201 KAR 16:110. Prescription and
dispensation of drugs
for animal use.
RELATES TO: KRS 321.181(5)(b)
STATUTORY AUTHORITY: KRS 321.235(3), 321.240(5)
NECESSITY, FUNCTION, AND CONFORMITY: KRS
321.181(5)(b) provides that the practice of veterinary medicine includes the
prescribing, administering, or dispensing of drugs and medications for
veterinary purposes. KRS 321.235(3) and 321.240(5) authorize the board to
promulgate administrative regulations to carry out and enforce the provisions
of KRS Chapter 321. This administrative regulation establishes a procedure for
the prescription and dispensation of drugs by licensed veterinarians for use in
animals and livestock.
Section
1. Definitions. (1)"Legend drug"
means veterinary prescription drug.
(2)
"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;
(3) "Veterinary drug" means:
(a) A drug for animal use recognized in the official United
States Pharmacopoeia or National Formulary of the United States;
(b) A drug intended for use in the diagnosis, cure, mitigation,
treatment, or prevention of disease in animals;
(c) 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
(d) A drug intended for
use as a component of a drug in paragraph (a), (b), or (c).
(4) "Veterinary prescription drug" means:
(a) A drug that is not safe for animal use without a veterinarian using or ordering the use of the
product, 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";
(b) A drug that is required
by state law to be dispensed only on order or prescription of a licensed
veterinarian;
(c) The extra-label use of an over-the-counter animal drug
or human drugs; and
(d) A medicament compounded
by mixing two (2) or more legally-obtained over-the-counter or prescription
drugs.
Section 2. Prescribing and Dispensing. (1) A veterinary prescription
shall include all of the following:
(a) The name and address of the
veterinarian and, if the prescription is a written order, the signature of the
veterinarian;
(b) The name and address of the client;
(c) The species and identity of the
patient for which the prescription is issued;
(d) The name, strength, and quantity of
the drug prescribed;
(e) The date on which the prescription is
issued;
(f) The directions for administering the
drug;
(g) If the patient is a food producing
animal, the withdrawal time for the veterinary drug;
(h) If the prescription authorizes
extra-label use, the manner in which the client may use the drug;
(i) Any cautionary statements required by
law; and
(j) Number of refills allowed.
(2) A veterinarian shall not:
(a) Prescribe for or dispense to a client
a veterinary prescription drug or a drug for extra-label use without personally
examining the patient unless a veterinary-client-patient relationship exists
between the prescribing veterinarian, client and patient, and the veterinarian
determines that the client has sufficient knowledge to administer the drug
properly;
(b) Prescribe or dispense a veterinary
prescription drug to a client unless the veterinarian indicates in the
appropriate records described in Section 4 of this administrative regulation,
within seventy-two (72) hours after the prescription is issued or the drug is
dispensed, that the prescription has been issued or that the drug has been dispensed;
(c) Prescribe a drug to a client for
extra-label use on a patient unless all of the following apply:
1. A veterinary-client-patient
relationship exists between the veterinarian, client and patient and the veterinarian
has made a careful medical diagnosis of the condition of the patient within the
context of that veterinarian-client-patient relationship;
2. The veterinarian determines that there
is no drug that is marketed specifically to treat the patient’s diagnosed
condition, or determines that all of the drugs that are marketed for that
purpose are clinically ineffective;
3. The veterinarian recommends procedures
for the client to follow to ensure that the identity of the patient shall be
maintained; and
4. If the patient is a food producing
animal, the veterinarian prescribes a sufficient time period for drug
withdrawal before the food from the patient may be marketed; or
(d) Transmit a prescription
electronically unless the client approves the transmission and the prescription
is transmitted to a pharmacist or veterinarian designated by the client.
Section 3. Labeling. (1) A veterinarian shall
not dispense a drug that has been prepared, mixed, formulated or packaged by
the veterinarian unless the veterinarian affixes to the container in which the
drug is dispensed a label containing all of the information specified in
Section 2(1) of this administrative regulation, except the address of the
client.
(2) A veterinarian shall not dispense a
veterinary prescription drug that has been prepackaged by its manufacturer for
dispensing unless the veterinarian affixes to the container in which the drug
is dispensed a label containing all of the information specified in Section 2(1)
of this administrative regulation, except the address of the client.
