2006 Minnesota Statutes

CHAPTER 151. PHARMACY

BOARD OF PHARMACY

151.01 DEFINITIONS.
    Subdivision 1. Words, terms, and phrases. Unless the language or context clearly indicates
that a different meaning is intended, the following words, terms, and phrases, for the purposes of
this chapter, shall be given the meanings subjoined to them.
    Subd. 2. Pharmacy. "Pharmacy" means an established place of business in which
prescriptions, drugs, medicines, chemicals, and poisons are prepared, compounded, dispensed,
vended, or sold to or for the use of patients and from which related clinical pharmacy services are
delivered.
    Subd. 3. Pharmacist. The term "pharmacist" means an individual with a currently valid
license issued by the Board of Pharmacy to practice pharmacy.
    Subd. 4.[Repealed, 1988 c 550 s 20]
    Subd. 5. Drug. The term "drug" means all medicinal substances and preparations recognized
by the United States Pharmacopoeia and National Formulary, or any revision thereof, and
all substances and preparations intended for external and internal use in the diagnosis, cure,
mitigation, treatment, or prevention of disease in humans or other animals, and all substances
and preparations, other than food, intended to affect the structure or any function of the bodies of
humans or other animals.
    Subd. 6. Medicine. The term "medicine" means any remedial agent that has the property of
curing, preventing, treating, or mitigating diseases, or that is used for that purpose.
    Subd. 7. Poisons. The term "poisons" means any substance which, when introduced into the
system, directly or by absorption, produces violent, morbid, or fatal changes, or which destroys
living tissue with which it comes in contact.
    Subd. 8. Chemical. The term "chemical" means all medicinal or industrial substances,
whether simple or compound, or obtained through the process of the science and art of chemistry,
whether of organic or inorganic origin.
    Subd. 9. Board or State Board of Pharmacy. The term "board" or "State Board of
Pharmacy" means the Minnesota State Board of Pharmacy.
    Subd. 10. Director. The term "director" means the director of the Minnesota State Board of
Pharmacy.
    Subd. 11. Person. The term "person" means an individual, firm, partnership, company,
corporation, trustee, association, agency, or other public or private entity.
    Subd. 12. Wholesale. The term "wholesale" means and includes any sale for the purpose
of resale.
    Subd. 13. Commercial purposes. The phrase "commercial purposes" means the ordinary
purposes of trade, agriculture, industry, and commerce, exclusive of the practices of medicine
and pharmacy.
    Subd. 14. Manufacturing. The term "manufacturing" except in the case of bulk
compounding, prepackaging or extemporaneous compounding within a pharmacy, means and
includes the production, quality control and standardization by mechanical, physical, chemical, or
pharmaceutical means, packing, repacking, tableting, encapsulating, labeling, relabeling, filling
or by any other process, of all drugs, medicines, chemicals, or poisons, without exception, for
medicinal purposes.
    Subd. 15. Pharmacist intern. The term "pharmacist intern" means (1) a natural person
satisfactorily progressing toward the degree in pharmacy required for licensure, or (2) a graduate
of the University of Minnesota College of Pharmacy, or other pharmacy college approved by the
board, who is registered by the State Board of Pharmacy for the purpose of obtaining practical
experience as a requirement for licensure as a pharmacist, or (3) a qualified applicant awaiting
examination for licensure.
    Subd. 15a. Pharmacy technician. The term "pharmacy technician" means a person not
licensed as a pharmacist or a pharmacist intern, who assists the pharmacist in the preparation
and dispensing of medications by performing computer entry of prescription data and other
manipulative tasks. A pharmacy technician shall not perform tasks specifically reserved to a
licensed pharmacist or requiring professional judgment.
    Subd. 16. Prescription. The term "prescription" means a signed written order, or an oral
order reduced to writing, given by a practitioner licensed to prescribe drugs for patients in the
course of the practitioner's practice, issued for an individual patient and containing the following:
the date of issue, name and address of the patient, name and quantity of the drug prescribed,
directions for use, and the name and address of the prescriber.
    Subd. 17. Legend drug. "Legend drug" means a drug which is required by federal law to
bear the following statement, "Caution: Federal law prohibits dispensing without prescription."
    Subd. 18. Label. "Label" means a display of written, printed, or graphic matter upon the
immediate container of any drug or medicine; and a requirement made by or under authority of
Laws 1969, chapter 933 that any word, statement, or other information appearing on the label
shall not be considered to be complied with unless such word, statement, or other information also
appears on the outside container or wrapper, if any there be, of the retail package of such drug or
medicine, or is easily legible through the outside container or wrapper.
    Subd. 19. Package. "Package" means any container or wrapping in which any drug or
medicine is enclosed for use in the delivery or display of that article to retail purchasers, but
does not include:
(a) shipping containers or wrappings used solely for the transportation of any such article in
bulk or in quantity to manufacturers, packers, processors, or wholesale or retail distributors;
(b) shipping containers or outer wrappings used by retailers to ship or deliver any such
article to retail customers if such containers and wrappings bear no printed matter pertaining
to any particular drug or medicine.
    Subd. 20. Labeling. "Labeling" means all labels and other written, printed, or graphic matter
(a) upon a drug or medicine or any of its containers or wrappers, or (b) accompanying such article.
    Subd. 21. Federal act. "Federal act" means the federal Food, Drug, and Cosmetic Act,
United States Code, title 21, section 301, et seq., as amended.
    Subd. 22. Pharmacist in charge. "Pharmacist in charge" means a duly licensed pharmacist
in the state of Minnesota who has been designated in accordance with the rules of the State
Board of Pharmacy to assume professional responsibility for the operation of the pharmacy in
compliance with the requirements and duties as established by the board in its rules.
    Subd. 23. Practitioner. "Practitioner" means a licensed doctor of medicine, licensed doctor
of osteopathy duly licensed to practice medicine, licensed doctor of dentistry, licensed doctor
of optometry, licensed podiatrist, or licensed veterinarian. For purposes of sections 151.15,
subdivision 4 , 151.37, subdivision 2, paragraph (b), and 151.461, "practitioner" also means a
physician assistant authorized to prescribe, dispense, and administer under chapter 147A, or an
advanced practice nurse authorized to prescribe, dispense, and administer under section 148.235.
    Subd. 24. Brand name. "Brand name" means the registered trademark name given to a drug
product by its manufacturer, labeler or distributor.
    Subd. 25. Generic name. "Generic name" means the established name or official name
of a drug or drug product.
    Subd. 26. Finished dosage form. "Finished dosage form" means that form of a drug which is
or is intended to be dispensed or administered to the patient and requires no further manufacturing
or processing other than packaging, reconstitution, or labeling.
    Subd. 27. Practice of pharmacy. "Practice of pharmacy" means:
(1) interpretation and evaluation of prescription drug orders;
(2) compounding, labeling, and dispensing drugs and devices (except labeling by a
manufacturer or packager of nonprescription drugs or commercially packaged legend drugs and
devices);
(3) participation in clinical interpretations and monitoring of drug therapy for assurance
of safe and effective use of drugs;
(4) participation in drug and therapeutic device selection; drug administration for first dosage
and medical emergencies; drug regimen reviews; and drug or drug-related research;
(5) participation in administration of influenza and pneumococcal vaccine to individuals
over 18 years of age under standing orders from a physician licensed under chapter 147 or by
written protocol with a physician provided that:
(i) the pharmacist is trained in a program approved by the American Council of
Pharmaceutical Education for the administration of immunizations or graduated from a college of
pharmacy in 2001 or thereafter; and
(ii) the pharmacist reports the administration of the immunization to the patient's primary
physician or clinic;
(6) participation in the practice of managing drug therapy and modifying drug therapy,
according to section 151.21, subdivision 1, on a case-by-case basis according to a written protocol
between the specific pharmacist and the individual dentist, optometrist, physician, podiatrist, or
veterinarian who is responsible for the patient's care and authorized to independently prescribe
drugs. Any significant changes in drug therapy must be reported by the pharmacist to the patient's
medical record;
(7) participation in the storage of drugs and the maintenance of records;
(8) responsibility for participation in patient counseling on therapeutic values, content,
hazards, and uses of drugs and devices; and
(9) offering or performing those acts, services, operations, or transactions necessary in the
conduct, operation, management, and control of a pharmacy.
    Subd. 28. Veterinary legend drug. "Veterinary legend drug" means a drug that is required
by federal law to bear the following statement: "Caution: Federal law restricts this drug to use
by or on the order of a licensed veterinarian."
    Subd. 29. Legend medical gas. "Legend medical gas" means a liquid or gaseous substance
used for medical purposes and that is required by federal law to bear the following statement:
"Caution: Federal law prohibits dispensing without a prescription."
    Subd. 30. Dispense. "Dispense or dispensing" means the preparation or delivery of a drug
pursuant to a lawful order of a practitioner in a suitable container appropriately labeled for
subsequent administration to or use by a patient or other individual entitled to receive the drug.
History: (5808-1) 1937 c 354 s 1; 1961 c 394 s 1; 1967 c 377 s 1,2; 1969 c 933 s 1-7; 1973
c 639 s 1,2; 1975 c 101 s 1; 1985 c 247 s 25; 1985 c 248 s 70; 1986 c 444; 1988 c 550 s 1-5; 1990
c 412 s 1,2; 1990 c 526 s 2; 1991 c 213 s 1; 1993 c 121 s 10; 1994 c 389 s 3; 1994 c 632 art 2 s
36; 1995 c 205 art 2 s 5; 1997 c 132 s 1; 1999 c 62 s 1; 2003 c 118 s 18

151.02 STATE BOARD OF PHARMACY.
The Minnesota State Board of Pharmacy shall consist of two public members as defined by
section 214.02 and five pharmacists actively engaged in the practice of pharmacy in this state.
Each of said pharmacists shall have had at least five consecutive years of practical experience as a
pharmacist immediately preceding appointment.
History: (5808-2) 1937 c 354 s 2; 1973 c 638 s 27; 1976 c 239 s 58; 1986 c 444

151.03 MEMBERSHIP.
Members of the board shall be appointed by the governor. The governor shall make
appointments to the board that reflect the geography of the state. The board members who are
pharmacists must, as a whole, reflect the broad mix of practice types of pharmacists practicing
in Minnesota. Membership terms, compensation of members, removal of members, the filling
of membership vacancies, and fiscal year and reporting requirements shall be as provided in
sections 214.07 to 214.09. The provision of staff, administrative services and office space; the
review and processing of complaints; the setting of board fees; and other provisions relating to
board operations shall be as provided in chapter 214. Any pharmacist on the board who, during
incumbency, ceases to be actively engaged in the practice of pharmacy in this state shall be
automatically disqualified from membership.
History: (5808-3) 1937 c 354 s 3; 1973 c 638 s 28; 1975 c 136 s 29; 1976 c 149 s 32; 1976 c
222 s 80; 1986 c 444; 1991 c 199 art 1 s 45; 1992 c 389 s 1

