II 

115TH CONGRESS 

1ST SESSION S. 1276 

To require the Attorney General to make a determination as to whether 

cannabidiol should be a controlled substance and listed in a schedule 

under the Controlled Substances Act and to expand research on the 

potential medical benefits of cannabidiol and other marihuana components. 

IN THE SENATE OF THE UNITED STATES 

MAY 25, 2017 

Mrs. FEINSTEIN (for herself, Mr. GRASSLEY, Mr. DURBIN, Mr. TILLIS, and 

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

A BILL 

To require the Attorney General to make a determination 

as to whether cannabidiol should be a controlled substance and listed in a schedule under the Controlled 

Substances Act and to expand research on the potential 

medical benefits of cannabidiol and other marihuana 

components. 

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. 

4 This Act may be cited as the ‘‘Cannabidiol Research 

5 Expansion Act’’. 


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1 SEC. 2. DEFINITIONS. 

2 In this Act— 

3 (1) the term ‘‘authorized medical research’’ 

4 means medical research that is— 

5 (A) a preclinical study or clinical investiga6 tion conducted in accordance with section 

7 505(i) of the Federal Food, Drug, and Cos8 metic Act (21 U.S.C. 355(i)) or otherwise per9 mitted by the Department of Health and 

10 Human Services to determine the potential 

11 medical benefits of marihuana or cannabidiol as 

12 a drug; and 

13 (B) conducted by a covered institution of 

14 higher education, practitioner, or manufacturer 

15 that is appropriately registered under the Con16 trolled Substances Act (21 U.S.C. 801 et seq.); 

17 (2) the term ‘‘cannabidiol’’ means the 

18 nonpsychoactive substance, cannabidiol, as derived 

19 from marihuana or the synthetic formulation; 

20 (3) the terms ‘‘controlled substance’’, ‘‘dis21 pense’’, ‘‘distribute’’, ‘‘manufacture’’, ‘‘marihuana’’, 

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

23 terms in section 102 of the Controlled Substances 

24 Act (21 U.S.C. 802); 

25 (4) the term ‘‘covered institution of higher edu26 cation’’ means an institution of higher education (as 


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1 defined in section 101 of the Higher Education Act 

2 of 1965 (20 U.S.C. 1001)) that— 

3 (A)(i) has highest or higher research activ4 ity, as defined by the Carnegie Classification of 

5 Institutions of Higher Education; or 

6 (ii) is an accredited medical school or an 

7 accredited school of osteopathic medicine; and 

8 (B) is appropriately registered under the 

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

10 seq.); 

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

12 term in section 201(g)(1) of the Federal Food Drug 

13 and Cosmetics Act (21 U.S.C. 321(g)(1)); 

14 (6) the term ‘‘registered manufacturer’’ means 

15 an individual or entity who is appropriately reg16 istered to manufacture controlled substances under 

17 the Controlled Substances Act (21 U.S.C. 801 et 

18 seq.), including an individual or entity appropriately 

19 registered to manufacture controlled substances as 

20 part of research; 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. 


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1 SEC. 3. PROCEEDINGS FOR CONTROL, TRANSFER, OR RE2 MOVAL OF CANNABIDIOL. 

3 (a) SCIENTIFIC AND MEDICAL EVALUATIONS.—Not 

4 later than 1 year after the date of enactment of this Act, 

5 the Attorney General and the Secretary of Health and 

6 Human Services shall each complete the scientific and 

7 medical evaluation described in section 201(b) of the Con8 trolled Substances Act (21 U.S.C. 811(b)) as to 

9 cannabidiol, which shall take into consideration the factors 

10 described in paragraphs (1) through (8) of subsection (c) 

11 of section 201 of that Act (21 U.S.C. 811(c)). 

