Drugs; adequate directions for use

CurrencyCurrent through May 31, 2023
Citation 21 C.F.R. §201.5
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1 cases
  • United States v. Hakim
    • United States
    • U.S. District Court — Southern District of New York
    • 26 Mayo 2020
    ...directions for use" as "directions under which the layman can use a drug safely and for the purposes for which it is intended." 21 C.F.R § 201.5.The FDCA defines a prescription drug as "[a] drug intended for use by man which because of its toxicity or other potentiality for harmful effect, ......

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