The FDA's 'Wish List': A Unified Agenda

By: David Steinberg, Steinberg & Associates

Posted: March 30, 2010, from the April 2010 issue of Cosmetics & Toiletries.

page 5 of 5

Alcohol
While researching the information for this column, this author came across an important and interesting proposed rule that was issued in May 1982 with no further action. This rule relates to the use of alcohol in topical OTC drugs. Drug actives are required to be monographed in the US Pharmacoepia (USP) and must meet these standards. Alcohol, per the USP, is listed as being 94.9% to 96% pure alcohol by volume. There is a monograph called “Rubbing Alcohol,” which is denatured alcohol—either SD alcohol 23-H or 40-A or B at different percentages of actual alcohol.

The major use of alcohol is in “instant skin sanitizers,” which is based on the TFM of 1994 requiring 60% to 95% alcohol that is denatured to meet any Alcohol, Tobacco and Firearms-listed products.

While it is clear from the intent of both Federal Register publications that for topical use, one must use denatured alcohol, a manufacturer would either be mislabeling a product by using the word alcohol as the active ingredient, which would not be USP, or would be in violation of the TFM if using the correct USP designation of rubbing alcohol, since it is not approved.

The simple solution would be to use the correct drug word and specification of alcohol and then list the denaturants in the inactive ingredient listing. However, these are mere suggestions and legal advice should be sought on this matter. Wouldn’t it be wonderful if the FDA cleared up this confusion?