09 Oct CVMA submits comments on proposed FDA guidance regarding compounded drugs from bulk substances
The CVMA Board of Directors agreed to comment on newly proposed FDA guidance on compounding animal drugs from bulk drug substances. CVMA joins AVMA in weighing in on the new compounding guidance. AVMA’s formal comments were sent to FDA on October 8 and were based on input from AVMA members, volunteers, state and allied veterinary groups, and other stakeholders.
CVMA’s board reviewed and discussed a summary of AVMA’s extensive analysis of FDA Guidance for Industry #256 Compounding Animal Drugs from Bulk Drug Substances. If finalized, the guidance would advise veterinarians on circumstances under which the FDA does not intend to take action for certain violations of the Federal Food, Drug, and Cosmetic Act when pharmacists and veterinarians participate in compounding of animal drugs from bulk drug substances.
Overall, CVMA commented on several key issues and potential benefits for veterinarians:
- CVMA supports the development of guidance to minimize potential risk to veterinarians by providing a framework for veterinarians to operate within when using drugs compounded from bulk drug substances. Because many veterinarians do not understand that the use of drugs compounded from bulk drug substances carries potential legal risk and that they should be operating within FDA’s enforcement parameters, having guidance in place will help mitigate potential legal risk for veterinarians and will be a tool to offer peace of mind while preserving access to medications prepared from bulk drug substances that veterinarians need to provide the best patient outcomes.
- GFI #256 must provide an operating framework for veterinarians to appropriately use drugs compounded from bulk drug substances.
- GFI #256 must minimize legal risk to veterinarians by clarifying how FDA will enforce the use of compounded drugs in veterinary medicine.
- Veterinarians must have access to affordable drugs that provide the best possible outcomes for animal patients. This is essential.
- GFI #256 must preserve access to medications prepared from bulk drug substances that veterinarians need to provide the best patient outcomes when no FDA-approved, conditionally-approved or indexed drug is available.
CVMA also noted that:
- Some compounding pharmacies oppose any guidance from FDA because they do not believe FDA has authority over their practice; they believe they should be governed by state boards of pharmacy.
- FDA believes that there are aspects of animal drug compounding that are subject to the federal Food, Drug, and Cosmetic Act and aspects that are subject to state pharmacy acts.
More information:
- Click here to read AVMA comments on the guidance
- Click here to read the AVMA FAQ about the guidance
- Click here to read an overview of the issue from FDA
- Click here to read the proposed guidance from FDA