Section 512 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. § 360b) establishes the requirements for new animal drug approval. FDA regulations specify the information you must submit as part of your new animal drug application (NADA) and the proper format for the NADA submission. 21 CFR part 514. As part of your NADA submission, you must include a “detailed description of the collection of samples and the analytical procedures to which they are subjected.” 21 CFR 514.1(b)(5)(vii). This should include a description of practicable methods of analysis that have adequate sensitivity to determine the amount of the new animal drug in the final dosage form. 21 CFR 514.1(b)(5)(vii)(a).

This guidance provides recommendations for describing methods for analyzing new animal drugs in Type C medicated feeds. This guidance applies to instrumental methods only (e.g., High Pressure Liquid Chromatography (HPLC), Gas Chromatography (GC)). For information on other methods (e.g., microbiological methods) you should contact us.

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