The Code of Federal Regulations, 21 CFR 515, requires certain medicated feed mills to be licensed with FDA. Licensed facilities are allowed to manufacture animal feeds from Category II, Type A medicated articles. See 21 CFR 558.3 for definitions of the categories and types of drugs and medicated articles. See 21 CFR 558.4 for listings of Category I and II drugs.
A medicated feed mill licensee certifies that:
Animal feeds bearing or containing new animal drugs are manufactured and labeled in accordance with the applicable regulations
The methods used in, and the facilities and controls used for, manufacturing, processing, packaging, and holding such animal feeds are in conformity with current good manufacturing practices; and
They will establish and maintain all records required and will permit access to, or copying or verification of such records by the FDA.
What can you expect during an inspection? Take a look at our Medicated Feed Inspection Checklist.
Visit the FDA website for more Medicated Feeds and Medicated Feed Mill Licensing information.