Medicated Feed Mill Licensing
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, and certain liquid and free-choice medicated feeds. Category II drugs require a withdrawal period at the lowest use level for at least one major species for which they are approved or are regulated on a “no-residue” basis or with a zero tolerance because of a carcinogenic concern regardless of whether a withdrawal period is required in any species. (See 21 CFR 558.3 for definitions of Category II drugs and Type A medicated articles and 21 CFR 558.4 for listings of Category I and II drugs). In some cases, FDA may exempt facilities that manufacture certain types of medicated feed from the requirement of obtaining a medicated feed mill license.
An approved medicated feed mill license, Form FDA 3448, is required for facilities that manufacture feed using Category II, Type A medicated articles; liquid and free-choice medicated feed containing a Category II drug; or liquid and free-choice medicated feed containing a Category I drug that follow an approved proprietary formula and/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
- Required as part of the application process (both original and supplemental) for a medicated feed mill license
- Required to be updated annually between October 1 and December 31 (see the Resources for Registering section below)
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 published pursuant to section 512(i) of 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 Practices (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 license applications promptly when changes in name, ownership, or address occur; and
- complying with all other applicable provisions 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 1) an approved medicated feed mill license and 2) current approved Type B and/or Type C feed labeling for the drug unless FDA has exempted manufacturers from the requirements to hold a license pursuant to the regulations.
Resources for Registering
21 CFR part 207 requires licensed medicated feed mills to register annually as drug establishments. The window to register is open every year between October 1 and December 31 and is completed electronically using the Medicated Feed Mill Establishment Registration portal below. Once submitted, registration status can be checked using the Drug Establishments Current Registration Site. For technical questions regarding drug establishment registration, including requesting a mill's most recent registration file or de-registering a facility, please contact SPL@fda.hhs.gov.
- Medicated Feed Mill Establishment Registration portal
- Drug Establishments Current Registration Site (check registration status)
- Information on how to obtain a DUNS number
- D&B Support for FDA eList Registration
Listing of Approved Medicated Feed Mill Licenses and Veterinary Feed Directive Distributor Notifications
See Animal Drugs @ FDA for current listings under the Medicated Feeds section. Lists are available in PDF and Excel formats. Updates to the lists are made as applications and notifications are processed.
Removal from the Medicated Feed Mill License List and/or Veterinary Feed Directive Distributor Notification List
If a facility would like to withdraw its medicated feed mill license or be removed from the Veterinary Feed Directive (VFD) Distributor Notification list, it should contact FDA/CVM.
- Medicated Feed Mill License Application
- Veterinary Feed Directive (VFD)
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