Stability Testing Medicated Premixes Draft Guidance
Summary
FDA has issued draft guidance on stability testing requirements for medicated premixes, opening a public comment period. The guidance applies to veterinary pharmaceutical manufacturers producing medicated feed premixes. Interested parties may submit comments through Regulations.gov. The docket number is FDA-2021-D-0613-0003.
What changed
FDA has published draft guidance addressing stability testing requirements for medicated premixes, which are veterinary pharmaceutical products used in animal feed. The draft guidance is now open for public comment.
Manufacturers of medicated premixes, veterinary pharmaceutical companies, and animal health industry stakeholders should review the draft guidance and consider submitting comments through Regulations.gov to provide feedback on the proposed stability testing requirements.
Archived snapshot
Apr 17, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
Write a Comment
Commenter's Checklist
Public Comments on Federal Regulations
Comment *
5000
What is your comment about?
Attach Files
You can attach up to 20 files, but each file cannot exceed 10MB. Valid file types include: bmp, docx, gif, jpg, jpeg, pdf, png, pptx, rtf, sgml, tif, tiff, txt, wpd, xlsx, xml. Drop files here or Browse...
Email Address
Opt to receive email confirmation of submission and tracking number?
If you choose to identify as Anonymous, the option to receive an email confirmation will not be displayed. (We will never post the email address entered in the field above on Regulations.gov nor share it with anyone else.)
Tell us about yourself! I am... *
(Select an identity below)
An Individual
Yourself or another person whom
you represent with their consent
An Organization
A company, organization,
or government agency
Anonymous
A person who does not want their name
associated with the comment
Note: If you choose to identify as Anonymous, the option to enter your email address for submission confirmation is not available.
reCAPTCHA *
Solve with 2Captcha Do not submit personally identifiable information through this form. Any personally identifiable information (e.g., name, address, phone number) included in the comment form or in an attachment may be publicly disclosed in a docket or on the Internet (via Regulations.gov, a federal agency website, or a third-party, non-government website with access to publicly-disclosed data on Regulations.gov). By submitting a comment, you agree to the terms of participation and privacy notice.
Submit Comment
Please see the Privacy Notice and User Notice regarding comment submission.
Any information (e.g., personal or contact) you provide on this comment form or in an attachment may be publicly disclosed and searchable on the Internet and in a paper docket and will be provided to the Department or Agency issuing the notice. To view any additional information for submitting comments, such as anonymous or sensitive submissions, refer to the Privacy Notice and User Notice, the Federal Register notice on which you are commenting, and the Web site of the Department or Agency.
Related changes
Get daily alerts for Regs.gov: Food and Drug Administration
Daily digest delivered to your inbox.
Free. Unsubscribe anytime.
Source
About this page
Every important government, regulator, and court update from around the world. One place. Real-time. Free. Our mission
Source document text, dates, docket IDs, and authority are extracted directly from FDA.
The summary, classification, recommended actions, deadlines, and penalty information are AI-generated from the original text and may contain errors. Always verify against the source document.
Classification
Who this affects
Taxonomy
Browse Categories
Get alerts for this source
We'll email you when Regs.gov: Food and Drug Administration publishes new changes.
Subscribed!
Optional. Filters your digest to exactly the updates that matter to you.