Yesterday, FDA released a Draft Guidance for Industry on Compounding Animal Drugs from Bulk Drug Substances (Draft Guidance). The Federal Register notice accompanying the Draft Guidance can be found here. The agency also withdrew its previous Compliance Policy Guide (CPG) 608.400, Compounding of Drugs for Use in Animals.
Though FDA has been actively implementing Title I of the Drug Quality and Security Act (DQSA) and exercising its new, clearer authority over outsourcing facilities and compounding pharmacies, the new §503B and amended §503A of the FD&C Act do not apply to the compounding of animal drugs. Arising from FDA’s recent, vigorous oversight of compounding pharmacies and outsourcing facilities, the Draft Guidance reflects the agency’s current, and more sophisticated, thinking about compounding.
The Draft Guidance describes the conditions under which FDA does not intend to initiate enforcement action against State-licensed pharmacies, licensed veterinarians, and facilities registered as outsourcing facilities under §503B of the FD&C Act that compound animal drugs from bulk drug substances. Outsourcing facilities are new entities created under the DQSA that, if they follow cGMPs and other requirements, are permitted to compound sterile injectable drugs for humans without FDA pre-approving an application under §505 and without the “adequate directions for use” required by §502(f)(1). The Draft Guidance sets out pre-conditions for the exercise of enforcement discretion for each type of entity – State-licensed pharmacies, licensed veterinarians, and outsourcing facilities. Unlike pharmacies and veterinarians, outsourcing facilities will only be permitted to compound from bulk substances identified in the to-be-developed Appendix A.
FDA separately seeks comments on the list of acceptable bulk substances to add to the Appendix A list. The agency also asks for comments on various other issues, including:
- The significance of drug shortages to animal drug compounding;
- The appropriate standards for compounding by licensed veterinarians;
- Possible limitations on total drugs to be compounded and whether they may be transferred or sold to others; and
- Whether the agency needs to address repackaging of animal drugs, as it did for human drugs.
For compounders of animal drugs, these are significant documents that warrant close inspection. FDA will be accepting comments for 90 days.