What is GFI 256?
Guidance for Industry (GFI) 256 Compounding Animal Drugs from Bulk Drug Substances describes the FDA’s enforcement policy regarding the compounding of animal drugs from bulk drug substances (BDS). This guidance applies to pharmacies and veterinaries preparing compounded medication from a BDS. When a veterinarian needs a compounded medication from a BDS a medical rationale is necessary when prescribing a patient-specific compounded medication. This rationale must be documented within the prescription if the FDA considers a similar medication to be commercially available. The GFI 256 changes are here.