November 5, 1996
FEED MILL LICENSING NOW A REALITY
Medicated Feed Applications (MFA's), or 1900's, are now a thing of the past. On October 9, 1996, the President signed the Animal Drug Availability Act of 1996 (ADAA), which amends Section 512(m) of the Federal Food, Drug, and Cosmetic Act to require a single facility license rather than multiple MFA's for each feed mill as previously required. FDA intends to revise its regulations to clarify that a license will be required for the manufacture of feeds using Category II, Type A medicated articles, the manufacture of free choice feeds, and the manufacture of liquid Type B feeds where the formula or specifications are not published in the 21 CFR 558 regulations.
This amendment streamlines the paperwork process for the approval to manufacture medicated feeds. Now, any feed manufacturing facility which currently holds one or more approved MFA's automatically holds a transitional license. The transitional license is valid up to 18 months, and will only be converted by CVM to a permanent license upon receipt of a license application accompanied by a copy of an approved MFA. Feed facilities that want to be licensed and do not hold a MFA will need to register with FDA, file a license application, and undergo a preapproval inspection.
License applications will be accepted in letter form, and should include the following:
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,
a statement that all medicated feed will be manufactured and labeled according to FDA regulations, and,
a certification that the firm is operating in compliance with current good manufacturing practice regulations.
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 a 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.
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 Federal Food, Drug, and Cosmetic 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 consisting of an assay of the first batch manufactured, followed thereafter by two samples at periodic intervals during the calendar year. 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. 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. Licensees are also required to register every year with the FDA.
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.
Issued by:
FDA, Center for Veterinary Medicine,
Communications Staff, HFV-12
7519 Standish Place, Rockville, MD 20855
Telephone: (240) 276-9300 FAX: (240) 276-9115
Internet Web Site: http://www.fda.gov/cvm
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