117TH CONGRESS 

2D SESSION S. 253 

AN ACT 

To expand research on the cannabidiol and marihuana. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 
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1 SECTION 1. SHORT TITLE; TABLE OF CONTENTS. 

2 (a) SHORT TITLE.—This Act may be cited as the 

3 ‘‘Cannabidiol and Marihuana Research Expansion Act’’. 

4 (b) TABLE OF CONTENTS.—The table of contents for 

5 this Act is as follows: 

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. 

6 SEC. 2. DEFINITIONS. 

7 In this Act— 

8 (1) the term ‘‘appropriately registered’’ means 

9 that an individual or entity is registered under the 

10 Controlled Substances Act (21 U.S.C. 801 et seq.) 

11 to engage in the type of activity that is carried out 

12 by the individual or entity with respect to a con-
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1 trolled substance on the schedule that is applicable 

2 to cannabidiol or marihuana, as applicable; 

3 (2) the term ‘‘cannabidiol’’ means— 

4 (A) the substance, cannabidiol, as derived 

5 from marihuana that has a delta-9- 

6 tetrahydrocannabinol level that is greater than 

7 0.3 percent; and 

8 (B) the synthetic equivalent of the sub9 stance described in subparagraph (A); 

10 (3) the terms ‘‘controlled substance’’, ‘‘dis11 pense’’, ‘‘distribute’’, ‘‘manufacture’’, ‘‘marihuana’’, 

12 and ‘‘practitioner’’ have the meanings given such 

13 terms in section 102 of the Controlled Substances 

14 Act (21 U.S.C. 802), as amended by this Act; 

15 (4) the term ‘‘covered institution of higher edu16 cation’’ means an institution of higher education (as 

17 defined in section 101 of the Higher Education Act 

18 of 1965 (20 U.S.C. 1001)) that— 

19 (A)(i) has highest or higher research activ20 ity, as defined by the Carnegie Classification of 

21 Institutions of Higher Education; or 

22 (ii) is an accredited medical school or an 

23 accredited school of osteopathic medicine; and 
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1 (B) is appropriately registered under the 

2 Controlled Substances Act (21 U.S.C. 801 et 

3 seq.); 

4 (5) the term ‘‘drug’’ has the meaning given the 

5 term in section 201(g)(1) of the Federal Food, 

6 Drug, and Cosmetic Act (21 U.S.C. 321(g)(1)); 

7 (6) the term ‘‘medical research for drug devel8 opment’’ means medical research that is— 

9 (A) a preclinical study or clinical investiga10 tion conducted in accordance with section 

11 505(i) of the Federal Food, Drug, and Cos12 metic Act (21 U.S.C. 355(i)) or otherwise per13 mitted by the Department of Health and 

14 Human Services to determine the potential 

15 medical benefits of marihuana or cannabidiol as 

16 a drug; and 

17 (B) conducted by a covered institution of 

18 higher education, practitioner, or manufacturer 

19 that is appropriately registered under the Con20 trolled Substances Act (21 U.S.C. 801 et seq.); 

21 and 

22 (7) the term ‘‘State’’ means any State of the 

23 United States, the District of Columbia, and any 

24 territory of the United States. 
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1 TITLE I—REGISTRATIONS FOR 

2 MARIHUANA RESEARCH 

3 SEC. 101. MARIHUANA RESEARCH APPLICATIONS. 

4 Section 303(f) of the Controlled Substances Act (21 

5 U.S.C. 823(f)) is amended— 

6 (1) by redesignating paragraphs (1) through 

7 (5) as subparagraphs (A) through (E), respectively; 

8 (2) by striking ‘‘(f) The Attorney General’’ and 

9 inserting ‘‘(f)(1) The Attorney General’’; 

10 (3) by striking ‘‘Registration applications’’ and 

11 inserting the following: 

12 ‘‘(2)(A) Registration applications’’; 

13 (4) by striking ‘‘Article 7’’ and inserting the 

14 following: 

15 ‘‘(3) Article 7’’; and 

16 (5) by inserting after paragraph (2)(A), as so 

17 designated, the following: 

