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.
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.
- 01Control and verify incoming components used in Type A medicated articles
- 02Assay the active drug to confirm correct potency
- 03Prevent cross-contamination and carryover between products
- 04Maintain complete manufacturing and control records
Long-standing FDA CVM cGMP; applied alongside Part 225 for medicated feeds. (Specific section numbers are intentionally not reproduced pending confirmation against primary text.)
21 CFR Part 226: frequently asked questions
Quick answers to common questions about 21 CFR Part 226.
What is 21 CFR Part 226?
21 CFR Part 226 — Current Good Manufacturing Practice for Type A Medicated Articles — is a regulation issued by the Food and Drug Administration (United States). 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.
Who does 21 CFR Part 226 apply to?
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.
What are the key requirements of 21 CFR Part 226?
FDA 21 CFR Part 226 requires, among other things: 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.
When was 21 CFR Part 226 last updated?
The current version of 21 CFR Part 226 dates from April 1986. Long-standing FDA CVM cGMP; applied alongside Part 225 for medicated feeds. (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.
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When 21 CFR Part 226 — or any GxP requirement — is revised, recalled against, or clarified by new guidance, the Weekly GxP Briefing surfaces it. Free, one email a week.