Medical Marijuana Research Act

Bill: 117-hr-5657
Sponsor: full_name: Rep. Blumenauer, Earl [D-OR-3]
Introduced: 2021-10-21
Policy area: Health
Subjects: Administrative law and regulatory procedures

Alternative treatments

Crime and Law Enforcement

Department of Health and Human Services

Drug safety, medical device, and laboratory regulation

Drug therapy

Drug trafficking and controlled substances

Food and Drug Administration (FDA)

Health personnel

Licensing and registrations

Medical research

Research administration and funding
Latest action: action_date: 2022-04-05
text: Received in the Senate.

Summaries:
action_date: 2021-10-21
action_desc: Introduced in House
text: <p><strong>Medical Marijuana Research Act</strong></p> <p>This bill establishes a new, separate registration process to facilitate medical marijuana research.</p> <p>Specifically, it directs the Drug Enforcement Administration to register (1) practitioners to conduct medical marijuana research, and (2) manufacturers and distributors to supply marijuana for such research.</p> <p>Additionally, the Department of Health and Human Services must continue to produce marijuana through the National Institute on Drug Abuse Drug Supply Program and implement a specialized process for supplying marijuana products available through state-authorized marijuana programs to researchers until manufacturers and distributors can provide a sufficient supply of marijuana for medical research.</p>

action_date: 2022-04-04
action_desc: Passed House
text: <p><strong>Medical Marijuana Research Act</strong></p> <p>This bill establishes a new, separate registration process to facilitate medical marijuana research.</p> <p>Specifically, it directs the Drug Enforcement Administration to register (1) practitioners to conduct medical marijuana research, and (2) manufacturers and distributors to supply marijuana for such research.</p> <p>Additionally, the Department of Health and Human Services must continue to produce marijuana through the National Institute on Drug Abuse Drug Supply Program and implement a specialized process for supplying marijuana products available through state-authorized marijuana programs to researchers until manufacturers and distributors can provide a sufficient supply of marijuana for medical research.</p>

tv_txt: II 117th CONGRESS 2d Session H. R. 5657 IN THE SENATE OF THE UNITED STATES April 5, 2022 Received AN ACT To amend the Controlled Substances Act to make marijuana accessible for use by qualified marijuana researchers for medical purposes, and for other purposes.

