116TH CONGRESS 

2D SESSION S. 2032 

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, 
2 

†S 2032 ES

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-
3 

†S 2032 ES

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 
4 

†S 2032 ES

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. 
5 

†S 2032 ES

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)); 
6 

†S 2032 ES

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-
7 

†S 2032 ES

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: 
8 

†S 2032 ES

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. 
9 

†S 2032 ES

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; 
10 

†S 2032 ES

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 

9 with respect to a notification under item (aa) is 

10 submitted for delivery to the registrant pro11 viding the notification not later than 3 days 

12 after receipt of the notification by the Attorney 

13 General; and 

14 ‘‘(BB) notice of receipt of a notification 

15 using an electronic means permitted under item 

16 (aa) is provided to the registrant providing the 

17 notification not later than 3 days after receipt 

18 of the notification by the Attorney General. 

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

20 subitem (BB), a registrant that submits a notifica21 tion in accordance with item (aa) may proceed with 

22 the research as if the change in quantity has been 

23 approved on such date, unless the Attorney General 

24 notifies the registrant of an objection described in 

25 item (ee). 
11 

†S 2032 ES

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

2 date on which a registrant submitting a notification 

3 under item (aa) receives the registered mail return 

4 receipt with respect to the notification or the date on 

5 which the registrant receives notice that the notifica6 tion using an electronic means permitted under item 

7 (aa) was received by the Attorney General, as the 

8 case may be. 

9 ‘‘(ee) A notification submitted under item (aa) 

10 shall be deemed to be approved unless the Attorney 

11 General, not later than 10 days after receiving the 

12 notification, explicitly objects based on a finding that 

13 the change in quantity— 

14 ‘‘(AA) does impact the source of the drug 

15 or the conditions under which the drug is 

16 stored, tracked, or administered; or 

17 ‘‘(BB) necessitates that the registrant im18 plement additional security measures to safe19 guard against diversion or abuse. 

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

21 of the Secretary of Health and Human Services over re22 quirements related to research protocols, including 

23 changes in— 

24 ‘‘(aa) the method of administration of mari25 huana; 
12 

†S 2032 ES

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

2 ‘‘(cc) the number of individuals or patients in3 volved in research.’’. 

4 (b) REGULATIONS.—Not later than 1 year after the 

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

6 promulgate regulations to carry out the amendment made 

7 by this section. 

8 SEC. 103. APPLICATIONS TO MANUFACTURE MARIHUANA 

9 FOR RESEARCH. 

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

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

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

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

14 (2) by inserting after subsection (b) the fol15 lowing: 

16 ‘‘(c)(1)(A) As it relates to applications to manufac17 ture marihuana for research purposes, if the Attorney 

18 General places a notice in the Federal Register to increase 

19 the number of entities registered under this Act to manu20 facture marihuana to supply appropriately registered re21 searchers in the United States, the Attorney General shall, 

22 not later than 60 days after the date on which the Attor23 ney General receives a completed application— 

24 ‘‘(i) approve the application; or 

25 ‘‘(ii) request supplemental information. 
13 

†S 2032 ES

1 ‘‘(B) For purposes of subparagraph (A), an applica2 tion shall be deemed complete when the applicant has sub3 mitted documentation showing each of the following: 

4 ‘‘(i) The requirements designated in the notice 

5 in the Federal Register are satisfied. 

6 ‘‘(ii) The requirements under this Act are satis7 fied. 

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

9 sale of any marihuana manufactured under this sub10 section— 

11 ‘‘(I) to researchers who are registered 

12 under this Act to conduct research with con13 trolled substances in schedule I; and 

14 ‘‘(II) for purposes of use in preclinical re15 search or in a clinical investigation pursuant to 

16 an investigational new drug exemption under 

17 505(i) of the Federal Food, Drug, and Cos18 metic Act (21 U.S.C. 355(i)). 

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

20 marihuana manufactured under this subsection only 

21 with prior, written consent for the transfer or sale 

22 by the Attorney General. 

23 ‘‘(v) The applicant has completed the applica24 tion and review process under subsection (a) for the 
14 

†S 2032 ES

1 bulk manufacture of controlled substances in sched2 ule I. 

