Sec. 7. Labeling requirements
475 words·~2 min read·
/bill/115/hr/1781/ih/section-7·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
Section 305 of the Controlled Substances Act ( 21 U.S.C. 825 ) is amended by adding at the end the following: It shall be unlawful to import, export, manufacture, distribute, dispense, or possess with intent to manufacture, distribute, or dispense, a synthetic opioid or product containing a synthetic opioid, unless the opioid or product bears a label clearly identifying a synthetic opioid or product containing a synthetic opioid by the nomenclature used by the International Union of Pure and Applied Chemistry (IUPAC). 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. A product is described in this subparagraph if the product— is the subject of an approved application as described in section 505(b) or
(j)of the Federal Food, Drug, and Cosmetic Act; or is exempt from the provisions of section 505 of such Act relating to new drugs because— it is intended solely for investigational use as described in section 505(i) of such Act; and such product is being used exclusively for purposes of a clinical trial that is the subject of an effective investigational new drug application. . Section 1010 of the Controlled Substances Import and Export Act ( 21 U.S.C. 960 ) is amended, in subsection (a)(1), by inserting 305, before 1002 . Section 402 of the Controlled Substances Act ( 21 U.S.C. 842 ) is amended— in subsection (a)— in paragraph (15), by striking or at the end; in paragraph (16), by striking the period at the end and inserting ; or ; and by inserting, after paragraph (16), the following: to violate subsection
(f)of section 825 of this title. ; and in subsection (c)(1)— by inserting, in subparagraph (A), after subparagraph (B), (C), striking or
(D)and inserting the following: , (D), (E), or
(F); and by inserting after subparagraph
(D)the following: In the case of a violation of paragraph
(17)of subsection
(a)of this section by an importer, exporter, manufacturer, or distributor (other than as provided in subparagraph (F)), up to $500,000 per violation. For purposes of this subparagraph, a violation is defined as each instance of importation, exportation, manufacturing, distribution, or possession with intent to manufacture or distribute, in violation of paragraph
(17)of subsection (a). In the case of a distribution, dispensing, or possession with intent to distribute or dispense in violation of paragraph
(17)of subsection
(a)of this section at the retail level, up to $1,000 per violation. Each package, container or other separate unit containing a synthetic opioid that is distributed, dispensed, or possessed with intent to distribute or dispense at the retail level in violation of such paragraph
(17)of subsection
(a)shall be considered a separate violation. .
Connectionstraces to 3
Traces to 3 documents
Citation graph
cites case law
Cites 3Cited by 0 across 0 sources