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COMPLIANCE POLICY GUIDE (CPG)

CPG Sec. 655.400 The Status of Syringes and Needles for Animal Use June 1987

Final

CPG Sec. 655.400 The Status of Syringes and Needles for Animal Use

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

BACKGROUND:

Since there are on the market a number of injectable drugs for animal use which are approved for over-the-counter sale, it follows that the needles and syringes necessary to deliver such drug to the animal must likewise be available without prescription. *CVM*, therefore, has never sought to require that needles and syringes be restricted to prescription legend use. *CVM* is aware, however, that in certain areas devices of this nature may be restricted to prescription sale by local or state laws.

POLICY:

*CVM* will not concur in regulatory action against needles and syringes intended for animal use merely because they are distributed without prescription legend labeling.

*Material between asterisks is new or revised*

Issued: 10/1/80
Revised: 6/2/87


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:

Division of Dockets Management (HFA- 305)
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
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Rockville, MD 20855
AskCVM@fda.hhs.gov
(240) 402-7002