In the November 19, 1999, Federal Register FDA published a final rule amending the new animal drug regulations to implement the medicated feed mill licensing requirements of the Animal Drug Availability Act of 1996 (ADAA). The ADAA replaced the requirement for feed mills to have an approved medicated feed application (MFA) for the manufacture of each medicated feed with the need for medicated feed mills to be licensed with FDA. Licensed facilities are allowed to manufacture animal feeds from Category II, Type A medicated articles. In addition, the ADAA amended the Federal Food, Drug, and Cosmetic Act (FFDCA) to provide the Agency with the authority, to the extent consistent with the public health, to exempt facilities that manufacture certain types of medicated feed from the requirement of obtaining a medicated feed mill license. This rule removed the medicated feed procedural regulations in Title 21, Part 514 of the Code of Federal Regulations (CFR) and placed a new section, Title 21, Part 515 in the CFR. The final rule became effective on December 20, 1999.

Documents which pertain to medicated feeds and feed mill licensing are below:

Listing of Approved Medicated Feed Mill Licenses

• CVM Listing of Approved Medicated Feed Mill Licenses - Sorted by Name, October 19, 2004 (pdf)

• CVM Listing of Approved Medicated Feed Mill Licenses - Sorted by State, Country or Province, October 19, 2004 (pdf)

Medicated Feed Mill License Form

• Form FDA 3448 | pdf | (12/03) (expires 12/30/06)

Registration of Drug Establishment – Please note that Medicated Feed Mill license holders are required to register with the FDA every year using the form below. For fiscal year 2001 FDA is not sending establishments Form 2656e. See CVM Update – Procedural Changes to the Annual Registration of Drug Establishments.

• Form FDA 2656 (Expiration Date: March 31, 2005) | pdf | | doc |

• Instructions

Code of Federal Regulations (CFR)

• Current Good Manufacturing Practice for Medicated Feeds (CGMPs) (21 CFR 225)

• Current Good Manufacturing Practice for Type A Medicated Articles (21 CFR 226)

• Type B or Type C Medicated Feed Labels (Blue Bird Labels)
  Regulatory Requirements (21 CFR 514.1(b)(3)(v)(b))

• New Animal Drugs for Use in Animal Feeds (21 CFR 558)

Guideline 72 - Guidance For Industry: GMPs For Medicated Feed Manufacturers Not Required to Register and be Licensed with FDA

CVM Updates

• FDA Publishes Final Rules for Liquid and Free-Choice Medicated Feeds, May 27, 2004

• CVM Update Regarding Records and Reports Rule Withdrawn,
  December 23, 2003

• Clarification of Records and Reports Rules for Animal Feeds, August 22, 2003
  Withdrawn by CVM Update Regarding Records and Reports Rule Withdrawn, December 23, 2003

• Proposed Rules for Liquid Medicated and Free-Choice Medicated Feed Available for Comment, May 28, 2003

• FDA Issues Final Rule for Records and Reports on Experiences with Animal Drugs, April 1, 2003

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