117 S253 ES: Cannabidiol and Marihuana Research Expansion Act U.S. Senate text/xml EN Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain.

117th CONGRESS2d SessionS. 253IN THE SENATE OF THE UNITED STATESAN ACTTo expand research on the cannabidiol and marihuana.

1.

Short title; table of contents

(a)

Short title

This Act may be cited as the Cannabidiol and Marihuana Research Expansion Act.(b)

Table of contents

The table of contents for this Act is as follows: Sec. 1. Short title; table of contents.Sec. 2. Definitions.TITLE I—Registrations for marihuana researchSec. 101. Marihuana research applications.Sec. 102. Research protocols.Sec. 103. Applications to manufacture marihuana for research.Sec. 104. Adequate and uninterrupted supply.Sec. 105. Security requirements.Sec. 106. Prohibition against reinstating interdisciplinary review process for non-NIH-funded researchers.TITLE II—Development of FDA-approved drugs using cannabidiol and marihuanaSec. 201. Medical research on cannabidiol.Sec. 202. Registration for the commercial production and distribution of Food and Drug Administration-approved drugs.Sec. 203. Importation of cannabidiol for research purposes.TITLE III—Doctor-patient relationshipSec. 301. Doctor-patient relationship.TITLE IV—Federal researchSec. 401. Federal research.

2.

Definitions

In this Act—(1)the term appropriately registered means that an individual or entity is registered under the Controlled Substances Act (21 U.S.C. 801 et seq.) to engage in the type of activity that is carried out by the individual or entity with respect to a controlled substance on the schedule that is applicable to cannabidiol or marihuana, as applicable;(2)the term cannabidiol means—(A)the substance, cannabidiol, as derived from marihuana that has a delta-9-tetrahydrocannabinol level that is greater than 0.3 percent; and(B)the synthetic equivalent of the substance described in subparagraph (A);(3)the terms controlled substance, dispense, distribute, manufacture, marihuana, and practitioner have the meanings given such terms in section 102 of the Controlled Substances Act (21 U.S.C. 802), as amended by this Act;(4)the term covered institution of higher education means an institution of higher education (as defined in section 101 of the Higher Education Act of 1965 (20 U.S.C. 1001)) that—(A)(i)has highest or higher research activity, as defined by the Carnegie Classification of Institutions of Higher Education; or(ii)is an accredited medical school or an accredited school of osteopathic medicine; and(B)is appropriately registered under the Controlled Substances Act (21 U.S.C. 801 et seq.);(5)the term drug has the meaning given the term in section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(g)(1));(6)the term medical research for drug development means medical research that is—(A)a preclinical study or clinical investigation conducted in accordance with section 505(i) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(i)) or otherwise permitted by the Department of Health and Human Services to determine the potential medical benefits of marihuana or cannabidiol as a drug; and(B)conducted by a covered institution of higher education, practitioner, or manufacturer that is appropriately registered under the Controlled Substances Act (21 U.S.C. 801 et seq.); and(7)the term State means any State of the United States, the District of Columbia, and any territory of the United States.

Passed the Senate March 24, 2022.Secretary