On April 1, 2023, the FDA released Guidance for Industry (GFI) # 256 which provides new guidelines on the prescribing and dispensing of compounded medications for animals. Listed below are the key points veterinary professionals should familiarize themselves on the new guidelines and how this may impact their prescribing and usage of compounded medications.
It is important to note the FDA has a broad definition of what constitutes a “copy” of an FDA approved or indexed drug. If a compounded medication is given by the same route of administration of an approved or indexed drug, then the FDA considers the compounded medication a “copy”. For instance, a medication compounded into a suspension or chew is considered a copy of the commercially approved tablet and now requires justification from the prescribing veterinarian.
The FDA states that the prescribing veterinarian should first determine if an “approved” manufactured product with the same active ingredient can be given via the same route. If so, the prescriber will need to provide and record the medical rationale noting why a compounded medication is needed.
If the prescribed compounded medication is not a copy of an approved drug, no medical justification is required: Examples include:
- No commercially available FDA approved drug exists (i.e., Cisapride)
- There is no commercially available FDA approved drug for the specific route of application.
(i.e. transdermal methimazole)
The FDA has indicated they will not question the professional judgement of veterinarians in most cases. They have also included several examples of what they consider valid clinical rationale including, but not limited to:
- An ingredient in the approved product is toxic to a specific species.
- The animal would require too many tablets of an approved product per dose.
- The approved product cannot be manipulated to provide a safe and efficacious dose to the animal.
As a result of the new FDA guidelines, we will begin asking for and capturing this information on all new prescriptions. Here are additional examples of justifications.
- Use of a commercial product will reduce compliance and/or will not be effective in achieving the desired medical outcome.
- Utilization of the commercially available product is unachievable or unsafe for the animal.
If you have any questions regarding these new guidelines and would like to review further with a pharmacist, please call the pharmacy.
