; implementation guidance (1) In general The amendment made by subsection (a) shall take effect on the date that is 1 year after the date of enactment of this Act. (2) Implementation and guidance Not later than 1 year after the date of enactment of this Act, the Secretary of Health and Human Services shall issue guidance and relevant informational bulletins for States, manufacturers (as defined in section 1927(k)(5) of the Social Security Act ( 42 U.S.C. 1396r–8(k)(5) )), and other relevant stakeholders, including health care providers, regarding implementation of the amendment made by subsection (a). III Food and Drug Administration A CREATES Act 301. Actions for delays of generic drugs and biosimilar biological products (a) Definitions In this section— (1) the term commercially reasonable, market-based terms means— (A) a nondiscriminatory price for the sale of the covered product at or below, but not greater than, the most recent wholesale acquisition cost for the drug, as defined in section 1847A(c)(6)(B) of the Social Security Act (42 U.S.C. 1395w–3a(c)(6)(B)); (B) a schedule for delivery that results in the transfer of the covered product to the eligible product developer consistent with the timing under subsection (b)(2)(A)(iv); and (C) no additional conditions are imposed on the sale of the covered product; (2) the term covered product — (A) means— (i) any drug approved under subsection (c) or (j) of section 505 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355 ) or biological product licensed under subsection (a) or (k) of section 351 of the Public Health Service Act ( 42 U.S.C. 262 ); (ii) any combination of a drug or biological product described in clause (i)