Cannabidiol and Marihuana Research Expansion Act

117TH CONGRESS 2D SESSION S. 253 AN ACT To expand research on the cannabidiol and marihuana. Be it enacted by the Senate and House of Representa- 1 tives of the United States of America in Congress assembled, 2 2 † S 253 ES SECTION 1. SHORT TITLE; TABLE OF CONTENTS. 1 (a) SHORT TITLE.—This Act may be cited as the 2 ‘‘Cannabidiol and Marihuana Research Expansion Act’’. 3 (b) TABLE OF CONTENTS.—The table of contents for 4 this Act is as follows: 5 Sec. 1. Short title; table of contents. Sec. 2. Definitions. TITLE I—REGISTRATIONS FOR MARIHUANA RESEARCH Sec. 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 MARIHUANA Sec. 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 RELATIONSHIP Sec. 301. Doctor-patient relationship. TITLE IV—FEDERAL RESEARCH Sec. 401. Federal research. SEC. 2. DEFINITIONS. 6 In this Act— 7 (1) the term ‘‘appropriately registered’’ means 8 that an individual or entity is registered under the 9 Controlled Substances Act (21 U.S.C. 801 et seq.) 10 to engage in the type of activity that is carried out 11 by the individual or entity with respect to a con- 12 3 † S 253 ES trolled substance on the schedule that is applicable 1 to cannabidiol or marihuana, as applicable; 2 (2) the term ‘‘cannabidiol’’ means— 3 (A) the substance, cannabidiol, as derived 4 from marihuana that has a delta-9- 5 tetrahydrocannabinol level that is greater than 6 0.3 percent; and 7 (B) the synthetic equivalent of the sub- 8 stance described in subparagraph (A); 9 (3) the terms ‘‘controlled substance’’, ‘‘dis- 10 pense’’, ‘‘distribute’’, ‘‘manufacture’’, ‘‘marihuana’’, 11 and ‘‘practitioner’’ have the meanings given such 12 terms in section 102 of the Controlled Substances 13 Act (21 U.S.C. 802), as amended by this Act; 14 (4) the term ‘‘covered institution of higher edu- 15 cation’’ means an institution of higher education (as 16 defined in section 101 of the Higher Education Act 17 of 1965 (20 U.S.C. 1001)) that— 18 (A)(i) has highest or higher research activ- 19 ity, as defined by the Carnegie Classification of 20 Institutions of Higher Education; or 21 (ii) is an accredited medical school or an 22 accredited school of osteopathic medicine; and 23 4 † S 253 ES (B) is appropriately registered under the 1 Controlled Substances Act (21 U.S.C. 801 et 2 seq.); 3 (5) the term ‘‘drug’’ has the meaning given the 4 term in section 201(g)(1) of the Federal Food, 5 Drug, and Cosmetic Act (21 U.S.C. 321(g)(1)); 6 (6) the term ‘‘medical research for drug devel- 7 opment’’ means medical research that is— 8 (A) a preclinical study or clinical investiga- 9 tion conducted in accordance with section 10 505(i) of the Federal Food, Drug, and Cos- 11 metic Act (21 U.S.C. 355(i)) or otherwise per- 12 mitted by the Department of Health and 13 Human Services to determine the potential 14 medical benefits of marihuana or cannabidiol as 15 a drug; and 16 (B) conducted by a covered institution of 17 higher education, practitioner, or manufacturer 18 that is appropriately registered under the Con- 19 trolled Substances Act (21 U.S.C. 801 et seq.); 20 and 21 (7) the term ‘‘State’’ means any State of the 22 United States, the District of Columbia, and any 23 territory of the United States. 24 5 † S 253 ES TITLE I—REGISTRATIONS FOR 1 MARIHUANA RESEARCH 2 SEC. 101. MARIHUANA RESEARCH APPLICATIONS. 3 Section 303(f) of the Controlled Substances Act (21 4 U.S.C. 823(f)) is amended— 5 (1) by redesignating paragraphs (1) through 6 (5) as subparagraphs (A) through (E), respectively; 7 (2) by striking ‘‘(f) The Attorney General’’ and 8 inserting ‘‘(f)(1) The Attorney General’’; 9 (3) by striking ‘‘Registration applications’’ and 10 inserting the following: 11 ‘‘(2)(A) Registration applications’’; 12 (4) by striking ‘‘Article 7’’ and inserting the 13 following: 14 ‘‘(3) Article 7’’; and 15 (5) by inserting after paragraph (2)(A), as so 16 designated, the following: 17 ‘‘(B)(i) The Attorney General shall register a practi- 18 tioner to conduct research with marihuana if— 19 ‘‘(I) the applicant’s research protocol— 20 ‘‘(aa) has been reviewed and allowed— 21 ‘‘(AA) by the Secretary of Health and 22 Human Services under section 505(i) of 23 the Federal Food, Drug, and Cosmetic Act 24 (21 U.S.C. 355(i)); 25 6 † S 253 ES ‘‘(BB) by the National Institutes of 1 Health or another Federal agency that 2 funds scientific research; or 3 ‘‘(CC) pursuant to sections 1301.18 4 and 1301.32 of title 21, Code of Federal 5 Regulations, or any successors thereto; and 6 ‘‘(II) the applicant has demonstrated to the At- 7 torney General that there are effective procedures in 8 place to adequately safeguard against diversion of 9 the controlled substance for legitimate medical or 10 scientific use pursuant to section 105 of the 11 Cannabidiol and Marihuana Research Expansion 12 Act, including demonstrating that the security meas- 13 ures are adequate for storing the quantity of mari- 14 huana the applicant would be authorized to possess. 