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Requirements for Registration of Veterinary Medicinal Products; Stability Testing for Medicated Premixes (Revision 1); Draft Guidance for Industry; Availability

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 This draft guidance has been developed for veterinary use by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal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 This draft guidance contains updated recommendations for stability testing of a medicated premix as well as considerations for demonstrating the stability of the medicated premix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.