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.
What this does not cover
stated in the document's own scope- Covers the manufacture of medicated feeds; the concentrated Type A medicated articles used to make them are governed by 21 CFR Part 226.
- Sets manufacturing cGMP for feeds, not the approval of the animal drugs they contain, which is the new-animal-drug application pathway.
- Governs medicated (drug-containing) feeds; general animal-food safety and preventive controls sit in 21 CFR Part 507.
Always verify against the current published text before relying on it for a submission or inspection.
Overview
21 CFR Part 225 is the FDA current good manufacturing practice regulation for medicated feeds — the feeds, supplements, and premixes that contain approved new animal drugs. Because the same equipment is used across many batches, the regulation gives particular attention to preventing drug carryover between products through flushing and production sequencing, and to confirming that each batch carries the correct drug concentration through periodic potency assays. It also covers equipment, components, labeling, and records. Its requirements are structured to distinguish facilities that operate under a medicated-feed mill license from those that do not.
Scope & applicability
Facilities manufacturing medicated feeds containing approved new animal drugs; enforced by FDA CVM under the FD&C Act.
Legal basis & how it acquires force
Part 225 is a binding regulation in Title 21 CFR, issued by the FDA under the Federal Food, Drug, and Cosmetic Act; a medicated feed not manufactured in conformity with it is deemed adulterated. It is administered by the Center for Veterinary Medicine and is tied to the new-animal-drug framework, which determines which drugs may be used and at what levels. The licensing distinction it draws reflects the statutory category of drugs that require a medicated-feed mill license, with those licensed facilities subject to the fuller set of controls.
Document structure
| Part | Covers |
|---|---|
| General provisions | Scope, definitions, and the licensed / non-licensed facility distinction |
| Buildings and equipment | Facility and equipment suitable for producing medicated feed and their upkeep |
| Components | Receipt, identity, and inventory control of drug and non-drug components |
| Master record and production records | Master record files and batch production records for each medicated feed |
| Cleanout and sequencing | Flushing, sequencing, and cleanout procedures that control drug carryover |
| Laboratory assays and labeling | Periodic potency assays and the labeling of finished medicated feeds |
Key requirements
- 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
- Maintain production and distribution records
Implementation tips
- Design production sequencing so sensitive species never follow an incompatible medicated feed
- Treat flush validation as contamination control — it is the animal-feed analogue of cleaning validation
- Keep labeling tight: withdrawal-time errors become food-chain residue problems
Revision notes
Long-standing FDA CVM cGMP. (Specific section numbers are intentionally not reproduced pending confirmation against primary text.)
Where this control fails
live FDA enforcementLive FDA recalls SPEQ maps to this standard’s topics — a SPEQ interpretation, not an FDA classification.
International alignment
Part 225 is the downstream companion of Part 226: the Type A medicated articles governed by Part 226 are the concentrated inputs that medicated-feed manufacturers dilute under Part 225. Both are administered by the Center for Veterinary Medicine and derive their permitted drug uses from new-animal-drug approvals. As a US veterinary-feed cGMP, it is not part of the ICH or PIC/S human-medicine harmonisation architecture.
21 CFR Part 225: frequently asked questions
Quick answers to common questions about 21 CFR Part 225.
What does 21 CFR Part 225 focus on?
The cGMP for manufacturing medicated feeds, with particular emphasis on preventing drug carryover between batches through flushing and sequencing, and on confirming correct drug concentration through periodic potency assays.
Why does Part 225 distinguish licensed and non-licensed facilities?
Because certain animal drugs require a medicated-feed mill license, the regulation applies its fuller set of controls to licensed facilities and a different structure to non-licensed ones, reflecting the statutory licensing category.
How is Part 225 different from Part 507?
Part 225 governs medicated feeds that contain approved new animal drugs; Part 507 sets general cGMP and preventive controls for animal food more broadly. A drug-containing feed falls under Part 225 for its medicated content.
This standard in practice
Recall domain is a SPEQ mapping of this standard’s topics, not an FDA classification.