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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Requirements for Registration of Veterinary Medicinal Products; Stability Testing for Medicated Premixes (Revision 1); Draft Guidance for Industry; Availability
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Summary (from the Federal Register abstract)
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft revised guidance for industry (GFI) #91 (VICH GL8(R1)) entitled "Stability Testing for Medicated Premixes (Revision 1)." This draft guidance has been developed for veterinary use by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). Medicated premixes are intended for oral administration following incorporation into animal feed. This draft guidance contains updated recommendations for stability testing of a medicated premix as well as considerations for demonstrating the stability of the medicated premix in the intended medicated feed.
- Document type
- Notice
- Federal Register document number
- 2026-07419
- Published
- Apr 16, 2026
- Action
- Notice of availability.
- Docket
- FDA-2021-D-0613
- Comments posted on Regulations.gov (at last check)
- 0
- DATES section (from the document)
- Submit either electronic or written/paper comments on the draft guidance by June 15, 2026 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.
- Topics (auto-tagged)
- CMC (chemistry, manufacturing & controls) Food & dietary supplements
Source: Federal Register API, document 2026-07419. Federal Register text is a U.S. government work. Confirm dates in the official document; later documents may extend, reopen or correct them.