151.04 RECOMMENDED NAMES.
The Minnesota State Pharmaceutical Association and the Minnesota Society of Hospital
Pharmacists may jointly recommend five names for each pharmacist to be appointed.
History: (5808-4) 1937 c 354 s 4; 1973 c 638 s 29; 1988 c 550 s 6

151.05 ELECTION OF OFFICERS.
The board shall annually elect one of its members as president and one of its members as
vice-president, and a pharmacist, who may or may not be a member, as secretary.
History: (5808-5) 1937 c 354 s 5

151.06 POWERS AND DUTIES.
    Subdivision 1. Generally; rules. (a) Powers and duties. The Board of Pharmacy shall have
the power and it shall be its duty:
(1) to regulate the practice of pharmacy;
(2) to regulate the manufacture, wholesale, and retail sale of drugs within this state;
(3) to regulate the identity, labeling, purity, and quality of all drugs and medicines dispensed
in this state, using the United States Pharmacopeia and the National Formulary, or any revisions
thereof, or standards adopted under the federal act as the standard;
(4) to enter and inspect by its authorized representative any and all places where drugs,
medicines, medical gases, or veterinary drugs or devices are sold, vended, given away,
compounded, dispensed, manufactured, wholesaled, or held; it may secure samples or specimens
of any drugs, medicines, medical gases, or veterinary drugs or devices after paying or offering
to pay for such sample; it shall be entitled to inspect and make copies of any and all records of
shipment, purchase, manufacture, quality control, and sale of these items provided, however, that
such inspection shall not extend to financial data, sales data, or pricing data;
(5) to examine and license as pharmacists all applicants whom it shall deem qualified to be
such;
(6) to license wholesale drug distributors;
(7) to deny, suspend, revoke, or refuse to renew any registration or license required under
this chapter, to any applicant or registrant or licensee upon any of the following grounds:
(i) fraud or deception in connection with the securing of such license or registration;
(ii) in the case of a pharmacist, conviction in any court of a felony;
(iii) in the case of a pharmacist, conviction in any court of an offense involving moral
turpitude;
(iv) habitual indulgence in the use of narcotics, stimulants, or depressant drugs; or habitual
indulgence in intoxicating liquors in a manner which could cause conduct endangering public
health;
(v) unprofessional conduct or conduct endangering public health;
(vi) gross immorality;
(vii) employing, assisting, or enabling in any manner an unlicensed person to practice
pharmacy;
(viii) conviction of theft of drugs, or the unauthorized use, possession, or sale thereof;
(ix) violation of any of the provisions of this chapter or any of the rules of the State Board of
Pharmacy;
(x) in the case of a pharmacy license, operation of such pharmacy without a pharmacist
present and on duty;
(xi) in the case of a pharmacist, physical or mental disability which could cause
incompetency in the practice of pharmacy;
(xii) in the case of a pharmacist, the suspension or revocation of a license to practice
pharmacy in another state; or
(xiii) in the case of a pharmacist, aiding suicide or aiding attempted suicide in violation of
section 609.215 as established by any of the following:
(A) a copy of the record of criminal conviction or plea of guilty for a felony in violation of
section 609.215, subdivision 1 or 2;
(B) a copy of the record of a judgment of contempt of court for violating an injunction
issued under section 609.215, subdivision 4;
(C) a copy of the record of a judgment assessing damages under section 609.215, subdivision
5 ; or
(D) a finding by the board that the person violated section 609.215, subdivision 1 or 2. The
board shall investigate any complaint of a violation of section 609.215, subdivision 1 or 2;
(8) to employ necessary assistants and make rules for the conduct of its business;
(9) to register pharmacy technicians; and
(10) to perform such other duties and exercise such other powers as the provisions of the
act may require.
(b) Temporary suspension. In addition to any other remedy provided by law, the board may,
without a hearing, temporarily suspend a license for not more than 60 days if the board finds that
a pharmacist has violated a statute or rule that the board is empowered to enforce and continued
practice by the pharmacist would create an imminent risk of harm to others. The suspension shall
take effect upon written notice to the pharmacist, specifying the statute or rule violated. At the
time it issues the suspension notice, the board shall schedule a disciplinary hearing to be held
under the Administrative Procedure Act. The pharmacist shall be provided with at least 20 days'
notice of any hearing held under this subdivision.
(c) Rules. For the purposes aforesaid, it shall be the duty of the board to make and publish
uniform rules not inconsistent herewith for carrying out and enforcing the provisions of this
chapter. The board shall adopt rules regarding prospective drug utilization review and patient
counseling by pharmacists. A pharmacist in the exercise of the pharmacist's professional judgment,
upon the presentation of a new prescription by a patient or the patient's caregiver or agent, shall
perform the prospective drug utilization review required by rules issued under this subdivision.
    Subd. 1a. Disciplinary action. It shall be grounds for disciplinary action by the Board of
Pharmacy against the registration of the pharmacy if the Board of Pharmacy determines that any
person with supervisory responsibilities at the pharmacy sets policies that prevent a licensed
pharmacist from providing drug utilization review and patient counseling as required by rules
adopted under subdivision 1. The Board of Pharmacy shall follow the requirements of chapter 14
in any disciplinary actions taken under this section.
    Subd. 2. Application. The provisions of subdivision 1 shall apply to an individual owner or
sole proprietor and shall also apply to the following:
(1) In the case of a partnership, each partner thereof;
(2) In the case of an association, each member thereof;
(3) In the case of a corporation, each officer or director thereof and each shareholder owning
30 percent or more of the voting stock of such corporation.
    Subd. 2a.[Repealed, 1988 c 550 s 20]
    Subd. 3. Application of Administrative Procedure Act. The board shall comply with the
provisions of chapter 14, before it fails to issue, renew, suspends, or revokes any license or
registration issued under this chapter.
    Subd. 4. Reinstatement. Any license or registration which has been suspended or revoked
may be reinstated by the board provided the holder thereof shall pay all costs of the proceedings
resulting in the suspension or revocation, and, in addition thereto, pay a fee set by the board.
    Subd. 5. Costs; penalties. The board may impose a civil penalty not exceeding $10,000 for
each separate violation, the amount of the civil penalty to be fixed so as to deprive a licensee or
registrant of any economic advantage gained by reason of the violation, to discourage similar
violations by the licensee or registrant or any other licensee or registrant, or to reimburse the
board for the cost of the investigation and proceeding, including, but not limited to, fees paid
for services provided by the Office of Administrative Hearings, legal and investigative services
provided by the Office of the Attorney General, court reporters, witnesses, reproduction of
records, board members' per diem compensation, board staff time, and travel costs and expenses
incurred by board staff and board members.
History: (5808-6) 1937 c 354 s 6; 1941 c 78 s 1; 1955 c 847 s 16; 1969 c 933 s 8; 1973 c
722 s 2; 1975 c 136 s 30; 1976 c 222 s 81,82; 1982 c 424 s 130; 1985 c 248 s 70; 1988 c 550 s
7; 1990 c 526 s 3; 1990 c 568 art 2 s 18; 1992 c 513 art 7 s 10,11; 1992 c 577 s 5; 1997 c
132 s 2; 2003 c 66 s 8

151.061 UNFAIR PRICE DISCRIMINATION.
    Subdivision 1. Generally. Any person doing business in this state and engaged in the
distribution (other than at retail) of any prescription drugs, who shall discriminate between
purchasers by selling prescription drugs at a lower price or rate to one purchaser or association of
purchasers than offered to another purchaser or association of purchasers within this state (other
than at retail) after making allowance for the difference, if any, in the grade, quality, or quantity,
and after equalizing the distance from the point of distribution and freight costs therefrom, shall
be guilty of unfair discrimination. Unfair discrimination occurs when quantity discounts are
not reasonably based on actual cost savings to all like purchasers. Unfair discrimination shall
embrace any scheme of special rebates, collateral contracts, or any device of any nature which in
substance violates the provisions of this subdivision. Nothing in this subdivision shall apply to
purchases for their own use by schools, colleges, universities, public libraries, churches, hospitals
or charitable institutions not operated for profit.
    Subd. 2. Remedy. Any person injured by unfair discrimination as defined in subdivision 1
may bring a civil action and recover damages, together with costs and disbursements, including
reasonable attorney's fees, and receive other equitable relief as determined by the court. The
remedies provided by this section are cumulative and shall not be construed as restricting any
remedy which is otherwise available.
History: 1973 c 722 s 1

151.07 MEETINGS; EXAMINATION FEE.
The board shall meet at times as may be necessary and as it may determine to examine
applicants for licensure and to transact its other business, giving reasonable notice of all
examinations by mail to known applicants therefor. The secretary shall record the names of all
persons licensed by the board, together with the grounds upon which the right of each to licensure
was claimed. The fee for examination shall be in such amount as the board may determine, which
fee may in the discretion of the board be returned to applicants not taking the examination.
History: (5808-7) 1937 c 354 s 7; 1953 c 76 s 1; 1961 c 394 s 2; 1975 c 136 s 31; 1976
c 222 s 83

151.08 [Repealed, 1975 c 136 s 77]

151.09 [Repealed, 1976 c 222 s 209]

151.095 INACTIVE STATUS LICENSE.
The board may, by rule, establish standards for an inactive status of licensure for previously
licensed pharmacists who have retired from active practice, have left the state, or have otherwise
ceased to be actively engaged in the practice of pharmacy in this state.
History: 1988 c 550 s 8

151.10 QUALIFICATIONS OF APPLICANTS.
    Subdivision 1. Graduates of schools in good standing. To be entitled to examination by the
board as a pharmacist the applicant shall be of good moral character, at least 18 years of age, and
shall be a graduate of the College of Pharmacy of the University of Minnesota or of a college
or school of pharmacy in good standing of which the board shall be the judge and shall have
completed internship requirements as prescribed by the board.
    Subd. 2. Graduates of schools outside the United States. An applicant who is a graduate of
a school or college of pharmacy located outside the United States, when that school or college of
pharmacy has not been recognized by the board as a school in good standing, may be entitled
to examination for licensure by the board if the applicant is of good moral character, at least 18
years of age, has completed the internship requirements prescribed by the board, has provided
verification of the applicant's academic record and graduation, and has successfully passed
examinations approved by the board to establish proficiency in English and equivalency of
education with graduates of schools or colleges of pharmacy which the board has determined to
be in good standing.
History: (5808-10) 1937 c 354 s 10; 1941 c 78 s 2; 1973 c 639 s 3; 1973 c 725 s 20; 1976 c
222 s 84; 1984 c 426 s 1; 1986 c 444

