Docket Number:
FDA-2018-D-0943
Issued by:
Guidance Issuing Office
Center for Veterinary Medicine

The submission of information regarding components and composition, as well as manufacturing methods, facilities, and controls is required under 21 CFR 514.1(b)(4) and (5) for new animal drug applications and under section 512(n)(1)(G) of the Federal Food, Drug, and Cosmetic Act for abbreviated new animal drug applications. The submission of manufacturing changes to an approved application is required under 21 CFR 514.8(b)(1)(i).

This guidance is intended to assist sponsors of animal drug products in addressing changes in the United States Pharmacopeia (USP) requirements for the control of elemental impurities in drug products marketed in the United States.  This document provides recommendations to sponsors regarding the control of elemental impurities in animal drug products, including all dosage forms and routes of administration. The information to be maintained on-site and information to be submitted to CVM is also clarified.

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You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

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Dockets Management
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-2018-D-0943.

Questions?

Contact Point
CVM
Center for Veterinary Medicine
Food and Drug Administration
7500 Standish Pl, HFV-1
Rockville, MD 20855
AskCVM@fda.hhs.gov
(240) 402-7002