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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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

 

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