18 ‘‘(B)(i) The Attorney General shall register a practi19 tioner to conduct research with marihuana if— 

20 ‘‘(I) the applicant’s research protocol— 

21 ‘‘(aa) has been reviewed and allowed— 

22 ‘‘(AA) by the Secretary of Health and 

23 Human Services under section 505(i) of 

24 the Federal Food, Drug, and Cosmetic Act 

25 (21 U.S.C. 355(i)); 
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1 ‘‘(BB) by the National Institutes of 

2 Health or another Federal agency that 

3 funds scientific research; or 

4 ‘‘(CC) pursuant to sections 1301.18 

5 and 1301.32 of title 21, Code of Federal 

6 Regulations, or any successors thereto; and 

7 ‘‘(II) the applicant has demonstrated to the At8 torney General that there are effective procedures in 

9 place to adequately safeguard against diversion of 

10 the controlled substance for legitimate medical or 

11 scientific use pursuant to section 105 of the 

12 Cannabidiol and Marihuana Research Expansion 

13 Act, including demonstrating that the security meas14 ures are adequate for storing the quantity of mari15 huana the applicant would be authorized to possess. 

16 ‘‘(ii) The Attorney General may deny an application 

17 for registration under this subparagraph only if the Attor18 ney General determines that the issuance of the registra19 tion would be inconsistent with the public interest. In de20 termining the public interest, the Attorney General shall 

21 consider the factors listed in— 

22 ‘‘(I) subparagraphs (B) through (E) of para23 graph (1); and 

24 ‘‘(II) subparagraph (A) of paragraph (1), if the 

25 applicable State requires practitioners conducting re-
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1 search to register with a board or authority de2 scribed in such subparagraph (A). 

3 ‘‘(iii)(I) Not later than 60 days after the date on 

4 which the Attorney General receives a complete applica5 tion for registration under this subparagraph, the Attor6 ney General shall— 

7 ‘‘(aa) approve the application; or 

8 ‘‘(bb) request supplemental information. 

9 ‘‘(II) For purposes of subclause (I), an application 

10 shall be deemed complete when the applicant has sub11 mitted documentation showing that the requirements 

12 under clause (i) are satisfied. 

13 ‘‘(iv) Not later than 30 days after the date on which 

14 the Attorney General receives supplemental information as 

15 described in clause (iii)(I)(bb) in connection with an appli16 cation described in this subparagraph, the Attorney Gen17 eral shall approve or deny the application. 

18 ‘‘(v) If an application described in this subparagraph 

19 is denied, the Attorney General shall provide a written ex20 planation of the basis of denial to the applicant.’’. 

21 SEC. 102. RESEARCH PROTOCOLS. 

22 (a) IN GENERAL.—Paragraph (2)(B) of section 

23 303(f) of the Controlled Substances Act (21 U.S.C. 

24 823(f)), as amended by section 101 of this Act, is further 

25 amended by adding at the end the following: 
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1 ‘‘(vi)(I) If the Attorney General grants an application 

2 for registration under clause (i), the registrant may amend 

3 or supplement the research protocol without reapplying if 

4 the registrant does not change— 

5 ‘‘(aa) the quantity or type of drug; 

6 ‘‘(bb) the source of the drug; or 

7 ‘‘(cc) the conditions under which the drug is 

8 stored, tracked, or administered. 

9 ‘‘(II)(aa) If a registrant under clause (i) seeks to 

10 change the type of drug, the source of the drug, or condi11 tions under which the drug is stored, tracked, or adminis12 tered, the registrant shall notify the Attorney General via 

13 registered mail, or an electronic means permitted by the 

14 Attorney General, not later than 30 days before imple15 menting an amended or supplemental research protocol. 

16 ‘‘(bb) A registrant may proceed with an amended or 

17 supplemental research protocol described in item (aa) if 

18 the Attorney General does not explicitly object during the 

19 30-day period beginning on the date on which the Attorney 

20 General receives the notice under item (aa). 

21 ‘‘(cc) The Attorney General may only object to an 

22 amended or supplemental research protocol under this 

23 subclause if additional security measures are needed to 

24 safeguard against diversion or abuse. 
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1 ‘‘(dd) If a registrant under clause (i) seeks to address 

2 additional security measures identified by the Attorney 

3 General under item (cc), the registrant shall notify the At4 torney General via registered mail, or an electronic means 

5 permitted by the Attorney General, not later than 30 days 

6 before implementing an amended or supplemental research 

7 protocol. 