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

4 operation of a process for storage and handling of 

5 controlled substances in schedule I, including for in6 ventory control and monitoring security in accord7 ance with section 105 of the Cannabidiol and Mari8 huana Research Expansion Act. 

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

10 which the applicant will conduct operations under 

11 this subsection, to manufacture marihuana, if that 

12 State requires such a license. 

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

14 the Attorney General receives supplemental information 

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

16 application, the Attorney General shall approve or deny 

17 the application. 

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

19 denied, the Attorney General shall provide a written expla20 nation of the basis of denial to the applicant.’’; 

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

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

23 inserting ‘‘subsection (g)’’; 
15 

†S 2032 ES

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

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

3 (e)’’; and 

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

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

6 inserting ‘‘subsection (g)’’. 

7 (b) TECHNICAL AND CONFORMING AMENDMENTS.— 

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

9 801 et seq.) is amended— 

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

11 (i) in paragraph (16)(B)— 

12 (I) in clause (i), by striking ‘‘or’’ 

13 at the end; 

14 (II) by redesignating clause (ii) 

15 as (iii); and 

16 (III) by inserting after clause (i) 

17 the following: 

18 ‘‘(ii) the synthetic equivalent of hemp-de19 rived cannabidiol that contains less than 0.3 

20 percent tetrahydrocannabinol; or’’; 

21 (ii) in paragraph (52)(B)— 

22 (I) by striking ‘‘303(f)’’ each 

23 place it appears and inserting 

24 ‘‘303(g)’’; and 
16 

†S 2032 ES

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

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

3 (f)’’; and 

4 (iii) in paragraph (54), by striking 

5 ‘‘303(f)’’ each place it appears and insert6 ing ‘‘303(g)’’; 

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

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

9 ‘‘303(f)’’ and inserting ‘‘303(g)’’; 

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

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

12 inserting ‘‘303(h)(1)’’; 

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

14 827(d)(2)), by striking ‘‘303(f)’’ and inserting 

15 ‘‘303(g)’’; 

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

17 829a(a)(2)), in the matter preceding subpara18 graph (A), by striking ‘‘303(g)(2)’’ and insert19 ing ‘‘303(h)(2)’’; 

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

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

22 inserting ‘‘303(g)’’; 

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

24 841(h)(2)), by striking ‘‘303(f)’’ each place it 

25 appears and inserting ‘‘303(g)’’; 
17 

†S 2032 ES

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

2 843(c)(2)(B)), by striking ‘‘303(f)’’ and insert3 ing ‘‘303(g)’’; and 

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

5 882(c)(1)) by striking ‘‘303(f)’’ and inserting 

6 ‘‘303(g)’’. 

7 (2) Section 1008(c) of the Controlled Sub8 stances Import and Export Act (21 U.S.C. 958(c)) 

9 is amended— 

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

11 and inserting ‘‘303(e)’’; and 

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

13 ‘‘303(h)’’ and inserting ‘‘303(i)’’. 

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

15 U.S.C. 290aa et seq.) is amended— 

16 (A) in section 520E–4(c) (42 U.S.C. 

17 290bb–36d(c)), by striking ‘‘303(g)(2)(B)’’ and 

18 inserting ‘‘303(h)(2)(B)’’; and 

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

20 290dd–3(a)(3)), by striking ‘‘303(g)’’ and in21 serting ‘‘303(h)’’. 

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

23 U.S.C. 1395 et seq.) is amended— 
18 

†S 2032 ES

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

2 1395l(bb)(3)(B)), by striking ‘‘303(g)’’ and in3 serting ‘‘303(h)’’; 

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

5 1395m(o)(3)(C)(ii)), by striking ‘‘303(g)’’ and 

6 inserting ‘‘303(h)’’; and 

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

8 1395cc–6(c)(3)(C)), by striking ‘‘303(g)’’ and 

9 inserting ‘‘303(h)’’. 

10 (5) Section 1903(aa)(2)(C)(ii) of the Social Se11 curity Act (42 U.S.C. 1396b(aa)(2)(C)(ii)) is 

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

13 and inserting ‘‘303(h)’’. 

