Outsourcing facility compounding

Section 503B of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 353b) is amended— (1) in subsection (a)(2)(A)(ii)— (A) by striking appears and inserting appeared; and (B) by striking at the time of and inserting at any time during the 180-day period ending on the date of; (2) in subsection (a)(10)(A)(iii)— (A) in subclause (VIII), by striking the semicolon at the end and inserting; and; (B) by striking subclause (IX); and (C) by redesignating subclause (X) as subclause (IX); (3) by redesignating the 2 subsections (d) (relating to definitions and relating to obligation to pay fees) as subsections (e) and (f), respectively; and (4) by inserting after subsection (c) the following: (d) List of identified bulk drug substances The Secretary shall make publicly available annual updates on the evaluation of bulk drug substances for purposes of the list maintained under subsection (a)(2)(A)(i).;