8 ‘‘(ee) A registrant may proceed with an amended or 

9 supplemental research protocol described in item (dd) if 

10 the Attorney General does not explicitly object during the 

11 30-day period beginning on the date on which the Attorney 

12 General receives the notice under item (dd). 

13 ‘‘(III)(aa) If a registrant under clause (i) seeks to 

14 change the quantity of marihuana needed for research and 

15 the change in quantity does not impact the factors de16 scribed in item (bb) or (cc) of subclause (I) of this clause, 

17 the registrant shall notify the Attorney General via reg18 istered mail or using an electronic means permitted by the 

19 Attorney General. 

20 ‘‘(bb) A notification under item (aa) shall include— 

21 ‘‘(AA) the Drug Enforcement Administration 

22 registration number of the registrant; 

23 ‘‘(BB) the quantity of marihuana already ob24 tained; 
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1 ‘‘(CC) the quantity of additional marihuana 

2 needed to complete the research; and 

3 ‘‘(DD) an attestation that the change in quan4 tity does not impact the source of the drug or the 

5 conditions under which the drug is stored, tracked, 

6 or administered. 

7 ‘‘(cc) The Attorney General shall ensure that— 

8 ‘‘(AA) any registered mail return receipt with 

9 respect to a notification under item (aa) is sub10 mitted for delivery to the registrant providing the 

11 notification not later than 3 days after receipt of the 

12 notification by the Attorney General; and 

13 ‘‘(BB) notice of receipt of a notification using 

14 an electronic means permitted under item (aa) is 

15 provided to the registrant providing the notification 

16 not later than 3 days after receipt of the notification 

17 by the Attorney General. 

18 ‘‘(dd)(AA) On and after the date described in subitem 

19 (BB), a registrant that submits a notification in accord20 ance with item (aa) may proceed with the research as if 

21 the change in quantity has been approved on such date, 

22 unless the Attorney General notifies the registrant of an 

23 objection described in item (ee). 

24 ‘‘(BB) The date described in this subitem is the date 

25 on which a registrant submitting a notification under item 
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1 (aa) receives the registered mail return receipt with re2 spect to the notification or the date on which the reg3 istrant receives notice that the notification using an elec4 tronic means permitted under item (aa) was received by 

5 the Attorney General, as the case may be. 

6 ‘‘(ee) A notification submitted under item (aa) shall 

7 be deemed to be approved unless the Attorney General, 

8 not later than 10 days after receiving the notification, ex9 plicitly objects based on a finding that the change in quan10 tity— 

11 ‘‘(AA) does impact the source of the drug or 

12 the conditions under which the drug is stored, 

13 tracked, or administered; or 

14 ‘‘(BB) necessitates that the registrant imple15 ment additional security measures to safeguard 

16 against diversion or abuse. 

17 ‘‘(IV) Nothing in this clause shall limit the authority 

18 of the Secretary of Health and Human Services over re19 quirements related to research protocols, including 

20 changes in— 

21 ‘‘(aa) the method of administration of mari22 huana; 

23 ‘‘(bb) the dosing of marihuana; and 

24 ‘‘(cc) the number of individuals or patients in25 volved in research.’’. 
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1 (b) REGULATIONS.—Not later than 1 year after the 

2 date of enactment of this Act, the Attorney General shall 

3 promulgate regulations to carry out the amendment made 

4 by this section. 