1. Short title This Act may be cited as the Medical Marijuana Research Act . 2. Facilitating marijuana research (a) Production and supply The Secretary of Health and Human Services— (1) until the date on which the Secretary determines that manufacturers and distributors (other than the Federal Government) can ensure a sufficient supply of marijuana (as defined in section 102 of the Controlled Substances Act ( 21 U.S.C. 802 ), as amended by section 8) intended for research by qualified marijuana researchers registered pursuant to paragraph (3) of section 303(f) of the Controlled Substances Act ( 21 U.S.C. 823(f) ), as added by section 3, shall— (A) continue, through grants, contracts, or cooperative agreements, to produce marijuana through the National Institute on Drug Abuse Drug Supply Program; (B) not later than one year after the date of enactment of this Act, act jointly with the Attorney General of the United States to establish and implement a specialized process for manufacturers and distributors, notwithstanding the registration requirements of section 303 of such Act ( 21 U.S.C. 823 ), to supply qualified marijuana researchers with marijuana products— (i) available through State-authorized marijuana programs; and (ii) consistent with the guidance issued under subsection (c); and (C) not later than 60 days after the date of enactment of this Act, jointly convene with the Attorney General a meeting to initiate the development of the specialized process described in subparagraph (B); and (2) beyond the date specified in paragraph (1), may, at the Secretary’s discretion, continue— (A) through grants, contracts, or cooperative agreements, to so produce marijuana; and (B) to implement such specialized process. (b) Requirement To verify registration Before supplying marijuana to any person through the National Institute on Drug Abuse Drug Supply Program or through implementation of the specialized process established under subsection (a)(1)(B), the Secretary of Health and Human Services shall— (1) require the person to submit documentation demonstrating that the person is a qualified marijuana researcher seeking to conduct research pursuant to section 303(f)(3) of the Controlled Substances Act, as added by subsection (d) of this section, or a manufacturer duly registered under section 303(l) of the Controlled Substances Act, as added by section 3 of this Act; and (2) not later than 60 days after receipt of such documentation, review such documentation and verify that the marijuana will be used for such research (and for no other purpose authorized pursuant to this Act or the amendments made by this Act). (c) Guidance on Use of State-Authorized marijuana programs Not later than 180 days after the date of the enactment of this Act, the Secretary of Health and Human Services shall issue guidance related to marijuana from State-authorized marijuana programs for research. (d) Research 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 the applicant to conduct research with marijuana (including any derivative, extract, preparation, and compound thereof) if, irrespective of whether the applicant is registered pursuant to paragraphs (1) and (2)— (i) the applicant meets the requirements for being registered under such paragraphs to dispense, or conduct research with respect to, controlled substances in schedule I, II, III, IV, or V; (ii) the applicant is compliant with, and authorized to conduct the activities described in clause (i) under, the laws of the State in which the applicant practices; and (iii) in the case of an applicant pursuing clinical research, the applicant’s clinical research protocol has been reviewed and authorized to proceed by the Secretary under section 505(i) of the Federal Food, Drug, and Cosmetic Act. (B) An applicant registered under subparagraph (A) shall be referred to in this section as a qualified marijuana researcher . (C) (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 approve or deny the application. (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. (iii) In the case of a denial under clause (i), the Attorney General shall provide a written explanation of the basis for the denial. (D) 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 or local laws relating to controlled substance misuse or diversion. (iv) Such other conduct which may threaten the public health and safety. (E) (i) A qualified marijuana researcher shall store marijuana to be used in research in a securely locked, substantially constructed cabinet. (ii) Except as provided in clause (i), any security measures required by the Attorney General for applicants conducting research with marijuana pursuant to a registration under this paragraph shall be consistent with the security measures for applicants conducting research on other controlled substances in schedule 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 and proceed with the research under such amended or supplemented protocol, without additional review or approval by the Attorney General or the Secretary of Health and Human Services if the applicant does not change the type of marijuana (including any derivative, extract, preparation, and compound thereof), the source of the marijuana, or the conditions under which the marijuana is stored, tracked, or administered. (ii) If an applicant amends or supplements the research protocol or initiates research on a new 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 or any new research protocol in the applicant’s renewal materials. (iii) (I) If an applicant amends or supplements a research protocol and the amendment or supplement involves a change to the type of marijuana, the source of the marijuana, or conditions under which the marijuana is stored, tracked, or administered, the applicant shall provide notice to the Attorney General not later than 30 days before proceeding on such amended or supplemental research or new research protocol, as the case may be. (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 or new research protocol. (iv) The Attorney General may object to an amended or supplemental protocol or a new research protocol under clause (i) or (iii) only if additional security measures are needed to safeguard against diversion or abuse. (G) If marijuana is listed on a schedule other than schedule I, the provisions of paragraphs (1), (2), and (4) that apply to research with a controlled substance in the applicable schedule shall apply to research with marijuana or that compound, as applicable, in lieu of the provisions of subparagraphs (A) through (F) of this paragraph. (H) Nothing in this paragraph shall be construed as limiting the authority of the Secretary under section 505(i) of the Federal Food, Drug, and Cosmetic Act or over requirements related to research protocols, including changes in— (i) the method of administration of marijuana; (ii) the dosing of marijuana; and (iii) the number of individuals or patients involved in research. . 