data
24.28accessed by a delegated agent or employee; and
24.29    (10) personnel of the health professionals services program established pursuant to
24.30section 214.31, to the extent that the information relates specifically to an individual
24.31who is currently enrolled in and being monitored by the program and provided that
24.32the information cannot be given to a health-related licensing board except as provided
24.33by section 214.33, subdivision 3.
24.34    For purposes of clause (3), access by an individual includes persons in the definition
24.35of an individual under section 13.02.
25.1    (c) Any permissible user identified in paragraph (b), who directly accesses
25.2the data electronically, shall implement and maintain a comprehensive information
25.3security program that contains administrative, technical, and physical safeguards that
25.4are appropriate to the user's size and complexity, and the sensitivity of the personal
25.5information obtained. The permissible user shall identify reasonably foreseeable internal
25.6and external risks to the security, confidentiality, and integrity of personal information
25.7that could result in the unauthorized disclosure, misuse, or other compromise of the
25.8information and assess the sufficiency of any safeguards in place to control the risks.
25.9    (d) The board shall not release data submitted under this section unless it is provided
25.10with evidence, satisfactory to the board, that the person requesting the information is
25.11entitled to receive the data.
25.12    (e) The board shall not release the name of a prescriber without the written consent
25.13of the prescriber or a valid search warrant or court order. The board shall provide a
25.14mechanism for a prescriber to submit to the board a signed consent authorizing the release
25.15of the prescriber's name when data containing the prescriber's name is requested.
25.16    (f) The board shall maintain a log of all persons who access the data for a period of
25.17at least five years and shall ensure that any permissible user complies with paragraph (c)
25.18prior to attaining direct access to the data.
25.19(g) (f) Section 13.05, subdivision 6, shall apply to any contract the board enters into
25.20pursuant to subdivision 2. A vendor shall not use data collected under this section for
25.21any purpose not specified in this section.
25.22(g) The board may participate in an interstate prescription monitoring program data
25.23exchange system provided that permissible users in other states may have access to the data
25.24only as allowed under this section and that section 13.05, subdivision 6, shall apply to any
25.25contract or memorandum of understanding that the board enters into under this paragraph.
25.26    Subd. 7. Disciplinary action. (a) A dispenser who knowingly fails to submit data to
25.27the board as required under this section is subject to disciplinary action by the appropriate
25.28health-related licensing board.
25.29    (b) A prescriber or dispenser authorized to access the data who knowingly discloses
25.30the data in violation of state or federal laws relating to the privacy of health care data
25.31shall be subject to disciplinary action by the appropriate health-related licensing board,
25.32and appropriate civil penalties.
25.33    Subd. 8. Evaluation and reporting. (a) The board shall evaluate the prescription
25.34electronic reporting system to determine if the system is negatively impacting appropriate
25.35prescribing practices of controlled substances. The board may contract with a vendor to
25.36design and conduct the evaluation.
26.1    (b) The board shall submit the evaluation of the system to the legislature by July
26.215, 2011.
26.3    Subd. 9. Immunity from liability; no requirement to obtain information. (a) A
26.4pharmacist, prescriber, or other dispenser making a report to the program in good faith
26.5under this section is immune from any civil, criminal, or administrative liability, which
26.6might otherwise be incurred or imposed as a result of the report, or on the basis that the
26.7pharmacist or prescriber did or did not seek or obtain or use information from the program.
26.8    (b) Nothing in this section shall require a pharmacist, prescriber, or other dispenser
26.9to obtain information about a patient from the program, and the pharmacist, prescriber,
26.10or other dispenser, if acting in good faith, is immune from any civil, criminal, or
26.11administrative liability that might otherwise be incurred or imposed for requesting,
26.12receiving, or using information from the program.
26.13    Subd. 10. Funding. (a) The board may seek grants and private funds from nonprofit
26.14charitable foundations, the federal government, and other sources to fund the enhancement
26.15and ongoing operations of the prescription electronic reporting system monitoring
26.16program established under this section. Any funds received shall be appropriated to the
26.17board for this purpose. The board may not expend funds to enhance the program in a way
26.18that conflicts with this section without seeking approval from the legislature.
26.19(b) Notwithstanding any other section, the administrative services unit for the
26.20health-related licensing boards shall apportion between the Board of Medical Practice, the
26.21Board of Nursing, the Board of Dentistry, the Board of Podiatric Medicine, the Board of
26.22Optometry, the Board of Veterinary Medicine, and the Board of Pharmacy an amount to
26.23be paid through fees by each respective board. The amount apportioned to each board
26.24shall equal each board's share of the annual appropriation to the Board of Pharmacy
26.25from the state government special revenue fund for operating the prescription electronic
26.26reporting system monitoring program under this section. Each board's apportioned share
26.27shall be based on the number of prescribers or dispensers that each board identified in
26.28this paragraph licenses as a percentage of the total number of prescribers and dispensers
26.29licensed collectively by these boards. Each respective board may adjust the fees that the
26.30boards are required to collect to compensate for the amount apportioned to each board by
26.31the administrative services unit.

26.32    Sec. 29. REPEALER.
26.33Minnesota Statutes 2012, sections 151.19, subdivision 2; 151.25; 151.37,
26.34subdivision 11; 151.45; 151.47, subdivision 2; and 151.48, are repealed.