Code of Federal Regulations · Section
§ 201.116 — Drugs Having Commonly Known Directions
21 C.F.R. § 201.116
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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.
Authorizing Statute
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Regulations42 U.S.C. § 216
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Definitions; generally21 U.S.C. § 321