3. Manufacture and distribution of marijuana for use in legitimate research Section 303 of the Controlled Substances Act ( 21 U.S.C. 823 ), as amended by section 2, is further amended by adding at the end the following: (l) Registration of persons To manufacture and distribute marijuana for use in legitimate research (1) Registration of manufacturers (A) In general Beginning not later than the day that is 1 year after the date of enactment of the Medical Marijuana Research Act, the Attorney General, pursuant to subsection (f)(3) and subject to subparagraph (B) of this paragraph, shall register an applicant to manufacture marijuana (including any derivative, extract, preparation, and compound thereof) that is intended for— (i) use by qualified marijuana researchers for research pursuant to subsection (f)(3); or (ii) subsequent downstream manufacture by a duly registered manufacturer for use by qualified marijuana researchers for research pursuant to subsection (f)(3). (B) Public interest The Attorney General shall register an applicant under subparagraph (A) unless the Attorney General determines that the issuance of such registration is inconsistent with the public interest. In determining the public interest, the Attorney General shall take into consideration— (i) maintenance of effective controls against diversion of marijuana and any controlled substance compounded therefrom into other than legitimate medical, scientific, or research channels; (ii) compliance with applicable State and local laws relating to controlled substance misuse and diversion; (iii) prior conviction record of the applicant under Federal or State laws relating to the manufacture, distribution, or dispensing of such substances; and (iv) such other conduct which may threaten the public health and safety. (2) Registration of distributors (A) In general Beginning not later than the day that is 1 year after the date of enactment of the Medical Marijuana Research Act, the Attorney General shall register an applicant to distribute marijuana (including any derivative, extract, preparation, and compound thereof) that is intended for use by qualified marijuana researchers for research pursuant to subsection (f)(3) or intended for subsequent downstream manufacture by a duly registered manufacturer for use by qualified marijuana researchers for research pursuant to such subsection, unless the Attorney General determines that the issuance of such registration is inconsistent with the public interest. (B) Public interest In determining the public interest under subparagraph (A), the Attorney General shall take into consideration— (i) the factors specified in clauses (i), (ii), (iii), and (iv) of paragraph (1)(B); and (ii) past experience in the distribution of controlled substances, and the existence of effective controls against diversion. (3) No limit on number of manufacturers and distributors Notwithstanding any other provision of law, the Attorney General shall not impose or implement any limit on the number of persons eligible to be registered to manufacture or distribute marijuana pursuant to paragraph (1) or (2). (4) Requirement to verify use for legitimate research As a condition of registration under this section to manufacture or distribute marijuana, the Attorney General shall require the registrant— (A) to require any person to whom the marijuana will be supplied to submit documentation demonstrating that the marijuana (including any derivative, extract, preparation, and compound thereof) will be used by qualified marijuana researchers for research pursuant to subsection (f)(3) or for subsequent downstream manufacture by a duly registered manufacturer for use by qualified marijuana researchers for research pursuant to such subsection; (B) in the case of distribution, to complete, with respect to that distribution, the appropriate order form in accordance with section 308 and to upload such forms to the system used by the Drug Enforcement Administration for such distribution; (C) to include in the labeling of any marijuana so manufactured or distributed— (i) the following statement: This material is for biomedical and scientific research purposes only. ; and (ii) the name of the requestor of the marijuana; (D) to limit the transfer and sale of any marijuana under this subsection— (i) to researchers who are registered under this Act to conduct research with marijuana or to manufacturers duly registered under this subsection; and (ii) for purposes of use in preclinical research or in a clinical investigation pursuant to an investigational new drug exemption under 505(i) of the Federal Food, Drug, and Cosmetic Act or for the purposes of further manufacturing of marijuana; and (E) to transfer or sell any marijuana manufactured under this subsection only with prior, written consent for the transfer or sale by the Attorney General. (5) Timing Not later than 60 days after receipt of a request for registration under this subsection to manufacture or distribute marijuana, the Attorney General shall— (A) grant or deny the request; and (B) in the case of a denial, provide a written explanation of the basis for the denial. (6) Deemed approval If the Attorney General fails to grant or deny a request for registration under this subsection to manufacture or distribute marijuana within the 60-day period referred to in paragraph (5), such request is deemed approved. . 4. Termination of interdisciplinary review process for non-NIH-funded qualified marijuana 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 only conducted for research on marijuana other than the review of research protocols performed at the request of a qualified marijuana researcher conducting nonhuman research that is not federally funded, in accordance with section 303(f)(3)(A) of the Controlled Substances Act, as added by section 2 of this Act. 5. Consideration of results of research Immediately upon the approval by the Food and Drug Administration of an application for a drug that contains marijuana (as defined in section 102 of the Controlled Substances Act ( 21 U.S.C. 802 ), as amended by section 8 of this Act) under section 505 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355 ), and (irrespective of whether any such approval is granted) not later than the date that is 5 years after the date of enactment of this Act, the Secretary of Health and Human Services shall— (1) conduct a review of existing medical and other research with respect to marijuana; (2) submit a report to the Congress on the results of such review; and (3) include in such report whether, taking into consideration the factors listed in section 201(c) of the Controlled Substances Act ( 21 U.S.C. 811(c) ), as well as any potential for medical benefits, any gaps in research, and any impacts of Federal restrictions and policy on research, marijuana should be transferred to a schedule other than schedule I (if marijuana has not been so transferred already). 6. Production quotas for marijuana grown for legitimate, scientific research Section 306 of the Controlled Substances Act ( 21 U.S.C. 826 ) is amended by adding at the end the following: (j) The Attorney General may only establish a quota for production of marijuana that is manufactured and distributed in accordance with the Medical Marijuana Research Act that meets the changing medical, scientific, and industrial needs for marijuana. . 7. Article 28 of the single convention on narcotic drugs Article 28 of the Single Convention on Narcotic Drugs shall not be construed to prohibit, or impose additional restrictions upon, research involving marijuana, or the manufacture, distribution, or dispensing of marijuana, that is conducted in accordance with the Controlled Substances Act ( 21 U.S.C. 801 et seq. ), this Act, and the amendments made by this Act. 8. Definitions (a) Qualified marijuana researcher In this Act, the term qualified marijuana researcher has the meaning given the term in section 303(f)(3) of the Controlled Substances Act, as added by section 2(d) of this Act. (b) Updating term Section 102(16) of the Controlled Substances Act ( 21 U.S.C. 802(16) ) is amended— (1) in subparagraph (A), by striking the term marihuana means and inserting the terms marihuana and marijuana mean ; and (2) in subparagraph (B), by striking The term marihuana does not and inserting The terms marihuana and marijuana do not . 9. Determination of budgetary effects The budgetary effects of this Act, for the purpose of complying with the Statutory Pay-As-You-Go Act of 2010, shall be determined by reference to the latest statement titled Budgetary Effects of PAYGO Legislation for this Act, submitted for printing in the Congressional Record by the Chairman of the House Budget Committee, pro- vided that such statement has been submitted prior to the vote on passage.

