Code of Federal Regulations · Section
§ 290.6 — Spanish-language Version Of Required Warning
21 C.F.R. § 290.6
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By direction of section 305(c) of the Federal Controlled Substances Act, § 290.5, promulgated under section 503(b) of the Federal Food, Drug, and Cosmetic Act, requires the following warning on the label of certain drugs when dispensed to or for a patient: “Caution: Federal law prohibits the transfer of this drug to any person other than the patient for whom it was prescribed.” The Spanish version of this is: “Precaucion: La ley Federal prohibe el transferir de esta droga a otra persona que no sea el paciente para quien fue recetada.”
Authorizing Statute
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Misbranded drugs and devices21 U.S.C. § 352