151.101 INTERNSHIP.
The board may license as an intern any natural persons who have satisfied the board that
they are of good moral character, not physically or mentally unfit, and who have successfully
completed the educational requirements for intern licensure prescribed by the board. The board
shall prescribe standards and requirements for interns, pharmacist-preceptors, and internship
training but may not require more than one year of such training.
The board in its discretion may accept internship experience obtained in another state
provided the internship requirements in such other state are in the opinion of the board equivalent
to those herein provided.
History: 1969 c 933 s 9; 1973 c 639 s 4; 1976 c 222 s 85; 1986 c 444; 1988 c 550 s 9

151.102 PHARMACY TECHNICIAN.
    Subdivision 1. General. A pharmacy technician may assist a pharmacist in the practice of
pharmacy by performing nonjudgmental tasks and works under the personal and direct supervision
of the pharmacist. A pharmacist may supervise two technicians, as long as the pharmacist assumes
responsibility for all the functions performed by the technicians. A pharmacy may exceed the
ratio of pharmacy technicians to pharmacists permitted in this subdivision or in rule by a total
of one technician at any given time in the pharmacy, provided at least one technician in the
pharmacy holds a valid certification from the Pharmacy Technician Certification Board or from
another national certification body for pharmacy technicians that requires passage of a nationally
recognized, psychometrically valid certification examination for certification as determined
by the Board of Pharmacy. The Board of Pharmacy may, by rule, set ratios of technicians to
pharmacists greater than two to one for the functions specified in rule. The delegation of any
duties, tasks, or functions by a pharmacist to a pharmacy technician is subject to continuing
review and becomes the professional and personal responsibility of the pharmacist who directed
the pharmacy technician to perform the duty, task, or function.
    Subd. 2. Waivers by board permitted. A pharmacist in charge in a pharmacy may
petition the board for authorization to allow a pharmacist to supervise more than two pharmacy
technicians. The pharmacist's petition must include provisions addressing the maintenance of
patient care and safety. A petition filed with the board under this subdivision shall be deemed
approved 90 days after the board receives the petition, unless the board denies the petition
within 90 days of receipt and notifies the petitioning pharmacist of the petition's denial and the
board's reasons for denial.
History: 1997 c 132 s 3; 1999 c 63 s 1; 2000 c 276 s 1

151.11 [Repealed, 1988 c 550 s 20]

151.12 RECIPROCITY; LICENSURE.
The board may in its discretion grant licensure without examination to any pharmacist
licensed by the Board of Pharmacy or a similar board of another state which accords similar
recognition to licensees of this state; provided, the requirements for licensure in such other state
are in the opinion of the board equivalent to those herein provided. The fee for licensure shall be
in such amount as the board may determine by rule.
History: (5808-12) 1937 c 354 s 12; 1961 c 394 s 4; 1973 c 639 s 5; 1976 c 222 s 87

151.13 RENEWAL FEE; CONTINUING EDUCATION.
    Subdivision 1. Renewal fee. Every person licensed by the board shall pay to the board a
renewal fee to be fixed by it. The board may promulgate by rule a charge to be assessed for the
delinquent payment of a fee. It shall be unlawful for any person licensed as a pharmacist who
refuses or fails to pay such renewal fee to practice pharmacy in this state. Every certificate and
license shall expire at the time therein prescribed.
    Subd. 2. Continuing education. The board may appoint an advisory task force on continuing
education, consisting of not more than ten members, to study continuing education programs and
requirements and to submit its report and recommendations to the board. The task force shall
expire, and the compensation and removal of members shall be as provided in section 15.059.
History: (5808-13) 1937 c 354 s 13; 1961 c 394 s 5; 1969 c 486 s 1; 1973 c 655 s 1; 1976
c 222 s 88; 1983 c 260 s 38; 1990 c 412 s 3

151.14 REINSTATEMENTS.
Any person who has been licensed by the board and has defaulted in the payment of the
renewal fee may be reinstated within two years of such default without examination, upon
payment of the arrears and upon compliance with the provisions of section 151.13, subdivision 2.
History: (5808-14) 1937 c 354 s 14; 1973 c 655 s 2; 1976 c 222 s 89

151.15 COMPOUNDING DRUGS UNLAWFUL UNDER CERTAIN CONDITIONS.
    Subdivision 1. Location. It shall be unlawful for any person to compound, dispense, vend,
or sell drugs, medicines, chemicals, or poisons in any place other than a pharmacy, except
as provided in this chapter.
    Subd. 2. Proprietors of pharmacies. No proprietor of a pharmacy shall permit the
compounding or dispensing of prescriptions except by a pharmacist or by a pharmacist intern
under the personal supervision of a pharmacist; or the vending or selling of drugs, medicines,
chemicals, or poisons in the proprietor's pharmacy except under the personal supervision of a
pharmacist.
    Subd. 3. Unlicensed persons; veterinary legend drugs. It shall be unlawful for any person
other than a licensed veterinarian or pharmacist to compound or dispense veterinary legend drugs
except as provided in this chapter.
    Subd. 4. Unlicensed persons; legend drugs. It shall be unlawful for any person other than a
licensed practitioner or pharmacist to compound or dispense legend drugs except as provided
in this chapter.
History: (5808-16) 1937 c 354 s 16; 1967 c 377 s 3; 1986 c 444; 1988 c 550 s 10; 1990 c
526 s 4; 1991 c 213 s 2; 1994 c 632 art 2 s 37

151.16 VIOLATION A GROSS MISDEMEANOR.
Every person who violates any of the provisions of section 151.15, when the death of a
human being results from such violation shall be guilty of a gross misdemeanor. This section is
supplementary to existing laws relating to homicide and not a repeal thereof.
History: (5808-17) 1937 c 354 s 17

151.17 UNLAWFUL USE OF "PHARMACIST."
It shall be unlawful for any person to falsely assume or pretend to the title of pharmacist.
History: (5808-18) 1937 c 354 s 18

151.18 UNLAWFUL TO USE MISLEADING NAME.
It is unlawful for any person to carry on, conduct, or transact a retail business under a name
which contains as a part thereof the words "drugs," "drug store," "pharmacy," "medicine,"
"apothecary," or "chemist shop," or any abbreviation, translation, extension, or variation thereof;
or in any manner by advertisement, circular, or poster, sign or otherwise, describe or refer to the
place of business conducted by such person by such term, abbreviation, translation, extension, or
variation unless the place so conducted is a pharmacy.
History: (5808-19) 1937 c 354 s 19

151.19 REGISTRATION; FEES.
    Subdivision 1. Pharmacy registration. The board shall require and provide for the annual
registration of every pharmacy now or hereafter doing business within this state. Upon the
payment of a fee to be set by the board, the board shall issue a registration certificate in such form
as it may prescribe to such persons as may be qualified by law to conduct a pharmacy. Such
certificate shall be displayed in a conspicuous place in the pharmacy for which it is issued and
expire on the 30th day of June following the date of issue. It shall be unlawful for any person to
conduct a pharmacy unless such certificate has been issued to the person by the board.
    Subd. 2. Nonresident pharmacies. The board shall require and provide for an annual
nonresident special pharmacy registration for all pharmacies located outside of this state that
regularly dispense medications for Minnesota residents and mail, ship, or deliver prescription
medications into this state. Nonresident special pharmacy registration shall be granted by the
board upon the disclosure and certification by a pharmacy:
(1) that it is licensed in the state in which the dispensing facility is located and from which
the drugs are dispensed;
(2) the location, names, and titles of all principal corporate officers and all pharmacists who
are dispensing drugs to residents of this state;
(3) that it complies with all lawful directions and requests for information from the Board of
Pharmacy of all states in which it is licensed or registered, except that it shall respond directly
to all communications from the board concerning emergency circumstances arising from the
dispensing of drugs to residents of this state;
(4) that it maintains its records of drugs dispensed to residents of this state so that the records
are readily retrievable from the records of other drugs dispensed;
(5) that it cooperates with the board in providing information to the Board of Pharmacy of
the state in which it is licensed concerning matters related to the dispensing of drugs to residents
of this state; and
(6) that during its regular hours of operation, but not less than six days per week, for
a minimum of 40 hours per week, a toll-free telephone service is provided to facilitate
communication between patients in this state and a pharmacist at the pharmacy who has access to
the patients' records; the toll-free number must be disclosed on the label affixed to each container
of drugs dispensed to residents of this state.
    Subd. 3. Sale of federally restricted medical gases. The board shall require and provide
for the annual registration of every person or establishment not licensed as a pharmacy or a
practitioner engaged in the retail sale or distribution of federally restricted medical gases. Upon
the payment of a fee to be set by the board, the board shall issue a registration certificate in such
form as it may prescribe to those persons or places that may be qualified to sell or distribute
federally restricted medical gases. The certificate shall be displayed in a conspicuous place in
the business for which it is issued and expire on the date set by the board. It is unlawful for a
person to sell or distribute federally restricted medical gases unless a certificate has been issued
to that person by the board.
History: (5808-20) 1937 c 354 s 20; 1953 c 76 s 3; 1961 c 394 s 6; 1969 c 486 s 2; 1976 c
222 s 90; 1986 c 444; 1988 c 550 s 11; 1989 c 314 s 1

151.20 [Repealed, 1969 c 933 s 22]