Passed the House of Representatives April 4, 2022. Cheryl L. Johnson, Clerk.

tv_txt: I 117th CONGRESS 1st Session H. R. 5657 IN THE HOUSE OF REPRESENTATIVES October 21, 2021 Mr. Blumenauer (for himself, Mr. Harris , Ms. Norton , Mrs. Dingell , Mr. Cohen , Mr. Griffith , Ms. Lee of California , and Mr. Case ) introduced the following bill; which was referred to the Committee on Energy and Commerce , and in addition to the Committees on the Judiciary , and the Budget , for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned A BILL To amend the Controlled Substances Act to make marijuana accessible for use by qualified marijuana researchers for medical purposes, and for other purposes.

1. Short title This Act may be cited as the Medical Marijuana Research Act . 2. Facilitating marijuana research (a) Production and supply The Secretary of Health and Human Services— (1) until the date on which the Secretary determines that manufacturers and distributors (other than the Federal Government) can ensure a sufficient supply of marijuana (as defined in section 102 of the Controlled Substances Act ( 21 U.S.C. 802 ), as amended by section 8) intended for research by qualified marijuana researchers registered pursuant to paragraph (3) of section 303(f) of the Controlled Substances Act ( 21 U.S.C. 823(f) ), as added by section 3, shall— (A) continue, through grants, contracts, or cooperative agreements, to produce marijuana through the National Institute on Drug Abuse Drug Supply Program; (B) not later than one year after the date of enactment of this Act, act jointly with the Attorney General of the United States to establish and implement a specialized process for manufacturers and distributors, notwithstanding the registration requirements of section 303 of such Act ( 21 U.S.C. 823 ), to supply qualified marijuana researchers with marijuana products— (i) available through State-authorized marijuana programs; and (ii) consistent with the guidance issued under subsection (c); and (C) not later than 60 days after the date of enactment of this Act, jointly convene with the Attorney General a meeting to initiate the development of the specialized process described in subparagraph (B); and (2) beyond the date specified in paragraph (1), may, at the Secretary’s discretion, continue— (A) through grants, contracts, or cooperative agreements, to so produce marijuana; and (B) to implement such specialized process. (b) Requirement To verify registration Before supplying marijuana to any person through the National Institute on Drug Abuse Drug Supply Program or through implementation of the specialized process established under subsection (a)(1)(B), the Secretary of Health and Human Services shall— (1) require the person to submit documentation demonstrating that the person is a qualified marijuana researcher seeking to conduct research pursuant to section 303(f)(3) of the Controlled Substances Act, as added by subsection (d) of this section, or a manufacturer duly registered under section 303(l) of the Controlled Substances Act, as added by section 3 of this Act; and (2) not later than 60 days after receipt of such documentation, review such documentation and verify that the marijuana will be used for such research (and for no other purpose authorized pursuant to this Act or the amendments made by this Act). (c) Guidance on Use of State-Authorized marijuana programs Not later than 180 days after the date of the enactment of this Act, the Secretary of Health and Human Services shall issue guidance related to marijuana from State-authorized marijuana programs for research. (d) Research 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 the applicant to conduct research with marijuana if— (i) the applicant is authorized to dispense, or conduct research with respect to, controlled substances in schedule I, II, III, IV, or V; (ii) the applicant is compliant with, and authorized to conduct the activities described in clause (i) under, the laws of the State in which the applicant practices; and (iii) in the case of an applicant pursuing clinical research, the applicant’s clinical research protocol has been reviewed and authorized to proceed by the Secretary under section 505(i) of the Federal Food, Drug, and Cosmetic Act. (B) An applicant registered under subparagraph (A) shall be referred to in this section as a qualified marijuana researcher . (C) (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 approve or deny the application. (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. (iii) In the case of a denial under clause (i), the Attorney General shall provide a written explanation of the basis for the denial. (D) 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 or local laws relating to controlled substance misuse or diversion. (iv) Such other conduct which may threaten the public health and safety. (E) (i) A qualified marijuana researcher shall store marijuana to be used in research in a securely locked, substantially constructed cabinet. (ii) Except as provided in clause (i), any security measures required by the Attorney General for applicants conducting research with marijuana pursuant to a registration under this paragraph shall be consistent with the security measures for applicants conducting research on other controlled substances in schedule 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 and proceed with the research under such amended or supplemented