Cannabidiol Research Expansion Act

Summary: Cannabidiol Research Expansion Act This bill requires the Drug Enforcement Administration (DEA) and the Department of Health and Human Services to each evaluate whether cannabidiol, the nonpsychoactive substance derived from marijuana or the synthetic formulation, should be a controlled substance under the Controlled Substances Act. After taking into consideration the evaluations, the DEA must initiate proceedings for classifying cannabidiol as a controlled substance if control is warranted. The bill expands the authority for: (1) conducting medical research on cannabidiol and other nonpsychoactive components of marijuana, and (2) possessing or transporting cannabidiol or any other nonpsychoactive component of marijuana for certain medicinal purposes. The Department of Justice shall register an applicant to manufacture or distribute cannabidiol or marijuana for the purpose of commercial production if approved by HHS.  Physicians who are licensed under state law may discuss the potential harms and benefits of cannabidiol or those components of marijuana as a treatment with their patients or the legal guardians of underage patients. The bill terminates four years after enactment.

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Cannabidiol Research Expansion 
Act''.

SEC. 2. DEFINITIONS.

    In this Act--
            (1) the term ``authorized medical research'' means medical 
        research that is--
                    (A) a preclinical study or clinical investigation 
                conducted in accordance with section 505(i) of the 
                Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(i)) 
                or otherwise permitted by the Department of Health and 
                Human Services to determine the potential medical 
                benefits of marihuana or cannabidiol as a drug; and
                    (B) conducted by a covered institution of higher 
                education, practitioner, or manufacturer that is 
                appropriately registered under the Controlled 
                Substances Act (21 U.S.C. 801 et seq.);
            (2) the term ``cannabidiol'' means the nonpsychoactive 
        substance, cannabidiol, as derived from marihuana or the 
        synthetic formulation;
            (3) the terms ``controlled substance'', ``dispense'', 
        ``distribute'', ``manufacture'', ``marihuana'', and 
        ``practitioner'' have the meanings given such terms in section 
        102 of the Controlled Substances Act (21 U.S.C. 802);
            (4) the term ``covered institution of higher education'' 
        means an institution of higher education (as defined in section 
        101 of the Higher Education Act of 1965 (20 U.S.C. 1001)) 
        that--
                    (A)(i) has highest or higher research activity, as 
                defined by the Carnegie Classification of Institutions 
                of Higher Education; or
                    (ii) is an accredited medical school or an 
                accredited school of osteopathic medicine; and
                    (B) is appropriately registered under the 
                Controlled Substances Act (21 U.S.C. 801 et seq.);
            (5) the term ``drug'' has the meaning given the term in 
        section 201(g)(1) of the Federal Food Drug and Cosmetics Act 
        (21 U.S.C. 321(g)(1));
            (6) the term ``registered manufacturer'' means an 
        individual or entity who is appropriately registered to 
        manufacture controlled substances under the Controlled 
        Substances Act (21 U.S.C. 801 et seq.), including an individual 
        or entity appropriately registered to manufacture controlled 
        substances as part of research; and
            (7) the term ``State'' means any State of the United 
        States, the District of Columbia, and any territory of the 
        United States.

SEC. 3. PROCEEDINGS FOR CONTROL, TRANSFER, OR REMOVAL OF CANNABIDIOL.

    (a) Scientific and Medical Evaluations.--Not later than 1 year 
after the date of enactment of this Act, the Attorney General and the 
Secretary of Health and Human Services shall each complete the 
scientific and medical evaluation described in section 201(b) of the 
Controlled Substances Act (21 U.S.C. 811(b)) as to cannabidiol, which 
shall take into consideration the factors described in paragraphs (1) 
through (8) of subsection (c) of section 201 of that Act (21 U.S.C. 
811(c)).
    (b) Proceedings To Control, Transfer, or Remove Cannabidiol.--After 
taking into consideration the evaluation described in subsection (a), 
if the Attorney General determines that the evaluations, 
recommendations, and all other relevant data warrant control, transfer, 
or removal of cannabidiol, the Attorney General shall initiate 
proceedings for control, transfer, or removal under section 201(a) of 
the Controlled Substances Act (21 U.S.C. 811(a)).

SEC. 4. RESEARCH PROTOCOLS.

