; or (B) 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. . (b) Assuring access and minimizing burden 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— (1) in clause (i) by striking and at the end; and (2) by adding at the end the following: (iii) patients with functional limitations; and . (c) Application to abbreviated new drug applications Section 505–1(i) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355–1(i) ) is amended— (1) in paragraph (1)— (A) by redesignating subparagraph (B) as subparagraph (C); and (B) inserting after subparagraph (A) the following: (B) A packaging or disposal requirement, if required under subsection (e)(4) for the applicable listed drug. ; and (2) in paragraph (2)— (A) in subparagraph (A), by striking and at the end; (B) by redesignating subparagraph (B) as subparagraph (C); and (C) by inserting after subparagraph (A) the following: (B) 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 . (d) GAO report 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— (1) a description of available evidence, if any, on the effectiveness of site-of-use, in-home controlled substance disposal products and packaging technologies