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COMPLIANCE POLICY GUIDE (CPG)

CPG Sec. 654.100 Dimethyl Sulfoxide (DMSO) for Animal Use March 1995

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

BACKGROUND:

DMSO is a by-product of the paper industry and is able to carry some drugs rapidly through the skin. Industrial grade DMSO is widely available for various non-medical uses such as paint remover and antifreeze. The *Center for* Veterinary Medicine has received inquiries concerning the status of DMSO for use in animals, probably prompted by the approval of DMSO for human use in April 1978. The product is a new animal drug with approved uses only in horses and dogs (See 21 CFR 524.660, 524.981d and 524.981e).

POLICY:

DMSO used for any veterinary purposes other than approved uses reflected in the CFR is a new animal drug without an approved new animal drug application (NADA). As such, it is adulterated under Section 501(a)(5) of the Act.

NOTE: At least one state (Florida, Bill No. S. 699) has passed legislation (1978) that prohibits interference with the use of DMSO.

*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