Animal & Veterinary
FDA Publishes Final Rule On Medicated Feed Mill Licensing
November 24, 1999
In the November 19, 1999, Federal Register, the Food and Drug Administration (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).
Prior to the passage of the ADAA, the Federal Food, Drug, and Cosmetic Act (the Act) required an approved medicated feed mill application (MFA) for the manufacture of medicated feed. The Act required a feed mill to submit a separate MFA for each medicated feed manufactured at each site. The ADAA eliminates this requirement, and provides for feed mills to be licensed. It allows licensed facilities to manufacture any approved medicated feed. In addition, the ADAA amendments to the Act 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.
The final rule takes all the medicated feed procedural regulations from Title 21, Part 514 of the Code of Federal Regulations (CFR), and places them in a new section, Title 21, Part 515 of the CFR. This new Part includes sub-sections on applications (515.10), supplemental applications (515.11), administrative actions on licenses (515.20 - 515.26), hearing procedures (515.30 - 515.31), and judicial review (515.40).
The final rule formalizes in Part 515.10 the licensing application approved by OMB with one minor modification. That modification clarifies that a licensed feed mill only needs to maintain current approved "Blue Bird" labels for each Type B and/or Type C medicated feed to be manufactured from a Type A medicated article they have in their possession, rather than for all possible medicated feeds that could be manufactured. "Blue Bird" labels are the only medicated feed labels approved by FDA, and, serve as the model label for feed mills in generating the actual medicated feed labels. All Type A medicated article NADA holders must have Type B and Type C medicated feed "Blue Bird" labels approved with their NADA. The "Blue Bird" feed labels are also on file with CVM in the NADA and as a part of the Freedom of Information approval package. CVM also concluded that the home office of multi-mill operations may maintain the Blue Bird labels for all of its satellite mills since the home office generates the actual labels for the satellite mills.
The final rule in Part 515.21 sets forth the criteria to be used in the CVM review of license applications. The application shall be refused if:
- The application is incomplete, false, or misleading in any particular; or
- The feed mill is deficient in their good manufacturing practices (GMP); or
- The facility has or is manufacturing feeds containing unapproved animal drugs, and/or has/is mislabeling feeds containing animal drugs.
The final rule provides an opportunity for a feed mill to voluntarily withdraw its license without prejudice to a future filing. This provision was not allowed for under the old MFA regulations, and should simplify paperwork for voluntary withdrawals.
The final rule maintains the general scheme for categories and types of medicated feeds, and provides that those feeds exempted from the MFA requirement would now be exempt from being required to be manufactured in a licensed feed mill. The possession of NADA approved Type B and Type C medicated feed labeling (Blue Bird) by a licensee satisfies the feed labeling requirements of the statute.
FDA made no substantive changes to the scope of the registration exemption. Registration, unlike medicated feed mill licensing, is required annually by Title 21, Part 207.22 of the CFR. FDA has found that firms comply with this requirement and provide annually the numbers and locations of registered facilities. This requirement allows FDA to update the information on feed mills.
The final rule allows drug sponsors to learn if a facility is licensed to manufacture medicated feed either by receiving written confirmation of the feed mill license number from the feed mill or by identifying the feed mill's license status on the FDA website. The confirmation and/or identification of a feed manufacturing facility's license number shows that the firm possesses current approved Blue Bird labeling, because the firm must commit to the possession of such labeling in the medicated feed mill license application. The drug sponsor's identification from the FDA website of a facility's license number would constitute ?notice from the Secretary? that the feed mill possesses a license and the current approved feed labeling.
To assist drug sponsors and feed manufacturers in the distribution of Blue Bird labels and to allow parties to determine more easily whether a feed mill is licensed, FDA has created a database of medicated feed mill licensing information, available to the public on our Home Page. Included in this information is a database of medicated feed mill licensees and CVM intends to post periodic updates.
The final rule will become effective on December 20, 1999. Additional information about the final rule is included in the November 19, 1999, Federal Register, and may be obtained from Dr. William D. Price, Center for Veterinary Medicine (HFV-200), Food and Drug Administration, 7500 Standish Place, Rockville, MD 20855, 301-827-6652.