II 

117TH CONGRESS 

1ST SESSION S. 253 

To expand research on the cannabidiol and marihuana. 

IN THE SENATE OF THE UNITED STATES 

FEBRUARY 4, 2021 

Mrs. FEINSTEIN (for herself, Mr. GRASSLEY, Mr. SCHATZ, Mr. DURBIN, Ms. 

KLOBUCHAR, Mr. TILLIS, Mr. KAINE, Ms. ERNST, Mr. TESTER, and Ms. 

MURKOWSKI) introduced the following bill; which was read twice and referred to the Committee on the Judiciary 

A BILL 

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, 

3 SECTION 1. SHORT TITLE; TABLE OF CONTENTS. 

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

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

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

7 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. 


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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. 

1 SEC. 2. DEFINITIONS. 

2 In this Act— 

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

4 that an individual or entity is registered under the 

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

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

7 by the individual or entity with respect to a con8 trolled substance on the schedule that is applicable 

9 to cannabidiol or marihuana, as applicable; 

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

11 (A) the substance, cannabidiol, as derived 

12 from marihuana that has a delta-9- 

13 tetrahydrocannabinol level that is greater than 

14 0.3 percent; and 

15 (B) the synthetic equivalent of the sub16 stance described in subparagraph (A); 


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1 (3) the terms ‘‘controlled substance’’, ‘‘dis2 pense’’, ‘‘distribute’’, ‘‘manufacture’’, ‘‘marihuana’’, 

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

4 terms in section 102 of the Controlled Substances 

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

6 (4) the term ‘‘covered institution of higher edu7 cation’’ means an institution of higher education (as 

8 defined in section 101 of the Higher Education Act 

9 of 1965 (20 U.S.C. 1001)) that— 

10 (A)(i) has highest or higher research activ11 ity, as defined by the Carnegie Classification of 

12 Institutions of Higher Education; or 

13 (ii) is an accredited medical school or an 

14 accredited school of osteopathic medicine; and 

15 (B) is appropriately registered under the 

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

17 seq.); 

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

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

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

21 (6) the term ‘‘medical research for drug devel22 opment’’ means medical research that is— 

23 (A) a preclinical study or clinical investiga24 tion conducted in accordance with section 

25 505(i) of the Federal Food, Drug, and CosVerDate Sep 11 2014 21:34 Feb 21, 2021 Jkt 019200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\S253.IS S253

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1 metic Act (21 U.S.C. 355(i)) or otherwise per2 mitted by the Department of Health and 

3 Human Services to determine the potential 

4 medical benefits of marihuana or cannabidiol as 

5 a drug; and 

6 (B) conducted by a covered institution of 

7 higher education, practitioner, or manufacturer 

8 that is appropriately registered under the Con9 trolled Substances Act (21 U.S.C. 801 et seq.); 

10 and 

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

12 United States, the District of Columbia, and any 

13 territory of the United States. 

14 TITLE I—REGISTRATIONS FOR 

15 MARIHUANA RESEARCH 

16 SEC. 101. MARIHUANA RESEARCH APPLICATIONS. 

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

18 U.S.C. 823(f)) is amended— 

19 (1) by redesignating paragraphs (1) through 

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

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

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

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

24 inserting the following: 

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


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

2 following: 

3 ‘‘(3) Article 7’’; and 

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

5 designated, the following: 

6 ‘‘(B)(i) The Attorney General shall register a practi7 tioner to conduct research with marihuana if— 

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

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

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

11 Human Services under section 505(i) of 

12 the Federal Food, Drug, and Cosmetic Act 

13 (21 U.S.C. 355(i)); 

14 ‘‘(BB) by the National Institutes of 

15 Health or another Federal agency that 

16 funds scientific research; or 

17 ‘‘(CC) pursuant to sections 1301.18 

18 and 1301.32 of title 21, Code of Federal 

19 Regulations, or any successors thereto; and 

20 ‘‘(II) the applicant has demonstrated to the At21 torney General that there are effective procedures in 

22 place to adequately safeguard against diversion of 

23 the controlled substance for legitimate medical or 

24 scientific use pursuant to section 105 of the 

25 Cannabidiol and Marihuana Research Expansion 


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1 Act, including demonstrating that the security meas2 ures are adequate for storing the quantity of mari3 huana the applicant would be authorized to possess. 

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

5 for registration under this subparagraph only if the Attor6 ney General determines that the issuance of the registra7 tion would be inconsistent with the public interest. In de8 termining the public interest, the Attorney General shall 

9 consider the factors listed in— 

10 ‘‘(I) subparagraphs (B) through (E) of para11 graph (1); and 

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

13 applicable State requires practitioners conducting re14 search to register with a board or authority de15 scribed in such subparagraph (A). 