151.21 SUBSTITUTION.
    Subdivision 1. Generally. Except as provided in this section, it shall be unlawful for any
pharmacist, assistant pharmacist, or pharmacist intern who dispenses prescriptions, drugs, and
medicines to substitute an article different from the one ordered, or deviate in any manner from
the requirements of an order or prescription without the approval of the prescriber.
    Subd. 2. Brand name specified. When a pharmacist receives a written prescription on which
the prescriber has personally written in handwriting "dispense as written" or "D.A.W.," or an oral
prescription in which the prescriber has expressly indicated that the prescription is to be dispensed
as communicated, the pharmacist shall dispense the brand name legend drug as prescribed.
    Subd. 3. Brand name not specified. When a pharmacist receives a written prescription
on which the prescriber has not personally written in handwriting "dispense as written" or
"D.A.W.," or an oral prescription in which the prescriber has not expressly indicated that the
prescription is to be dispensed as communicated, and there is available in the pharmacist's stock
a less expensive generically equivalent drug that, in the pharmacist's professional judgment,
is safely interchangeable with the prescribed drug, then the pharmacist shall, after disclosing
the substitution to the purchaser, dispense the generic drug, unless the purchaser objects. A
pharmacist may also substitute pursuant to the oral instructions of the prescriber. A pharmacist
may not substitute a generically equivalent drug product unless, in the pharmacist's professional
judgment, the substituted drug is therapeutically equivalent and interchangeable to the prescribed
drug. A pharmacist shall notify the purchaser if the pharmacist is dispensing a drug other than the
brand name drug prescribed.
    Subd. 4. Pricing. A pharmacist dispensing a drug under the provisions of subdivision 3
shall not dispense a drug of a higher retail price than that of the brand name drug prescribed. If
more than one safely interchangeable generic drug is available in a pharmacist's stock, then the
pharmacist shall dispense the least expensive alternative. Any difference between acquisition cost
to the pharmacist of the drug dispensed and the brand name drug prescribed shall be passed
on to the purchaser.
    Subd. 4a. Sign. A pharmacy must post a sign in a conspicuous location and in a typeface
easily seen at the counter where prescriptions are dispensed stating: "In order to save you money,
this pharmacy will substitute whenever possible an FDA-approved, less expensive, generic drug
product, which is therapeutically equivalent to and safely interchangeable with the one prescribed
by your doctor, unless you object to this substitution."
    Subd. 5. Reimbursement. Nothing in this section requires a pharmacist to substitute a
generic drug if the substitution will make the transaction ineligible for third-party reimbursement.
    Subd. 6. Disclosure. When a pharmacist dispenses a brand name legend drug and, at that
time, a less expensive generically equivalent drug is also available in the pharmacist's stock, the
pharmacist shall disclose to the purchaser that a generic drug is available.
    Subd. 7. Drug formulary. This section does not apply when a pharmacist is dispensing a
prescribed drug to persons covered under a managed health care plan that maintains a mandatory
or closed drug formulary.
    Subd. 8. List of excluded products. The Drug Formulary Committee established under
section 256B.0625, subdivision 13, shall establish a list of drug products that are to be excluded
from this section. This list shall be updated on an annual basis and shall be provided to the board
for dissemination to pharmacists licensed in the state.
History: (5808-22) 1937 c 354 s 22; 1969 c 933 s 10; 1975 c 101 s 2; 1986 c 444; 1993 c
345 art 5 s 10; 1994 c 625 art 8 s 48,49; 1997 c 202 art 2 s 40

151.211 RECORDS OF PRESCRIPTIONS.
All prescriptions dispensed shall be kept on file at the location in which such dispensing
occurred for a period of at least two years. No prescription shall be refilled except with the written
or verbal consent of the prescriber. The date of such refill must be recorded and initialed upon the
original prescription or within the electronically maintained record of the original prescription by
the pharmacist, pharmacist intern, or practitioner who refills the prescription.
History: 1969 c 933 s 11; 1973 c 639 s 6; 1986 c 444; 1988 c 550 s 12

151.212 LABEL OF PRESCRIPTION DRUG CONTAINERS.
    Subdivision 1. Prescription drugs. Drugs dispensed pursuant to a prescription shall bear a
label permanently affixed to the immediate container in which the drug is dispensed and which is
received by the purchaser. The label shall bear the name of the manufacturer or distributor of
the finished dosage form of the drug and all other information required by law and by rules of
the board.
    Subd. 2. Controlled substances. In addition to the requirements of subdivision 1, when the
use of any drug containing a controlled substance, as defined in chapter 152, or any other drug
determined by the board, either alone or in conjunction with alcoholic beverages, may impair
the ability of the user to operate a motor vehicle, the board shall require by rule that notice be
prominently set forth on the label or container. Rules promulgated by the board shall specify
exemptions from this requirement when there is evidence that the user will not operate a motor
vehicle while using the drug.
    Subd. 3. Veterinary drugs. Drugs dispensed, sold, or distributed in any manner pursuant to
the order of a licensed veterinarian shall bear a label permanently affixed to the container in which
the drug is dispensed and which is received by the purchaser. The label shall bear the name of
the manufacturer or distributor of the finished dosage form of the drug and all other information
required by law and the rules of the board.
History: 1969 c 933 s 12; 1975 c 101 s 3; 1975 c 356 s 1; 1976 c 338 s 5; 1985 c 248 s 70;
1988 c 550 s 13,14

151.213 COPIES OF PRESCRIPTIONS.
Prescriptions on file in a pharmacy are not a public record. A person having custody of or
access to such prescription orders shall not divulge the contents thereof or provide a copy thereof
to anyone except to:
(1) The patient for whom the prescription was issued, the patient's agent, or another
pharmacist acting on behalf of the patient or the patient's agent;
(2) The licensed practitioner who issued the prescription;
(3) The licensed practitioner who is then treating the patient;
(4) A member, inspector, or investigator of the board or any federal, state, county, or
municipal officer whose duty it is to enforce the laws of this state or the United States relating to
drugs and who is engaged in a specific investigation involving a designated person or drug;
(5) An agency of government charged with the responsibility of providing medical care
for the patient;
(6) An insurance carrier or attorney on receipt of written authorization signed by the patient
or the patient's legal representative, authorizing the release of such information;
(7) Any person duly authorized by a court order.
Such copies furnished shall bear on the face thereof the statement "Copy for information
only," and may be filed to account for the dispensing of a drug only if such dispensing is
authorized in writing or orally by the prescriber and communicated to the pharmacist dispensing
and filing such copy.
History: 1969 c 933 s 13; 1986 c 444

151.214 PAYMENT DISCLOSURE.
    Subdivision 1. Explanation of pharmacy benefits. A pharmacist licensed under this chapter
must provide to a patient, for each prescription dispensed where part or all of the cost of the
prescription is being paid or reimbursed by an employer-sponsored plan or health plan company,
or its contracted pharmacy benefit manager, the patient's co-payment amount and the pharmacy's
own usual and customary price of the prescription or the amount the pharmacy will be paid for
the prescription drug by the patient's employer-sponsored plan or health plan company, or its
contracted pharmacy benefit manager.
    Subd. 2. No prohibition on disclosure. No contracting agreement between an
employer-sponsored health plan or health plan company, or its contracted pharmacy benefit
manager, and a resident or nonresident pharmacy registered under this chapter, may prohibit the
pharmacy from disclosing to patients information a pharmacy is required or given the option to
provide under subdivision 1.
History: 2004 c 268 s 13; 2004 c 288 art 3 s 5; 2005 c 10 art 1 s 82; 2006 c 267 art 1 s 6

151.22 LIABILITY FOR QUALITY OF DRUGS.
Every pharmacist in charge or proprietor of a pharmacy shall be responsible for the quality of
all drugs, medicines, chemicals, and poisons procured for use and sold therein, except proprietary
medicines or other articles sold in the original package of the manufacturer.
History: (5808-23) 1937 c 354 s 23; 1969 c 933 s 14

151.23 POISONS MUST BE LABELED.
It shall be unlawful for any person to sell at retail any poison without affixing to the package
or receptacle containing the same a label conspicuously bearing the word "poison," and the name
and the business address of the seller, and being satisfied that such poison is to be legitimately
used. This section shall not apply to the sale of poison on a physician's written prescription or
in the original package of the manufacturer.
History: (5808-24) 1937 c 354 s 24; 1986 c 444

151.24 SALE OF POISONS MUST BE RECORDED.
It shall be unlawful:
(1) For any person, either acting independently or while in the employ of another, to sell or
give away any poison, as designated by the board, without first recording in a book to be kept
for that purpose with an indelible pencil or ink the date, the name and address of the person to
whom, and the amount and kind of poison, delivered, except when such poison is sold on the
written prescription of a physician;
(2) To give a false name to be recorded;
(3) For any person having custody of any such record book to refuse to produce it on demand
for the inspection of any authorized agent of the board or other duly authorized officer.
History: (5808-25) 1937 c 354 s 25; 1986 c 444

151.25 REGISTRATION OF MANUFACTURERS; FEE; PROHIBITIONS.
The board shall require and provide for the annual registration of every person engaged in
manufacturing drugs, medicines, chemicals, or poisons for medicinal purposes, now or hereafter
doing business with accounts in this state. Upon a payment of a fee as set by the board, the
board shall issue a registration certificate in such form as it may prescribe to such manufacturer.
Such registration certificate shall be displayed in a conspicuous place in such manufacturer's or
wholesaler's place of business for which it is issued and expire on the date set by the board. It
shall be unlawful for any person to manufacture drugs, medicines, chemicals, or poisons for
medicinal purposes unless such a certificate has been issued to the person by the board. It shall be
unlawful for any person engaged in the manufacture of drugs, medicines, chemicals, or poisons
for medicinal purposes, or the person's agent, to sell legend drugs to other than a pharmacy,
except as provided in this chapter.
History: (5808-26) 1937 c 354 s 26; 1953 c 76 s 4; 1961 c 394 s 7; 1973 c 639 s 7; 1976
c 222 s 91; 1986 c 444; 1988 c 550 s 15; 1990 c 526 s 5; 1990 c 568 art 2 s 19; 1991 c 213
s 3; 1994 c 632 art 2 s 38

151.26 EXCEPTIONS.
    Subdivision 1. Generally. Nothing in this chapter shall subject a person duly licensed in this
state to practice medicine, dentistry, or veterinary medicine, to inspection by the State Board of
Pharmacy, nor prevent the person from administering drugs, medicines, chemicals, or poisons
in the person's practice, nor prevent a duly licensed practitioner from furnishing to a patient
properly packaged and labeled drugs, medicines, chemicals, or poisons as may be considered
appropriate in the treatment of such patient; unless the person is engaged in the dispensing, sale,
or distribution of drugs and the board provides reasonable notice of an inspection.
Except for the provisions of section 151.37, nothing in this chapter applies to or interferes
with the dispensing, in its original package and at no charge to the patient, of a legend drug, other
than a controlled substance, that was packaged by a manufacturer and provided to the dispenser
for distribution as a professional sample.
Nothing in this chapter shall prevent the sale of drugs, medicines, chemicals, or poisons
at wholesale to licensed physicians, dentists and veterinarians for use in their practice, nor
to hospitals for use therein.
Nothing in this chapter shall prevent the sale of drugs, chemicals, or poisons either at
wholesale or retail for use for commercial purposes, or in the arts, nor interfere with the sale of
insecticides, as defined in Minnesota Statutes 1974, section 24.069, and nothing in this chapter
shall prevent the sale of common household preparations and other drugs, chemicals, and poisons
sold exclusively for use for nonmedicinal purposes.
Nothing in this chapter shall apply to or interfere with the vending or retailing of any
nonprescription medicine or drug not otherwise prohibited by statute which is prepackaged, fully
prepared by the manufacturer or producer for use by the consumer, and labeled in accordance with
the requirements of the state or federal Food and Drug Act; nor to the manufacture, wholesaling,
vending, or retailing of flavoring extracts, toilet articles, cosmetics, perfumes, spices, and other
commonly used household articles of a chemical nature, for use for nonmedicinal purposes.
Nothing in this chapter shall prevent the sale of drugs or medicines by licensed pharmacists at
a discount to persons over 65 years of age.
    Subd. 2.[Repealed, 1973 c 639 s 11]
History: (5808-27) 1937 c 354 s 27; 1953 c 76 s 5; 1969 c 627 s 1; 1971 c 192 s 1; 1973 c
639 s 8; 1Sp1981 c 4 art 1 s 82; 1986 c 444; 1988 c 550 s 16