    The Attorney General shall amend section 1301.18 of title 21, Code 
of Federal Regulations (as in effect on the date of enactment of this 
Act), by striking subsections (c) and (d) and inserting the following:
    ``(c) In the event that the registrant desires to increase the 
quantity of a controlled substance used for an approved research 
project, he/she shall submit a request to the Registration Unit, Drug 
Enforcement Administration, by registered mail, return receipt 
requested. See the Table of DEA Mailing Addresses in Sec.  1321.01 of 
this chapter for the current mailing address. The request shall contain 
the following information: DEA registration number; name of the 
controlled substance or substances and the quantity of each authorized 
in the approved protocol; and the additional quantity of each desired. 
Upon return of the receipt, the registrant shall be authorized to 
purchase and use the additional quantity of the controlled substance or 
substances specified in the request.
    ``(d) In the event the registrant desires to conduct research 
beyond the variations provided in the registrant's approved protocol 
(excluding any increase in the quantity of the controlled substance 
requested for his/her research project as outlined in paragraph (c) of 
this section), he/she shall submit three copies by registered mail, 
with a return receipt requested, of a supplemental protocol in 
accordance with paragraph (a) of this section describing the new 
research and omitting information in the supplemental protocol which 
has been stated in the original protocol. Unless explicitly denied, 
supplemental protocols shall be considered approved 30 days after the 
date on which the return receipt is returned.''.

SEC. 5. MEDICAL RESEARCH ON CANNABIDIOL.

    (a) In General.--Notwithstanding any provision of the Controlled 
Substances Act (21 U.S.C. 801 et seq.), the Safe and Drug-Free Schools 
and Communities Act (20 U.S.C. 7101 et seq.), chapter 81 of title 41, 
United States Code, or any other Federal law, an appropriately 
registered covered institution of higher education, a practitioner, or 
a manufacturer may manufacture, distribute, dispense, or possess 
marihuana or cannabidiol if the marihuana or cannabidiol is 
manufactured, distributed, dispensed, or possessed, respectively, for 
purposes of authorized medical research.
    (b) Registration for Research Involving Cannabidiol.--
            (1) Initial period.--During the period beginning on the 
        date of enactment of this Act and ending on the date on which 
        the Attorney General makes a determination regarding control of 
        cannabidiol, an individual or entity engaged in authorized 
        medical research may distribute, dispense, or possess 
        cannabidiol for purposes of the authorized medical research if 
        the individual or entity is registered under the Controlled 
        Substances Act (21 U.S.C. 801 et seq.) to engage in such 
        activity with a controlled substance in schedule II in section 
        202(c) of the Controlled Substances Act (21 U.S.C. 812(c)).
            (2) Completion of ongoing research.--If, as a result of the 
        determination and proceedings described in section 3, 
        cannabidiol is a controlled substance in schedule I in section 
        202(c) of the Controlled Substances Act (21 U.S.C. 812(c)), an 
        individual or entity engaged in authorized medical research may 
        continue to distribute, dispense, or possess cannabidiol for 
        purposes of completing the authorized medical research if the 
        individual or entity--
                    (A) was engaged in the authorized medical research 
                in accordance with paragraph (1) on or before the date 
                on which the proceedings are completed; and
                    (B) is registered under the Controlled Substances 
                Act (21 U.S.C. 801 et seq.) to engage in such activity 
                with a controlled substance in schedule II in section 
                202(c) of the Controlled Substances Act (21 U.S.C. 
                812(c)).
    (c) Registration for the Commercial Production and Distribution of 
Food and Drug Administration Approved Drugs.--The Attorney General 
shall register an applicant to manufacture or distribute cannabidiol or 
marihuana for the purpose of commercial production of a drug containing 
or derived from marihuana that is approved by the Secretary of Health 
and Human Services under section 505 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 355), in accordance with the applicable 
requirements under subsection (a) or (b) of section 303 of the 
Controlled Substances Act (21 U.S.C. 823).
    (d) Timely Processing of Registration Applications.--
            (1) In general.--Not later than 60 days after the Attorney 
        General receives an application for registration under the 
        Controlled Substances Act (21 U.S.C. 801 et seq.) to 
        manufacture, distribute, dispense, or possess controlled 
        substances, the Attorney General shall--
                    (A) grant or deny the application; or
                    (B) request supplemental information.
            (2) Additional information.--Not later than 30 days after 
        the Attorney General receives supplemental information as 
        described in paragraph (1)(B) in connection with an application 
        described in paragraph (1), the Attorney General shall grant or 
        deny the application.
    (e) Information Regarding Denials.--If an application described in 
subsection (d)(1) is denied, the Attorney General shall provide a 
written explanation of the basis of denial to the applicant.

SEC. 6. IMPORTATION OF CANNABIDIOL FOR RESEARCH PURPOSES.