protocol, without additional review or approval by the Attorney General or the Secretary of Health and Human Services if the applicant does not change the type of marijuana, the source of the marijuana, or the conditions under which the marijuana is stored, tracked, or administered. (ii) If an applicant amends or supplements the research protocol or initiates research on a new 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 or any new research protocol in the applicant’s renewal materials. (iii) (I) If an applicant amends or supplements a research protocol and the amendment or supplement involves a change to the type of marijuana, the source of the marijuana, or conditions under which the marijuana is stored, tracked, or administered, the applicant shall provide notice to the Attorney General not later than 30 days before proceeding on such amended or supplemental research or new research protocol, as the case may be. (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 or new research protocol. (iv) The Attorney General may object to an amended or supplemental protocol or a new research protocol under clause (i) or (iii) only if additional security measures are needed to safeguard against diversion or abuse. (G) If marijuana is listed on a schedule other than schedule I, the provisions of paragraphs (1), (2), and (4) that apply to research with a controlled substance in the applicable schedule shall apply to research with marijuana or that compound, as applicable, in lieu of the provisions of subparagraphs (A) through (F) of this paragraph. (H) Nothing in this paragraph shall be construed as limiting the authority of the Secretary under section 505(i) of the Federal Food, Drug, and Cosmetic Act or over requirements related to research protocols, including changes in— (i) the method of administration of marijuana; (ii) the dosing of marijuana; and (iii) the number of individuals or patients involved in research. . 3. Manufacture and distribution of marijuana for use in legitimate research Section 303 of the Controlled Substances Act ( 21 U.S.C. 823 ), as amended by section 2, is further amended by adding at the end the following: (l) Registration of persons To manufacture and distribute marijuana for use in legitimate research (1) Registration of manufacturers (A) In general Beginning not later than the day that is 1 year after the date of enactment of the Medical Marijuana Research Act, the Attorney General, pursuant to subsection (f)(3) and subject to subparagraph (B) of this paragraph, shall register an applicant to manufacture marijuana (including any derivative, extract, preparation, and compound thereof) that is intended for— (i) the ultimate and exclusive use by qualified marijuana researchers for research pursuant to subsection (f)(3); or (ii) subsequent downstream manufacture by a duly registered manufacturer for the ultimate and exclusive use by qualified marijuana researchers for research pursuant to subsection (f)(3). (B) Public interest The Attorney General shall register an applicant under subparagraph (A) unless the Attorney General determines that the issuance of such registration is inconsistent with the public interest. In determining the public interest, the Attorney General shall take into consideration— (i) maintenance of effective controls against diversion of marijuana and any controlled substance compounded therefrom into other than legitimate medical, scientific, or research channels; (ii) compliance with applicable State and local laws relating to controlled substance misuse and diversion; (iii) prior conviction record of the applicant under Federal or State laws relating to the manufacture, distribution, or dispensing of such substances; and (iv) such other conduct which may threaten the public health and safety. (2) Registration of distributors (A) In general Beginning not later than the day that is 1 year after the date of enactment of the Medical Marijuana Research Act, the Attorney General shall register an applicant to distribute marijuana (including any derivative, extract, preparation, and compound thereof) that is intended for the ultimate and exclusive use by qualified marijuana researchers for research pursuant to subsection (f)(3) or intended for subsequent downstream manufacture by a duly registered manufacturer for use by qualified marijuana researchers for research pursuant to such subsection, unless the Attorney General determines that the issuance of such registration is inconsistent with the public interest. (B) Public interest In determining the public interest under subparagraph (A), the Attorney General shall take into consideration— (i) the factors specified in clauses (i), (ii), (iii), and (iv) of paragraph (1)(B); and (ii) past experience in the distribution of controlled substances, and the existence of effective controls against diversion. (3) No limit on number of manufacturers and distributors Notwithstanding any other provision of law, the Attorney General shall not impose or implement any limit on the number of persons eligible to be registered to manufacture or distribute marijuana pursuant to paragraph (1) or (2). (4) Requirement to verify use for legitimate research As a condition of registration under this section to manufacture or distribute marijuana, the Attorney General shall require the registrant— (A) to require any person to whom the marijuana will be supplied to submit documentation