# Draft CVM GFI #256B - Compounding Animal Drugs from Bulk Drug Substances: Compounding under CGMP in Federally-Registered Facilities - FDA Guidance Document

Source: https://www.keypedia.com/guidances/guidance-document/draft-cvm-gfi-256b-compounding-animal-drugs-from-bulk-drug-substances-compounding-under-cgmp-in-federally-registered-facilities/0be1c40c-3d00-4c75-a0cf-c03febf18951

> FDA guidance document: Draft CVM GFI #256B - Compounding Animal Drugs from Bulk Drug Substances: Compounding under CGMP in Federally-Registered Facilities. Issue date: August 28, 2026. Get complete insights and analysis.

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## Details

- Title: Draft CVM GFI #256B - Compounding Animal Drugs from Bulk Drug Substances: Compounding under CGMP in Federally-Registered Facilities
- Communication Type: Guidance Document
- Product Type: veterinary
- Office Name: Center for Veterinary Medicine
- Office URL: /offices/center-for-veterinary-medicine/7e30a309-56e4-4e7a-8b8b-e07674bb07b4
- Issue Date: 2026-08-28
- Comment Close Date: 2026-11-27
- Last Changed: 2026-08-27
- Docket Number: <a href="https://www.regulations.gov/docket/ FDA-2018-D-4533"> FDA-2018-D-4533</a>

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