Top Summary
This section of the US bill requires the Secretary of Health and Human Services to review the scheduling of approved products containing a combination of buprenorphine and naloxone, in accordance with the Controlled Substances Act, and to request the Attorney General to initiate rulemaking proceedings if necessary. The Attorney General must then evaluate such requests and decide whether to proceed with revising the schedules based on the established criteria.
Original Bill Text:
SEC. 209.Reviewing the scheduling of approved products containing a combination of buprenorphine and naloxone.
(a) Secretary of HHS.—The Secretary of Health and Human Services shall, consistent with the requirements and procedures set forth in sections 201 and 202 of the Controlled Substances Act (21 U.S.C. 811, 812)—
(1) review the relevant data pertaining to the scheduling of products containing a combination of buprenorphine and naloxone that have been approved under section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355); and
(2) if appropriate, request that the Attorney General initiate rulemaking proceedings to revise the schedules accordingly with respect to such products.
(b) Attorney General.—The Attorney General shall review any request made by the Secretary of Health and Human Services under subsection (a)(2) and determine whether to initiate proceedings to revise the schedules in accordance with the criteria set forth in sections 201 and 202 of the Controlled Substances Act (21 U.S.C. 811, 812).