demonstrating that the marijuana (including any derivative, extract, preparation, and compound thereof) will be ultimately used exclusively by qualified marijuana researchers for research pursuant to subsection (f)(3) or for subsequent downstream manufacture by a duly registered manufacturer for use by qualified marijuana researchers for research pursuant to such subsection; (B) in the case of distribution, to complete, with respect to that distribution, the appropriate order form in accordance with section 308 and to upload such forms to the system used by the Drug Enforcement Administration for such distribution; (C) to include in the labeling of any marijuana so manufactured or distributed— (i) the following statement: This material is for biomedical and scientific research purposes only. ; and (ii) the name of the requestor of the marijuana; (D) to limit the transfer and sale of any marijuana under this subsection— (i) to researchers who are registered under this Act to conduct research with marijuana or to manufacturers duly registered under this subsection; and (ii) for purposes of use in preclinical research or in a clinical investigation pursuant to an investigational new drug exemption under 505(i) of the Federal Food, Drug, and Cosmetic Act or for the purposes of further manufacturing of marijuana; and (E) to transfer or sell any marijuana manufactured under this subsection only with prior, written consent for the transfer or sale by the Attorney General. (5) Timing Not later than 60 days after receipt of a request for registration under this subsection to manufacture or distribute marijuana, the Attorney General shall— (A) grant or deny the request; and (B) in the case of a denial, provide a written explanation of the basis for the denial. (6) Deemed approval If the Attorney General fails to grant or deny a request for registration under this subsection to manufacture or distribute marijuana within the 60-day period referred to in paragraph (5), such request is deemed approved. . 4. Termination of interdisciplinary review process for non-NIH-funded qualified marijuana 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 only conducted for research on marijuana other than the review of research protocols performed at the request of a qualified marijuana researcher conducting nonhuman research that is not federally funded, in accordance with section 303(f)(3)(A) of the Controlled Substances Act, as added by section 2 of this Act. 5. Consideration of results of research Immediately upon the approval by the Food and Drug Administration of an application for a drug that contains marijuana (as defined in section 102 of the Controlled Substances Act ( 21 U.S.C. 802 ), as amended by section 8 of this Act) under section 505 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355 ), and (irrespective of whether any such approval is granted) not later than the date that is 5 years after the date of enactment of this Act, the Secretary of Health and Human Services shall— (1) conduct a review of existing medical and other research with respect to marijuana; (2) submit a report to the Congress on the results of such review; and (3) include in such report whether, taking into consideration the factors listed in section 201(c) of the Controlled Substances Act ( 21 U.S.C. 811(c) ), as well as any potential for medical benefits, any gaps in research, and any impacts of Federal restrictions and policy on research, marijuana should be transferred to a schedule other than schedule I (if marijuana has not been so transferred already). 6. Production quotas for marijuana grown for legitimate, scientific research Section 306 of the Controlled Substances Act ( 21 U.S.C. 826 ) is amended by adding at the end the following: (j) The Attorney General may only establish a quota for production of marijuana that is manufactured and distributed in accordance with the Medical Marijuana Research Act that meets the changing medical, scientific, and industrial needs for marijuana. . 7. Article 28 of the single convention on narcotic drugs Article 28 of the Single Convention on Narcotic Drugs shall not be construed to prohibit, or impose additional restrictions upon, research involving marijuana, or the manufacture, distribution, or dispensing of marijuana, that is conducted in accordance with the Controlled Substances Act ( 21 U.S.C. 801 et seq. ), this Act, and the amendments made by this Act. 8. Definitions (a) Qualified marijuana researcher In this Act, the term qualified marijuana researcher has the meaning given the term in section 303(f)(3) of the Controlled Substances Act, as added by section 2(d) of this Act. (b) Updating term Section 102(16) of the Controlled Substances Act ( 21 U.S.C. 802(16) ) is amended— (1) in subparagraph (A), by striking the term marihuana means and inserting the terms marihuana and marijuana mean ; and (2) in subparagraph (B), by striking The term marihuana does not and inserting The terms marihuana and marijuana do not . 9. Determination of budgetary effects The budgetary effects of this Act, for the purpose of complying with the Statutory Pay-As-You-Go Act of 2010, shall be determined by reference to the latest statement titled Budgetary Effects of PAYGO Legislation for this Act, submitted for printing in the Congressional Record by the Chairman of the House Budget Committee, provided that such statement has been submitted prior to the vote on passage.