15 ‘‘(ii) The Attorney General may deny an application 16 for registration under this subparagraph only if the Attor- 17 ney General determines that the issuance of the registra- 18 tion would be inconsistent with the public interest. In de- 19 termining the public interest, the Attorney General shall 20 consider the factors listed in— 21 ‘‘(I) subparagraphs (B) through (E) of para- 22 graph (1); and 23 ‘‘(II) subparagraph (A) of paragraph (1), if the 24 applicable State requires practitioners conducting re- 25 7 † S 253 ES search to register with a board or authority de- 1 scribed in such subparagraph (A). 2 ‘‘(iii)(I) Not later than 60 days after the date on 3 which the Attorney General receives a complete applica- 4 tion for registration under this subparagraph, the Attor- 5 ney General shall— 6 ‘‘(aa) approve the application; or 7 ‘‘(bb) request supplemental information. 8 ‘‘(II) For purposes of subclause (I), an application 9 shall be deemed complete when the applicant has sub- 10 mitted documentation showing that the requirements 11 under clause (i) are satisfied. 12 ‘‘(iv) Not later than 30 days after the date on which 13 the Attorney General receives supplemental information as 14 described in clause (iii)(I)(bb) in connection with an appli- 15 cation described in this subparagraph, the Attorney Gen- 16 eral shall approve or deny the application. 17 ‘‘(v) If an application described in this subparagraph 18 is denied, the Attorney General shall provide a written ex- 19 planation of the basis of denial to the applicant.’’. 20 SEC. 102. RESEARCH PROTOCOLS. 21 (a) IN GENERAL.—Paragraph (2)(B) of section 22 303(f) of the Controlled Substances Act (21 U.S.C. 23 823(f)), as amended by section 101 of this Act, is further 24 amended by adding at the end the following: 25 8 † S 253 ES ‘‘(vi)(I) If the Attorney General grants an application 1 for registration under clause (i), the registrant may amend 2 or supplement the research protocol without reapplying if 3 the registrant does not change— 4 ‘‘(aa) the quantity or type of drug; 5 ‘‘(bb) the source of the drug; or 6 ‘‘(cc) the conditions under which the drug is 7 stored, tracked, or administered. 8 ‘‘(II)(aa) If a registrant under clause (i) seeks to 9 change the type of drug, the source of the drug, or condi- 10 tions under which the drug is stored, tracked, or adminis- 11 tered, the registrant shall notify the Attorney General via 12 registered mail, or an electronic means permitted by the 13 Attorney General, not later than 30 days before imple- 14 menting an amended or supplemental research protocol. 15 ‘‘(bb) A registrant may proceed with an amended or 16 supplemental research protocol described in item (aa) if 17 the Attorney General does not explicitly object during the 18 30-day period beginning on the date on which the Attorney 19 General receives the notice under item (aa). 20 ‘‘(cc) The Attorney General may only object to an 21 amended or supplemental research protocol under this 22 subclause if additional security measures are needed to 23 safeguard against diversion or abuse. 24 9 † S 253 ES ‘‘(dd) If a registrant under clause (i) seeks to address 1 additional security measures identified by the Attorney 2 General under item (cc), the registrant shall notify the At- 3 torney General via registered mail, or an electronic means 4 permitted by the Attorney General, not later than 30 days 5 before implementing an amended or supplemental research 6 protocol. 7 ‘‘(ee) A registrant may proceed with an amended or 8 supplemental research protocol described in item (dd) if 9 the Attorney General does not explicitly object during the 10 30-day period beginning on the date on which the Attorney 11 General receives the notice under item (dd). 12 ‘‘(III)(aa) If a registrant under clause (i) seeks to 13 change the quantity of marihuana needed for research and 14 the change in quantity does not impact the factors de- 15 scribed in item (bb) or (cc) of subclause (I) of this clause, 16 the registrant shall notify the Attorney General via reg- 17 istered mail or using an electronic means permitted by the 18 Attorney General. 19 ‘‘(bb) A notification under item (aa) shall include— 20 ‘‘(AA) the Drug Enforcement Administration 21 registration number of the registrant; 22 ‘‘(BB) the quantity of marihuana already ob- 23 tained; 24 10 † S 253 ES ‘‘(CC) the quantity of additional marihuana 1 needed to complete the research; and 2 ‘‘(DD) an attestation that the change in quan- 3 tity does not impact the source of the drug or the 4 conditions under which the drug is stored, tracked, 5 or administered. 