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CPG Sec. 650.100 Animal Drugs for Euthanasia March 1995

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


Euthanasia, or painless killing, is widely practiced by veterinarians to destroy unwanted pets and other animals. It is accomplished by a variety of methods one of which involves drug injection. Pest control is not considered euthanasia, and the substances used in this practice are usually regulated by the Environmental Protection Agency.


*CVM* considers products intended for animal euthanasia to conform to the definition of a drug under section 201(g) of the Act since they are clearly intended to affect the function of the body by inducing death. Moreover, with one exception, namely sodium pentabarbital, *CVM* considers all such products to be new animal drugs, within the meaning of section 201(w) which may be legally marketed only after approval of an NADA. The data must establish that the product results in a humane and painless death when used as directed. Euthanasia drugs may be distributed only under the veterinary prescription legend.

*Material between asterisks is new or revised*

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

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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:

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Food and Drug Administration
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Rockville, MD 20852

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


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