151.27 EXPENSES.
The expenses of administering sections 151.01 to 151.40 shall be paid from the
appropriations made to the State Board of Pharmacy.
History: (5808-28) 1937 c 354 s 28; 1973 c 638 s 30; 1976 c 222 s 92

151.28 [Repealed, 1988 c 550 s 20]

151.29 VIOLATION A MISDEMEANOR.
Any person violating any of the provisions of this chapter, or rules hereunder, shall be guilty
of a misdemeanor, unless otherwise provided.
History: (5808-30) 1937 c 354 s 30; 1985 c 248 s 70

151.30 COUNTY ATTORNEY TO PROSECUTE.
It shall be the duty of the county attorney of the county wherein any offense under this
chapter is committed to prosecute the offender, except that when offenses hereunder are
committed in cities of the first class it shall be the duty of the city attorney thereof to prosecute the
offender. Such prosecutor is authorized to examine the books of any manufacturer or wholesale
dealer within the state for the purpose of acquiring information to aid in the prosecution.
History: (5808-31) 1937 c 354 s 31

151.301 REPORTS TO THE COMMISSIONER OF HEALTH.
(a) The board shall maintain a record of an event that comes to the board's attention that,
in the judgment of the board or a committee of the board, qualifies as an adverse health care
event under section 144.7065.
(b) Within 30 days of making a determination under paragraph (a) that an event qualifies as
an adverse health care event, the board shall forward to the commissioner of health a report of
the event, including the facility involved, the date of the event, and information known to the
board regarding the event. The report shall not include any identifying information for any of the
health care professionals, facility employees, or patients involved.
History: 2004 c 186 s 9

151.302 IMMUNITY.
Members of the board and persons employed by the board or engaged in maintaining records
and making reports regarding adverse health care events are immune from civil liability and
criminal prosecution for any actions, transactions, or publications in the execution of or relating to
their duties under section 151.301.
History: 2004 c 186 s 10

151.31 [Repealed, 1988 c 550 s 20]

PHARMACY PRACTICE ACT OF 1988

151.32 CITATION.
The title of sections 151.01 to 151.40 shall be the Pharmacy Practice Act of 1988.
History: (5808-35) 1937 c 354 s 35; 1988 c 550 s 17

151.33 CARELESS DISTRIBUTION OF DRUGS.
    Subdivision 1. Prohibited. No person, directly or indirectly, by agent or otherwise, shall
scatter, distribute, or give away any samples of any medicine, drugs, or medical compounds,
salve, or liniment of any kind unless the same is delivered into the hands of an adult person, or
mailed to such persons through the regular mail service.
    Subd. 2. Penalty. Any person violating any provision of this section shall be guilty of
a misdemeanor.
History: (10275, 10276) 1905 c 33 s 1,2; 1971 c 23 s 15

151.34 PROHIBITED ACTS.
It shall be unlawful to:
(1) manufacture, sell or deliver, hold or offer for sale any drug that is adulterated or
misbranded;
(2) adulterate or misbrand any drug;
(3) receive in commerce any drug that is adulterated or misbranded, and to deliver or proffer
delivery thereof for pay or otherwise;
(4) refuse to permit entry or inspection, or to permit the taking of a sample, or to permit
access to or copying of any record as authorized by this chapter;
(5) remove or dispose of a detained or embargoed article in violation of this chapter;
(6) alter, mutilate, destroy, obliterate, or remove the whole or any part of the labeling of, or to
do any other act with respect to a drug, if such act is done while such drug is held for sale and
results in such drug being adulterated or misbranded;
(7) use for a person's own advantage or to reveal other than to the board or its authorized
representative or to the courts when required in any judicial proceeding under this chapter any
information acquired under authority of this chapter concerning any method or process which is a
trade secret and entitled to protection;
(8) use on the labeling of any drug any representation or suggestion that an application
with respect to such drug is effective under the federal act or that such drug complies with such
provisions;
(9) in the case of a manufacturer, packer, or distributor offering legend drugs for sale within
this state, fail to maintain for transmittal or to transmit, to any practitioner licensed by applicable
law to administer such drug who makes written request for information as to such drug, true and
correct copies of all printed matter which is required to be included in any package in which that
drug is distributed or sold, or such other printed matter as is approved under the federal act.
Nothing in this paragraph shall be construed to exempt any person from any labeling requirement
imposed by or under provisions of this chapter;
(10) conduct a pharmacy without a pharmacist in charge;
(11) dispense a legend drug without first obtaining a valid prescription for that drug;
(12) conduct a pharmacy without proper registration with the board;
(13) practice pharmacy without being licensed to do so by the board; or
(14) sell at retail federally restricted medical gases without proper registration with the board
except as provided in this chapter.
History: 1969 c 933 s 15; 1971 c 25 s 35; 1988 c 550 s 18; 1989 c 314 s 2; 1990 c 412 s 4

151.35 DRUGS, ADULTERATION.
A drug shall be deemed to be adulterated:
(1) if it consists in whole or in part of any filthy, putrid or decomposed substance; or if it
has been produced, prepared, packed, or held under unsanitary conditions whereby it may have
been rendered injurious to health, or whereby it may have been contaminated with filth; or if the
methods used in, or the facilities or controls used for, its manufacture, processing, packing, or
holding do not conform to or are not operated or administered in conformity with current good
manufacturing practice as required under the federal act to assure that such drug is safe and
has the identity, strength, quality, and purity characteristics, which it purports or is represented
to possess; or, its container is composed, in whole or in part, of any poisonous or deleterious
substance which may render the contents injurious to health; or it bears or contains, for purposes
of coloring only, a color additive which is unsafe within the meaning of the federal act, or it is a
color additive, the intended use of which in or on drugs is for the purposes of coloring only, and is
unsafe within the meaning of the federal act;
(2) if it purports to be or is represented as a drug the name of which is recognized in the
United States Pharmacopoeia or the National Formulary, and its strength differs from, or its
quality or purity falls below, the standard set forth therein. Such determination as to strength,
quality, or purity shall be made in accordance with the tests or methods of assay set forth in
such compendium, or in the absence of or inadequacy of such tests or methods of assay, those
prescribed under authority of the federal act. No drug defined in the United States Pharmacopoeia
or the National Formulary shall be deemed to be adulterated under this paragraph because it
differs from the standard of strength, quality, or purity therefor set forth in such compendium, if
its difference in strength, quality, or purity from such standard is plainly stated on its label;
(3) if it is not subject to the provisions of paragraph (2) of this section and its strength differs
from, or its purity or quality differs from that which it purports or is represented to possess;
(4) if any substance has been mixed or packed therewith so as to reduce its quality or
strength, or substituted wholly or in part therefor.
History: 1969 c 933 s 16

151.36 DRUGS, MISBRANDING.
A drug shall be deemed to be misbranded:
(1) if its labeling is false or misleading in any particular;
(2) if in package form and not dispensed pursuant to a prescription unless it bears a label
containing (a) the name and place of business of the manufacturer, packer, or distributor, (b) a
statement of identity, and (c) an accurate statement of the net quantity of the contents in terms
of weight, measure, or numerical count, provided, however, that under (c) reasonable variations
shall be permitted, and exceptions as to small packages shall be allowed in accordance with
the federal act;
(3) if any word, statement, or other information required by or under authority of this chapter
to appear on the label or labeling is not prominently placed thereon with such conspicuousness (as
compared with other words, statements, designs or devices, in the labeling) and in such terms
as to render it to be read and understood by the ordinary individual under customary conditions
of purchase and use;
(4) if it otherwise fails to meet the labeling requirements of the federal act.
History: 1969 c 933 s 17

151.361 MANUFACTURER DISCLOSURE.
    Subdivision 1. After January 1, 1976. The manufacturer, packager, or distributor of any
human use legend drug sold, delivered, or offered for sale in the state of Minnesota after January
1, 1976 must have printed on the label on the immediate container of the drug the name and
address of the manufacturer of the finished dosage form of the drug.
    Subd. 2. After January 1, 1983. (a) No legend drug in solid oral dosage form may be
manufactured, packaged or distributed for sale in this state after January 1, 1983 unless it is
clearly marked or imprinted with a symbol, number, company name, words, letters, national drug
code or other mark uniquely identifiable to that drug product. An identifying mark or imprint
made as required by federal law or by the federal Food and Drug Administration shall be deemed
to be in compliance with this section.
(b) The Board of Pharmacy may grant exemptions from the requirements of this section
on its own initiative or upon application of a manufacturer, packager, or distributor indicating
size or other characteristics which render the product impractical for the imprinting required
by this section.
(c) The provisions of clauses (a) and (b) shall not apply to any of the following:
(1) Drugs purchased by a pharmacy, pharmacist, or licensed wholesaler prior to January 1,
1983, and held in stock for resale.
(2) Drugs which are manufactured by or upon the order of a practitioner licensed by law to
prescribe or administer drugs and which are to be used solely by the patient for whom prescribed.
    Subd. 3. Penalty. Failure to comply with the requirements of this section shall subject a drug
to embargo in accordance with section 151.38.
History: 1975 c 101 s 4; 1981 c 206 s 1

