Compounding Drug Rule Guidance

GUIDANCE REGARDING THE BOARD’S DRUG COMPOUNDING RULE (573.44) AND COMPOUNDED CONTROLLED SUBSTANCES

Summary of Issue

The Board has received notice that many of its licensees interpret Board Rule 573.44, Compounding Drugs, to prohibit Texas veterinarians from obtaining compounded multi-use vials of controlled substances—specifically buprenorphine. The Board has been asked to clarify if this is indeed its position.

Applicable Rule: Board Rule 573.44 – Compounding Drugs

(a) A veterinarian may only compound drugs for a specific animal or herd with which the veterinarian has established and maintained a valid veterinarian-client-patient relationship.

(b) A veterinarian may only prescribe, administer, or dispense compounded drugs to treat a specific occurrence of a disease or condition that threatens the health of the animal or will cause suffering or death if left untreated. This condition must be observed and diagnosed in the particular patient. The compounded amount must not exceed the established need.

(c) Labeling Requirements

1. All compounded drugs must include labeling per §573.40 and must include:
   • (A) Date the drug was compounded
   • (B) Name and strength of active ingredients
   • (C) Identity of treated animals
   • (D) Withdrawal/withholding times (if applicable)
   • (E) Condition or disease being treated
2. If dispensed to the client, the label must also state:
   • Date dispensed
   • Expiration date (not exceeding the treatment duration)

(d) Limitations on Compounded Products

1. A compounded drug cannot be used if an FDA-approved alternative is available that effectively treats the condition.
2. Only FDA-approved animal or human drugs may be used as active ingredients.
3. Compounded drugs that mimic FDA-approved products cannot be promoted/distributed.
4. The veterinarian must ensure safety, efficacy, and compatibility of compounded drugs. If complex, a licensed pharmacist must perform the compounding.

(e) Compounding for Food-Producing Animals

1. Must establish a scientifically supported withdrawal interval and avoid prohibited substances.
2. Must not result in violative or risky food residue.
3. Cannot compound from human drugs if suitable animal drugs are available.
4. Must maintain identity tracking of treated animals and document procedures in records.

(f) Limitations on Promotion and Sale

1. Cannot use fanciful names, colorings, or misleading branding.
2. Cannot promote, advertise, display, or resell compounded drugs.
3. Cannot offer compounded drugs for resale to others.

Board’s Interpretation

Board Rule 573.44 does not prohibit Texas veterinarians from obtaining compounded multi-use vials of controlled substances such as buprenorphine for office use only.

However, veterinarians may not dispense compounded multi-use vials of controlled substances for at-home use. See subsection (f)(2).

All compounded controlled substances must meet the requirements under subsections (b), (d), and (e) of the rule.

Additional Resources

• Compounding – American Veterinary Medical Association
• Animal Drug Compounding – FDA