Stability Testing Medicated Premix Draft Guidance Revision 1

Search for FDA
Guidance Documents

Submit Comments by

06/15/2026

Submit Comments Online Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either online or written comments on the draft guidance before the close date.

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2021-D-0613

Docket Number: FDA-2021-D-0613 Issued by: Guidance Issuing Office Center for Veterinary Medicine This guidance document is an annex to the parent guidance VICH GL3, “Stability Testing of New Veterinary Drug Substances and Medicinal Products.”  It addresses the recommendations for stability testing of new veterinary medicinal Medicated Premix products intended for submission for approval to the European Union, Japan and the United States.  The parent guidance (VICH GL3) provides a general indication of the information on product stability generated, but the annex for Medicated Premixes leaves sufficient flexibility to encompass a variety of different practical and scientific considerations that are specific to the characteristics of the drug products being evaluated. Other stability studies which might be important to consider like stability in relation to conditioning and pelleting, segregation and homogeneity studies are not within the scope of this guidance.

The guidance primarily addresses the generation of acceptable stability information for submission in Registration Applications for medicated premix drug products containing new molecular entities. Medicated Premixes are intended for oral administration following incorporation into animal feed. The guidance only pertains to Medicated Premixes, and does not currently seek to cover information required for products manufactured from medicated premixes. Stability studies carried out with a medicated premix should be in line with the parent guidance. However, the application of the parent guidance may be limited in some instances. This guidance therefore describes those areas where there may be differences in the stability data package for medicated premixes.

Questions?

Contact Point CVM Center for Veterinary Medicine
Food and Drug Administration
5001 Campus Drive
College Park, MD 20740
AskCVM@fda.hhs.gov (240) 402-7002

• ## Content current as of:

04/21/2026

• Regulated Product(s)

  • Animal & Veterinary
  • Animal Feed

Topic(s)

• VICH
• Chemistry, Manufacturing, and Controls (CMC)