6 ‘‘(cc) The Attorney General shall ensure that— 7 ‘‘(AA) any registered mail return receipt with 8 respect to a notification under item (aa) is sub- 9 mitted for delivery to the registrant providing the 10 notification not later than 3 days after receipt of the 11 notification by the Attorney General; and 12 ‘‘(BB) notice of receipt of a notification using 13 an electronic means permitted under item (aa) is 14 provided to the registrant providing the notification 15 not later than 3 days after receipt of the notification 16 by the Attorney General. 17 ‘‘(dd)(AA) On and after the date described in subitem 18 (BB), a registrant that submits a notification in accord- 19 ance with item (aa) may proceed with the research as if 20 the change in quantity has been approved on such date, 21 unless the Attorney General notifies the registrant of an 22 objection described in item (ee). 23 ‘‘(BB) The date described in this subitem is the date 24 on which a registrant submitting a notification under item 25 11 † S 253 ES (aa) receives the registered mail return receipt with re- 1 spect to the notification or the date on which the reg- 2 istrant receives notice that the notification using an elec- 3 tronic means permitted under item (aa) was received by 4 the Attorney General, as the case may be. 5 ‘‘(ee) A notification submitted under item (aa) shall 6 be deemed to be approved unless the Attorney General, 7 not later than 10 days after receiving the notification, ex- 8 plicitly objects based on a finding that the change in quan- 9 tity— 10 ‘‘(AA) does impact the source of the drug or 11 the conditions under which the drug is stored, 12 tracked, or administered; or 13 ‘‘(BB) necessitates that the registrant imple- 14 ment additional security measures to safeguard 15 against diversion or abuse. 16 ‘‘(IV) Nothing in this clause shall limit the authority 17 of the Secretary of Health and Human Services over re- 18 quirements related to research protocols, including 19 changes in— 20 ‘‘(aa) the method of administration of mari- 21 huana; 22 ‘‘(bb) the dosing of marihuana; and 23 ‘‘(cc) the number of individuals or patients in- 24 volved in research.’’. 25 12 † S 253 ES (b) REGULATIONS.—Not later than 1 year after the 1 date of enactment of this Act, the Attorney General shall 2 promulgate regulations to carry out the amendment made 3 by this section. 4 SEC. 103. APPLICATIONS TO MANUFACTURE MARIHUANA 5 FOR RESEARCH. 6 (a) IN GENERAL.—Section 303 of the Controlled 7 Substances Act (21 U.S.C. 823) is amended— 8 (1) by redesignating subsections (c) through (k) 9 as subsections (d) through (l), respectively; 10 (2) by inserting after subsection (b) the fol- 11 lowing: 12 ‘‘(c)(1)(A) As it relates to applications to manufac- 13 ture marihuana for research purposes, if the Attorney 14 General places a notice in the Federal Register to increase 15 the number of entities registered under this Act to manu- 16 facture marihuana to supply appropriately registered re- 17 searchers in the United States, the Attorney General shall, 18 not later than 60 days after the date on which the Attor- 19 ney General receives a completed application— 20 ‘‘(i) approve the application; or 21 ‘‘(ii) request supplemental information. 22 ‘‘(B) For purposes of subparagraph (A), an applica- 23 tion shall be deemed complete when the applicant has sub- 24 mitted documentation showing each of the following: 25 13 † S 253 ES ‘‘(i) The requirements designated in the notice 1 in the Federal Register are satisfied. 2 ‘‘(ii) The requirements under this Act are satis- 3 fied. 4 ‘‘(iii) The applicant will limit the transfer and 5 sale of any marihuana manufactured under this sub- 6 section— 7 ‘‘(I) to researchers who are registered 8 under this Act to conduct research with con- 9 trolled substances in schedule I; and 10 ‘‘(II) for purposes of use in preclinical re- 11 search or in a clinical investigation pursuant to 12 an investigational new drug exemption under 13 505(i) of the Federal Food, Drug, and Cos- 14 metic Act (21 U.S.C. 355(i)). 15 ‘‘(iv) The applicant will transfer or sell any 16 marihuana manufactured under this subsection only 17 with prior, written consent for the transfer or sale 18 by the Attorney General. 19 ‘‘(v) The applicant has completed the applica- 20 tion and review process under subsection (a) for the 21 bulk manufacture of controlled substances in sched- 22 ule I. 23 ‘‘(vi) The applicant has established and begun 24 operation of a process for storage and handling of 25 14 † S 253 ES controlled substances in schedule I, including for in- 1 ventory control and monitoring securit [Text truncated for display. 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