; and (bb) a substantial clinical investigation has been instituted, and such investigation has been made public; or (ii) a substance that has a chemical structure that is substantially similar to the chemical structure of an active ingredient in a drug or biological product described in subclause (I) or (II) of clause (i). (2) Effect This subsection shall not be construed to bear upon any determination of whether an article is a drug within the meaning of section 201(g), other than for the purposes described in paragraph (1). . 4 Securing Opioids and Unused Narcotics with Deliberate Disposal and Packaging 3031. Short title This chapter may be cited as the Securing Opioids and Unused Narcotics with Deliberate Disposal and Packaging Act of 2018 or the SOUND Disposal and Packaging Act . 3032. Safety-enhancing packaging and disposal features (a) Deliberate disposal and packaging elements of strategy 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: (4) Packaging and disposal 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— (A) 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