Issue Date: August 28, 2026
Issued by: Center for Veterinary Medicine
Topic(s): Compounding
Status: Draft
Compounding Animal Drugs From Bulk Drug Substances: Compounding Under CGMP in Federally-Registered Facilities
This draft guidance (GFI #256B) describes circumstances where FDA generally does not intend to take enforcement action against the compounding of animal drug products from bulk drug substances at facilities registered under sections 503B(b) or 510(b) of the FD&C Act operating under current good manufacturing practice (CGMP). It extends FDA’s existing enforcement discretion policy under final GFI #256 to federally-registered facilities, covering nonfood-producing animals and certain uses for food-producing animals and wildlife. FDA states that, once finalized, this guidance will be combined with final GFI #256 as a Level 2 (non-binding) change.
Download the Guidance Document