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

17 which the Attorney General receives a complete applica18 tion for registration under this subparagraph, the Attor19 ney General shall— 

20 ‘‘(aa) approve the application; or 

21 ‘‘(bb) request supplemental information. 

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

23 shall be deemed complete when the applicant has sub24 mitted documentation showing that the requirements 

25 under clause (i) are satisfied. 


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

2 the Attorney General receives supplemental information as 

3 described in clause (iii)(I)(bb) in connection with an appli4 cation described in this subparagraph, the Attorney Gen5 eral shall approve or deny the application. 

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

7 is denied, the Attorney General shall provide a written ex8 planation of the basis of denial to the applicant.’’. 

9 SEC. 102. RESEARCH PROTOCOLS. 

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

11 303(f) of the Controlled Substances Act (21 U.S.C. 

12 823(f)), as amended by section 101 of this Act, is further 

13 amended by adding at the end the following: 

14 ‘‘(vi)(I) If the Attorney General grants an application 

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

16 or supplement the research protocol without reapplying if 

17 the registrant does not change— 

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

19 ‘‘(bb) the source of the drug; or 

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

21 stored, tracked, or administered. 

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

23 change the type of drug, the source of the drug, or condi24 tions under which the drug is stored, tracked, or adminis25 tered, the registrant shall notify the Attorney General via 


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1 registered mail, or an electronic means permitted by the 

2 Attorney General, not later than 30 days before imple3 menting an amended or supplemental research protocol. 

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

5 supplemental research protocol described in item (aa) if 

6 the Attorney General does not explicitly object during the 

7 30-day period beginning on the date on which the Attorney 

8 General receives the notice under item (aa). 

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

10 amended or supplemental research protocol under this 

11 subclause if additional security measures are needed to 

12 safeguard against diversion or abuse. 

13 ‘‘(dd) If a registrant under clause (i) seeks to address 

14 additional security measures identified by the Attorney 

15 General under item (cc), the registrant shall notify the At16 torney General via registered mail, or an electronic means 

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

18 before implementing an amended or supplemental research 

19 protocol. 

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

21 supplemental research protocol described in item (dd) if 

22 the Attorney General does not explicitly object during the 

23 30-day period beginning on the date on which the Attorney 

24 General receives the notice under item (dd). 


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

2 change the quantity of marihuana needed for research and 

3 the change in quantity does not impact the factors de4 scribed in item (bb) or (cc) of subclause (I) of this clause, 

5 the registrant shall notify the Attorney General via reg6 istered mail or using an electronic means permitted by the 

7 Attorney General. 

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

9 ‘‘(AA) the Drug Enforcement Administration 

10 registration number of the registrant; 

11 ‘‘(BB) the quantity of marihuana already ob12 tained; 

13 ‘‘(CC) the quantity of additional marihuana 

14 needed to complete the research; and 

15 ‘‘(DD) an attestation that the change in quan16 tity does not impact the source of the drug or the 

17 conditions under which the drug is stored, tracked, 

18 or administered. 

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

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

21 respect to a notification under item (aa) is sub22 mitted for delivery to the registrant providing the 

23 notification not later than 3 days after receipt of the 

24 notification by the Attorney General; and 


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

2 an electronic means permitted under item (aa) is 

3 provided to the registrant providing the notification 

4 not later than 3 days after receipt of the notification 

5 by the Attorney General. 

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

7 (BB), a registrant that submits a notification in accord8 ance with item (aa) may proceed with the research as if 

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

10 unless the Attorney General notifies the registrant of an 

11 objection described in item (ee). 

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

13 on which a registrant submitting a notification under item 

14 (aa) receives the registered mail return receipt with re15 spect to the notification or the date on which the reg16 istrant receives notice that the notification using an elec17 tronic means permitted under item (aa) was received by 

18 the Attorney General, as the case may be. 

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

20 be deemed to be approved unless the Attorney General, 

21 not later than 10 days after receiving the notification, ex22 plicitly objects based on a finding that the change in quan23 tity— 


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

2 the conditions under which the drug is stored, 

3 tracked, or administered; or 

4 ‘‘(BB) necessitates that the registrant imple5 ment additional security measures to safeguard 

6 against diversion or abuse. 

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

8 of the Secretary of Health and Human Services over re9 quirements related to research protocols, including 

10 changes in— 

11 ‘‘(aa) the method of administration of mari12 huana; 

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

14 ‘‘(cc) the number of individuals or patients in15 volved in research.’’. 

