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S. 3228IntroducedSenate · nowHousePresidentLawIn committee
Sec. 5 · S. 3228

False labeling of schedule A controlled substances

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(a) In general Section 305 of the Controlled Substances Act (21 U.S.C. 825) is amended by adding at the end the following: (f) False labeling of schedule A controlled substances (1) It shall be unlawful to import or export, with intent to manufacture, distribute, or dispense, a schedule A substance or product containing a schedule A substance, unless the substance or product bears a label clearly identifying a schedule A substance or product containing a schedule A substance by the nomenclature used by the International Union of Pure and Applied Chemistry (IUPAC). (2) (A) A product described in subparagraph (B) is exempt from the International Union of Pure and Applied Chemistry nomenclature requirement of this subsection if such product is labeled in the manner required under the Federal Food, Drug, and Cosmetic Act. (B) A product is described in this subparagraph if the product— (i) is the subject of an approved application as described in section 505(b) or (j) of the Federal Food, Drug, and Cosmetic Act; or (ii) is exempt from the provisions of section 505 of such Act relating to new drugs because— (I) it is intended solely for investigational use as described in section 505(i) of such Act; and (II) such product is being used exclusively for purposes of a clinical trial that is the subject of an effective investigational new drug application.. (b) Penalties Section 402 of the Controlled Substances Act (21 U.S.C. 842) is amended— (1) in subsection (a)— (A) in paragraph (16), by striking or at the end; (B) by redesignating paragraph (17) as paragraph (18); and (C) by inserting after paragraph (16) the following: (17) to violate section 305(f); or; and (2) in subsection (c)— (A) in paragraph (1)— (i) in subparagraph (B)(i), by striking (17) and inserting (18); and (ii) in subparagraph (C), by inserting or (17) after paragraph (16) each place it appears; and (B) in paragraph (2)(D), by striking (17) and inserting (18).

Sec. 5: False labeling of schedule A controlled substances · Public Law Tracker