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COMPLIANCE POLICY GUIDE (CPG)

CPG Sec. 645.100 Biological Drugs for Animal Use December 2017

Final
Issued by:
Guidance Issuing Office
Center for Veterinary Medicine
Office of Regulatory Affairs

Animal biologicals are subject to both the Food, Drug, and Cosmetic Act and the Virus, Serum, Toxin Act (Public Law 430 of 1913, 73 Stat 832-833, 21 U.S.C. 151-158).


Submit Comments

Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All comments should be identified with the title of the guidance.

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