Sec. 302. Clarifying FDA packaging authorities

186 words·~1 min read·/bill/115/s/2680/is/section-302

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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), 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 other packaging system that the Secretary determines may help 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 unused 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 help mitigate such serious risk and exists in sufficient quantities, in consultation with other relevant Federal agencies with authorities over drug packaging. .

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21 USC 355–1(e)

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Sec. 302

Clarifying FDA packaging authorities

Cite21 USC 355–1(e)

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