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COMPLIANCE POLICY GUIDE (CPG)

CPG Sec. 607.100 - Adequate Directions for Use (Species Designation) - Animal Drugs and Veterinary Devices March 1995

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

BACKGROUND:

The effects of drugs and medical treatment of animals may vary from drug to drug and from species to species due to physiological and other species differences. In addition, the effectiveness of the drug and use of a medical device may be expected to vary within a species due to the sex of the animal or to significant differences in age, weight, size, etc. *Further*, it may be necessary to have directions for use of the drug and medical device in subspecies or varieties of animals *or even in wider taxonomic groupings* for the labeling to be adequate.

The *Center for* Veterinary Medicine requires species specific labeling for *each new animal drug and feed containing a new drug to be submitted for approval prior to marketing. Medical device labeling may not be false or misleading and must be adequately labeled for the intended use(s). However, at the present there is no specific regulation reflecting these requirements.*

POLICY:

Animal drug (including medicated feed) and veterinary device labeling *is* in violation of Section 502(f) of the Act if it fails to *identify the target species or* bear directions for use which are adequate for each target *animal group* for which it is intended.

*Material between asterisks is new or revised*

Issued: 10/1/80
Revised: 3/95


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