GroundRules
21 CFR 350.60: Guidelines for effectiveness testing of antiperspirant drug products.
Where this section sits in the code
- Title 21—Food and Drugs
- CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
- SUBCHAPTER D—DRUGS FOR HUMAN USE
- PART 350—ANTIPERSPIRANT DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
- Subpart D—Guidelines for Effectiveness Testing
An antiperspirant in finished dosage form may vary in degree of effectiveness because of minor variations in formulation. To assure the effectiveness of an antiperspirant, the Food and Drug Administration is providing guidelines that manufacturers may use in testing for effectiveness. These guidelines are on file in the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. These guidelines are available on the FDA's web site at http://www.fda.gov/cder/otc/index.htm or on request for a nominal charge by submitting a Freedom of Information (FOI) request in writing to FDA's Division of Freedom of Information (address is located on the agency's web site at http://www.fda.gov.
Collected 2026-08-27T02:24:47Z. Source file · JSON