tv_txt: I 117th CONGRESS 2d Session H. R. 5657 IN THE HOUSE OF REPRESENTATIVES AN ACT To amend the Controlled Substances Act to make marijuana accessible for use by qualified marijuana researchers for medical purposes, and for other purposes.

1. Short title This Act may be cited as the Medical Marijuana Research Act . 2. Facilitating marijuana research (a) Production and supply The Secretary of Health and Human Services— (1) until the date on which the Secretary determines that manufacturers and distributors (other than the Federal Government) can ensure a sufficient supply of marijuana (as defined in section 102 of the Controlled Substances Act ( 21 U.S.C. 802 ), as amended by section 8) intended for research by qualified marijuana researchers registered pursuant to paragraph (3) of section 303(f) of the Controlled Substances Act ( 21 U.S.C. 823(f) ), as added by section 3, shall— (A) continue, through grants, contracts, or cooperative agreements, to produce marijuana through the National Institute on Drug Abuse Drug Supply Program; (B) not later than one year after the date of enactment of this Act, act jointly with the Attorney General of the United States to establish and implement a specialized process for manufacturers and distributors, notwithstanding the registration requirements of section 303 of such Act ( 21 U.S.C. 823 ), to supply qualified marijuana researchers with marijuana products— (i) available through State-authorized marijuana programs; and (ii) consistent with the guidance issued under subsection (c); and (C) not later than 60 days after the date of enactment of this Act, jointly convene with the Attorney General a meeting to initiate the development of the specialized process described in subparagraph (B); and (2) beyond the date specified in paragraph (1), may, at the Secretary’s discretion, continue— (A) through grants, contracts, or cooperative agreements, to so produce marijuana; and (B) to implement such specialized process. (b) Requirement To verify registration Before supplying marijuana to any person through the National Institute on Drug Abuse Drug Supply Program or through implementation of the specialized process established under subsection (a)(1)(B), the Secretary of Health and Human Services shall— (1) require the person to submit documentation demonstrating that the person is a qualified marijuana researcher seeking to conduct research pursuant to section 303(f)(3) of the Controlled Substances Act, as added by subsection (d) of this section, or a manufacturer duly registered under section 303(l) of the Controlled Substances Act, as added by section 3 of this Act; and (2) not later than 60 days after receipt of such documentation, review such documentation and verify that the marijuana will be used for such research (and for no other purpose authorized pursuant to this Act or the amendments made by this Act). (c) Guidance on Use of State-Authorized marijuana programs Not later than 180 days after the date of the enactment of this Act, the Secretary of Health and Human Services shall issue guidance related to marijuana from State-authorized marijuana programs for research. (d) Research 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 the applicant to conduct research with marijuana (including any derivative, extract, preparation, and compound thereof) if, irrespective of whether the applicant is registered pursuant to paragraphs (1) and (2)— (i) the applicant meets the requirements for being registered under such paragraphs to dispense, or conduct research with respect to, controlled substances in schedule I, II, III, IV, or V; (ii) the applicant is compliant with, and authorized to conduct the activities described in clause (i) under, the laws of the State in which the applicant practices; and (iii) in the case of an applicant pursuing clinical research, the applicant’s clinical research protocol has been reviewed and authorized to proceed by the Secretary under section 505(i) of the Federal Food, Drug, and Cosmetic Act. (B) An applicant registered under subparagraph (A) shall be referred to in this section as a qualified marijuana researcher . (C) (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 approve or deny the application. (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. (iii) In the case of a denial under clause (i), the Attorney General shall provide a written explanation of the basis for the denial. (D) 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 or local laws relating to controlled substance misuse or diversion. (iv) Such other conduct which may threaten the public health and safety. (E) (i) A qualified marijuana researcher shall store marijuana to be used in research in a securely locked, substantially constructed cabinet. (ii) Except as provided in clause (i), any security measures required by the Attorney General for applicants conducting research with marijuana pursuant to a registration under this paragraph shall be consistent with the security measures for applicants conducting research on other controlled substances in schedule 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 and proceed with the research under such amended or supplemented protocol, without additional review or approval by the Attorney General or the Secretary of Health and Human Services if the applicant does not change the type of marijuana (including any derivative, extract, preparation, and compound thereof), the source of the marijuana, or the conditions under which the marijuana is stored, tracked, or administered. (ii) If an applicant amends or supplements the research protocol or initiates research on a new 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 or any new research protocol in the applicant’s renewal materials. (iii) (I) If an applicant amends or supplements a research protocol and the amendment or supplement involves a change to the type of marijuana, the source of the marijuana, or conditions under which the marijuana is stored, tracked, or administered, the applicant shall provide notice to the Attorney General not later than 30 days before proceeding on such amended or supplemental research or new research protocol, as the case may be. (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 or new research protocol. (iv) The Attorney General may object to an amended or supplemental protocol or a new research protocol under clause (i) or (iii) only if additional security measures are needed to safeguard against diversion or abuse. (G) If marijuana is listed on a schedule other than schedule I, the provisions of paragraphs (1), (2), and (4) that apply to research with a controlled substance in the applicable schedule shall apply to research with marijuana or that compound, as applicable, in lieu of the provisions of subparagraphs (A) through (F) of this paragraph. (H) Nothing in this paragraph shall be construed as limiting the authority of the Secretary under section 505(i) of the Federal Food, Drug, and Cosmetic Act or over requirements related to research protocols, including changes in— (i) the method of administration of marijuana; (ii) the dosing of marijuana; and (iii) the number of individuals or patients involved in research. . 