5 SEC. 103. APPLICATIONS TO MANUFACTURE MARIHUANA 

6 FOR RESEARCH. 

7 (a) IN GENERAL.—Section 303 of the Controlled 

8 Substances Act (21 U.S.C. 823) is amended— 

9 (1) by redesignating subsections (c) through (k) 

10 as subsections (d) through (l), respectively; 

11 (2) by inserting after subsection (b) the fol12 lowing: 

13 ‘‘(c)(1)(A) As it relates to applications to manufac14 ture marihuana for research purposes, if the Attorney 

15 General places a notice in the Federal Register to increase 

16 the number of entities registered under this Act to manu17 facture marihuana to supply appropriately registered re18 searchers in the United States, the Attorney General shall, 

19 not later than 60 days after the date on which the Attor20 ney General receives a completed application— 

21 ‘‘(i) approve the application; or 

22 ‘‘(ii) request supplemental information. 

23 ‘‘(B) For purposes of subparagraph (A), an applica24 tion shall be deemed complete when the applicant has sub25 mitted documentation showing each of the following: 
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1 ‘‘(i) The requirements designated in the notice 

2 in the Federal Register are satisfied. 

3 ‘‘(ii) The requirements under this Act are satis4 fied. 

5 ‘‘(iii) The applicant will limit the transfer and 

6 sale of any marihuana manufactured under this sub7 section— 

8 ‘‘(I) to researchers who are registered 

9 under this Act to conduct research with con10 trolled substances in schedule I; and 

11 ‘‘(II) for purposes of use in preclinical re12 search or in a clinical investigation pursuant to 

13 an investigational new drug exemption under 

14 505(i) of the Federal Food, Drug, and Cos15 metic Act (21 U.S.C. 355(i)). 

16 ‘‘(iv) The applicant will transfer or sell any 

17 marihuana manufactured under this subsection only 

18 with prior, written consent for the transfer or sale 

19 by the Attorney General. 

20 ‘‘(v) The applicant has completed the applica21 tion and review process under subsection (a) for the 

22 bulk manufacture of controlled substances in sched23 ule I. 

24 ‘‘(vi) The applicant has established and begun 

25 operation of a process for storage and handling of 
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1 controlled substances in schedule I, including for in2 ventory control and monitoring security in accord3 ance with section 105 of the Cannabidiol and Mari4 huana Research Expansion Act. 

5 ‘‘(vii) The applicant is licensed by each State in 

6 which the applicant will conduct operations under 

7 this subsection, to manufacture marihuana, if that 

8 State requires such a license. 

9 ‘‘(C) Not later than 30 days after the date on which 

10 the Attorney General receives supplemental information 

11 requested under subparagraph (A)(ii) with respect to an 

12 application, the Attorney General shall approve or deny 

13 the application. 

14 ‘‘(2) If an application described in this subsection is 

15 denied, the Attorney General shall provide a written expla16 nation of the basis of denial to the applicant.’’; 

17 (3) in subsection (h)(2), as so redesignated, by 

18 striking ‘‘subsection (f)’’ each place it appears and 

19 inserting ‘‘subsection (g)’’; 

20 (4) in subsection (j)(1), as so redesignated, by 

21 striking ‘‘subsection (d)’’ and inserting ‘‘subsection 

22 (e)’’; and 

23 (5) in subsection (k), as so redesignated, by 

24 striking ‘‘subsection (f)’’ each place it appears and 

25 inserting ‘‘subsection (g)’’. 
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1 (b) TECHNICAL AND CONFORMING AMENDMENTS.— 

2 (1) The Controlled Substances Act (21 U.S.C. 

3 801 et seq.) is amended— 

4 (A) in section 102 (21 U.S.C. 802)— 

5 (i) in paragraph (52)(B)— 

6 (I) by striking ‘‘303(f)’’ each 

7 place it appears and inserting 

8 ‘‘303(g)’’; and 

9 (II) in clause (i), by striking 

10 ‘‘(d), or (e)’’ and inserting ‘‘(e), or 

11 (f)’’; and 

12 (ii) in paragraph (54), by striking 

13 ‘‘303(f)’’ each place it appears and insert14 ing ‘‘303(g)’’; 

15 (B) in section 302(g)(5)(A)(iii)(I)(bb) (21 

16 U.S.C. 822(g)(5)(A)(iii)(I)(bb)), by striking 

17 ‘‘303(f)’’ and inserting ‘‘303(g)’’; 

18 (C) in section 304 (21 U.S.C. 824), by 

19 striking ‘‘303(g)(1)’’ each place it appears and 

20 inserting ‘‘303(h)(1)’’; 

21 (D) in section 307(d)(2) (21 U.S.C. 

