FDA Asks: How Do You Paper-Trail Your Medicated Moo Juice?
Published Date: 2/25/2026
Notice
Summary
The FDA wants feedback on how medicated animal feed makers keep their records to make sure everything’s safe and up to date. This affects companies that produce medicated feeds, and they have until April 27, 2026, to share their thoughts. No big money changes yet, just a chance to improve how info is collected and stored.
Analyzed Economic Effects
5 provisions identified: 1 benefits, 4 costs, 0 mixed.
Licensed Feedmills: Large recordkeeping burden
If you run a registered, licensed commercial medicated feed mill, you must establish, maintain, and retain records under 21 CFR part 225 documenting receipts, inventory of drug components, batch production, laboratory assay results, labels, and product distribution. FDA estimates for these registered licensed commercial feed mills a total of 2,241,792 annual responses and 683,747 total annual recordkeeping hours (average 18.3 minutes or 0.305 hours per response).
Non‑licensed Mixer/Feeders: recordkeeping hours
If you run a nonregistered, non‑licensed mixer/feeder that produces medicated feeds, you must keep records under 21 CFR part 225 for components, lab controls, labeling, production, and distribution. FDA estimates 3,400 such recordkeepers producing 309,400 total annual records and requiring 420,784 total annual hours (average 1.36 hours per record).
Non‑licensed Commercial Feedmills: recordkeeping needs
If you operate a nonregistered, non‑licensed commercial feed mill that manufactures medicated feeds, you must keep records under 21 CFR part 225 for components, laboratory controls, packaging and labeling, production, and distribution. FDA estimates 1,658 recordkeepers with 150,878 total annual records and 217,265 total annual hours (average 1.44 hours per record).
Type A Medicated Article Makers: hourly burden
If you manufacture Type A medicated articles under 21 CFR part 226, you must keep records for premix components, laboratory controls, packaging, master formulas, batch production, distribution, and complaint files. FDA estimates 65 respondents generating 89,050 annual responses with about 89,050 total annual hours (approximately 1 hour per response).
FDA lowers estimated paperwork burden
FDA reports it adjusted its inventory and reduced the estimated number of medicated‑feed recordkeepers by 2,722, resulting in a decrease of 13,731,017 records and a decrease of 913,153 total annual recordkeeping hours. This change updates the compliance burden estimate for affected manufacturers.
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