Tenn. Comp. R. & Regs. 1730-01-.21

Current through October 22, 2024

Section 1730-01-.21 - PRESCRIBING, DISPENSING, OR OTHERWISE DISTRIBUTING PHARMACEUTICALS

(1) Prerequisites to Prescribing

(a) For purposes of this Rule, pursuant to 21 CFR 201.105, "animal drugs" are those drugs that are required by federal law to be prescribed by a licensed veterinarian.

(b) Before prescribing animal drugs, the veterinarian must first, pursuant to appropriate protocols or veterinary orders, complete and appropriately document all of the following for the animal, herd, or flock on whose behalf the prescription is to be written:

1. Perform an appropriate history and physical examination;

2. Make a diagnosis based upon the history, physical examination, and pertinent diagnostic and laboratory tests;

3. Formulate a therapeutic plan and discuss it with the animal's owner, along with the basis for it and the risks and benefits of various treatment options, a part of which might be a prescription or drug; and

4. Ensure availability of the veterinarian or the veterinarian's staff for appropriate follow-up care.

(c) Notwithstanding the provisions of subparagraph (b), a veterinarian, pursuant to appropriate protocols or veterinary orders, may prescribe or dispense drugs for an animal when such prescribing or dispensing is consistent with sound veterinary practice, examples of which are as follows:

1. As part of an initial evaluation order; or

2. For an animal/patient of another veterinarian for whom the prescriber is taking calls or for whom the prescriber has verified the appropriateness of the medication; or

3. For continuation medications on a short-term basis before the veterinarian personally examining the animal, herd, or flock; or

4. For medications administered by the owner of the animal, herd, or flock when the veterinarian has prescribed and/or dispensed in a manner consistent with this rule.

(2) Dispensing Requirements. Veterinarians who dispense pharmaceuticals must comply with the following minimum standards for drug procedures:

(a) All federal and state regulations for the dispensing of controlled substances.

(b) Except for labeled manufactured drugs with proper instructions, all non-controlled drugs are to be dispensed in an appropriate container labeled with at least, the following:

1. Animal's name and the name of the animal's owner;

2. Date dispensed;

3. Complete directions for usage;

4. The facility's name, address and phone number;

5. The name, strength, and amount of the medication;

6. The statement: "For veterinary use only";

7. The dispensing veterinarian's name; and

8. Keep out of the reach of children.

(c) A record of all drugs administered or dispensed shall be kept in the client's record. In the case of companion animals, this record shall be by individual animal.

(3) Distribution of Veterinary Prescription Drugs.

(a) Distribution of veterinary prescription drugs to laymen may occur only on the prescription or other order of a licensed veterinarian. The prescriptions must be issued in the course of professional practice, with a veterinarian-client-patient relationship existing.

Tenn. Comp. R. & Regs. 1730-01-.21

Original rule filed April 28, 1995; effective July 12, 1995. Amendment filed June 15, 1999; effective August 29, 1999. Amendment filed July 18, 2007; effective October 1, 2007. Amendment filed May 23, 2014; effective 8/21/2014.

Authority: T.C.A. §§ 4-5-202, 4-5-204, 63-12-103, 63-12-105, and 63-12-106.