14 SEC. 104. ADEQUATE AND UNINTERRUPTED SUPPLY. 

15 On an annual basis, the Attorney General shall assess 

16 whether there is an adequate and uninterrupted supply of 

17 marihuana, including of specific strains, for research pur18 poses. 

19 SEC. 105. SECURITY REQUIREMENTS. 

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

21 in researching marihuana or its components shall store it 

22 in a securely locked, substantially constructed cabinet. 

23 (b) REQUIREMENTS FOR OTHER MEASURES.—Any 

24 other security measures required by the Attorney General 

25 to safeguard against diversion shall be consistent with 
19 

†S 2032 ES

1 those required for practitioners conducting research on 

2 other controlled substances in schedules I and II in section 

3 202(c) of the Controlled Substances Act (21 U.S.C. 

4 812(c)) that have a similar risk of diversion and abuse. 

5 SEC. 106. PROHIBITION AGAINST REINSTATING INTER6 DISCIPLINARY REVIEW PROCESS FOR NON7 NIH FUNDED RESEARCHERS. 

8 The Secretary of Health and Human Services may 

9 not— 

10 (1) reinstate the Public Health Service inter11 disciplinary review process described in the guidance 

12 entitled ‘‘Guidance on Procedures for the Provision 

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

14 21, 1999); or 

15 (2) require another review of scientific protocols 

16 that is applicable only to research on marihuana or 

17 its components. 

18 TITLE II—DEVELOPMENT OF 

19 FDA-APPROVED DRUGS 

20 USING CANNABIDIOL AND 

21 MARIHUANA 

22 SEC. 201. MEDICAL RESEARCH ON CANNABIDIOL. 

23 Notwithstanding any provision of the Controlled Sub24 stances Act (21 U.S.C. 801 et seq.), the Safe and Drug25 Free Schools and Communities Act (20 U.S.C. 7101 et 
20 

†S 2032 ES

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

2 other Federal law, an appropriately registered covered in3 stitution of higher education, a practitioner, or a manufac4 turer may manufacture, distribute, dispense, or possess 

5 marihuana or cannabidiol if the marihuana or cannabidiol 

6 is manufactured, distributed, dispensed, or possessed, re7 spectively, for purposes of medical research for drug devel8 opment or subsequent commercial production in accord9 ance with section 202. 

10 SEC. 202. REGISTRATION FOR THE COMMERCIAL PRODUC11 TION AND DISTRIBUTION OF FOOD AND 

12 DRUG ADMINISTRATION APPROVED DRUGS. 

13 The Attorney General shall register an applicant to 

14 manufacture or distribute cannabidiol or marihuana for 

15 the purpose of commercial production of a drug containing 

16 or derived from marihuana that is approved by the Sec17 retary of Health and Human Services under section 505 

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

19 355), in accordance with the applicable requirements 

20 under subsection (a) or (b) of section 303 of the Con21 trolled Substances Act (21 U.S.C. 823). 

22 SEC. 203. IMPORTATION OF CANNABIDIOL FOR RESEARCH 

23 PURPOSES. 

24 The Controlled Substances Import and Export Act 

25 (21 U.S.C. 951 et seq.) is amended— 
21 

†S 2032 ES

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

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

3 the end; 

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

5 ‘‘and’’ after ‘‘uses,’’; and 

6 (C) inserting before the undesignated mat7 ter following paragraph (2)(C) the following: 

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

9 (as defined in section 2 of the Cannabidiol and Mar10 ihuana Research Expansion Act) as are— 

11 ‘‘(A) approved for medical research for 

12 drug development (as such terms are defined in 

13 section 2 of the Cannabidiol and Marihuana Re14 search Expansion Act), or 

15 ‘‘(B) necessary for registered manufactur16 ers to manufacture drugs containing marihuana 

17 or cannabidiol that have been approved for use 

18 by the Commissioner of Food and Drugs under 

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

20 U.S.C. 301 et seq.),’’; and 

21 (2) in section 1007 (21 U.S.C. 957), by amend22 ing subsection (a) to read as follows: 

23 ‘‘(a)(1) Except as provided in paragraph (2), no per24 son may— 
22 

†S 2032 ES

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

2 United States from any place outside thereof (but 

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

4 States from any place outside thereof, any controlled 

5 substance or list I chemical, or 

6 ‘‘(B) export from the United States any con7 trolled substance or list I chemical, 

8 unless there is in effect with respect to such person 

9 a registration issued by the Attorney General under 

10 section 1008, or unless such person is exempt from 

11 registration under subsection (b). 

