Federal Register #FDA2021D0613

FDA Draft Guidance on Stability Testing for Veterinary Medicated Premixes

This notice announces the release of a draft guidance by the Food and Drug Administration (FDA) regarding stability testing for medicated premixes used in veterinary medicine. - Government Buyer: - Food and Drug Administration (FDA), Department of Health and Human Services - Purpose: - Release of draft revised guidance (GFI #91, VICH GL8(R1)) for public comment - Developed by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH) - Scope of Guidance: - Provides updated recommendations for stability testing of medicated premixes intended for oral administration in animal feed - Includes considerations for demonstrating stability in final medicated feed - Notable Details: - No procurement of products or services is requested - Notice is for public comment only; not a solicitation or award - OEMs and Vendors: - No specific OEMs or vendors are mentioned - Locations: - FDA offices in College Park, MD and Rockville, MD are listed as points of contact

Description

The Food and Drug Administration (FDA) announces the availability of a draft revised guidance for industry (GFI) #91 (VICH GL8(R1)) entitled "Stability Testing for Medicated Premixes (Revision 1)." This guidance, developed by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH), provides updated recommendations for stability testing of medicated premixes intended for oral administration after incorporation into animal feed. The draft guidance also includes considerations for demonstrating the stability of medicated premixes in the intended medicated feed. Comments on the draft guidance are due by June 15, 2026.

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