12 (b) PROCEEDINGS TO CONTROL, TRANSFER, OR RE13 MOVE CANNABIDIOL.—After taking into consideration the 

14 evaluation described in subsection (a), if the Attorney 

15 General determines that the evaluations, recommenda16 tions, and all other relevant data warrant control, trans17 fer, or removal of cannabidiol, the Attorney General shall 

18 initiate proceedings for control, transfer, or removal under 

19 section 201(a) of the Controlled Substances Act (21 

20 U.S.C. 811(a)). 

21 SEC. 4. RESEARCH PROTOCOLS. 

22 The Attorney General shall amend section 1301.18 

23 of title 21, Code of Federal Regulations (as in effect on 

24 the date of enactment of this Act), by striking subsections 

25 (c) and (d) and inserting the following: 


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1 ‘‘(c) In the event that the registrant desires to in2 crease the quantity of a controlled substance used for an 

3 approved research project, he/she shall submit a request 

4 to the Registration Unit, Drug Enforcement Administra5 tion, by registered mail, return receipt requested. See the 

6 Table of DEA Mailing Addresses in § 1321.01 of this 

7 chapter for the current mailing address. The request shall 

8 contain the following information: DEA registration num9 ber; name of the controlled substance or substances and 

10 the quantity of each authorized in the approved protocol; 

11 and the additional quantity of each desired. Upon return 

12 of the receipt, the registrant shall be authorized to pur13 chase and use the additional quantity of the controlled 

14 substance or substances specified in the request. 

15 ‘‘(d) In the event the registrant desires to conduct 

16 research beyond the variations provided in the registrant’s 

17 approved protocol (excluding any increase in the quantity 

18 of the controlled substance requested for his/her research 

19 project as outlined in paragraph (c) of this section), he/ 

20 she shall submit three copies by registered mail, with a 

21 return receipt requested, of a supplemental protocol in ac22 cordance with paragraph (a) of this section describing the 

23 new research and omitting information in the supple24 mental protocol which has been stated in the original pro25 tocol. Unless explicitly denied, supplemental protocols 


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1 shall be considered approved 30 days after the date on 

2 which the return receipt is returned.’’. 

3 SEC. 5. MEDICAL RESEARCH ON CANNABIDIOL. 

4 (a) IN GENERAL.—Notwithstanding any provision of 

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

6 the Safe and Drug-Free Schools and Communities Act (20 

7 U.S.C. 7101 et seq.), chapter 81 of title 41, United States 

8 Code, or any other Federal law, an appropriately reg9 istered covered institution of higher education, a practi10 tioner, or a manufacturer may manufacture, distribute, 

11 dispense, or possess marihuana or cannabidiol if the mari12 huana or cannabidiol is manufactured, distributed, dis13 pensed, or possessed, respectively, for purposes of author14 ized medical research. 

15 (b) REGISTRATION FOR RESEARCH INVOLVING

16 CANNABIDIOL.— 

17 (1) INITIAL PERIOD.—During the period begin18 ning on the date of enactment of this Act and end19 ing on the date on which the Attorney General 

20 makes a determination regarding control of 

21 cannabidiol, an individual or entity engaged in au22 thorized medical research may distribute, dispense, 

23 or possess cannabidiol for purposes of the authorized 

24 medical research if the individual or entity is reg25 istered under the Controlled Substances Act (21 


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1 U.S.C. 801 et seq.) to engage in such activity with 

2 a controlled substance in schedule II in section 

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

4 812(c)). 

5 (2) COMPLETION OF ONGOING RESEARCH.—If, 

6 as a result of the determination and proceedings de7 scribed in section 3, cannabidiol is a controlled sub8 stance in schedule I in section 202(c) of the Con9 trolled Substances Act (21 U.S.C. 812(c)), an indi10 vidual or entity engaged in authorized medical re11 search may continue to distribute, dispense, or pos12 sess cannabidiol for purposes of completing the au13 thorized medical research if the individual or enti14 ty— 

15 (A) was engaged in the authorized medical 

16 research in accordance with paragraph (1) on 

17 or before the date on which the proceedings are 

18 completed; and 

19 (B) is registered under the Controlled Sub20 stances Act (21 U.S.C. 801 et seq.) to engage 