151.37 LEGEND DRUGS, WHO MAY PRESCRIBE, POSSESS.
    Subdivision 1. Prohibition. Except as otherwise provided in this chapter, it shall be unlawful
for any person to have in possession, or to sell, give away, barter, exchange, or distribute a legend
drug.
    Subd. 2. Prescribing and filing. (a) A licensed practitioner in the course of professional
practice only, may prescribe, administer, and dispense a legend drug, and may cause the same
to be administered by a nurse, a physician assistant, or medical student or resident under the
practitioner's direction and supervision, and may cause a person who is an appropriately certified,
registered, or licensed health care professional to prescribe, dispense, and administer the same
within the expressed legal scope of the person's practice as defined in Minnesota Statutes.
A licensed practitioner may prescribe a legend drug, without reference to a specific patient,
by directing a nurse, pursuant to section 148.235, subdivisions 8 and 9, physician assistant, or
medical student or resident to adhere to a particular practice guideline or protocol when treating
patients whose condition falls within such guideline or protocol, and when such guideline
or protocol specifies the circumstances under which the legend drug is to be prescribed and
administered. An individual who verbally, electronically, or otherwise transmits a written, oral, or
electronic order, as an agent of a prescriber, shall not be deemed to have prescribed the legend
drug. This paragraph applies to a physician assistant only if the physician assistant meets the
requirements of section 147A.18.
(b) A licensed practitioner that dispenses for profit a legend drug that is to be administered
orally, is ordinarily dispensed by a pharmacist, and is not a vaccine, must file with the practitioner's
licensing board a statement indicating that the practitioner dispenses legend drugs for profit, the
general circumstances under which the practitioner dispenses for profit, and the types of legend
drugs generally dispensed. It is unlawful to dispense legend drugs for profit after July 31, 1990,
unless the statement has been filed with the appropriate licensing board. For purposes of this
paragraph, "profit" means (1) any amount received by the practitioner in excess of the acquisition
cost of a legend drug for legend drugs that are purchased in prepackaged form, or (2) any amount
received by the practitioner in excess of the acquisition cost of a legend drug plus the cost of
making the drug available if the legend drug requires compounding, packaging, or other treatment.
The statement filed under this paragraph is public data under section 13.03. This paragraph does
not apply to a licensed doctor of veterinary medicine or a registered pharmacist. Any person other
than a licensed practitioner with the authority to prescribe, dispense, and administer a legend drug
under paragraph (a) shall not dispense for profit. To dispense for profit does not include dispensing
by a community health clinic when the profit from dispensing is used to meet operating expenses.
    Subd. 2a. Delegation. A supervising physician may delegate to a physician assistant who
is registered with the Board of Medical Practice and certified by the National Commission on
Certification of Physician Assistants and who is under the supervising physician's supervision,
the authority to prescribe, dispense, and administer legend drugs and medical devices, subject to
the requirements in chapter 147A and other requirements established by the Board of Medical
Practice in rules.
    Subd. 3. Veterinarians. A licensed doctor of veterinary medicine, in the course of
professional practice only and not for use by a human being, may personally prescribe, administer,
and dispense a legend drug, and may cause the same to be administered or dispensed by an
assistant under the doctor's direction and supervision.
    Subd. 4. Research. Any qualified person may use legend drugs in the course of a bona fide
research project, but cannot administer or dispense such drugs to human beings unless such drugs
are prescribed, dispensed, and administered by a person lawfully authorized to do so.
    Subd. 5. Exclusion for course of practice. Nothing in this chapter shall prohibit the sale
to, or the possession of, a legend drug by licensed drug wholesalers, licensed manufacturers,
registered pharmacies, local detoxification centers, licensed hospitals, bona fide hospitals wherein
animals are treated, or licensed pharmacists and licensed practitioners while acting within the
course of their practice only.
    Subd. 6. Exclusion for course of employment. Nothing in this chapter shall prohibit the
possession of a legend drug by an employee, agent, or sales representative of a registered drug
manufacturer, or an employee or agent of a registered drug wholesaler, or registered pharmacy,
while acting in the course of employment.
    Subd. 7. Exclusion for prescriptions. Nothing in this chapter shall prohibit the possession
of a legend drug by a person for that person's use when it has been dispensed to the person in
accordance with a written or oral prescription by a practitioner.
    Subd. 8. Misrepresentation. It is unlawful for a person to procure, attempt to procure,
possess, or control a legend drug by any of the following means:
(1) deceit, misrepresentation, or subterfuge;
(2) using a false name; or
(3) falsely assuming the title of, or falsely representing a person to be a manufacturer,
wholesaler, pharmacist, practitioner, or other authorized person for the purpose of obtaining
a legend drug.
    Subd. 9. Exclusion for course of laboratory employment. Nothing in this chapter shall
prohibit the possession of a legend drug by an employee or agent of a registered analytical
laboratory while acting in the course of laboratory employment.
    Subd. 10. Purchase of drugs for communicable diseases. The commissioner of health,
in carrying out the duties of section 144.05, may purchase and distribute antituberculosis drugs,
biologics, and vaccines to treat and prevent communicable disease.
    Subd. 11. Complaint reporting. The Board of Pharmacy shall report on a quarterly basis to
the Board of Optometry any complaints received regarding the prescription or administration of
legend drugs under section 148.576.
History: 1969 c 933 s 18; 1973 c 639 s 9; 1974 c 369 s 1; 1976 c 222 s 93,94; 1976 c 338 s
6; 1986 c 444; 1988 c 440 s 2; 1988 c 550 s 19; 1990 c 489 s 1; 1990 c 524 s 2; 1991 c 30 s 11;
1991 c 106 s 6; 1993 c 121 s 11; 1994 c 389 s 4,5; 1995 c 69 s 2; 1995 c 205 art 2 s 6; 1996 c
305 art 1 s 43; 2002 c 362 s 4; 2003 c 62 s 7

151.38 EMBARGOES.
(1) Whenever a duly authorized agent of the board finds or has probable cause to believe that
any drug or medicine is adulterated, or so misbranded as to be dangerous or fraudulent, or is being
sold, delivered, or offered for sale in violation of section 151.361, the agent shall affix thereto
an appropriate marking, giving notice that the article is, or is suspected of being, adulterated,
misbranded or sold, delivered, or offered for sale in violation of section 151.361 and has been
embargoed, and warning that it is unlawful for any person to remove or dispose of the embargoed
article by sale or otherwise without permission from the agent or the court.
(2) When an embargoed article has been found by the agent to be adulterated or misbranded,
or is being sold, delivered, or offered for sale in violation of section 151.361, the board shall,
within 30 days, petition the district court in whose jurisdiction the article is embargoed for an
order of condemnation. When an embargoed article is not so found by the agent , the agent
shall remove the marking.
(3) If the court finds that an embargoed article is adulterated or misbranded, or is being
sold, delivered, or offered for sale in violation of section 151.361, the article shall be destroyed
at the expense of the claimant thereof, who shall also pay all court costs and fees, storage and
other proper expenses. If the adulteration or misbranding, or lack of manufacturer disclosure as
required by section 151.361 can be corrected by proper labeling or processing of the article, or
by filing the proper documents with the court, the court, after the costs, fees, and expenses have
been paid and a sufficient bond has been executed, may order that the article be delivered to the
claimant for labeling, processing or filing under supervision of an agent of the board. The expense
of the supervision shall be paid by claimant. The bond shall be returned to the claimant on the
representation to the court by the board that the article is no longer in violation of this chapter and
that the expenses of supervision have been paid.
History: 1969 c 933 s 19; 1975 c 101 s 5; 1986 c 444

151.39 DISTRESSED DRUGS.
    Subdivision 1. Definition. Distressed drugs shall mean drugs or medicines which have
been subjected to accident, fire, flood, adverse temperatures, or other physical influences which
could affect the potency, quality, purity, or efficacy of such drug or medicine could otherwise
cause the drug or medicine to be adulterated or misbranded within the meaning of the provisions
of this chapter.
    Subd. 2. Prohibition. No person shall sell, barter, vend, give away, or exchange distressed
drugs until the board has determined that such drugs are not adulterated or misbranded within
the meaning of this chapter.
    Subd. 3. Notification. Every person who owns or controls distressed drugs shall immediately
notify the board of the existence of such drugs and the location thereof and the board shall
promptly cause an inspection and examination to be made of such drugs.
    Subd. 3a. Importation. No person may import distressed drugs into this state without
notification to the board of the source, destination, kind and quantity of such drugs. Such drugs
may not be sold or offered for sale without written approval of the board. The board shall grant
such approval when the applicant has clearly demonstrated that such distressed drugs were
inspected on the site within a reasonable period after the occurrence set forth in subdivision 1 by
an agency of the foreign state satisfactory to the board and the furnishing of a written certification
by such agency in such form as is satisfactory to the board indicating that there is no reasonable
cause to believe the drugs are not adulterated or misbranded. Nothing herein shall be construed
to prevent the board from exerting its authority and rights set forth in section 151.38 after such
drugs have entered this state.
    Subd. 4. Board certification. The board shall, within 30 days of such notification, indicate
whether or not it has probable cause to believe that such drugs are adulterated or misbranded
within the meaning of this chapter. If the board determines that no such probable cause exists, it
shall furnish the owner or person having control of such drugs a written certificate to that effect.
If the board has probable cause to believe that the drugs are adulterated or misbranded, it shall
follow the procedure set forth in section 151.38.
History: 1969 c 933 s 20; 1971 c 24 s 14; 1973 c 639 s 10; 1986 c 444

151.40 POSSESSION AND SALE OF HYPODERMIC SYRINGES AND NEEDLES.
    Subdivision 1. Generally. Except as otherwise provided in subdivision 2, it is unlawful
for any person to possess, control, manufacture, sell, furnish, dispense, or otherwise dispose
of hypodermic syringes or needles or any instrument or implement which can be adapted for
subcutaneous injections, except by the following persons when acting in the course of their
practice or employment: licensed practitioners, registered pharmacies and their employees
or agents, licensed pharmacists, licensed doctors of veterinary medicine or their assistants,
registered nurses, registered medical technologists, medical interns, licensed drug wholesalers,
their employees or agents, licensed hospitals, licensed nursing homes, bona fide hospitals where
animals are treated, licensed morticians, syringe and needle manufacturers, their dealers and
agents, persons engaged in animal husbandry, clinical laboratories, persons engaged in bona fide
research or education or industrial use of hypodermic syringes and needles provided such persons
cannot use hypodermic syringes and needles for the administration of drugs to human beings
unless such drugs are prescribed, dispensed, and administered by a person lawfully authorized
to do so, persons who administer drugs pursuant to an order or direction of a licensed doctor of
medicine or of a licensed doctor of osteopathy duly licensed to practice medicine.
    Subd. 2. Sales of limited quantities of clean needles and syringes. (a) A registered
pharmacy or its agent or a licensed pharmacist may sell, without a prescription, unused
hypodermic needles and syringes in quantities of ten or fewer, provided the pharmacy or
pharmacist complies with all of the requirements of this subdivision.
(b) At any location where hypodermic needles and syringes are kept for retail sale under this
subdivision, the needles and syringes shall be stored in a manner that makes them available only
to authorized personnel and not openly available to customers.
(c) No registered pharmacy or licensed pharmacist may advertise to the public the availability
for retail sale, without a prescription, of hypodermic needles or syringes in quantities of ten
or fewer.
(d) A registered pharmacy or licensed pharmacist that sells hypodermic needles or syringes
under this subdivision may give the purchaser the materials developed by the commissioner
of health under section 325F.785.
(e) A registered pharmacy or licensed pharmacist that sells hypodermic needles or syringes
must certify to the commissioner of health participation in an activity, including but not limited
to those developed under section 325F.785, that supports proper disposal of used hypodermic
needles or syringes.
History: 1969 c 933 s 21; 1976 c 222 s 95; 1986 c 444; 1997 c 203 art 2 s 17

151.41 [Repealed, 1981 c 323 s 4; 1983 c 312 art 1 s 27]

WHOLESALE DRUG DISTRIBUTION LICENSING ACT

151.42 CITATION.
Sections 151.42 to 151.51 may be cited as the "Wholesale Drug Distribution Licensing Act
of 1990."
History: 1990 c 568 art 2 s 20

