Sec. 3032. Safety-enhancing packaging and disposal features
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/bill/115/hr/6/eah/section-3032A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
Section 505–1(e) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355–1(e) ) is amended by adding at the end the following: The Secretary may require a risk evaluation mitigation strategy for a drug for which there is a serious risk of an adverse drug experience described in subparagraph
(B)or
(C)of subsection (b)(1), taking into consideration the factors described in subparagraphs
(C)and
(D)of subsection (f)(2) and in consultation with other relevant Federal agencies with authorities over drug disposal packaging, which may include requiring that— the drug be made available for dispensing to certain patients in unit dose packaging, packaging that provides a set duration, or another packaging system that the Secretary determines may mitigate such serious risk; or the drug be dispensed to certain patients with a safe disposal packaging or safe disposal system for purposes of rendering drugs nonretrievable (as defined in section 1300.05 of title 21, Code of Federal Regulations (or any successor regulation)) if the Secretary determines that such safe disposal packaging or system may mitigate such serious risk and is sufficiently available. . Section 505–1(f)(2)(C) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355–1(f)(2)(C) ) is amended— in clause
(i)by striking and at the end; and by adding at the end the following: patients with functional limitations; and . Section 505–1(i) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355–1(i) ) is amended— in paragraph (1)— by redesignating subparagraph
(B)as subparagraph (C); and inserting after subparagraph
(A)the following: A packaging or disposal requirement, if required under subsection (e)(4) for the applicable listed drug. ; and in paragraph (2)— in subparagraph (A), by striking and at the end; by redesignating subparagraph
(B)as subparagraph (C); and by inserting after subparagraph
(A)the following: shall permit packaging systems and safe disposal packaging or safe disposal systems that are different from those required for the applicable listed drug under subsection (e)(4); and . Not later than 12 months after the date of enactment of this Act, the Comptroller General of the United States shall prepare and submit to Congress a report containing— a description of available evidence, if any, on the effectiveness of site-of-use, in-home controlled substance disposal products and packaging technologies; an evaluation of existing reference standards with respect to controlled substance disposal products and packaging technologies, including any such standards established by a standards development organization, and how such standards should be considered in ensuring effectiveness of such products and technologies; identification of ways in which such disposal products intended for use by patients, consumers, and other end users that are not registrants under the Controlled Substances Act ( 21 U.S.C. 801 et seq.), are made available to the public and any barriers to the use of such disposal products; identification of ways in which packaging technologies are made available to the public and any barriers to the use of such technologies; a description of current Federal oversight, if any, of site-of-use, in-home controlled substance disposal products, including— identification of the Federal agencies that oversee such products; identification of the methods of disposal of controlled substances recommended by such agencies for site-of-use, in-home disposal; and a description of the effectiveness of such recommendations at preventing the diversion of legally prescribed controlled substances; a description of current Federal oversight, if any, of controlled substance packaging technologies, including— identification of the Federal agencies that oversee such technologies; identification of the technologies recommended by such agencies, including unit dose packaging, packaging that provides a set duration, and other packaging systems that may mitigate abuse or misuse; and a description of the effectiveness of such recommendations at preventing the diversion of legally prescribed controlled substances; and recommendations, as appropriate, on— whether site-of-use, in-home controlled substance disposal products and packaging technologies require Federal oversight and, if so, which agency or agencies should be responsible for such oversight and, as applicable, review of such products or technologies; and whether there are applicable standards that should be considered to ensure the effectiveness of such products.
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- 21 USC 355–1(e)
- 21 USC 355–1(f)(2)(C)
- 21 USC 355–1(i)
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Sec. 3032
Safety-enhancing packaging and disposal features
Cite21 USC 355–1(e)
Cite21 USC 355–1(f)(2)(C)
Cite21 USC 355–1(i)
Cites 4Cited by 0 across 0 sources