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22 FDA Veterinarian 1 (2007)

handle is hein.animal/fdavt0022 and id is 1 raw text is: 2007 Vol. XXII, No. I Draft Compliance Policy Guide Explains Voluntary Self Inspection of Medicated Feed Manufacturing Facilities T he Food and Drug Administration has announced a draft Compliance Policy Guide (CPG)to provideguidance to FDA field offices to help prioritize inspections of medicated feed manu- facturing facilities based on a number of factors, including whether the facil- ity conducts self-inspections. The draft CPG describes a proposed approach for medicated feed manufacturing fa- cilities to conduct self-inspections to determine compliance with the Federal Food, Drug, and Cosmetic Act (FFD CA) and the appropriate regulations (21 Code of Federal Regulations, Part 225) with respect to the manufacture and dis- tribution of medicated animal feed (i.e., animal feed containing approved new animal drugs). In addition to seeking comments on this new concept, FDA is considering piloting the new voluntary self inspection approach for at least one Pet Food Recall Qnce mid-March, the Food and Drug %.Administration has been working diligently to investigate the contami- nation of certain pet food ingredients with melamine and melamine-related compounds and to contain the distri- bution of the contaminated products. Immediately after FDA received the initial reports about the problem, it began an extensive program of recall coordination, inspections, and prod- uct tracking. FDA's Office of the Com- missioner, the Center for Veterinary Medicine, and the Office of Regula- tory Affairs have been leading the ef- fort. Within the Federal Government, FDA has consulted with the Centers for Disease Control and Prevention and the U.S. Department of Agri- culture. Outside government, FDA has been working with universities, Banfield Pet Hospitals (a network of pet hospitals across the country), the Veterinary Information Network, the American Association of Veterinary Laboratory Diagnosticians, and other groups. FDA has also taken extra steps to keep consumers informed and to be a source of up-to-date, reliable informa- tion. FDA continues to place as much information as possible on the FDA Web site, including a searchable da- tabase of all pet foods subject to the recall, so consumers can quickly de- terminewhat pet food issafeto use. When the investigation is complete, FDA Veterinarian will present afull report of the recall. IN THI In the meantime, interested Three stakeholders should continue MU to go to the FDA Web site for Anima the latest information. (http:// Con www. fda.gov/oc/opacom/ CVM hottopicspetfood.html) Anr year. The pilot would be announced in a future Federal Register notice. Manufacturers of medicated animal feeds Medicated feed is usually manufac- tured at commercial establishments and on-farm mixer/feeder operations which are made up of both licensed and unlicensed facilities. FDA con- ducts inspections of licensed and un- licensed feed mills. There are approxi- mately 1,130 FDA-licensed feed mills and 5,500 non-FDA-licensed commer- cial feed mills in the United States; the number of non-FDA-licensed on-farm mixer/feeder operations is not known. Many of the feeds being manufactured at these facilities are designed for use in food-producing animals, thereby necessitating oversight to ensure that any edible products from animals that consume these feeds are safe and do not contain potentially hazardous resi- dues of drugs. Also, medicated animal feed needs to be produced properly in order to protect the health and safety of the animal itself. (Continued, next page) S ISSUE Important Approvals U nder the M S A ct ............................................... . . 3 1 By-Products Renderer Signs sent Decree .......................................... 5 Keeping Pace with Developmentsin New mal Technologies .................................... 7

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