21 CFR 201.116 - Drugs having commonly known directions.

Regulations last checked for updates: Feb 11, 2026

Title 21 - Food and Drugs last revised: Dec 18, 2026

§ 201.116 - Drugs having commonly known directions.

A drug shall be exempt from section 502(f)(1) of the act insofar as adequate directions for common uses thereof are known to the ordinary individual.

[41 FR 6910, Feb. 13, 1976]

authority: 21 U.S.C. 321,331,343,351,352,353,355,358,360,360b,360ccc,360ccc-1,360ddd,360ddd-1,360ee,360gg-360ss,371,374,379e; 42 U.S.C. 216,241,262,264

source: 40 FR 13998, Mar. 27, 1975, unless otherwise noted.

cite as: 21 CFR 201.116