[Congressional Bills 114th Congress]
[From the U.S. Government Publishing Office]
[S. 3077 Introduced in Senate (IS)]

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114th CONGRESS
  2d Session
                                S. 3077

               To improve medical research on marijuana.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                             June 20, 2016

    Mr. Schatz (for himself, Mr. Hatch, Mr. Tillis, and Mr. Coons) 
introduced the following bill; which was read twice and referred to the 
                       Committee on the Judiciary

_______________________________________________________________________

                                 A BILL


 
               To improve medical research on marijuana.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Marijuana Effective Drug Studies Act 
of 2016'' or the ``MEDS Act''.

SEC. 2. MARIJUANA RESEARCH.

    (a) In General.--Section 303(f) of the Controlled Substances Act 
(21 U.S.C. 823(f)) is amended--
            (1) by redesignating paragraphs (1) through (5) as 
        subparagraphs (A) through (E), respectively;
            (2) by striking ``(f) The Attorney General'' and inserting 
        ``(f)(1) The Attorney General'';
            (3) by striking ``Registration applications'' and inserting 
        the following:
    ``(2) Registration applications'';
            (4) in paragraph (2), as so designated, by striking 
        ``schedule I'' each place that term appears and inserting 
        ``schedule I, except marijuana,'';
            (5) by striking ``Article 7'' and inserting the following:
    ``(4) Article 7''; and
            (6) by inserting before paragraph (4), as so designated, 
        the following:
    ``(3)(A) The Attorney General shall register a practitioner to 
conduct research with marijuana if--
            ``(i) the applicant is authorized to dispense, or conduct 
        research with respect to, controlled substances in schedules 
        II, III, IV, and V under the laws of the State in which the 
        applicant practices;
            ``(ii) the applicant's research protocol--
                    ``(I) has been reviewed and allowed by--
                            ``(aa) the Secretary under section 505(i) 
                        of the Federal Food, Drug, and Cosmetic Act (21 
                        U.S.C. 355(i)); or
                            ``(bb) the National Institutes of Health or 
                        another Federal agency that funds scientific 
                        research; or
                    ``(II) in the case of nonhuman research that is not 
                federally funded, has been voluntarily submitted by the 
                applicant to, and approved by, the National Institutes 
                of Health; and
            ``(iii) the applicant has demonstrated that there are 
        effective procedures in place to adequately safeguard against 
        diversion of the marijuana from legitimate medical or 
        scientific use, in accordance with subparagraph (E).
    ``(B) The Attorney General shall grant an application for 
registration under this paragraph unless the Attorney General 
determines that the issuance of the registration would be inconsistent 
with the public interest. In determining the public interest, the 
following factors shall be considered:
            ``(i) The applicant's experience in dispensing, or 
        conducting research with respect to, controlled substances.
            ``(ii) The applicant's conviction record under Federal or 
        State laws relating to the manufacture, distribution, or 
        dispensing of controlled substances.
            ``(iii) Compliance with applicable State, Federal, or local 
        laws relating to controlled substances.
            ``(iv) Such other conduct by the applicant that may 
        threaten the public health and safety.
    ``(C) Not later than 90 days after the date of enactment of this 
paragraph, for purposes of subparagraph (A)(ii)(II), the National 
Institutes of Health shall establish a process that--
            ``(i) allows a researcher to voluntarily submit the 
        research protocol of the researcher for review and approval; 
        and
            ``(ii) provides a researcher described in clause (i) with a 
        decision not later than 30 days after the date on which the 
        research protocol is submitted.
    ``(D)(i) Not later than 60 days after the date on which the 
Attorney General receives a complete application for registration under 
this paragraph, the Attorney General shall--
            ``(I) approve the application; or
            ``(II) serve an order to show cause upon the applicant in 
        accordance with section 304(c).
    ``(ii) For purposes of clause (i), an application shall be deemed 
complete when the applicant has submitted documentation showing that 
the requirements under subparagraph (A) are satisfied.
    ``(E)(i) A researcher registered under this paragraph shall store 
marijuana to be used in research in a securely locked, substantially 
constructed cabinet.
    ``(ii) Any other security measures required by the Attorney General 
under this paragraph to safeguard against diversion shall be consistent 
with those required for practitioners conducting research on other 
controlled substances in schedules I and II that have a similar risk of 
diversion and abuse.
    ``(F)(i) If the Attorney General grants an application for 
registration under this paragraph, the applicant may amend or 
supplement the research protocol without reapplying if the applicant 
does not--
            ``(I) change the type of drug, the source of the drug, or 
        the conditions under which the drug is stored, tracked, or 
        administered; or
            ``(II) otherwise increase the risk of diversion.
    ``(ii) If an applicant amends or supplements the research protocol 
under clause (i), the applicant shall, in order to renew the 
registration under this paragraph, provide notice to the Attorney 
General of the amended or supplemented research protocol in the 
applicant's renewal materials.
    ``(iii)(I) If an applicant amends or supplements the research 
protocol in a manner that involves a change to the type of drug, the 
source of the drug, or conditions under which the drug is stored, 
tracked, or administered or otherwise increases the risk of diversion, 
the applicant shall provide notice to the Attorney General not later 
than 30 days before proceeding on such amended or supplemental research 
protocol.
    ``(II) If the Attorney General does not object during the 30-day 
period following a notification under subclause (I), the applicant may 
proceed with the amended or supplemental research protocol.
    ``(iv) The Attorney General may object to an amended or 
supplemental research protocol under clause (i) or (iii) if additional 
security measures are needed to safeguard against diversion or abuse.
    ``(G) Article 28 of the Single Convention on Narcotic Drugs shall 
not be construed to prohibit, or impose additional restrictions upon, 
research involving marijuana that is conducted in accordance with this 
paragraph and other applicable provisions of this title.
    ``(H) If marijuana or a compound of marijuana is listed on a 
schedule other than schedule I--
            ``(i) the provisions of this subsection that apply to 
        research with a controlled substance in the applicable schedule 
        shall apply to research with marijuana or that compound, as 
        applicable; and
            ``(ii) subparagraphs (A) through (G) of this paragraph 
        shall not apply to research with marijuana or that compound, as 
        applicable.''.
    (b) Conforming Amendment.--Section 102(16) of the Controlled 
Substances Act (21 U.S.C. 802(16)) is amended by inserting ``or 
`marijuana''' after ``The term `marihuana'''.

