Sec. 1302. Clarifying FDA packaging authorities

324 words·~1 min read·/bill/115/hr/6/eas/section-1302

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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 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 non-retrievable (as defined in section 1300.05 of title 21, Code of Federal Regulations (or any successor regulation)) if the Secretary has determines that such safe disposal packaging or system may mitigate such serious risk and exists in sufficient quantities. . 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 needs; 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 .

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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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cites case law

Sec. 1302

Clarifying FDA packaging authorities

Cite21 USC 355–1(e)

Cite21 USC 355–1(f)(2)(C)

Cite21 USC 355–1(i)

Cites 3Cited by 0 across 0 sources