What is GFI #256?
FDA Guidance for Industry #256 regarding compounding animal drugs from bulk drug substances. Requires documentation of veterinarian-client-patient relationships (VCPR) and compliance with the FDA Bulk Drug Substance (BDS) list.
GFI #256 describes when the FDA does not intend to enforce certain FDCA provisions against compounding animal drugs from bulk drug substances — provided the pharmacy meets conditions including using substances consistent with the FDA's evaluated BDS list, maintaining VCPR documentation, and reporting adverse events to the FDA within 15 days.
For veterinary compounding pharmacies the operational impact is record-keeping: per-compound BDS verification, prescriber and patient documentation, and an adverse-event process with deadline tracking.
See how CompliRx handles this in practice:
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