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Guidance Issuing OfficeCenter for Veterinary Medicine
Section 512(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. § 360b) establishes the requirements for new animal drug approval. 21 CFR 514.1 specifies the information required to be submitted as part of the application and the proper form for the submission. Section 514.1(b)(5)(vii) requires an applicant to describe analytical procedures that should be capable of determining the active component(s) within a reasonable degree of accuracy and of assuring the identity of such components. Section 514.1(b)(5)(vii)(a) states that a description of practicable methods of analysis of adequate sensitivity to determine the amount of the new animal drug in the final dosage form should be included.
The purpose of this guidance is to provide recommendations on how to consider the various validation characteristics for each analytical procedure used in medicated feed assays. This guidance is written primarily for chromatographic methods; however, the guidance does not limit the analytical technique to chromatographic procedures, as other techniques may be appropriate. In some cases (for example, demonstration of specificity), the overall capabilities of a number of analytical procedures in combination may be investigated in order to ensure the quality of the medicated feed.
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2004-D-0370.