; and (2) the term opioid sparing means reducing, replacing, or avoiding the use of opioids or other controlled substances. 302. Clarifying FDA packaging authorities 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) Serious adverse drug experience 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— (A) 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