language to be deleted (2) new language
Laws of Minnesota 1989 CHAPTER 314-S.F.No. 1378 An act relating to animals; regulating use of certain prescription veterinary drugs; changing certain procedures for licensing veterinarians; establishing an animal population control study commission; amending Minnesota Statutes 1988, sections 151.19, subdivision 3; 151.34; and 156.02, subdivision 1; proposing coding for new law in Minnesota Statutes, chapter 156. BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF MINNESOTA: Section 1. Minnesota Statutes 1988, section 151.19, subdivision 3, is amended to read: Subd. 3. [SALE OF
OTHER DRUGS AND DEVICESFEDERALLY 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 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 itemsfederally 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 these itemsfederally restricted medical gases unless a certificate has been issued to that person by the board. Sec. 2. Minnesota Statutes 1988, 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; (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 ,or medical gases , or veterinary drugs or deviceswithout proper registration with the board except as provided in this chapter. Sec. 3. Minnesota Statutes 1988, section 156.02, subdivision 1, is amended to read: Subdivision 1. [LICENSE APPLICATION.] Application for a license to practice veterinary medicine in this state shall be made in writing to the board of veterinary medicine upon a form furnished by the board, accompanied by satisfactory evidence that the applicant is at least 18 years of age, is of good moral character, and has one of the following: (1) a diploma conferring the degree of doctor of veterinary medicine, or an equivalent degree, from an accredited or approved college of veterinary medicine; (2) an ECFVG certificate; or (3) a certificate from the dean of an accredited or approved college of veterinary medicine stating that the applicant is a student in good standing expecting to be graduated at the completion of the nextcurrent academic termyear of the college in which the applicant is enrolled. The application shall contain the information and material required by subdivision 2 and any other information that the board may, in its sound judgment, require. The application shall be filed with the secretary of the board at least 3045 days before the date of the examination. If the board deems it advisable, it may require that such application be verified by the oath of the applicant. Sec. 4. [156.16] [DEFINITIONS.] Subdivision 1. [APPLICABILITY.] The definitions in this section apply to sections 4 to 8. Subd. 2. [CLIENT.] "Client" means the owner or caretaker of an animal who arranges for the animal's veterinary care. Subd. 3. [DISPENSING.] "Dispensing" means distribution of veterinary prescription drugs or over-the-counter drugs for extra-label use by a person registered by the board of pharmacy to dispense or a person licensed by the board of veterinary medicine. Subd. 4. [EXTRA-LABEL USE.] "Extra-label use" means the actual or intended use of a human or veterinary drug in an animal in a manner that is not in accordance with the drug's labeling. Subd. 5. [FOOD-PRODUCING ANIMALS.] "Food-producing animals" means livestock or poultry raised commercially for human consumption. Subd. 6. [OVER-THE-COUNTER DRUG.] "Over-the-counter drug" means a veterinary drug labeled "for veterinary use only" or "for animal use only" that does not require a prescription or is not required to have the restrictive legend: "Caution: federal law restricts this drug to use by or on the order of a licensed veterinarian." Subd. 7. [PATIENT.] "Patient" means an animal for which a veterinary prescription drug is used or intended to be used. Subd. 8. [PERSON.] "Person" means an individual, or a firm, partnership, company, corporation, trustee, association, agency, or other public or private entity. Subd. 9. [PHARMACIST.] "Pharmacist" means an individual with a valid Minnesota license to practice pharmacy. Subd. 10. [PRESCRIPTION.] "Prescription" means an order from a veterinarian to a pharmacist or another veterinarian authorizing the dispensing of a veterinary prescription drug to a client for use on or in a patient. Subd. 11. [VETERINARIAN.] "Veterinarian" means an individual with a valid Minnesota license to practice veterinary medicine. Subd. 12. [VETERINARIAN-CLIENT-PATIENT RELATIONSHIP.] "Veterinarian-client-patient relationship" means a relationship in which the conditions in paragraphs (a) to (d) have been met. (a) The veterinarian has assumed the responsibility for making medical judgments regarding the health of the animal and the need for medical treatment, and the client has agreed to follow the instructions of the veterinarian. (b) The veterinarian has sufficient knowledge of the animal to initiate at least a general, preliminary, or tentative diagnosis of the medical condition of the animal. The veterinarian must be acquainted with the keeping and care of the animal by virtue of an examination of the animal or medically appropriate and timely visits to the premises where the animal is kept. (c) The veterinarian is available for consultation in case of adverse reactions or failure of the regimen of therapy. (d) The veterinarian maintains records documenting patient visits, diagnosis, treatments, and drugs prescribed, dispensed, or administered, and other relevant information. Subd. 13. [VETERINARY DRUG.] "Veterinary drug" means: (1) a drug for animal use recognized in the official United States Pharmacopoeia or National Formulary of the United States; (2) a drug intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in animals; (3) a drug, other than feed, medicated feed, or a growth promoting implant intended to affect the structure or function of the body of an animal; or (4) a drug intended for use as a component of a drug in clause (1), (2), or (3). Subd. 14. [VETERINARY PRESCRIPTION DRUG.] "Veterinary prescription drug" means: (1) a drug that is not safe for animal use except under the supervision of a veterinarian, and 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"; (2) a drug that is required by state law to be dispensed only on order or prescription of a licensed veterinarian; and (3) the extra-label use of an over-the-counter drug. Sec. 5. [156.17] [POSSESSION PROHIBITED.] A person may not possess a veterinary prescription drug unless the person is a licensed veterinarian or pharmacist, a client holding a veterinary prescription drug by or on the order of a veterinarian, a