21 in such activity with a controlled substance in 

22 schedule II in section 202(c) of the Controlled 

23 Substances Act (21 U.S.C. 812(c)). 

24 (c) REGISTRATION FOR THE COMMERCIAL PRODUC25 TION AND DISTRIBUTION OF FOOD AND DRUG ADMINISVerDate Sep 11 2014 22:44 Jun 07, 2017 Jkt 069200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\S1276.IS S1276

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1 TRATION APPROVED DRUGS.—The Attorney General shall 

2 register an applicant to manufacture or distribute 

3 cannabidiol or marihuana for the purpose of commercial 

4 production of a drug containing or derived from mari5 huana that is approved by the Secretary of Health and 

6 Human Services under section 505 of the Federal Food, 

7 Drug, and Cosmetic Act (21 U.S.C. 355), in accordance 

8 with the applicable requirements under subsection (a) or 

9 (b) of section 303 of the Controlled Substances Act (21 

10 U.S.C. 823). 

11 (d) TIMELY PROCESSING OF REGISTRATION APPLI12 CATIONS.— 

13 (1) IN GENERAL.—Not later than 60 days after 

14 the Attorney General receives an application for reg15 istration under the Controlled Substances Act (21 

16 U.S.C. 801 et seq.) to manufacture, distribute, dis17 pense, or possess controlled substances, the Attorney 

18 General shall— 

19 (A) grant or deny the application; or 

20 (B) request supplemental information. 

21 (2) ADDITIONAL INFORMATION.—Not later 

22 than 30 days after the Attorney General receives 

23 supplemental information as described in paragraph 

24 (1)(B) in connection with an application described in 


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1 paragraph (1), the Attorney General shall grant or 

2 deny the application. 

3 (e) INFORMATION REGARDING DENIALS.—If an ap4 plication described in subsection (d)(1) is denied, the At5 torney General shall provide a written explanation of the 

6 basis of denial to the applicant. 

7 SEC. 6. IMPORTATION OF CANNABIDIOL FOR RESEARCH 

8 PURPOSES. 

9 The Controlled Substances Import and Export Act 

10 (21 U.S.C. 951 et seq.) is amended— 

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

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

13 the end; 

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

15 ‘‘and’’ after ‘‘uses,’’; and 

16 (C) inserting before the undesignated mat17 ter following paragraph (2)(C) the following: 

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

19 as are— 

20 ‘‘(A) approved for authorized medical re21 search (as such terms are defined in section 2 

22 of the Cannabidiol Research Expansion Act), or 

23 ‘‘(B) necessary for registered manufactur24 ers to manufacture drugs containing marihuana 

25 or cannabidiol that have been approved for use 


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1 by the Commissioner of Food and Drugs under 

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

3 U.S.C. 301 et seq.),’’; and 

4 (2) in section 1007 (21 U.S.C. 957), by amend5 ing subsection (a) to read as follows: 

6 ‘‘(a)(1) Except as provided in paragraph (2), no per7 son may— 

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

9 United States from any place outside thereof (but 

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

11 States from any place outside thereof, any controlled 

12 substance or list I chemical, or 

13 ‘‘(B) export from the United States any con14 trolled substance or list I chemical, 

15 unless there is in effect with respect to such person a reg16 istration issued by the Attorney General under section 

17 1008, or unless such person is exempt from registration 

18 under subsection (b). 