SEC. 3. MANUFACTURING OF MARIJUANA FOR CLINICAL USE.

    Section 303 of the Controlled Substances Act (21 U.S.C. 823) is 
amended by adding at the end the following:
    ``(j) Registration of Persons To Manufacture and Distribute 
Marijuana.--
            ``(1) Manufacture and distribution for use in research.--
        The Attorney General shall register an applicant to manufacture 
        or distribute marijuana on behalf of the Federal Government to 
        the extent that the marijuana is intended to be used 
        exclusively for legitimate research and scientific uses, in 
        accordance with the applicable requirements under subsection 
        (a) or (b) of this section for registration of manufacturers or 
        distributors of controlled substances in schedule I or II.
            ``(2) Manufacture and distribution for commercial 
        production of fda-approved drugs.--The Attorney General shall 
        register an applicant to manufacture or distribute marijuana on 
        behalf of the Federal Government exclusively for the purpose of 
        commercial production of a drug containing or derived from 
        marijuana that is approved by the Secretary 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 this section for registration of manufacturers or 
        distributors of controlled substances in schedule I or II.
            ``(3) No limit on number of manufacturers and 
        distributors.--The Attorney General shall not impose a limit on 
        the number of applicants eligible to be registered under 
        paragraph (1) or (2).
            ``(4) Timing.--Not later than 30 days after the date on 
        which the Attorney General receives an application for 
        registration under paragraph (1) or (2), the Attorney General 
        shall--
                    ``(A) grant the application; or
                    ``(B) serve an order to show cause upon the 
                applicant in accordance with section 304(c).
            ``(5) Determination of supply.--In considering the factors 
        under subsection (a) or (b), as applicable, for the purposes of 
        registering an applicant eligible under paragraph (1) or (2) of 
        this subsection, the Attorney General shall consider the demand 
        from researchers for an adequate and uninterrupted supply of 
        specific strains of marijuana and for marijuana grown pursuant 
        to specific manufacturing processes.
            ``(6) Relation to the single convention on narcotic 
        drugs.--
                    ``(A) Constructive possession and control.--The 
                registration of manufacturers and distributors of 
                marijuana under paragraphs (1) and (2) shall constitute 
                constructive possession and control by the Federal 
                Government for the purposes of the obligations under 
                the Single Convention on Narcotic Drugs.
                    ``(B) Article 28.--Article 28 of the Single 
                Convention on Narcotic Drugs shall not be construed to 
                prohibit, or impose additional restrictions upon, the 
                manufacturing of marijuana that is conducted in 
                accordance with paragraph (1) or (2), as applicable, 
                and other applicable provisions of this title.''.

SEC. 4. GOOD MANUFACTURING PRACTICES.

    Not later than 180 days after the date of enactment of this Act, 
the National Institute for Drug Abuse shall develop and publish 
recommendations for good manufacturing practices for growing and 
producing marijuana (as defined in section 102 of the Controlled 
Substance Act (21 U.S.C. 802), as amended by this Act) for research.

SEC. 5. QUOTAS.

    Section 306(e) of the Controlled Substances Act (21 U.S.C. 826(e)) 
is amended in the third sentence by striking ``exceeds the aggregate of 
the quotas of all registrants under this section'' and inserting 
``should be increased to meet the changing medical, scientific, and 
industrial needs for the controlled substance''.

SEC. 6. TERMINATION OF INTERDISCIPLINARY REVIEW PROCESS FOR NON-NIH-
              FUNDED RESEARCHERS.

    The Secretary of Health and Human Services may not--
            (1) reinstate the Public Health Service interdisciplinary 
        review process described in the guidance entitled ``Guidance on 
        Procedures for the Provision of Marijuana for Medical 
        Research'' (issued on May 21, 1999); or
            (2) create an additional review of scientific protocols 
        that is conducted only for research on marijuana (as defined in 
        section 102 of the Controlled Substances Act (21 U.S.C. 802), 
        as amended by section 2(b)) other than the review of research 
        protocols performed at the request of a researcher conducting 
        nonhuman research that is not federally funded, in accordance 
        with section 303(f)(3)(A)(ii)(II) of the Controlled Substances 
        Act (21 U.S.C. 823(f)(3)(A)(ii)(II)), as amended by section 
        2(a).
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