Current Good Manufacturing Practice for Type A Medicated Articles
The FDA (Center for Veterinary Medicine) cGMP for Type A medicated articles — the concentrated drug premixes used to manufacture medicated feeds. It sets controls on components, potency/assay, equipment, and records so the active drug is present at the correct concentration and free of unintended carryover.
What this does not cover
stated in the document's own scope- Covers the manufacture of Type A medicated articles (concentrated premixes); the finished medicated feeds made from them are governed by 21 CFR Part 225.
- Sets manufacturing cGMP, not the approval of the new animal drug itself, which runs through the new-animal-drug application pathway.
- Applies to animal-drug premixes, not to human-drug manufacturing, which is governed by 21 CFR Parts 210 and 211.
Always verify against the current published text before relying on it for a submission or inspection.
Overview
21 CFR Part 226 is the FDA current good manufacturing practice regulation for Type A medicated articles — the concentrated drug premixes that feed mills dilute to make finished medicated feeds. A Type A medicated article is a highly potent starting material, so the regulation concentrates on the controls that keep its drug at the right strength and free of unintended carryover: identity and control of components, potency and assay of the finished article, equipment cleaning and sequencing, master and batch production records, and labeling. It is the upstream companion to Part 225, which governs the feeds those premixes are used to manufacture.
Scope & applicability
Manufacturers of Type A medicated articles (concentrated new-animal-drug premixes) intended for use in making medicated feeds; enforced by FDA CVM under the FD&C Act.
Legal basis & how it acquires force
Part 226 is a binding regulation in Title 21 of the Code of Federal Regulations, issued by the FDA under the Federal Food, Drug, and Cosmetic Act. A Type A medicated article that is not manufactured in conformity with these cGMP requirements is deemed adulterated under the Act. The regulation is administered by the Center for Veterinary Medicine, since Type A medicated articles carry approved new animal drugs, and it works together with the new-animal-drug approval framework that establishes which drugs and concentrations are permitted in the first place.
Document structure
| Part | Covers |
|---|---|
| Definitions and general provisions | What a Type A medicated article is and the scope of the cGMP requirements |
| Buildings and equipment | Facility and equipment suitable for manufacturing, and their cleaning and maintenance |
| Components | Identity, inventory, and control of the drug and other components used |
| Production and process controls | Batch production, mixing, and controls that maintain correct drug concentration |
| Laboratory and potency assays | Assay of the finished article to confirm the labeled drug potency |
| Records and labeling | Master and batch production records, distribution records, and labeling |
Key requirements
- Control and verify incoming components used in Type A medicated articles
- Assay the active drug to confirm correct potency
- Prevent cross-contamination and carryover between products
- Maintain complete manufacturing and control records
Implementation tips
- Treat potency assay as the release-critical test — downstream feeds inherit any error
- Validate cleanout/sequencing between products to control carryover
- Keep component and batch records reconcilable for CVM inspection
Revision notes
Long-standing FDA CVM cGMP; applied alongside Part 225 for medicated feeds. (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 226 sits at the top of the medicated-feed manufacturing chain: the Type A medicated articles it governs are the inputs to the Type B and Type C medicated feeds regulated under Part 225. Both parts flow from the new-animal-drug approvals administered by the Center for Veterinary Medicine, which fix the permitted drugs, concentrations, and labeled claims. It is a US veterinary-feed regulation and does not participate in a human-medicine harmonisation scheme such as ICH or PIC/S.
21 CFR Part 226: frequently asked questions
Quick answers to common questions about 21 CFR Part 226.
What is a Type A medicated article under 21 CFR Part 226?
A Type A medicated article is a concentrated form of a new animal drug — a premix intended to be diluted into medicated feeds rather than fed directly. Part 226 sets the cGMP for manufacturing these concentrated articles so the drug is present at the labeled potency.
How does Part 226 relate to Part 225?
Part 226 governs the concentrated Type A medicated articles; Part 225 governs the medicated feeds manufactured by diluting those articles. They are the upstream and downstream halves of the same medicated-feed chain.
Which FDA center administers Part 226?
The Center for Veterinary Medicine, because Type A medicated articles carry approved new animal drugs. The regulation is enforced under the Federal Food, Drug, and Cosmetic Act.
This standard in practice
Recall domain is a SPEQ mapping of this standard’s topics, not an FDA classification.