Rev. Rul. 63-81

Section 502(e) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 352(e), as amended by Public Law 87-871, October 10, 1962, effective May 1, 1963, provides, in part, that a drug shall be deemed to be misbranded unless its label bears, to the exclusion of any other nonproprietary name (except the applicable systematic chemical name or chemical formula), the established name of the drug. The term `established name,' with respect to a drug, means the applicable official name designated pursuant to section 508 of the Act, or if there is no such name and such drug is an article recognized in an official compendium, then the official title thereof in such compendium.

Rubbing alcohol compound is a drug within the meaning of the Act. See 21 U.S.C. 321(g). No regulations designating a name for this product have been promulgated pursuant to section 508 of the Act. However, the National Formulary, which is an official compendium, has redesignated `Rubbing Alcohol Compound' as `Rubbing Alcohol,' effective May 1, 1963. Thus, on and after May 1, 1963, `Rubbing Alcohol' will be the `established name' of the product which should appear on the label.

In view of the foregoing, the designation `Rubbing Alcohol' has become the equivalent of `Rubbing Alcohol Compound' and its use is considered to be in substantial compliance with the provisions of section 211.188 of the regulations relating to Distribution and Use of Denatured Alcohol and Rum. Therefore, it is held that this product, when manufactured with specially denatured alcohol under approved formula, may be designated and labeled as `Rubbing Alcohol.'

Accordingly, labels bearing the designation `Rubbing Alcohol Compound' will not be approved after May 1, 1963. However, labels bearing this designation may continue to be used on a `use-up' basis. Assistant Regional Commissioners, Alcohol and Tobacco Tax may, in advance of appropriate amendment of section 211.188 of the regulations, approve Forms 1479-A, Formula for Article made with Specially Denatured Alcohol or Rum, which manufacturers must file for approval of new labels using the designation `Rubbing Alcohol.'