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U.S. Department of Health and Human Services

Animal & Veterinary

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Guidance On Mass Spectrometry For Confirmation Of Animal Drug Residues Available

May 19, 2003

The Food and Drug Administration (FDA) is announcing the availability of “Guidance For Industry: Mass Spectrometry for Confirmation of the Identity of Animal Drug Residues” (Guidance #118.) Final Guidance #118 elaborates the description of method specificity in Center for Veterinary Medicine (CVM) Guidance Document 3, “General Principles for Evaluating the Safety of Compounds Used in Food Producing Animals,” Part V, Guideline for Approval of a Method of Analysis for Residues, section B.1 The aim of Guidance Document #118 is to facilitate the development, review, and testing of methods submitted to CVM.

Where it can be predicted that using a new animal drug in food animals will likely result in the presence of drug residues in the edible tissue of a treated animal, a full confirmatory procedure should be developed and validated. The Guidance includes specific recommendations on method development and validation, method description, confirmation criteria for a range of data acquisition techniques, and quality control. For cases when a full procedure is unavailable and time does not permit a procedure to be fully validated, an ad hoc confirmatory package may be assembled.

Guidance Document #118 is posted on the FDA/Center for Veterinary Medicine Home Page . Single copies of the guidance may be obtained by writing to the Communications Staff, FDA/Center for Veterinary Medicine, 7519 Standish Place, HFV-12, Rockville, MD 20855. Please send a self-addressed adhesive label to assist in processing your request.

Written or electronic comments on Agency guidance documents may be submitted at any time to the Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852. Comments should be identified with the full title of the guidance document and Docket number 01D-0224. Electronic comments may be submitted to http://www.fda.gov/dockets/ecomments Once on this site, select “Docket number 01D-0224, Guidance for Industry: Mass Spectrometry for Confirmation of the Identity of Animal Drug Residues.”

Additional information about the guidance document may be found in the May 13, 2003, Federal Registerand from David N. Heller, Center for Veterinary Medicine (HFV-510), Food and Drug Administration, 8401 Muirkirk Rd., Laurel, MD 20708, 301-827-8156, e-mail: dheller@cvm.fda.gov


Contact FDA

240-276-9115 FAX
Issued by: FDA, Center for Veterinary Medicine

Communications Staff, HFV-12

7519 Standish Place

Rockville, MD 20855