22 827(d)(2)), by striking ‘‘303(f)’’ and inserting 

23 ‘‘303(g)’’; 

24 (E) in section 309A(a)(2) (21 U.S.C. 

25 829a(a)(2)), in the matter preceding subpara-
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1 graph (A), by striking ‘‘303(g)(2)’’ and insert2 ing ‘‘303(h)(2)’’; 

3 (F) in section 311(h) (21 U.S.C. 831(h)), 

4 by striking ‘‘303(f)’’ each place it appears and 

5 inserting ‘‘303(g)’’; 

6 (G) in section 401(h)(2) (21 U.S.C. 

7 841(h)(2)), by striking ‘‘303(f)’’ each place it 

8 appears and inserting ‘‘303(g)’’; 

9 (H) in section 403(c)(2)(B) (21 U.S.C. 

10 843(c)(2)(B)), by striking ‘‘303(f)’’ and insert11 ing ‘‘303(g)’’; and 

12 (I) in section 512(c)(1) (21 U.S.C. 

13 882(c)(1)) by striking ‘‘303(f)’’ and inserting 

14 ‘‘303(g)’’. 

15 (2) Section 1008(c) of the Controlled Sub16 stances Import and Export Act (21 U.S.C. 958(c)) 

17 is amended— 

18 (A) in paragraph (1), by striking ‘‘303(d)’’ 

19 and inserting ‘‘303(e)’’; and 

20 (B) in paragraph (2)(B), by striking 

21 ‘‘303(h)’’ and inserting ‘‘303(i)’’. 

22 (3) Title V of the Public Health Service Act (42 

23 U.S.C. 290aa et seq.) is amended— 
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1 (A) in section 520E–4(c) (42 U.S.C. 

2 290bb–36d(c)), by striking ‘‘303(g)(2)(B)’’ and 

3 inserting ‘‘303(h)(2)(B)’’; and 

4 (B) in section 544(a)(3) (42 U.S.C. 

5 290dd–3(a)(3)), by striking ‘‘303(g)’’ and in6 serting ‘‘303(h)’’. 

7 (4) Title XVIII of the Social Security Act (42 

8 U.S.C. 1395 et seq.) is amended— 

9 (A) in section 1833(bb)(3)(B) (42 U.S.C. 

10 1395l(bb)(3)(B)), by striking ‘‘303(g)’’ and in11 serting ‘‘303(h)’’; 

12 (B) in section 1834(o)(3)(C)(ii) (42 U.S.C. 

13 1395m(o)(3)(C)(ii)), by striking ‘‘303(g)’’ and 

14 inserting ‘‘303(h)’’; and 

15 (C) in section 1866F(c)(3)(C) (42 U.S.C. 

16 1395cc–6(c)(3)(C)), by striking ‘‘303(g)’’ and 

17 inserting ‘‘303(h)’’. 

18 (5) Section 1903(aa)(2)(C)(ii) of the Social Se19 curity Act (42 U.S.C. 1396b(aa)(2)(C)(ii)) is 

20 amended by striking ‘‘303(g)’’ each place it appears 

21 and inserting ‘‘303(h)’’. 

22 SEC. 104. ADEQUATE AND UNINTERRUPTED SUPPLY. 

23 On an annual basis, the Attorney General shall assess 

24 whether there is an adequate and uninterrupted supply of 
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1 marihuana, including of specific strains, for research pur2 poses. 

3 SEC. 105. SECURITY REQUIREMENTS. 

4 (a) IN GENERAL.—An individual or entity engaged 

5 in researching marihuana or its components shall store it 

6 in a securely locked, substantially constructed cabinet. 

7 (b) REQUIREMENTS FOR OTHER MEASURES.—Any 

8 other security measures required by the Attorney General 

9 to safeguard against diversion shall be consistent with 

10 those required for practitioners conducting research on 

11 other controlled substances in schedules I and II in section 

12 202(c) of the Controlled Substances Act (21 U.S.C. 

