H.R. 9559
IBOGAINE Act
Sponsor: Morgan Luttrell
5 cosponsors
Official summary
No official summary yet.
Text of the bill
(a) In general. Section 306 of the Controlled Substances Act (21 U.S.C. 826) is amended—
(1) in subsection (a)—
(A) in paragraph (1)—
(i) by striking total;
(ii) by inserting clinical, after research,; and
(iii) by inserting and paragraph (3) after (2);
(B) in paragraph (2), by inserting , in consultation with the Secretary of Health and Human Services, after if the Attorney General determines; and
(C) by adding at the end the following:
(3) The Attorney General shall revise the annually established production quotas within 90 days for any basic class of controlled substance in schedule I, and within 60 days for any basic class of controlled substance in schedule II, if any of the following triggering events occurs during the calendar year:
(A) A controlled substance in schedule I or II is transferred or placed into another class of controlled substances in accordance with applicable law.
(B) A controlled substance in schedule I or II is approved or cleared by the Food and Drug Administration in accordance with the Federal Food, Drug, and Cosmetic Act.
(C) A controlled substance in schedule I or II is designated as a breakthrough therapy under section 506 of such Act.
(D) An exemption for investigational use is granted for a drug in schedule I or II investigational use under section 505(i) of such Act.
(E) A drug in schedule I or II is approved by the Food and Drug Administration for use in a phase 3 clinical trial.
(2) in subsection (c), by adding at the end the following: Upon the occurrence of a triggering event listed in subsection (a)(3) with respect to a controlled substance, a registered manufacturer may apply for an expedited mid-year adjustment of the manufacturing quota determined for such manufacturer under this subsection with respect to such controlled substance.; and
(3) by adding at the end the following:
(j) The Attorney General shall establish annual sufficiency standards for each established production quota at levels necessary to meet the legitimate medical, scientific, research, clinical, and industrial needs of the United States.