12 ‘‘(2) Paragraph (1) shall not apply to the im13 port or export of marihuana or cannabidiol (as de14 fined in section 2 of the Cannabidiol and Marihuana 

15 Research Expansion Act) that has been approved 

16 for— 

17 ‘‘(A) medical research for drug develop18 ment authorized under section 201 of the 

19 Cannabidiol and Marihuana Research Expan20 sion Act; or 

21 ‘‘(B) use by registered manufacturers to 

22 manufacture drugs containing marihuana or 

23 cannabidiol that have been approved for use by 

24 the Commissioner of Food and Drugs under the 
23 

†S 2032 ES

1 Federal Food, Drug, and Cosmetic Act (21 

2 U.S.C. 301 et seq.).’’. 

3 TITLE III—DOCTOR-PATIENT 

4 RELATIONSHIP 

5 SEC. 301. DOCTOR-PATIENT RELATIONSHIP. 

6 It shall not be a violation of the Controlled Sub7 stances Act (21 U.S.C. 801 et seq.) for a State-licensed 

8 physician to discuss— 

9 (1) the currently known potential harms and 

10 benefits of marihuana derivatives, including 

11 cannabidiol, as a treatment with the legal guardian 

12 of the patient of the physician if the patient is a 

13 child; or 

14 (2) the currently known potential harms and 

15 benefits of marihuana and marihuana derivatives, 

16 including cannabidiol, as a treatment with the pa17 tient or the legal guardian of the patient of the phy18 sician if the patient is a legal adult. 

19 TITLE IV—FEDERAL RESEARCH 

20 SEC. 401. FEDERAL RESEARCH. 

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

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

23 Human Services, in coordination with the Director of the 

24 National Institutes of Health and the heads of other rel25 evant Federal agencies, shall submit to the Caucus on 
24 

†S 2032 ES

1 International Narcotics Control, the Committee on the Ju2 diciary, and the Committee on Health, Education, Labor, 

3 and Pensions of the Senate and the Committee on Energy 

4 and Commerce and the Committee on the Judiciary of the 

5 House of Representatives a report on— 

6 (1) the potential therapeutic effects of 

7 cannabidiol or marihuana on serious medical condi8 tions, including intractable epilepsy; 

9 (2) the potential effects of marihuana, includ10 ing— 

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

12 tetrahydrocannabinol levels on the human body 

13 and developing adolescent brains; and 

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

15 tetrahydrocannabinol levels on cognitive abili16 ties, such as those that are required to operate 

17 motor vehicles or other heavy equipment; and 

18 (3) the barriers associated with researching 

19 marihuana or cannabidiol in States that have legal20 ized the use of such substances, which shall in21 clude— 

22 (A) recommendations as to how such bar23 riers might be overcome, including whether pub24 lic-private partnerships or Federal-State re25 search partnerships may or should be imple-
25 

†S 2032 ES

1 mented to provide researchers with access to 

2 additional strains of marihuana and 

3 cannabidiol; and 

4 (B) recommendations as to what safe5 guards must be in place to verify— 

6 (i) the levels of tetrahydrocannabinol, 

7 cannabidiol, or other cannabinoids con8 tained in products obtained from such 

9 States is accurate; and 

10 (ii) that such products do not contain 

11 harmful or toxic components. 

12 (b) ACTIVITIES.—To the extent practicable, the Sec13 retary of Health and Human Services, either directly or 

14 through awarding grants, contacts, or cooperative agree15 ments, shall expand and coordinate the activities of the 

16 National Institutes of Health and other relevant Federal 

17 agencies to better determine the effects of cannabidiol and 

18 marihuana, as outlined in the report submitted under 

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

Passed the Senate December 15, 2020. 

Attest: 

Secretary. 
116TH CONGRESS 

2D SESSION S. 2032 

AN ACT 

To expand research on the cannabidiol and 

marihuana.