• full statement of the business name, address, and FDA registration central file number (CFN) of the specific manufacturing site;
  
  

• the name and signature of the responsible individuals for that facility;
  
  

• the certification statement that the animal feeds bearing or containing new animal drugs are manufactured and labeled in accordance with the applicable regulations published pursuant to 512 (i) of the Act; and
  
  

• the certification statement that the methods used in, and the facilities and controls used for, manufacturing, processing, packaging, and holding such animal feeds are in conformity with good manufacturing practice as described in 21 CFR 225.

If I do not have an approved MFA, how do I submit a license application?

Register with FDA and submit a license application as outlined above.

What happens when a feed mill license application is filed?

It is checked for completeness. If it is incomplete, it will be returned to the applicant. If it is complete, CVM will request a feed mill inspection of the facility by FDA Field unless the mill is covered under the transitional provisions of the October 9, 1996 act, in which case a license will issue. Upon completion of the inspection, a license will issue if the facility is found to be in substantial compliance with CGMP requirements. If the result of the inspection is classified Official Action Indicated (OAI), the license will not be approved unless FDA and the applicant agree on an extended review time (beyond 90 days) so that the applicant has time to correct the deficiencies and FDA has reinspected.

What is required prior to shipment of a Type A Medicated Article for use in medicated feeds?

Prior to shipment of a new animal drug intended for use in the manufacture of medicated animal feed, the seller must have a written statement from the buyer that the buyer has a feed mill license and possesses current approved Type B and/or C feed labeling for the drug, unless FDA has exempted by regulation manufacturers of animal feed bearing or containing such drug from the requirement to hold a license. In the event that the buyer is not the feed manufacturer, the buyer must provide the seller with a statement that the drug will be sold only to feed mill license holders. The source of the labeling is the approved labeling in the new animal drug application (NADA), and is available from the Type A article manufacturer or the distributor.

How does licensing affect the records and assay requirements?

Licensees are required to establish and maintain all records and make such reports as required by regulation or order issued under 512 (m)(5)(A) of the Act and as now published in 21 CFR 510.301. They are also required by good manufacturing practice regulations to establish and maintain a program of sampling and analysis of at least three representative samples of the medicated feed collected at periodic intervals during the calendar year. The program must provide for sampling and assay of the first batch manufactured. If a medicated feed contains a combination of animal drugs, only one of the drugs need be subject to analysis each time, provided the one tested is different from the one(s) previously tested. Reports of assays shall be kept on the premises for not less than 1 year after the date of manufacture of the medicated feed.

Do licensees still have to register and be inspected?

Licensees are required to register every year with the FDA. Licensees will be subject to biennial inspections, the same as MFA holders, and if regulatory action is indicated, will be subject to the same regulatory procedures as MFA holders were.

Where do feed mills get approved Type B and C medicated feed labels?

Type A medicated article manufacturers are required to have Type B and C Blue Bird labeling (model labeling) approved as part of the New Animal Drug Application (NADA) approval procedure. The seller, Type A medicated article manufacturers or the distributor, is required to furnish Type B and/or C medicated feed labels to the feed mill prior to shipment of the Type A medicated article.

How will licensing affect the Veterinary Feed Directive?

CVM is working on regulations to implement the Veterinary Feed Directive drug provisions of the ADAA. In accordance with Congress' directive, FDA will not delay any approvals of veterinary feed directive drugs pending the publication of implementing regulations.

CVM is available to answer questions during the transition to a feed mill licensing system. For additional information, please contact the Division of Animal Feeds, Office of Surveillance and Compliance, Center for Veterinary Medicine, 7500 Standish Place, Rockville, MD 20855, telephone 301-594-1724.