Animal & Veterinary
Draft Compliance Policy Guide Explains Voluntary Self Inspection of Medicated Feed Manufacturing Facilities
FDA Veterinarian Newsletter 2007 Volume XXII, No I
The Food and Drug Administration has announced a draft Compliance Policy Guide (CPG) to provide guidance to FDA field offices to help prioritize inspections of medicated feed manufacturing facilities based on a number of factors, including whether the facility conducts self-inspections. The draft CPG describes a proposed approach for medicated feed manufacturing facilities to conduct self-inspections to determine compliance with the Federal Food, Drug, and Cosmetic Act (FFDCA) and the appropriate regulations (21 Code of Federal Regulations, Part 225) with respect to the manufacture and distribution 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 year. The pilot would be announced in a future Federal Register notice.
Manufacturers of medicated animal feeds
Medicated feed is usually manufactured at commercial establishments and on-farm mixer/feeder operations which are made up of both licensed and unlicensed facilities. FDA conducts inspections of licensed and unlicensed feed mills. There are approximately 1,130 FDA-licensed feed mills and 5,500 non-FDA-licensed commercial 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 residues of drugs. Also, medicated animal feed needs to be produced properly in order to protect the health and safety of the animal itself.
Medicated feeds must comply with manufacturing controls specified in the current Good Manufacturing Practice for Medicated Feeds regulations (cGMP). The cGMP regulations (21 CFR 225) represent minimum standards that producers of medicated feed must adhere to, or else be subject to adulteration sanctions set forth in Section 501(a)(2)(B) of the FFDCA. These minimum standards help ensure that the drugs (including drugs contained in animal feeds) produced meet the requirements of the FFDCA as to safety and that they have the identity and strength, and meet the quality and purity characteristics that they claim to have.
Section 510(h) of the FFDCA requires inspection of every FDA-licensed feed mill at registration and at least once in every 2-year period after that. Non-FDA-licensed feed mills are also subject to inspection. However, there is no requirement that such facilities be inspected every 2 years.
Routine self-checking for compliance with cGMP by feed manufacturing operations is not a consistent practice in the industry; some do and some do not. Among the ones that do, some have quality assurance programs that include some kind of periodic audit or assessment procedure of “self inspection.” This concept of “self inspection” was incorporated in a proposed Model National Medicated Feed Program sponsored by the Association of American Feed Control Officials. As noted in the draft CPG, FDA encourages the use of quality assurance programs that include internal audits or assessments for compliance with cGMP.
As part of the agency’s determination of priorities for cGMP inspections of medicated feed manufacturing firms, it intends to consider whether the establishments follow the approach outlined in the section of the CPG entitled, “Voluntary Self Inspection Conduct and Reporting.” A higher priority for inspections will be given to those medicated feed manufacturers that do not correct cGMP violations after an opportunity for correction and/or those that do not conduct self inspections as outlined in the CPG. By doing this, FDA will be able to focus more effectively its available resources on monitoring and inspecting medicated feed manufacturers that have a history of non-compliance with cGMP or about which the agency has no information about their compliance. It will also allow FDA to recognize the proactive and successful efforts of those feed manufacturing establishments that have taken steps to ensure cGMP compliance. The various steps to follow and a description of the forms to be used for voluntary self inspection conduct and reporting are detailed in the CPG. However, as noted in the CPG, nothing contained in the draft document restricts FDA from conducting inspections or affects the legal responsibilities of medicated feed establishments.
The agency expects approximately 1,000 feed mills will conduct self inspections; 800 of these are expected to be licensed and 200 are expected to be non-licensed. FDA also expects that 9 hours will be needed for each licensed facility to review any previous self inspection, conduct an inspection, and complete the report; non-licensed facilities are expected to need only 4 hours each. The agency also expects that completing and sending the voluntary self inspection notifications to FDA will take 15 minutes per firm.
The notice of availability published on February 12, 2007 (72 F.R. 6572), and the comment period on the draft guidance document closed April 30, 2007. However, in a Federal Register notice that published on May 4, 2007, the comment period was reopened for 30 days to allow comments through June 4, 2007. The actual draft guidance document is available electronically at: http://www.fda.gov/OHRMS/DOCKETS/98fr/07d-0027-gdl0001.pdf. Questions regarding the draft CPG may be directed to the CVM contact, Paul Bachman, CVM, HFV-320, FDA, 7519 Standish Place, MPN-4, Room 128, Rockville, MD 20855; ph: 240-276-9225; e-mail: Paul.Bachman@fda.hhs.gov.