CFR - Code of Federal Regulations Title 21

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For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

[Code of Federal Regulations]

[Title 21, Volume 5]

[CITE: 21CFR350]

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

Sec. 350.60 Guidelines for effectiveness testing of antiperspirant drug products.

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 Branch (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.

[68 FR 34291, June 9, 2003, as amended at 76 FR 31470, June 1, 2011; 79 FR 68115, Nov. 14, 2014]

Authority: 21 U.S.C. 321, 351, 352, 353, 355, 360, 371.
Source: 68 FR 34291, June 9, 2003, unless otherwise noted.