Minnesota Session Laws - 1988, Regular Session

  

                         Laws of Minnesota 1988 

                        CHAPTER 550-S.F.No. 752 
           An act relating to occupations and professions; 
          amending the laws regulating the practice of pharmacy; 
          providing definitions; providing for registration of 
          pharmacies, drug manufacturers, and others; providing 
          for licensing of pharmacists; providing remedies for 
          violations; amending Minnesota Statutes 1986, sections 
          151.01, subdivision 2, and by adding subdivisions; 
          151.04; 151.06, subdivision 1; 151.101; 151.15; 
          151.19; 151.211; 151.212, subdivision 1, and by adding 
          a subdivision; 151.25; 151.26, subdivision 1; 151.32; 
          151.34; and 151.37; proposing coding for new law in 
          Minnesota Statutes, chapter 151; repealing Minnesota 
          Statutes 1986, sections 151.01, subdivision 4; 151.06, 
          subdivision 2a; 151.11; 151.28; and 151.31. 
BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF MINNESOTA: 
    Section 1.  Minnesota Statutes 1986, section 151.01, 
subdivision 2, is amended to read:  
    Subd. 2.  [PHARMACY.] The term "pharmacy" means a drug 
store or other established place regularly registered by the 
state board of pharmacy, in which prescriptions, drugs, 
medicines, chemicals, and poisons are compounded, dispensed, 
vended, or sold at retail "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.  
    Sec. 2.  Minnesota Statutes 1986, section 151.01, is 
amended by adding a subdivision to read: 
    Subd. 27.  [PRACTICE OF PHARMACY.] "Practice of pharmacy" 
means (1) the interpretation and evaluation of prescriptions or 
drug orders; (2) the compounding, dispensing, or labeling of 
drugs and devices (except labeling by a manufacturer or packager 
of nonprescription drugs or commercially packaged legend drugs 
and devices); (3) the participation in clinical interpretations 
of drug therapy for assurance of safe and effective use of 
drugs; (4) participation in drug selection and drug utilization 
reviews; (5) participation in the storage of drugs and the 
maintenance of records therefor; (6) the responsibility for 
advising on therapeutic values, content, hazards and uses of 
drugs and devices; and (7) the offering or performing of those 
acts, services, operations, or transactions necessary in the 
conduct, operation, management, and control of a pharmacy. 
    Sec. 3.  Minnesota Statutes 1986, section 151.01, is 
amended by adding a subdivision to read: 
    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." 
    Sec. 4.  Minnesota Statutes 1986, section 151.01, is 
amended by adding a subdivision to read: 
    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." 
    Sec. 5.  Minnesota Statutes 1986, section 151.01, is 
amended by adding a subdivision to read: 
    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. 
    Sec. 6.  Minnesota Statutes 1986, section 151.04, is 
amended to read:  
    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.  
    Sec. 7.  Minnesota Statutes 1986, section 151.06, 
subdivision 1, is amended to read:  
    Subdivision 1.  (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 or medicines 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 pharmacopoeia and the national formulary, or any 
revisions thereof, or standards adopted under the federal act as 
the standard; 
    (4) It may, by its duly authorized representative, to enter 
and inspect by its authorized representative any and all places 
where drugs or, 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 drug or medicine 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 drugs or medicines 
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 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: 
    (a) (i) fraud or deception in connection with the securing 
of such license or registration; 
    (b) (ii) in the case of a pharmacist, conviction in any 
court of a felony; 
    (c) (iii) in the case of a pharmacist, conviction in any 
court of an offense involving moral turpitude; 
    (d) (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; 
    (e) (v) unprofessional conduct or conduct endangering 
public health; 
    (f) (vi) gross immorality; 
    (g) (vii) employing, assisting, or enabling in any manner 
an unlicensed person to practice pharmacy; 
    (h) (viii) conviction of theft of drugs, or the 
unauthorized use, possession, or sale thereof; 
    (i) (ix) violation of any of the provisions of this chapter 
or any of the rules of the state board of pharmacy; 
    (j) (x) in the case of a pharmacy license, operation of 
such pharmacy without a pharmacist present and on duty; 
    (k) (xi) in the case of a pharmacist, physical or mental 
disability which could cause incompetency in the practice of 
pharmacy; or 
   (xii) in the case of a pharmacist, the suspension or 
revocation of a license to practice pharmacy in another state; 
    (7) to employ necessary assistants and make rules for the 
conduct of its business; and 
    (8) 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. 
    (9) (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.  
    Sec. 8.  [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. 
    Sec. 9.  Minnesota Statutes 1986, section 151.101, is 
amended to read:  
    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. 
    Sec. 10.  Minnesota Statutes 1986, section 151.15, is 
amended to read:  
    151.15 [COMPOUNDING DRUGS UNLAWFUL UNDER CERTAIN 
CONDITIONS.] 
    Subdivision 1.  [LOCATION.] It shall be unlawful for any 
person to compound, dispense, vend, or sell at retail, 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 an assistant 
pharmacist, or by a pharmacist intern under the personal 
supervision of a pharmacist; or the vending or selling at retail 
of drugs, medicines, chemicals, or poisons in the proprietor's 
