Key: (1) 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 DEVICES 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 or of
veterinary drugs or devices. Upon the payment of a fee to be
set by the board, the board shall issue a registration
certificate in such form as it may prescribe to those persons or
places that may be qualified to sell or distribute these items
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 these items federally
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 devices
without 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 next current academic term
year 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 30 45
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.
Official Publication of the State of Minnesota
Revisor of Statutes