H.R. 9559
IBOGAINE Act
Sponsor: Morgan Luttrell
5 cosponsors
Official summary
No official summary yet.
Text of the bill
(a) In general. Section 201 of the Controlled Substances Act (21 U.S.C. 811) is amended by adding at the end the following:
(k)
(1) Upon successful completion of phase 3 clinical trials for a drug in schedule I intended to treat a serious mental health disorder, the Attorney General, in consultation with the Secretary of Health and Human Services, shall initiate and complete proceedings under subsection (a) to determine whether to place such drug in another schedule.
(2) The Attorney General shall complete proceedings under subsection (a) for a drug as quickly as practicable.
(3) In this subsection, the term phase 3 clinical trial means phase 3 clinical investigations conducted pursuant to an exemption for investigational use under section 505(i) of the Federal Food, Drug, and Cosmetic Act or section 351(a)(3) of the Public Health Service Act.
(b) Necessary steps for rescheduling determination. Notwithstanding section 201 and subsections (a) and (b) of section 202 of the Controlled Substances Act (21 U.S.C. 811, 812) respecting the scheduling of controlled substances, the Attorney General shall, by order, not later than 60 days after the date of enactment of this Act, take all necessary steps to determine whether to transfer ibogaine and ibogaine compounds from schedule I of such Act to schedule II of such Act.