International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Stability Testing for Medicated Premixes (Revision 1); Draft Guidance for Industry; Availability
AI-generated summary for informational purposes only. Not legal advice. See the original source for the authoritative text.
This draft guidance from the FDA provides updated recommendations for testing the stability of medicated premixes, which are intended to be incorporated into animal feed. The guidance affects manufacturers of veterinary medicinal products who will need to align their stability testing procedures with these revised recommendations. This guidance aims to harmonize international standards and ensure consistent quality and safety in veterinary products.
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Key Changes
- Updated recommendations for stability testing of medicated premixes.
- Guidelines for demonstrating stability in intended medicated feed.
- Harmonization of international standards for veterinary product registration.
Obligations
What this law requires
Manufacturers of veterinary medicinal products must align their stability testing procedures with the updated recommendations outlined in the draft guidance GFI #91 (VICH GL8(R1)).
Comments on the draft guidance must be submitted to the FDA by June 15, 2026, to be considered before the final version is prepared.
Comments submitted electronically must include Docket No. FDA-2021-D-0613 to ensure proper identification.
Any comments with confidential information must be submitted as a written/paper submission, including one redacted copy for public viewing.
Manufacturers must demonstrate the stability of their medicated premixes in the intended medicated feed as per the updated testing recommendations.