    The Controlled Substances Import and Export Act (21 U.S.C. 951 et 
seq.) is amended--
            (1) in section 1002(a) (21 U.S.C. 952(a))--
                    (A) in paragraph (1), by striking ``and'' at the 
                end;
                    (B) in paragraph (2)(C), by inserting ``and'' after 
                ``uses,''; and
                    (C) inserting before the undesignated matter 
                following paragraph (2)(C) the following:
            ``(3) such amounts of marihuana or cannabidiol as are--
                    ``(A) approved for authorized medical research (as 
                such terms are defined in section 2 of the Cannabidiol 
                Research Expansion Act), or
                    ``(B) necessary for registered manufacturers to 
                manufacture drugs containing marihuana or cannabidiol 
                that have been approved for use by the Commissioner of 
                Food and Drugs under the Federal Food, Drug, and 
                Cosmetic Act (21 U.S.C. 301 et seq.),''; and
            (2) in section 1007 (21 U.S.C. 957), by amending subsection 
        (a) to read as follows:
    ``(a)(1) Except as provided in paragraph (2), no person may--
            ``(A) import into the customs territory of the United 
        States from any place outside thereof (but within the United 
        States), or import into the United States from any place 
        outside thereof, any controlled substance or list I chemical, 
        or
            ``(B) export from the United States any controlled 
        substance or list I chemical,
unless there is in effect with respect to such person a registration 
issued by the Attorney General under section 1008, or unless such 
person is exempt from registration under subsection (b).
            ``(2) Paragraph (1) shall not apply to the import or export 
        of marihuana or cannabidiol that has been approved for--
                    ``(A) authorized medical research authorized under 
                section 5 of the Cannabidiol Research Expansion Act; or
                    ``(B) use by registered manufacturers to 
                manufacture drugs containing marihuana or cannabidiol 
                that have been approved for use by the Commissioner of 
                Food and Drugs under the Federal Food, Drug, and 
                Cosmetic Act (21 U.S.C. 301 et seq.).''.

SEC. 7. SAFE HARBOR.

    (a) Definitions.--In this section--
            (1) the term ``adult'' means an individual who is not less 
        than 18 years of age;
            (2) the term ``child'' means an individual who is not more 
        than 17 years of age;
            (3) the term ``intractable epilepsy'' means an epileptic 
        seizure disorder for which standard medical treatment--
                    (A) does not prevent or significantly ameliorate 
                recurring, uncontrollable seizures; or
                    (B) results in harmful side effects; and
            (4) the term ``neurologist'' means an allopathic or 
        osteopathic physician board-certified in neurology in good 
        standing and licensed in the State in which the physician 
        practices neurology.
    (b) Safe Harbor.--Notwithstanding the Controlled Substances Act (21 
U.S.C. 801 et seq.), the Controlled Substances Import and Export Act 
(21 U.S.C. 951 et seq.), or any other Federal law, it shall not be 
unlawful for--
            (1) a legal guardian to possess or transport cannabidiol or 
        any other nonpsychoactive component of marihuana for purposes 
        of dispensing the cannabidiol or other nonpsychoactive 
        component to a child of the legal guardian if--
                    (A) the child has been treated by a neurologist for 
                intractable epilepsy for not less than 6 months;
                    (B) the child's neurologist attests that other 
                treatment options have not resulted in significant 
                clinical improvement;
                    (C) the child's neurologist attests that he or she 
                has discussed the currently known potential harms and 
                benefits of using cannabidiol or other nonpsychoactive 
                components of marihuana as a treatment with the child's 
                legal guardian;
                    (D) the child's neurologist attests that he or she 
                will monitor the child for potential adverse reactions; 
                and
                    (E) the legal guardian provides documentation for 
                the requirements under subparagraphs (A), (B), (C), and 
                (D);
            (2) an adult to possess or transport cannabidiol or any 
        other nonpsychoactive component of marihuana if--
                    (A) the adult has been treated by a neurologist for 
                intractable epilepsy for not less than 6 months;
                    (B) the adult's neurologist attests that other 
                treatment options have not resulted in significant 
                clinical improvement;
                    (C) the adult's neurologist attests that he or she 
                has discussed the currently known potential harms and 
                benefits of using cannabidiol or other nonpsychoactive 
                components of marihuana as a treatment with the adult;
                    (D) the adult's neurologist attests that he or she 
                will monitor the adult for potential adverse reactions; 
                and
                    (E) the adult provides documentation for the 
                requirements under subparagraphs (A), (B), (C), and 
                (D); or
            (3) a State-licensed physician to discuss the currently 
        known potential harms and benefits of cannabidiol or any other 
        nonpsychoactive component of marihuana as a treatment with a 
        patient of the physician, or the legal guardian of the patient 
        if the patient is a child.
    (c) Sunset.--This section shall cease to have force or effect on 
the date that is 4 years after the date of enactment of this Act.

SEC. 8. FEDERAL RESEARCH.

    The Secretary of Health and Human Services, either directly or 
through awarding grants, contracts, or cooperative agreements to 
covered institutions of higher education, medical or osteopathic 
schools, or practitioners, or a consortia of covered institutions of 
higher education, medical or osteopathic schools, or practitioners, 
shall expand, intensify, and coordinate the activities of the National 
Institutes of Health with respect to research on cannabidiol and other 
nonpsychoactive components of marihuana to better determine their 
potential therapeutic effects on serious medical conditions, including 
intractable epilepsy.