(3) A veterinarian may dispense a
veterinary over the counter drug without affixing any information to the
container in which the drug is dispensed if a label that has been affixed to
the container by its manufacturer provides adequate information for its use.
Section 4. Prescription Records. (1) A veterinarian
shall maintain complete records of each veterinary prescription drug that the
veterinarian receives, prescribes, dispenses or administers, and of each
prescription issued by the veterinarian that authorizes extra-label use.
(2) Records of each veterinary
prescription drug shall include the name of each veterinary prescription drug
that is received, the name and address of the person from whom the drug is
received and the date and quantity received, the name and address of the person
to whom the drug is dispensed and the date and quantity dispensed and, if the
veterinarian prescribes or administers the drug, the information specified in
Section 2(1) of this administrative regulation.
(3) Records of each prescription
authorizing extra-label use shall include the information specified in Section
2(1) of this administrative regulation.
(4) A veterinarian shall maintain records
of each veterinary prescription drug for not less than five (5) years after the
date on which the veterinarian prescribes, dispenses or administers the drug or
extra-label use.
Section 5. (1) A veterinarian shall not
be required to write a prescription for controlled substances or a prescription
for any medication that, in the veterinarian’s medical judgment, is not
appropriate for the patient’s medical care.
(2) A veterinarian may refuse to write a
prescription if it is not directly requested by a client with whom there is, in
the veterinarian’s opinion, a current and existing veterinarian-patient-client
relationship.
(3) A prescription shall be construed to
include any manner of authorization for filling a prescription, including verbal
or electronic communication.
(4) The veterinarian may delegate to an
office employee the authority to communicate a refill of a legend drug to the
pharmacy on behalf of the veterinarian pursuant to written protocol established
prior to the delegation of that authority.
Section 6. (1) A veterinarian shall ensure
that all federal legend drugs and veterinary prescription drugs are maintained,
administered, prescribed, dispensed, and destroyed in compliance with all state
and federal laws.
(2) A veterinarian shall not prescribe or
dispense a quantity of drug that is greater than that the amount required for
six (6) months of treatment for an animal, herd, or flock.
(3) To prescribe, sell, distribute, or
dispense any drug requiring a prescription for use in the context of an animal,
herd, or flock, a veterinarian shall first do all of the following:
(a) Perform an appropriate history and
physical examination;
(b) Make a diagnosis based upon the
history, physical examination, and pertinent diagnostic and laboratory tests;
(c) Formulate a therapeutic plan, and discussed
it with the animal’s owner, agent, or guardian, along with the basis for it and
the risks and benefits of various treatments options, a part of which might be
a prescription drug; and
(d) Ensure availability of the veterinarian
or the veterinarian’s staff for appropriate follow-up care.
Section 7. (1) A veterinarian may
dispense a prescription drug only if the prescribing veterinarian has
established a veterinarian-client-patient relationship.
(2) If the dispensing veterinarian does
not have a veterinarian-client-patient relationship, a veterinary assistant may
assist in the delivery of a veterinary drug, legend drug, or veterinary
prescription drug only under the direct supervision of the licensed
veterinarian by who the assistant is employed.
(3) If the dispensing veterinarian does
have a veterinarian-client-patient relationship, a veterinary assistant may
assist in the delivery of a veterinary drug, legend drug, or veterinary
prescription drug under the indirect supervision of the veterinarian by whom
the assistant is employed.
(4) If a veterinary assistant acts under
the provisions of this section, it shall be the responsibility of the licensed veterinarian
to ensure that the requirements of this administrative regulation are met.
Section 8. Enforcement.
Except as
provided in subsection 2 of this section, if the board has reason to believe
that a person is violating or has violated this administrative regulation, the
examining board may:
(1) Inspect the premises on which the
person possesses, prescribes, dispenses, labels or administers veterinary drugs;
(2) Inspect pertinent records, equipment,
materials, containers or facilities that are relevant to determining whether
the person is violating or has violated this administrative regulation; and
(3) Collect relevant samples of
veterinary drugs found on the premises. (35 Ky.R. 1902; eff. 10-31-2008.)
