Compounding Animal Drugs from Bulk Drug Substances Guidance for Industry: GFI 256 What does it mean for my practice?

Affective April 1 2023, the Food and Drug Administration (FDA)’s new recommendations regarding compounding of animal drugs from bulk drug substances (also known as Active Pharmaceutical Ingredients (APIs)) GPI 256 will go live. These recommendations are meant for any pharmacy or veterinarian that uses compounded animal prescription medications from APIs. Below is an abbreviated summary on these new set of recommendations. For the full recommendation please see link below:

CVM GFI #256 - Compounding Animal Drugs from Bulk Drug Substances | FDA

How do I know if this guideline affects my practice?

This guideline applies to any veterinary practice and pharmacy that uses or produces compounded animal medications from bulk drug substances. It does not apply to animal drugs that are compounded for investigational purposes for new drug applications. If your practice uses compounds in house and/or writes prescriptions for compounded medications, there is a high probability your practice is affected by this regulation.

Guideline overview

GFI 256 was released by the FDA to provide guidance and clarity to the public regarding existing requirements for animal compounding from bulk products. This document is intended to ensure the safety of animals but limiting the use of animal compounded drugs that have not met the requirements of the Federal Food, Drug, and Cosmetic Act. The FDA’s enforcement of these guidelines will be on a case-by-case basis.

For nonfood-producing animals the following conditions should be met for individual compounded medications:

  1. Drug is compounded under direct supervision of a license veterinarian or pharmacist
  2. Drug is compounded in full compliance with state laws and other governing bodies
  3. All substances used in the compound meet standards set forth in the USP-NF monographs
  4. The drug is dispensed by:
    1. a pharmacy after receipt of a prescription for a specific animal to the owner or caregiver
    2. the veterinarian to the owner or caregiver of the patient in his or her practice in the same physical location
  5. The compound is not a copy of an FDA approved medication.
    1. If a copy is compounded due to a legitimate medical rationale, the pharmacist should maintain a record of such rationale.
      1. No compounds shall be made as copies due to lesser cost, personal preference
        or half strength needed.
  6. Proper documentation of the source of the active ingredients
  7. Correct reporting of adverse events
  8. Current compound labeling

There are similar regulation requirements for office use medications. It is important to understand that all state and federal laws must be followed. The more stringent policy supersedes any other existing regulations or requirements. According to the FDA, there are now a list of accepted office use compounds that veterinarians may keep on hand. You can find the list here. List of Bulk Drug Substances for Compounding Office Stock Drugs for Use in Nonfood- Producing Animals | FDA

What does this mean for my practice?

Often FDA available products are not in a suitable form or strength for animal patients. Veterinarians can still prescribe compounded medications for their nonfood producing patients. The important take away is to ensure your office use medications are in line with the FDA recommendations. In addition, we recommend veterinarians use pharmacies the specialize in veterinary compounds. Compounding pharmacies will need to keep extensive records in order to be in compliance with these FDA guidelines. Dalcoma Specilaty Pharmacy is aware of all these regulations and will uphold all compliance when servicing your patients.

If your office has any questions, please contact Dr. Erin Young at the pharmacy via email at [email protected] or by phone 586-697-3877.

When does this regulation go into effect?

This recommendation will be live April 1 2023.