manufacturer or wholesaler of veterinary drugs, an animal health researcher, or a person performing official state or federal regulatory duties. Sec. 6. [156.18] [VETERINARY PRESCRIPTION DRUGS.] Subdivision 1. [PRESCRIPTION.] (a) A person may not dispense a veterinary prescription drug to a client without a prescription or other veterinary authorization. A person may not make extra-label use of a veterinary drug without a prescription from a veterinarian. A veterinarian or the veterinarian's authorized agent may dispense a veterinary prescription drug to a client or oversee the extra-label use of a veterinary drug directly by a client without a separate written prescription. (b) A veterinarian may sell prescription veterinary drugs and prescribe extra-label use drugs to a client without personally examining the animal if a veterinarian-client-patient relationship exists and in the judgment of the veterinarian the client has sufficient knowledge to use the drugs properly. (c) A veterinarian may issue a prescription or other veterinary authorization by oral or written communication to the dispenser, or by computer connection. If the communication is oral, the veterinarian must enter it into the patient's record. The dispenser must record the veterinarian's prescription or other veterinary authorization within 72 hours. (d) A prescription or other veterinary authorization must include: (1) the name, address, and, if written, the signature of the prescriber; (2) the name and address of the client; (3) identification of the species for which the drug is prescribed or ordered; (4) the name, strength, and quantity of the drug; (5) the date of issue; (6) directions for use; and (7) withdrawal time. Subd. 2. [LABEL OF DISPENSED VETERINARY DRUGS.] (a) A veterinarian or the veterinarian's authorized agent dispensing a veterinary prescription drug or prescribing the extra-label use of an over-the-counter drug must provide written information which includes the name and address of the veterinarian, date of filling, species of patient, name or names of drug, directions for use, withdrawal time, and cautionary statements, if any, appropriate for the drug. (b) If the veterinary drug has been prepared, mixed, formulated, or packaged by the dispenser, all of the information required in paragraph (a) must be provided on a label affixed to the container. (c) If the veterinary drug is in the manufacturer's original package, the information required in paragraph (a) must be supplied in writing but need not be affixed to the container. Information required in paragraph (a) that is provided by the manufacturer on the original package does not need to be repeated in the separate written information. Written information required by this paragraph may be written on the sales invoice. Subd. 3. [RECORDS ON VETERINARY DRUG TRANSACTIONS.] A veterinarian must maintain complete records of receipt and distribution of each prescription veterinary drug. The records may be kept in the form of sales invoices, shipping records, prescription files, or a record or log established solely to satisfy the requirements of this subdivision. Records must include: (1) the name of the drug; (2) the name and address of the person from whom the drug was shipped and the date and quantity received; and (3) the name and address of the person to whom the drug was distributed and the date and quantity shipped or otherwise distributed. Subd. 4. [RECORDKEEPING.] Records required by this section must be kept for at least two years after dispensing of the drug has been completed. Sec. 7. [156.19] [EXTRA-LABEL USE.] A person, other than a veterinarian or a person working under the control of a veterinarian, must not make extra-label use of a veterinary drug in or on a food-producing animal, unless permitted by the prescription of a veterinarian. A veterinarian may prescribe the extra-label use of a veterinary drug if: (1) the veterinarian makes a careful medical diagnosis within the context of a valid veterinarian-client-patient relationship; (2) the veterinarian determines that there is no marketed drug specifically labeled to treat the condition diagnosed, or that drug therapy as recommended by the labeling has, in the judgment of the attending veterinarian, been found to be clinically ineffective; (3) the veterinarian recommends procedures to ensure that the identity of the treated animal will be carefully maintained; and (4) the veterinarian prescribes a significantly extended time period for drug withdrawal before marketing meat, milk, or eggs. Sec. 8. [156.20] [INSPECTIONS AND SAMPLES.] Subdivision 1. [AUTHORITY.] To enforce sections 4 to 7, a veterinarian must allow authorized representatives of the board of veterinary medicine, after receiving allegations of a violation of sections 4 to 7 and upon presenting appropriate credentials to the veterinarian in charge, to: (1) enter premises in which veterinary drugs are held for distribution in Minnesota at reasonable times, within reasonable limits, and in a reasonable manner; (2) inspect pertinent records, equipment, materials, containers, and facilities bearing on whether veterinary drugs are in compliance with sections 4 to 7; and (3) collect samples. Subd. 2. [LIMITS ON INSPECTION.] An inspection authorized by this section may not extend to financial information, pricing information, personnel information, or sales information other than shipment information. An inspection must be started and completed with reasonable promptness. Sec. 9. [ANIMAL POPULATION CONTROL PROGRAM.] Subdivision 1. [STUDY COMMISSION.] An animal population control study commission is established, consisting of seven members as follows: one senator appointed by the senate committee on rules and administration; one representative appointed by the speaker of the house; one member each appointed by the St. Paul and Minneapolis animal control offices; one veterinarian licensed to practice veterinary medicine in Minnesota; and two public members. The commissioner of health shall appoint the veterinarian and public members of the study commission. The members shall elect a chair. Subd. 2. [DUTIES; REPORT.] The study commission established in subdivision 1 shall study the feasibility of a pilot program in the seven-county metropolitan area to reduce the population of unwanted and stray dogs and cats. The study commission shall report its finding to the speaker of the house and the president of the senate by January 1, 1990. Presented to the governor May 30, 1989 Signed by the governor June 1, 1989, 11:02 p.m.