Current Good Manufacturing Practice for Medicated Feeds
The FDA CVM cGMP for medicated feeds — feeds, supplements, and premixes containing approved new animal drugs. It controls drug carryover between batches (flushing and sequencing), correct drug concentration, periodic potency assays, equipment, and labeling, structured differently for licensed and non-licensed facilities.
Facilities manufacturing medicated feeds containing approved new animal drugs; enforced by FDA CVM under the FD&C Act.
- 01Validate flushing and sequencing to prevent drug carryover between batches
- 02Ensure the finished feed contains the correct drug concentration
- 03Perform periodic assays to verify potency
- 04Label medicated feeds accurately, including cautions and withdrawal times
- 05Maintain production and distribution records
Long-standing FDA CVM cGMP. (Specific section numbers are intentionally not reproduced pending confirmation against primary text.)
21 CFR Part 225: frequently asked questions
Quick answers to common questions about 21 CFR Part 225.
What is 21 CFR Part 225?
21 CFR Part 225 — Current Good Manufacturing Practice for Medicated Feeds — is a regulation issued by the Food and Drug Administration (United States). The FDA CVM cGMP for medicated feeds — feeds, supplements, and premixes containing approved new animal drugs. It controls drug carryover between batches (flushing and sequencing), correct drug concentration, periodic potency assays, equipment, and labeling, structured differently for licensed and non-licensed facilities.
Who does 21 CFR Part 225 apply to?
Facilities manufacturing medicated feeds containing approved new animal drugs; enforced by FDA CVM under the FD&C Act.
What are the key requirements of 21 CFR Part 225?
FDA 21 CFR Part 225 requires, among other things: Validate flushing and sequencing to prevent drug carryover between batches; Ensure the finished feed contains the correct drug concentration; Perform periodic assays to verify potency; Label medicated feeds accurately, including cautions and withdrawal times.
When was 21 CFR Part 225 last updated?
The current version of 21 CFR Part 225 dates from April 1986. Long-standing FDA CVM cGMP. (Specific section numbers are intentionally not reproduced pending confirmation against primary text.).
Live openFDA recalls SPEQ maps to this standard’s topics — a SPEQ interpretation, not an FDA classification.
Recall domain is a SPEQ mapping of this standard’s topics, not an FDA classification.
Track the standards that move
When 21 CFR Part 225 — or any GxP requirement — is revised, recalled against, or clarified by new guidance, the Weekly GxP Briefing surfaces it. Free, one email a week.