13 812(c)) that have a similar risk of diversion and abuse. 

14 SEC. 106. PROHIBITION AGAINST REINSTATING INTER15 DISCIPLINARY REVIEW PROCESS FOR NON16 NIH-FUNDED RESEARCHERS. 

17 The Secretary of Health and Human Services may 

18 not— 

19 (1) reinstate the Public Health Service inter20 disciplinary review process described in the guidance 

21 entitled ‘‘Guidance on Procedures for the Provision 

22 of Marijuana for Medical Research’’ (issued on May 

23 21, 1999); or 
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1 (2) require another review of scientific protocols 

2 that is applicable only to research on marihuana or 

3 its components. 

4 TITLE II—DEVELOPMENT OF 

5 FDA-APPROVED DRUGS 

6 USING CANNABIDIOL AND 

7 MARIHUANA 

8 SEC. 201. MEDICAL RESEARCH ON CANNABIDIOL. 

9 Notwithstanding any provision of the Controlled Sub10 stances Act (21 U.S.C. 801 et seq.), the Safe and Drug11 Free Schools and Communities Act (20 U.S.C. 7101 et 

12 seq.), chapter 81 of title 41, United States Code, or any 

13 other Federal law, an appropriately registered covered in14 stitution of higher education, a practitioner, or a manufac15 turer may manufacture, distribute, dispense, or possess 

16 marihuana or cannabidiol if the marihuana or cannabidiol 

17 is manufactured, distributed, dispensed, or possessed, re18 spectively, for purposes of medical research for drug devel19 opment or subsequent commercial production in accord20 ance with section 202. 

21 SEC. 202. REGISTRATION FOR THE COMMERCIAL PRODUC22 TION AND DISTRIBUTION OF FOOD AND 

23 DRUG ADMINISTRATION-APPROVED DRUGS. 

24 The Attorney General shall register an applicant to 

25 manufacture or distribute cannabidiol or marihuana for 
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1 the purpose of commercial production of a drug containing 

2 or derived from marihuana that is approved by the Sec3 retary of Health and Human Services under section 505 

4 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

5 355), in accordance with the applicable requirements 

6 under subsection (a) or (b) of section 303 of the Con7 trolled Substances Act (21 U.S.C. 823). 

8 SEC. 203. IMPORTATION OF CANNABIDIOL FOR RESEARCH 

9 PURPOSES. 

10 The Controlled Substances Import and Export Act 

11 (21 U.S.C. 951 et seq.) is amended— 

12 (1) in section 1002(a) (21 U.S.C. 952(a))— 

13 (A) in paragraph (1), by striking ‘‘and’’ at 

14 the end; 

15 (B) in paragraph (2)(C), by inserting 

16 ‘‘and’’ after ‘‘uses,’’; and 

17 (C) inserting before the undesignated mat18 ter following paragraph (2)(C) the following: 

19 ‘‘(3) such amounts of marihuana or cannabidiol 

20 (as defined in section 2 of the Cannabidiol and Mar21 ihuana Research Expansion Act) as are— 

22 ‘‘(A) approved for medical research for 

23 drug development (as such terms are defined in 

24 section 2 of the Cannabidiol and Marihuana Re25 search Expansion Act), or 
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1 ‘‘(B) necessary for registered manufactur2 ers to manufacture drugs containing marihuana 

3 or cannabidiol that have been approved for use 

4 by the Commissioner of Food and Drugs under 

5 the Federal Food, Drug, and Cosmetic Act (21 

6 U.S.C. 301 et seq.),’’; and 

7 (2) in section 1007 (21 U.S.C. 957), by amend8 ing subsection (a) to read as follows: 

9 ‘‘(a)(1) Except as provided in paragraph (2), no per10 son may— 

11 ‘‘(A) import into the customs territory of the 

12 United States from any place outside thereof (but 

13 within the United States), or import into the United 

14 States from any place outside thereof, any controlled 

15 substance or list I chemical, or 

16 ‘‘(B) export from the United States any con17 trolled substance or list I chemical, 

18 unless there is in effect with respect to such person a reg19 istration issued by the Attorney General under section 

20 1008, or unless such person is exempt from registration 

21 under subsection (b). 

