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COMPLIANCE POLICY GUIDE (CPG)

CPG Sec. 654.300 Chloramphenicol as an Unapproved New Animal Drug - Direct Reference Seizure Authority August 1996

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

Chloramphenicol, for animal use, is a new animal drug. The drug must be the subject of an approved NADA for legal commercial marketing. In addition, chloramphenicol is a veterinary prescription drug and must be used by or under the direction of a licensed veterinarian. The drug must be handled in accordance with the requirements of Section 503(f) of the Federal Food, Drug, and Cosmetic Act and 21 CFR 201.105 to meet the exemption from bearing adequate directions for use.


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