Assures that feed… - PowerPoint Presentation

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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)

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21 CFR 225Feed manufacturers required to hold a medicated feed mill license21 CFR 225.10 – 21 CFR 225.115Feed manufacturers NOT

required to hold a medicated feed mill license

21 CFR 225.120 – 21 CFR 225.202

Current Good Manufacturing Practices for Medicated Animal FeedSlide4

General ProvisionsConstruction and Maintenance of Facilities and EquipmentProduct Quality Control

Packaging and Labeling

Records and Reports

Current Good Manufacturing Practices for Licensed Feed ManufacturersSlide5

Facilities and EquipmentBuildings and GroundsEquipmentWork and Storage AreasProduct Quality Assurance

Components

Laboratory Assays

Equipment Cleanout Procedures

Labeling

Records

Formula, production, and distribution records

Current Good Manufacturing Practices for Non-Licensed Feed ManufacturersSlide6

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 ProgramsSlide7

OBJECTIVES To 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 and superpotent

and

subpotent

feeds.

To verify compliance with VFD requirements as needed.

To encourage voluntary corrective action by firms when appropriate.

To initiate administrative and/or regulatory action against

violative

firms and feed products.

Feed Manufacturing

Compliance ProgramSlide8

Priority 1For cause – public health concern, animal deaths, etc.Priority 2Assignment List Starting with tier 1 facilities

Re-inspection of firms with ‘Official Action Indicated’ decisions

Priority 3

Pre-Approval Inspections

Inspection required within 60 days of a medicated feed mill license application

Feed Manufacturing

Compliance Program PrioritiesSlide9

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 ObjectiveSlide10

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 Articles

Program PrioritiesSlide11

21 CFR 51521 CFR 558Form FDA 3448

Registration of Drug Establishment

Medicated Feed Mill Licensing Slide12

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 515Slide13

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 Feeds

510.455 - Requirements for free-choice medicated feeds

Significant Regulations for New Animal Drugs For Use in Animal Feeds

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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

); and

they will establish and maintain all records required and will permit access to, or copying or verification of such records by the FDA

Form FDA 3448Slide15

Possessing current approved or index listed Type B and/or Type C medicated feed labeling prior to receiving the Type A Medicated Article Renewing 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; and

Complying with all other applicable provision of the Act.

A medicated feed mill licensee commitments

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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 of

Type A Medicated ArticlesSlide17

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 EstablishmentSlide18

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 on

http://www.fda.gov

Licensed feed mills are not required to drug list.

Registration of Drug EstablishmentSlide19

Approved products and uses21 Code of Federal Regulations (CFR) section 558US Government Printing Office – 866-512-1800

http://bookstore.gpo.gov

or

http://www.access.gpo.gov/cgi-bin/cfrassemble.cgi?title=200021

Electronic Code of Federal Regulations

http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?c=ecfr&tpl=%2Findex.tpl

The Federal Register

http://www.gpoaccess.gov/fr/advanced.html

Animal

Drugs@FDA

http://www.accessdata.fda.gov/scripts/animaldrugsatfda/

Where to look for more information?Slide20

Members of the Medicated Feeds Team, CVM, FDATeam Leader – Ms. Jo Gulley 240-453-6858

Dragan

Momcilovic

240-453-6856Phares

Okelo

240-453-6862

Isabel

Pocurull

240-453-6853

Gabriel Davila 240-453-6855

Sonya Dilley 240-276-8690

Where to look for more information?Slide21
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Dragan Momcilovicdragan.momcilovic@fda.hhs.gov

1-240-453-6856