21 CFR Part 225 – Medicated Feed cGMP Requirements

This topic is part of the SG Systems Global regulatory glossary series.

Updated October 2025 • FDA / CVM • Medicated Feed Manufacturing

21 CFR Part 225 establishes current Good Manufacturing Practice (cGMP) requirements for facilities that manufacture medicated feeds or feed premixes containing approved animal drugs. It ensures proper mixing, labeling, and control to prevent drug carryover or contamination that could harm animals or humans via the food chain.

“Part 225 bridges veterinary drug control and feed manufacturing GMP — ensuring medicated feeds are accurate, safe, and fully traceable.”

1) What It Is

Part 225 applies to all manufacturers of medicated feeds, supplements, and premixes using approved Type A medicated articles (21 CFR 558). It defines facility and equipment requirements, testing obligations, mixing accuracy, recordkeeping, and label controls to ensure drug levels are within approved limits and cross-contamination is prevented.

Scope & application. Covers both licensed and unlicensed facilities producing medicated feed for commercial distribution in the U.S., regulated by the FDA’s Center for Veterinary Medicine (CVM).

Selected requirements under Part 225:

• Equipment design & maintenance. Mixers, conveyors, and hoppers must minimize cross-contamination and be maintained in a clean, calibrated state.
• Component control. Drug source verification, lot tracking, and segregated storage for Type A medicated articles.
• Mixing accuracy & testing. Periodic assay verification to confirm uniform drug distribution within ± 15% of the intended level.
• Recordkeeping. Batch records including formulation, weights, assays, equipment cleaning, and operator signatures.
• Labeling & distribution control. Correct drug claims, warnings, and withdrawal times on feed labels; reconciliation of label stocks.
• Training & supervision. Qualified personnel overseeing mixing operations and compliance with cGMP procedures.

Relation to other rules. Part 225 interacts with Part 507 (FSMA animal food controls) and Part 11 (electronic records and signatures). Drug approvals are referenced in Part 558.

2) FAQ

Q1. What does Part 225 apply to?
Any facility manufacturing feed that contains approved animal drugs or premixes for commercial use.

Q2. What is the difference between licensed and unlicensed facilities?
Licensed facilities may use Category II drugs and must meet additional inspection criteria; unlicensed facilities handle lower-risk Category I drugs.

Q3. Is assay testing required?
Yes — periodic assays must verify drug levels are within tolerance and mixing uniformity is maintained.

Q4. What records must be kept?
Complete batch records including ingredient lots, quantities, mixing times, equipment cleaning, and label use reconciliation.

Q5. How does Part 225 link to FSMA?
Feed manufacturers covered under Part 225 must also comply with Part 507 preventive control requirements if producing non-drug feeds in the same facility.

Q6. Where can I read the full rule?
See the eCFR for 21 CFR Part 225.

3) How It Relates to V5

V5 by SG Systems Global helps medicated feed manufacturers meet Part 225 through digital batch enforcement, traceability, and integrated quality oversight.

• Batch execution & recordkeeping. eBMR records weighings, mixing steps, and drug verifications with audit-trails.
• Weighing & formulation control. Batch Weighing module enforces accurate drug addition within specified tolerances.
• Calibration & equipment maintenance. QMS tracks preventive maintenance and cleaning schedules to prevent carryover.
• Label & distribution control. WMS ensures label reconciliation and lot status control before shipment.
• Electronic records & signatures. Part 11 compliance ensures secure sign-offs and audit trail traceability.

End-to-end example. A feed mill creates a drug premix batch in V5 eBMR; weighing data are captured in real-time; QA verifies mixing uniformity via LIMS; label issuance and reconciliation are tracked in WMS; Part 11 signatures finalize the record for inspection.

Primary References:
• FDA eCFR: 21 CFR Part 225
• Animal Food FSMA: 21 CFR Part 507
• Drug Use in Feed: 21 CFR Part 558
• Electronic Controls: 21 CFR Part 11