22 ‘‘(2) Paragraph (1) shall not apply to the import or 

23 export of marihuana or cannabidiol (as defined in section 

24 2 of the Cannabidiol and Marihuana Research Expansion 

25 Act) that has been approved for— 
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1 ‘‘(A) medical research for drug development au2 thorized under section 201 of the Cannabidiol and 

3 Marihuana Research Expansion Act; or 

4 ‘‘(B) use by registered manufacturers to manu5 facture drugs containing marihuana or cannabidiol 

6 that have been approved for use by the Commis7 sioner of Food and Drugs under the Federal Food, 

8 Drug, and Cosmetic Act (21 U.S.C. 301 et seq.).’’. 

9 TITLE III—DOCTOR-PATIENT 

10 RELATIONSHIP 

11 SEC. 301. DOCTOR-PATIENT RELATIONSHIP. 

12 It shall not be a violation of the Controlled Sub13 stances Act (21 U.S.C. 801 et seq.) for a State-licensed 

14 physician to discuss— 

15 (1) the currently known potential harms and 

16 benefits of marihuana derivatives, including 

17 cannabidiol, as a treatment with the legal guardian 

18 of the patient of the physician if the patient is a 

19 child; or 

20 (2) the currently known potential harms and 

21 benefits of marihuana and marihuana derivatives, 

22 including cannabidiol, as a treatment with the pa23 tient or the legal guardian of the patient of the phy24 sician if the patient is a legal adult. 
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1 TITLE IV—FEDERAL RESEARCH 

2 SEC. 401. FEDERAL RESEARCH. 

3 (a) IN GENERAL.—Not later than 1 year after the 

4 date of enactment of this Act, the Secretary of Health and 

5 Human Services, in coordination with the Director of the 

6 National Institutes of Health and the heads of other rel7 evant Federal agencies, shall submit to the Caucus on 

8 International Narcotics Control, the Committee on the Ju9 diciary, and the Committee on Health, Education, Labor, 

10 and Pensions of the Senate and the Committee on Energy 

11 and Commerce and the Committee on the Judiciary of the 

12 House of Representatives a report on— 

13 (1) the potential therapeutic effects of 

14 cannabidiol or marihuana on serious medical condi15 tions, including intractable epilepsy; 

16 (2) the potential effects of marihuana, includ17 ing— 

18 (A) the effect of increasing delta-9- 

19 tetrahydrocannabinol levels on the human body 

20 and developing adolescent brains; and 

21 (B) the effect of various delta-9- 

22 tetrahydrocannabinol levels on cognitive abili23 ties, such as those that are required to operate 

24 motor vehicles or other heavy equipment; and 
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1 (3) the barriers associated with researching 

2 marihuana or cannabidiol in States that have legal3 ized the use of such substances, which shall in4 clude— 

5 (A) recommendations as to how such bar6 riers might be overcome, including whether pub7 lic-private partnerships or Federal-State re8 search partnerships may or should be imple9 mented to provide researchers with access to 

10 additional strains of marihuana and 

11 cannabidiol; and 

12 (B) recommendations as to what safe13 guards must be in place to verify— 

14 (i) the levels of tetrahydrocannabinol, 

15 cannabidiol, or other cannabinoids con16 tained in products obtained from such 

17 States is accurate; and 

18 (ii) that such products do not contain 

19 harmful or toxic components. 

20 (b) ACTIVITIES.—To the extent practicable, the Sec21 retary of Health and Human Services, either directly or 

22 through awarding grants, contacts, or cooperative agree23 ments, shall expand and coordinate the activities of the 

24 National Institutes of Health and other relevant Federal 

25 agencies to better determine the effects of cannabidiol and 
25 

†S 253 ES

1 marihuana, as outlined in the report submitted under 

2 paragraphs (1) and (2) of subsection (a). 

Passed the Senate March 24, 2022. 

Attest: 

Secretary. 
117TH CONGRESS 

2D SESSION S. 253 

AN ACT 

To expand research on the cannabidiol and 

marihuana.