1997 Minnesota Statutes

CHAPTER 151. 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 Repealed, 1988 c 550 s 20 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) 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. 

    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. 

    HIST: (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 

     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. 

    HIST: (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. 

    HIST: (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.  

    HIST: (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.  

    HIST: (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. 

    HIST: (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 

     151.061 Unfair price discrimination.  

    Subdivision 1.  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.  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.  

    HIST: 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. 

    HIST: (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. 

    HIST: 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.  

    HIST: (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. 

    HIST: 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. 

    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.  Nothing in this section prohibits 
 the board of pharmacy from operating according to established 
 rules setting 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. 

    HIST: 1997 c 132 s 3 

  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. 

    HIST: (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. 

    HIST: (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. 

    HIST: (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. 

    HIST: (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.  

    HIST: (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.  

    HIST: (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.  

    HIST: (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.

    HIST: (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.  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.  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.  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.  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.  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.  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.  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.  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.  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. 

    HIST: (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. 

    HIST: 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. 

    HIST: 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.  

    HIST: 1969 c 933 s 13; 1986 c 444 

     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.  

    HIST: (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.  

    HIST: (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.  

    HIST: (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. 

    HIST: (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.  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 

    HIST: (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. 

    HIST: (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.  

    HIST: (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.  

    HIST: (5808-31) 1937 c 354 s 31 

  151.31 Repealed, 1988 c 550 s 20 

     151.32 Citation. 

    The title of sections 151.01 to 151.40 shall be the 
 pharmacy practice act of 1988.  

    HIST: (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.  

    HIST: (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. 

    HIST: 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.  

    HIST: 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.  

    HIST: 1969 c 933 s 17 

     151.361 Manufacturer disclosure. 

    Subdivision 1.  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.  (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.  Failure to comply with the requirements of this 
 section shall subject a drug to embargo in accordance with 
 section 151.38. 

    HIST: 1975 c 101 s 4; 1981 c 206 s 1 

     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) 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 registered nurse, 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.  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.  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 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 in accordance with a 
 written or oral prescription by a practitioner. 

    Subd. 8.  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.  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 topical legend drugs under section 148.576. 

    HIST: 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 

     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.  

    HIST: 1969 c 933 s 19; 1975 c 101 s 5; 1986 c 444 

     151.39 Distressed drugs.  

    Subdivision 1.  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.  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.  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.  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.  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.  

    HIST: 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. 

    HIST: 1969 c 933 s 21; 1976 c 222 s 95; 1986 c 444; 1997 c 203 
 art 2 s 17 

*   NOTE:  The amendment to this section by Laws 1997, chapter 
*203, article 2, section 17, is effective July 1, 1998.  Laws 
*1997, chapter 203, article 2, section 38.

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

     151.42 Citation. 

    Sections 151.42 to 151.51 may be cited as the "wholesale 
 drug distribution licensing act of 1990." 

    HIST: 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. 

    HIST: 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. 

    HIST: 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. 

    HIST: 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. 

    HIST: 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. 

    HIST: 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. 

    HIST: 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 
  requirements. 

    (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. 

    HIST: 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. 

    HIST: 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. 

    HIST: 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. 

    HIST: 1990 c 526 s 14; 1990 c 568 art 2 s 29