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General discussion on the regulation of medicated feed

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Assures that feed…has the identity and strength, which it purportsmeets the quality, purity, and safety requirements, which it is represented to possessMinimum requirements for manufacture of medicated animal feed
Current Good Manufacturing Practices (cGMPs)
21 CFR 225Feed manufacturers required to hold a medicated feed mill license21 CFR 225.10 – 21 CFR 225.115Feed manufacturersNOTrequired to hold a medicated feed mill license21 CFR 225.120 – 21 CFR 225.202
Current Good Manufacturing Practices for Medicated Animal Feed
General ProvisionsConstruction and Maintenance of Facilities and EquipmentProduct Quality ControlPackaging and LabelingRecords and Reports
Current Good Manufacturing Practices for Licensed Feed Manufacturers
Facilities and EquipmentBuildings and GroundsEquipmentWork and Storage AreasProduct Quality AssuranceComponentsLaboratory AssaysEquipment Cleanout ProceduresLabelingRecordsFormula, production, and distribution records
Current Good Manufacturing Practices for Non-Licensed Feed Manufacturers
Program 7371.005 – Type A Medicated ArticlesType ARegulated as new animal drugsProgram 7371.004 – Feed ManufacturingType B and Type CRegulated as feeds bearing or containing a new animal drug
Compliance Programs
OBJECTIVESTo conduct inspections of registered medicated feed firms and determine whether the firms are in compliance with the Federal Food, Drug, and Cosmetic Act and the implementing regulations.To address concerns of drug residue carryover andsuperpotentandsubpotentfeeds.To verify compliance with VFD requirements as needed.To encourage voluntary corrective action by firms when appropriate.To initiate administrative and/or regulatory action againstviolativefirms and feed products.
Feed ManufacturingCompliance Program
Priority 1For cause – public health concern, animal deaths, etc.Priority 2Assignment ListStarting with tier 1 facilitiesRe-inspection of firms with ‘Official Action Indicated’ decisionsPriority 3Pre-Approval InspectionsInspection required within 60 days of a medicated feed mill license application
Feed ManufacturingCompliance Program Priorities
To assure that Type A medicated articles meet the requirements of the Act as to safety, identity and strength and meets the quality and purity characteristics that it purports or is represented to possess.
Type A Medicated Articles Compliance Program Objective
The Center provides a risk-based work planFurther priorities, as follows:Firms handling Category II Type A medicated articlesFirms handling Category I Type A medicated articles
Type A Medicated ArticlesProgram Priorities
21 CFR 51521 CFR 558Form FDA 3448Registration of Drug Establishment
Medicated Feed Mill Licensing
If licensed:Facilities are allowed to manufacture animal feeds from Category II, Type A medicated articles or certain liquid and free-choice feed, using Category I, Type A medicated articles that must follow proprietary formulas or specifications.
21 CFR 515
558.3 - Definitions and general considerations applicable to this part.558.4 - Requirement of a medicated feed mill license.558.5 - Requirements for liquid medicated feed.558.6 - Veterinary feed directive drugs.558.35 – 558.680 - Specific New Drugs For Use in Animal Feeds510.455 - Requirements for free-choice medicated feeds
Significant Regulations for New Animal Drugs For Use in Animal Feeds
A medicated feeds 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) to 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;are in conformity with current good manufacturing practice (cGMPs); andthey will establish and maintain all records required and will permit access to, or copying or verification of such records by the FDA
Form FDA 3448
Possessing current approved or index listed Type B and/or Type C medicated feed labeling prior to receiving the Type A Medicated ArticleRenewing drug establishment registration each year;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 application when changes in ownership or address occur; andComplying with all other applicable provision of the Act.
A medicated feed mill licensee commitments
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 an approved feed mill license and possesses current approved Type B and/or Type C feed labeling for the drug.Lists of approved license holders are on the FDA/CVM website.
Distributors ofType A Medicated Articles
Requirements for drug registration are found inSection 510 of the FFD&C ActSection 351 of the Public Health Service ActPart 207 of Title 21 of the Code of Federal RegulationsThe Food and Drug Administration Amendments Act (FDAAA) of 2007 requires that drug establishment registration and drug listing information be submitted electronically.
Registration of Drug Establishment
The Drug Registration and Listing System (DRLS) and the new electronic Drug Registration and Listing System (eDRLS).FDA no longer accepts drug establishment registration in paper format unless a waiver is granted.Guidance for Industry: Providing Regulatory Submission in Electronic Format – Drug Establishment Registration and Drug Listing is found onhttp://www.fda.govLicensed feed mills are not required to drug list.
Registration of Drug Establishment
Approved products and uses21 Code of Federal Regulations (CFR) section 558US Government Printing Office – 866-512-1800http://bookstore.gpo.govorhttp://www.access.gpo.gov/cgi-bin/cfrassemble.cgi?title=200021Electronic Code of Federal Regulationshttp://ecfr.gpoaccess.gov/cgi/t/text/text-idx?c=ecfr&tpl=%2Findex.tplThe Federal Registerhttp://www.gpoaccess.gov/fr/advanced.htmlAnimalDrugs@FDAhttp://www.accessdata.fda.gov/scripts/animaldrugsatfda/
Where to look for more information?
Members of the Medicated Feeds Team, CVM, FDATeam Leader – Ms. Jo Gulley 240-453-6858DraganMomcilovic240-453-6856PharesOkelo240-453-6862IsabelPocurull240-453-6853Gabriel Davila 240-453-6855Sonya Dilley 240-276-8690
Where to look for more information?
DraganMomcilovicdragan.momcilovic@fda.hhs.gov1-240-453-6856

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General discussion on the regulation of medicated feed