151.43 SCOPE.
Sections 151.42 to 151.51 apply to any person, partnership, corporation, or business firm
engaging in the wholesale distribution of prescription drugs within the state.
History: 1990 c 526 s 6; 1990 c 568 art 2 s 21

151.44 DEFINITIONS.
As used in sections 151.43 to 151.51, the following terms have the meanings given in
paragraphs (a) to (f):
(a) "Wholesale drug distribution" means distribution of prescription drugs to persons other
than a consumer or patient, but does not include:
(1) a sale between a division, subsidiary, parent, affiliated, or related company under the
common ownership and control of a corporate entity;
(2) the purchase or other acquisition, by a hospital or other health care entity that is a member
of a group purchasing organization, of a drug for its own use from the organization or from other
hospitals or health care entities that are members of such organizations;
(3) the sale, purchase, or trade of a drug or an offer to sell, purchase, or trade a drug by a
charitable organization described in section 501(c)(3) of the Internal Revenue Code of 1986, as
amended through December 31, 1988, to a nonprofit affiliate of the organization to the extent
otherwise permitted by law;
(4) the sale, purchase, or trade of a drug or offer to sell, purchase, or trade a drug among
hospitals or other health care entities that are under common control;
(5) the sale, purchase, or trade of a drug or offer to sell, purchase, or trade a drug for
emergency medical reasons;
(6) the sale, purchase, or trade of a drug, an offer to sell, purchase, or trade a drug, or the
dispensing of a drug pursuant to a prescription;
(7) the transfer of prescription drugs by a retail pharmacy to another retail pharmacy to
alleviate a temporary shortage;
(8) the distribution of prescription drug samples by manufacturers representatives; or
(9) the sale, purchase, or trade of blood and blood components.
(b) "Wholesale drug distributor" means anyone engaged in wholesale drug distribution
including, but not limited to, manufacturers; repackers; own-label distributors; jobbers; brokers;
warehouses, including manufacturers' and distributors' warehouses, chain drug warehouses, and
wholesale drug warehouses; independent wholesale drug traders; and pharmacies that conduct
wholesale drug distribution. A wholesale drug distributor does not include a common carrier or
individual hired primarily to transport prescription drugs.
(c) "Manufacturer" means anyone who is engaged in the manufacturing, preparing,
propagating, compounding, processing, packaging, repackaging, or labeling of a prescription drug.
(d) "Prescription drug" means a drug required by federal or state law or regulation to be
dispensed only by a prescription, including finished dosage forms and active ingredients subject
to United States Code, title 21, sections 811 and 812.
(e) "Blood" means whole blood collected from a single donor and processed either for
transfusion or further manufacturing.
(f) "Blood components" means that part of blood separated by physical or mechanical means.
History: 1990 c 526 s 7; 1990 c 568 art 2 s 22

151.45 WHOLESALE DRUG DISTRIBUTOR ADVISORY TASK FORCE.
The board shall appoint a Wholesale Drug Distributor Advisory Task Force composed of
five members, to be selected and to perform duties and responsibilities as follows:
(a) One member shall be a pharmacist who is neither a member of the board nor a board
employee.
(b) Two members shall be representatives of wholesale drug distributors as defined in section
151.44, paragraph (b).
(c) One member shall be a representative of drug manufacturers.
(d) One member shall be a public member as defined by section 214.02.
(e) The advisory task force shall review and make recommendations to the board on the merit
of all rules dealing with wholesale drug distributors and drug manufacturers that are proposed
by the board; and no rule affecting wholesale drug distributors proposed by the board shall be
adopted without first being submitted to the task force for review and comment.
(f) In making advisory task force appointments, the board shall consider recommendations
received from each of the wholesale drug distributor, pharmacist, and drug manufacturer
classes cited in paragraphs (a) to (c), and shall adopt rules that provide for solicitation of the
recommendations.
History: 1990 c 526 s 8; 1990 c 568 art 2 s 23

151.46 PROHIBITED DRUG PURCHASES OR RECEIPT.
It is unlawful for any person to knowingly purchase or receive a prescription drug from a
source other than a person or entity licensed under the laws of the state, except where otherwise
provided. Licensed wholesale drug distributors other than pharmacies shall not dispense or
distribute prescription drugs directly to patients. A person violating the provisions of this section
is guilty of a misdemeanor.
History: 1990 c 526 s 9; 1990 c 568 art 2 s 24

151.461 GIFTS TO PRACTITIONERS PROHIBITED.
It is unlawful for any manufacturer or wholesale drug distributor, or any agent thereof, to offer
or give any gift of value to a practitioner. A medical device manufacturer that distributes drugs as
an incidental part of its device business shall not be considered a manufacturer, a wholesale drug
distributor, or agent under this section. As used in this section, "gift" does not include:
(1) professional samples of a drug provided to a prescriber for free distribution to patients;
(2) items with a total combined retail value, in any calendar year, of not more than $50;
(3) a payment to the sponsor of a medical conference, professional meeting, or other
educational program, provided the payment is not made directly to a practitioner and is used
solely for bona fide educational purposes;
(4) reasonable honoraria and payment of the reasonable expenses of a practitioner who
serves on the faculty at a professional or educational conference or meeting;
(5) compensation for the substantial professional or consulting services of a practitioner in
connection with a genuine research project;
(6) publications and educational materials; or
(7) salaries or other benefits paid to employees.
History: 1993 c 345 art 5 s 11

151.47 WHOLESALE DRUG DISTRIBUTOR LICENSING REQUIREMENTS.
    Subdivision 1. Requirements. All wholesale drug distributors are subject to the requirements
in paragraphs (a) to (f).
(a) No person or distribution outlet shall act as a wholesale drug distributor without first
obtaining a license from the board and paying the required fee.
(b) No license shall be issued or renewed for a wholesale drug distributor to operate unless
the applicant agrees to operate in a manner prescribed by federal and state law and according
to the rules adopted by the board.
(c) The board may require a separate license for each facility directly or indirectly owned
or operated by the same business entity within the state, or for a parent entity with divisions,
subsidiaries, or affiliate companies within the state, when operations are conducted at more than
one location and joint ownership and control exists among all the entities.
(d) As a condition for receiving and retaining a wholesale drug distributor license issued
under sections 151.42 to 151.51, an applicant shall satisfy the board that it has and will
continuously maintain:
(1) adequate storage conditions and facilities;
(2) minimum liability and other insurance as may be required under any applicable federal or
state law;
(3) a viable security system that includes an after hours central alarm, or comparable entry
detection capability; restricted access to the premises; comprehensive employment applicant
screening; and safeguards against all forms of employee theft;
(4) a system of records describing all wholesale drug distributor activities set forth in section
151.44 for at least the most recent two-year period, which shall be reasonably accessible as
defined by board regulations in any inspection authorized by the board;
(5) principals and persons, including officers, directors, primary shareholders, and key
management executives, who must at all times demonstrate and maintain their capability of
conducting business in conformity with sound financial practices as well as state and federal law;
(6) complete, updated information, to be provided to the board as a condition for obtaining
and retaining a license, about each wholesale drug distributor to be licensed, including all
pertinent corporate licensee information, if applicable, or other ownership, principal, key
personnel, and facilities information found to be necessary by the board;
(7) written policies and procedures that assure reasonable wholesale drug distributor
preparation for, protection against, and handling of any facility security or operation problems,
including, but not limited to, those caused by natural disaster or government emergency, inventory
inaccuracies or product shipping and receiving, outdated product or other unauthorized product
control, appropriate disposition of returned goods, and product recalls;
(8) sufficient inspection procedures for all incoming and outgoing product shipments; and
(9) operations in compliance with all federal requirements applicable to wholesale drug
distribution.
(e) An agent or employee of any licensed wholesale drug distributor need not seek licensure
under this section.
(f) A wholesale drug distributor shall file with the board an annual report, in a form and on
the date prescribed by the board, identifying all payments, honoraria, reimbursement or other
compensation authorized under section 151.461, clauses (3) to (5), paid to practitioners in
Minnesota during the preceding calendar year. The report shall identify the nature and value of
any payments totaling $100 or more, to a particular practitioner during the year, and shall identify
the practitioner. Reports filed under this provision are public data.
    Subd. 2. Requirements must conform with federal law. All requirements set forth in this
section shall conform to wholesale drug distributor licensing guidelines formally adopted by the
United States Food and Drug Administration; and in case of conflict between a wholesale drug
distributor licensing requirement imposed by the board and a Food and Drug Administration
wholesale drug distributor guideline, the latter shall control.
History: 1990 c 526 s 10; 1990 c 568 art 2 s 25; 1993 c 345 art 5 s 12

151.48 OUT-OF-STATE WHOLESALE DRUG DISTRIBUTOR LICENSING.
(a) It is unlawful for an out-of-state wholesale drug distributor to conduct business in the
state without first obtaining a license from the board and paying the required fee.
(b) Application for an out-of-state wholesale drug distributor license under this section shall
be made on a form furnished by the board.
(c) No person acting as principal or agent for any out-of-state wholesale drug distributor may
sell or distribute drugs in the state unless the distributor has obtained a license.
(d) The board may adopt regulations that permit out-of-state wholesale drug distributors
to obtain a license on the basis of reciprocity to the extent that an out-of-state wholesale drug
distributor:
(1) possesses a valid license granted by another state under legal standards comparable to
those that must be met by a wholesale drug distributor of this state as prerequisites for obtaining a
license under the laws of this state; and
(2) can show that the other state would extend reciprocal treatment under its own laws
to a wholesale drug distributor of this state.
History: 1990 c 526 s 11; 1990 c 568 art 2 s 26; 1995 c 234 art 9 s 2

151.49 LICENSE RENEWAL APPLICATION PROCEDURES.
Application blanks for renewal of a license required by sections 151.42 to 151.51 shall be
mailed to each licensee on or before the first day of the month prior to the month in which the
license expires and, if application for renewal of the license with the required fee is not made
before the expiration date, the existing license or renewal shall lapse and become null and void
upon the date of expiration.
History: 1990 c 526 s 12; 1990 c 568 art 2 s 27

151.50 RULES.
The board shall adopt rules to carry out the purposes and enforce the provisions of sections
151.42 to 151.51. All rules adopted under this section shall conform to wholesale drug distributor
licensing guidelines formally adopted by the United States Food and Drug Administration; and
in case of conflict between a rule adopted by the board and a Food and Drug Administration
wholesale drug distributor guideline, the latter shall control.
History: 1990 c 526 s 13; 1990 c 568 art 2 s 28

151.51 BOARD ACCESS TO WHOLESALE DRUG DISTRIBUTOR RECORDS.
Wholesale drug distributors may keep records at a central location apart from the principal
office of the wholesale drug distributor or the location at which the drugs were stored and from
which they were shipped, provided that the records shall be made available for inspection within
two working days of a request by the board. The records may be kept in any form permissible
under federal law applicable to prescription drugs record keeping.
History: 1990 c 526 s 14; 1990 c 568 art 2 s 29