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

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

18 promulgate regulations to carry out the amendment made 

19 by this section. 

20 SEC. 103. APPLICATIONS TO MANUFACTURE MARIHUANA 

21 FOR RESEARCH. 

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

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

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

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


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1 (2) by inserting after subsection (b) the fol2 lowing: 

3 ‘‘(c)(1)(A) As it relates to applications to manufac4 ture marihuana for research purposes, if the Attorney 

5 General places a notice in the Federal Register to increase 

6 the number of entities registered under this Act to manu7 facture marihuana to supply appropriately registered re8 searchers in the United States, the Attorney General shall, 

9 not later than 60 days after the date on which the Attor10 ney General receives a completed application— 

11 ‘‘(i) approve the application; or 

12 ‘‘(ii) request supplemental information. 

13 ‘‘(B) For purposes of subparagraph (A), an applica14 tion shall be deemed complete when the applicant has sub15 mitted documentation showing each of the following: 

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

17 in the Federal Register are satisfied. 

18 ‘‘(ii) The requirements under this Act are satis19 fied. 

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

21 sale of any marihuana manufactured under this sub22 section— 

23 ‘‘(I) to researchers who are registered 

24 under this Act to conduct research with con25 trolled substances in schedule I; and 


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1 ‘‘(II) for purposes of use in preclinical re2 search or in a clinical investigation pursuant to 

3 an investigational new drug exemption under 

4 505(i) of the Federal Food, Drug, and Cos5 metic Act (21 U.S.C. 355(i)). 

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

7 marihuana manufactured under this subsection only 

8 with prior, written consent for the transfer or sale 

9 by the Attorney General. 

10 ‘‘(v) The applicant has completed the applica11 tion and review process under subsection (a) for the 

12 bulk manufacture of controlled substances in sched13 ule I. 

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

15 operation of a process for storage and handling of 

16 controlled substances in schedule I, including for in17 ventory control and monitoring security in accord18 ance with section 105 of the Cannabidiol and Mari19 huana Research Expansion Act. 

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

21 which the applicant will conduct operations under 

22 this subsection, to manufacture marihuana, if that 

23 State requires such a license. 

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

25 the Attorney General receives supplemental information 


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

2 application, the Attorney General shall approve or deny 

3 the application. 

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

5 denied, the Attorney General shall provide a written expla6 nation of the basis of denial to the applicant.’’; 

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

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

9 inserting ‘‘subsection (g)’’; 

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

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

12 (e)’’; and 

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

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

15 inserting ‘‘subsection (g)’’. 

16 (b) TECHNICAL AND CONFORMING AMENDMENTS.— 

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

18 801 et seq.) is amended— 

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

20 (i) in paragraph (16)(B)— 

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

22 at the end; 

23 (II) by redesignating clause (ii) 

24 as (iii); and 


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1 (III) by inserting after clause (i) 

2 the following: 

3 ‘‘(ii) the synthetic equivalent of hemp-de4 rived cannabidiol that contains less than 0.3 

5 percent tetrahydrocannabinol; or’’; 

6 (ii) in paragraph (52)(B)— 

7 (I) by striking ‘‘303(f)’’ each 

8 place it appears and inserting 

9 ‘‘303(g)’’; and 

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

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

12 (f)’’; and 

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

14 ‘‘303(f)’’ each place it appears and insert15 ing ‘‘303(g)’’; 

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

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

18 ‘‘303(f)’’ and inserting ‘‘303(g)’’; 

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

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

21 inserting ‘‘303(h)(1)’’; 

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

23 827(d)(2)), by striking ‘‘303(f)’’ and inserting 

24 ‘‘303(g)’’; 


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

2 829a(a)(2)), in the matter preceding subpara3 graph (A), by striking ‘‘303(g)(2)’’ and insert4 ing ‘‘303(h)(2)’’; 

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

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

7 inserting ‘‘303(g)’’; 

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

9 841(h)(2)), by striking ‘‘303(f)’’ each place it 

10 appears and inserting ‘‘303(g)’’; 

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

12 843(c)(2)(B)), by striking ‘‘303(f)’’ and insert13 ing ‘‘303(g)’’; and 

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

15 882(c)(1)) by striking ‘‘303(f)’’ and inserting 

16 ‘‘303(g)’’. 

17 (2) Section 1008(c) of the Controlled Sub18 stances Import and Export Act (21 U.S.C. 958(c)) 

19 is amended— 

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

21 and inserting ‘‘303(e)’’; and 

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

23 ‘‘303(h)’’ and inserting ‘‘303(i)’’. 

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

25 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 


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1 marihuana, as outlined in the report submitted under 

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

Æ 


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