Title 21 of the Code of Federal Regulations (CFR) Part 515 (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 a definition of Category II and Type A medicated articles). In addition, FDA may exempt facilities that manufacture certain types of medicated feed from the requirement of obtaining a medicated feed mill license.
Medicated Feed Mill Licensing
An approved medicated feed mill license, Form FDA 3448, is required for facilities that manufacture feed using Category II, Type A medicated articles or manufacture certain liquid and free-choice feed, using Category I, Type A medicated articles that must follow proprietary formulas or specifications.
- Type of Application - submitted to FDA/CVM in hard copy with original signature
- Original - for new applicants
- Supplement - for change in name, ownership, and/or address (manufacturing site and/or mailing)
- Approved licenses
- Do not expire but are required to supplement if changes occur in name, ownership, and/or address
- Registration of Drug Establishment
- Established with application for an Original medicated feed mill license
- Annual registration required for current approved license holders
- See Resources for Registering.
A medicated feeds licensee certifies that:
- animal feeds bearing or containing new animal drugs are manufactured and label in accordance with the applicable regulations published pursuant to section 512(i) to the Federal Food, Drug and Cosmetic Act (the Act), or in accordance with the index listing published under section 572(e)(2) of the Act;
- 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 practice (cGMPs); and
- they will establish and maintain all records required and will permit access to, or copying or verification of such records by the FDA.
In addition, a medicated feed mill licensee commits to:
- possessing current approved or index listed Type B and/or Type C medicated feed labeling for each Type B and/or Type C medicated feed to be manufactured prior to receiving the Type A Medicated Article containing such drug;
- renewing drug establishment registration each year with the FDA;
- using only non-drug feed components recognized in the Official Publication of the Association of American Feed Control Officials (AAFCO) or sanctions by FDA under 21 CFR 573, 582 and 584 as suitable for use in animal feeds;
- supplementing your license application promptly when changes in ownership or address occur; and
- complying with all other applicable provision of the Act.
Distributors of Type A Medicated Articles
Before shipping a new animal drug for use in the manufacture of medicated animal feed, the seller must have a written statement from the buyer that the buyer has an approved feed mill license and have current approved Type B and/or Type C feed labeling for the drug, unless FDA has exempted by regulation manufacturers of animal feed with the drug from the requirements to hold a license.
- Information on how to obtain a DUNS number
- D&B Support for FDA eList Registration
- Registration User Manual (pdf - 47 pages)
- Registration Application