CANCER DRUG REPOSITORY PROGRAM

151.55 CANCER DRUG REPOSITORY PROGRAM.
    Subdivision 1. Definitions. (a) For the purposes of this section, the terms defined in this
subdivision have the meanings given.
(b) "Board" means the Board of Pharmacy.
(c) "Cancer drug" means a prescription drug that is used to treat:
(1) cancer or the side effects of cancer; or
(2) the side effects of any prescription drug that is used to treat cancer or the side effects
of cancer.
(d) "Cancer drug repository" means a medical facility or pharmacy that has notified the board
of its election to participate in the cancer drug repository program.
(e) "Cancer supply" or "supplies" means prescription and nonprescription cancer supplies
needed to administer a cancer drug.
(f) "Dispense" has the meaning given in section 151.01, subdivision 30.
(g) "Distribute" means to deliver, other than by administering or dispensing.
(h) "Donor" means an individual and not a drug manufacturer or wholesale drug distributor
who donates a cancer drug or supply according to the requirements of the cancer drug repository
program.
(i) "Medical facility" means an institution defined in section 144.50, subdivision 2.
(j) "Medical supplies" means any prescription and nonprescription medical supply needed to
administer a cancer drug.
(k) "Pharmacist" has the meaning given in section 151.01, subdivision 3.
(l) "Pharmacy" means any pharmacy registered with the Board of Pharmacy according to
section 151.19, subdivision 1.
(m) "Practitioner" has the meaning given in section 151.01, subdivision 23.
(n) "Prescription drug" means a legend drug as defined in section 151.01, subdivision 17.
(o) "Side effects of cancer" means symptoms of cancer.
(p) "Single-unit-dose packaging" means a single-unit container for articles intended for
administration as a single dose, direct from the container.
(q) "Tamper-evident unit dose packaging" means a container within which a drug is sealed so
that the contents cannot be opened without obvious destruction of the seal.
    Subd. 2. Establishment. The Board of Pharmacy shall establish and maintain a cancer drug
repository program, under which any person may donate a cancer drug or supply for use by an
individual who meets the eligibility criteria specified under subdivision 4. Under the program,
donations may be made on the premises of a medical facility or pharmacy that elects to participate
in the program and meets the requirements specified under subdivision 3.
    Subd. 3. Requirements for participation by pharmacies and medical facilities. (a) To be
eligible for participation in the cancer drug repository program, a pharmacy or medical facility
must be licensed and in compliance with all applicable federal and state laws and administrative
rules.
(b) Participation in the cancer drug repository program is voluntary. A pharmacy or medical
facility may elect to participate in the cancer drug repository program by submitting the following
information to the board, in a form provided by the board:
(1) the name, street address, and telephone number of the pharmacy or medical facility;
(2) the name and telephone number of a pharmacist who is employed by or under contract
with the pharmacy or medical facility, or other contact person who is familiar with the pharmacy's
or medical facility's participation in the cancer drug repository program; and
(3) a statement indicating that the pharmacy or medical facility meets the eligibility
requirements under paragraph (a) and the chosen level of participation under paragraph (c).
(c) A pharmacy or medical facility may fully participate in the cancer drug repository
program by accepting, storing, and dispensing or administering donated drugs and supplies, or
may limit its participation to only accepting and storing donated drugs and supplies. If a pharmacy
or facility chooses to limit its participation, the pharmacy or facility shall distribute any donated
drugs to a fully participating cancer drug repository according to subdivision 8.
(d) A pharmacy or medical facility may withdraw from participation in the cancer drug
repository program at any time upon notification to the board. A notice to withdraw from
participation may be given by telephone or regular mail.
    Subd. 4. Individual eligibility requirements. Any Minnesota resident who is diagnosed
with cancer is eligible to receive drugs or supplies under the cancer drug repository program.
Drugs and supplies shall be dispensed or administered according to the priority given under
subdivision 6, paragraph (d).
    Subd. 5. Donations of cancer drugs and supplies. (a) Any one of the following persons
may donate legally obtained cancer drugs or supplies to a cancer drug repository, if the drugs or
supplies meet the requirements under paragraph (b) or (c) as determined by a pharmacist who is
employed by or under contract with a cancer drug repository:
(1) an individual who is 18 years old or older; or
(2) a pharmacy, medical facility, drug manufacturer, or wholesale drug distributor, if the
donated drugs have not been previously dispensed.
(b) A cancer drug is eligible for donation under the cancer drug repository program only if
the following requirements are met:
(1) the donation is accompanied by a cancer drug repository donor form described under
paragraph (d) that is signed by the person making the donation or that person's authorized
representative;
(2) the drug's expiration date is at least six months later than the date that the drug was
donated;
(3) the drug is in its original, unopened, tamper-evident unit dose packaging that includes
the drug's lot number and expiration date. Single-unit dose drugs may be accepted if the
single-unit-dose packaging is unopened; and
(4) the drug is not adulterated or misbranded.
(c) Cancer supplies are eligible for donation under the cancer drug repository program
only if the following requirements are met:
(1) the supplies are not adulterated or misbranded;
(2) the supplies are in their original, unopened, sealed packaging; and
(3) the donation is accompanied by a cancer drug repository donor form described under
paragraph (d) that is signed by the person making the donation or that person's authorized
representative.
(d) The cancer drug repository donor form must be provided by the board and shall state that
to the best of the donor's knowledge the donated drug or supply has been properly stored and that
the drug or supply has never been opened, used, tampered with, adulterated, or misbranded. The
board shall make the cancer drug repository donor form available on the Board of Pharmacy's
Web site.
(e) Controlled substances and drugs and supplies that do not meet the criteria under this
subdivision are not eligible for donation or acceptance under the cancer drug repository program.
(f) Drugs and supplies may be donated on the premises of a cancer drug repository to
a pharmacist designated by the repository. A drop box may not be used to deliver or accept
donations.
(g) Cancer drugs and supplies donated under the cancer drug repository program must
be stored in a secure storage area under environmental conditions appropriate for the drugs or
supplies being stored. Donated drugs and supplies may not be stored with nondonated inventory.
    Subd. 6. Dispensing requirements. (a) Drugs and supplies must be dispensed by a licensed
pharmacist pursuant to a prescription by a practitioner or may be dispensed or administered by
a practitioner according to the requirements of chapter 151 and within the practitioner's scope
of practice.
(b) Cancer drugs and supplies shall be visually inspected by the pharmacist or practitioner
before being dispensed or administered for adulteration, misbranding, and date of expiration.
Drugs or supplies that have expired or appear upon visual inspection to be adulterated,
misbranded, or tampered with in any way may not be dispensed or administered.
(c) Before a cancer drug or supply may be dispensed or administered to an individual, the
individual must sign a cancer drug repository recipient form provided by the board acknowledging
that the individual understands the information stated on the form. The form shall include the
following information:
(1) that the drug or supply being dispensed or administered has been donated and may have
been previously dispensed;
(2) that a visual inspection has been conducted by the pharmacist or practitioner to ensure
that the drug has not expired, has not been adulterated or misbranded, and is in its original,
unopened packaging; and
(3) that the dispensing pharmacist, the dispensing or administering practitioner, the cancer
drug repository, the Board of Pharmacy, and any other participant of the cancer drug repository
program cannot guarantee the safety of the drug or supply being dispensed or administered and
that the pharmacist or practitioner has determined that the drug or supply is safe to dispense
or administer based on the accuracy of the donor's form submitted with the donated drug or
supply and the visual inspection required to be performed by the pharmacist or practitioner
before dispensing or administering.
The board shall make the cancer drug repository form available on the Board of Pharmacy's
Web site.
(d) Drugs and supplies shall only be dispensed or administered to individuals who meet the
eligibility requirements in subdivision 4 and in the following order of priority:
(1) individuals who are uninsured;
(2) individuals who are enrolled in medical assistance, general assistance medical care,
MinnesotaCare, Medicare, or other public assistance health care; and
(3) all other individuals who are otherwise eligible under subdivision 4 to receive drugs or
supplies from a cancer drug repository.
    Subd. 7. Handling fees. A cancer drug repository may charge the individual receiving a
drug or supply a handling fee of no more than 250 percent of the medical assistance program
dispensing fee for each cancer drug or supply dispensed or administered.
    Subd. 8. Distribution of donated cancer drugs and supplies. (a) Cancer drug repositories
may distribute drugs and supplies donated under the cancer drug repository program to other
repositories if requested by a participating repository.
(b) A cancer drug repository that has elected not to dispense donated drugs or supplies
shall distribute any donated drugs and supplies to a participating repository upon request of
the repository.
(c) If a cancer drug repository distributes drugs or supplies under paragraph (a) or (b),
the repository shall complete a cancer drug repository donor form provided by the board. The
completed form and a copy of the donor form that was completed by the original donor under
subdivision 5 shall be provided to the fully participating cancer drug repository at the time of
distribution.
    Subd. 9. Resale of donated drugs or supplies. Donated drugs and supplies may not be
resold.
    Subd. 10. Record-keeping requirements. (a) Cancer drug repository donor and recipient
forms shall be maintained for at least five years.
(b) A record of destruction of donated drugs and supplies that are not dispensed under
subdivision 6 shall be maintained by the dispensing repository for at least five years. For each
drug or supply destroyed, the record shall include the following information:
(1) the date of destruction;
(2) the name, strength, and quantity of the cancer drug destroyed;
(3) the name of the person or firm that destroyed the drug; and
(4) the source of the drugs or supplies destroyed.
    Subd. 11. Liability. (a) The manufacturer of a drug or supply is not subject to criminal or
civil liability for injury, death, or loss to a person or to property for causes of action described in
clauses (1) and (2). A manufacturer is not liable for:
(1) the intentional or unintentional alteration of the drug or supply by a party not under
the control of the manufacturer; or
(2) the failure of a party not under the control of the manufacturer to transfer or communicate
product or consumer information or the expiration date of the donated drug or supply.
(b) A medical facility or pharmacy participating in the program, a pharmacist dispensing
a drug or supply pursuant to the program, a practitioner dispensing or administering a drug or
supply pursuant to the program, or a donor of a cancer drug or supply as defined in subdivision 1
is immune from civil liability for an act or omission that causes injury to or the death of an
individual to whom the cancer drug or supply is dispensed and no disciplinary action shall be
taken against a pharmacist or practitioner so long as the drug or supply is donated, accepted,
distributed, and dispensed according to the requirements of this section. This immunity does not
apply if the act or omission involves reckless, wanton, or intentional misconduct, or malpractice
unrelated to the quality of the cancer drug or supply.
History: 1Sp2005 c 4 art 5 s 2