19 ‘‘(2) Paragraph (1) shall not apply to the im20 port or export of marihuana or cannabidiol that has 

21 been approved for— 

22 ‘‘(A) authorized medical research author23 ized under section 5 of the Cannabidiol Re24 search Expansion Act; or 


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1 ‘‘(B) use by registered manufacturers to 

2 manufacture drugs containing marihuana or 

3 cannabidiol that have been approved for use by 

4 the Commissioner of Food and Drugs under the 

5 Federal Food, Drug, and Cosmetic Act (21 

6 U.S.C. 301 et seq.).’’. 

7 SEC. 7. SAFE HARBOR. 

8 (a) DEFINITIONS.—In this section— 

9 (1) the term ‘‘adult’’ means an individual who 

10 is not less than 18 years of age; 

11 (2) the term ‘‘child’’ means an individual who 

12 is not more than 17 years of age; 

13 (3) the term ‘‘intractable epilepsy’’ means an 

14 epileptic seizure disorder for which standard medical 

15 treatment— 

16 (A) does not prevent or significantly ame17 liorate recurring, uncontrollable seizures; or 

18 (B) results in harmful side effects; and 

19 (4) the term ‘‘neurologist’’ means an allopathic 

20 or osteopathic physician board-certified in neurology 

21 in good standing and licensed in the State in which 

22 the physician practices neurology. 

23 (b) SAFE HARBOR.—Notwithstanding the Controlled 

24 Substances Act (21 U.S.C. 801 et seq.), the Controlled 

25 Substances Import and Export Act (21 U.S.C. 951 et 


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1 seq.), or any other Federal law, it shall not be unlawful 

2 for— 

3 (1) a legal guardian to possess or transport 

4 cannabidiol or any other nonpsychoactive component 

5 of marihuana for purposes of dispensing the 

6 cannabidiol or other nonpsychoactive component to a 

7 child of the legal guardian if— 

8 (A) the child has been treated by a neu9 rologist for intractable epilepsy for not less than 

10 6 months; 

11 (B) the child’s neurologist attests that 

12 other treatment options have not resulted in 

13 significant clinical improvement; 

14 (C) the child’s neurologist attests that he 

15 or she has discussed the currently known poten16 tial harms and benefits of using cannabidiol or 

17 other nonpsychoactive components of mari18 huana as a treatment with the child’s legal 

19 guardian; 

20 (D) the child’s neurologist attests that he 

21 or she will monitor the child for potential ad22 verse reactions; and 

23 (E) the legal guardian provides docu24 mentation for the requirements under subpara25 graphs (A), (B), (C), and (D); 


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1 (2) an adult to possess or transport cannabidiol 

2 or any other nonpsychoactive component of mari3 huana if— 

4 (A) the adult has been treated by a neu5 rologist for intractable epilepsy for not less than 

6 6 months; 

7 (B) the adult’s neurologist attests that 

8 other treatment options have not resulted in 

9 significant clinical improvement; 

10 (C) the adult’s neurologist attests that he 

11 or she has discussed the currently known poten12 tial harms and benefits of using cannabidiol or 

13 other nonpsychoactive components of mari14 huana as a treatment with the adult; 

15 (D) the adult’s neurologist attests that he 

16 or she will monitor the adult for potential ad17 verse reactions; and 

18 (E) the adult provides documentation for 

19 the requirements under subparagraphs (A), 

20 (B), (C), and (D); or 

21 (3) a State-licensed physician to discuss the 

22 currently known potential harms and benefits of 

23 cannabidiol or any other nonpsychoactive component 

24 of marihuana as a treatment with a patient of the 


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1 physician, or the legal guardian of the patient if the 

2 patient is a child. 

3 (c) SUNSET.—This section shall cease to have force 

4 or effect on the date that is 4 years after the date of enact5 ment of this Act. 

6 SEC. 8. FEDERAL RESEARCH. 

7 The Secretary of Health and Human Services, either 

8 directly or through awarding grants, contracts, or coopera9 tive agreements to covered institutions of higher edu10 cation, medical or osteopathic schools, or practitioners, or 

11 a consortia of covered institutions of higher education, 

12 medical or osteopathic schools, or practitioners, shall ex13 pand, intensify, and coordinate the activities of the Na14 tional Institutes of Health with respect to research on 

15 cannabidiol and other nonpsychoactive components of 

16 marihuana to better determine their potential therapeutic 

17 effects on serious medical conditions, including intractable 

18 epilepsy. 

Æ 


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