pharmacy except under the personal supervision of a 
pharmacist or of an assistant pharmacist in the temporary 
absence of the 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. 
    Sec. 11.  Minnesota Statutes 1986, section 151.19, is 
amended to read:  
    151.19 [REGISTRATION OF PHARMACIES; LICENSE, FEE; 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 license registration certificate in such form as 
it may prescribe to such persons as may be qualified by law to 
conduct a pharmacy.  Such license certificate shall be exposed 
displayed in a conspicuous place in the pharmacy for which it is 
issued and expire on the thirtieth day of June following the 
date of issue.  It shall be unlawful for any person to conduct a 
pharmacy unless such license 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 OTHER DRUGS AND DEVICES.] 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 or of veterinary drugs or 
devices.  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 these items.  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 these items unless a 
certificate has been issued to him by the board. 
    Sec. 12.  Minnesota Statutes 1986, section 151.211, is 
amended to read:  
    151.211 [RECORDS OF PRESCRIPTIONS.] 
    All prescriptions dispensed shall be kept on file in at the 
pharmacy 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; provided 
that.  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, assistant pharmacist or pharmacist intern, or 
practitioner who refills the prescription. 
    Sec. 13.  Minnesota Statutes 1986, section 151.212, 
subdivision 1, is amended to read:  
    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. 
    Sec. 14.  Minnesota Statutes 1986, section 151.212, is 
amended by adding a subdivision to read: 
    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. 
    Sec. 15.  Minnesota Statutes 1986, section 151.25, is 
amended to read:  
    151.25 [LICENSURE REGISTRATION OF MANUFACTURERS OR 
WHOLESALERS; FEE; PROHIBITIONS.] 
    The board shall require and provide for the annual 
licensure registration of every person engaged in manufacturing 
or selling at wholesale drugs, medicines, chemicals or poisons 
for medicinal purposes, now or hereafter doing business within 
with accounts in this state.  Upon a payment of a fee as set by 
the board, the board shall issue a license registration 
certificate in such form as it may prescribe to such 
manufacturer or wholesaler.  Such license registration 
certificate shall be exposed displayed in a conspicuous place in 
such manufacturer's or wholesaler's place of business for which 
it is issued and expire on the 13th day of June following the 
date of issue date set by the board.  It shall be unlawful for 
any person to manufacture or sell at wholesale drugs, medicines, 
chemicals or poisons for medicinal purposes unless such 
a license certificate has been issued to the person by the 
board.  It shall be unlawful for any person engaged in the 
manufacture or selling at wholesale, or the person's agent, to 
sell legend drugs to other than a pharmacy, except as provided 
in this chapter. 
    Sec. 16.  Minnesota Statutes 1986, section 151.26, 
subdivision 1, is amended to read:  
    Subdivision 1.  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 such a the person from 
compounding or using administering drugs, medicines, chemicals, 
or poisons in the person's practice, nor prevent one a duly 
licensed to practice medicine practitioner from furnishing to a 
patient such properly packaged and labeled drugs, medicines, 
chemicals, or poisons the licensed person deems proper 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. 
    Sec. 17.  Minnesota Statutes 1986, section 151.32, is 
amended to read:  
    151.32 [CITATION.] 
    The title of sections 151.01 to 151.32 151.40 shall be the 
pharmacy law of 1937 practice act of 1988.  
    Sec. 18.  Minnesota Statutes 1986, section 151.34, is 
amended to read:  
    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; or 
    (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; or 
    (13) sell at retail federally restricted medical devices, 
medical gases, or veterinary drugs or devices without proper 
registration with the board except as provided in this chapter. 
    Sec. 19.  Minnesota Statutes 1986, section 151.37, is 
amended to read:  
    151.37 [LEGEND DRUGS, WHO MAY PRESCRIBE, POSSESS.] 
    Subdivision 1.  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.  A licensed practitioner in the course of 
professional practice only, may prescribe, administer, and 
dispense a legend drug, or and may cause the same to be 
administered by a nurse or intern under the practitioner's 
direction and supervision.  
    Subd. 3.  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.  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.  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.  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 licensed manufacturer, licensed registered drug 
wholesaler, or registered pharmacy, while acting in the course 
of employment. 
    Subd. 7.  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 pursuant to in 
accordance with a written or oral prescription by a practitioner.
    Subd. 8.  It shall be is unlawful for any a person to 
procure, attempt to procure, possess, or control a legend drug 
by any of the following means: 
    (a) (1) deceit, misrepresentation, or subterfuge; 
    (b) (2) using a false name; or 
    (c) (3) falsely assuming the title of, or falsely 
representing any a person to be a manufacturer, wholesaler, 
pharmacist, practitioner, or other authorized person for the 
purpose of obtaining a legend drug. 
    Subd. 9.  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. 
    Sec. 20.  [REPEALER.] 
    Minnesota Statutes 1986, sections 151.01, subdivision 4; 
151.06, subdivision 2a; 151.11; 151.28; and 151.31, are repealed.
    Approved April 18, 1988