3. Manufacture and distribution of marijuana for use in legitimate research Section 303 of the Controlled Substances Act ( 21 U.S.C. 823 ), as amended by section 2, is further amended by adding at the end the following: (l) Registration of persons To manufacture and distribute marijuana for use in legitimate research (1) Registration of manufacturers (A) In general Beginning not later than the day that is 1 year after the date of enactment of the Medical Marijuana Research Act, the Attorney General, pursuant to subsection (f)(3) and subject to subparagraph (B) of this paragraph, shall register an applicant to manufacture marijuana (including any derivative, extract, preparation, and compound thereof) that is intended for— (i) use by qualified marijuana researchers for research pursuant to subsection (f)(3); or (ii) subsequent downstream manufacture by a duly registered manufacturer for use by qualified marijuana researchers for research pursuant to subsection (f)(3). (B) Public interest The Attorney General shall register an applicant under subparagraph (A) unless the Attorney General determines that the issuance of such registration is inconsistent with the public interest. In determining the public interest, the Attorney General shall take into consideration— (i) maintenance of effective controls against diversion of marijuana and any controlled substance compounded therefrom into other than legitimate medical, scientific, or research channels; (ii) compliance with applicable State and local laws relating to controlled substance misuse and diversion; (iii) prior conviction record of the applicant under Federal or State laws relating to the manufacture, distribution, or dispensing of such substances; and (iv) such other conduct which may threaten the public health and safety. (2) Registration of distributors (A) In general Beginning not later than the day that is 1 year after the date of enactment of the Medical Marijuana Research Act, the Attorney General shall register an applicant to distribute marijuana (including any derivative, extract, preparation, and compound thereof) that is intended for use by qualified marijuana researchers for research pursuant to subsection (f)(3) or intended for subsequent downstream manufacture by a duly registered manufacturer for use by qualified marijuana researchers for research pursuant to such subsection, unless the Attorney General determines that the issuance of such registration is inconsistent with the public interest. (B) Public interest In determining the public interest under subparagraph (A), the Attorney General shall take into consideration— (i) the factors specified in clauses (i), (ii), (iii), and (iv) of paragraph (1)(B); and (ii) past experience in the distribution of controlled substances, and the existence of effective controls against diversion. (3) No limit on number of manufacturers and distributors Notwithstanding any other provision of law, the Attorney General shall not impose or implement any limit on the number of persons eligible to be registered to manufacture or distribute marijuana pursuant to paragraph (1) or (2). (4) Requirement to verify use for legitimate research As a condition of registration under this section to manufacture or distribute marijuana, the Attorney General shall require the registrant— (A) to require any person to whom the marijuana will be supplied to submit documentation demonstrating that the marijuana (including any derivative, extract, preparation, and compound thereof) will be used by qualified marijuana researchers for research pursuant to subsection (f)(3) or for subsequent downstream manufacture by a duly registered manufacturer for use by qualified marijuana researchers for research pursuant to such subsection; (B) in the case of distribution, to complete, with respect to that distribution, the appropriate order form in accordance with section 308 and to upload such forms to the system used by the Drug Enforcement Administration for such distribution; (C) to include in the labeling of any marijuana so manufactured or distributed— (i) the following statement: This material is for biomedical and scientific research purposes only. ; and (ii) the name of the requestor of the marijuana; (D) to limit the transfer and sale of any marijuana under this subsection— (i) to researchers who are registered under this Act to conduct research with marijuana or to manufacturers duly registered under this subsection; and (ii) for purposes of use in preclinical research or in a clinical investigation pursuant to an investigational new drug exemption under 505(i) of the Federal Food, Drug, and Cosmetic Act or for the purposes of further manufacturing of marijuana; and (E) to transfer or sell any marijuana manufactured under this subsection only with prior, written consent for the transfer or sale by the Attorney General. (5) Timing Not later than 60 days after receipt of a request for registration under this subsection to manufacture or distribute marijuana, the Attorney General shall— (A) grant or deny the request; and (B) in the case of a denial, provide a written explanation of the basis for the denial. (6) Deemed approval If the Attorney General fails to grant or deny a request for registration under this subsection to manufacture or distribute marijuana within the 60-day period referred to in paragraph (5), such request is deemed approved. . 4. Termination of interdisciplinary review process for non-NIH-funded qualified marijuana 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 only conducted for research on marijuana other than the review of research protocols performed at the request of a qualified marijuana researcher conducting nonhuman research that is not federally funded, in accordance with section 303(f)(3)(A) of the Controlled Substances Act, as added by section 2 of this Act. 5. Consideration of results of research Immediately upon the approval by the Food and Drug Administration of an application for a drug that contains marijuana (as defined in section 102 of the Controlled Substances Act ( 21 U.S.C. 802 ), as amended by section 8 of this Act) under section 505 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355 ), and (irrespective of whether any such approval is granted) not later than the date that is 5 years after the date of enactment of this Act, the Secretary of Health and Human Services shall— (1) conduct a review of existing medical and other research with respect to marijuana; (2) submit a report to the Congress on the results of such review; and (3) include in such report whether, taking into consideration the factors listed in section 201(c) of the Controlled Substances Act ( 21 U.S.C. 811(c) ), as well as any potential for medical benefits, any gaps in research, and any impacts of Federal restrictions and policy on research, marijuana should be transferred to a schedule other than schedule I (if marijuana has not been so transferred already). 6. Production quotas for marijuana grown for legitimate, scientific research Section 306 of the Controlled Substances Act ( 21 U.S.C. 826 ) is amended by adding at the end the following: (j) The Attorney General may only establish a quota for production of marijuana that is manufactured and distributed in accordance with the Medical Marijuana Research Act that meets the changing medical, scientific, and industrial needs for marijuana. . 7. Article 28 of the single convention on narcotic drugs Article 28 of the Single Convention on Narcotic Drugs shall not be construed to prohibit, or impose additional restrictions upon, research involving marijuana, or the manufacture, distribution, or dispensing of marijuana, that is conducted in accordance with the Controlled Substances Act ( 21 U.S.C. 801 et seq. ), this Act, and the amendments made by this Act. 8. Definitions (a) Qualified marijuana researcher In this Act, the term qualified marijuana researcher has the meaning given the term in section 303(f)(3) of the Controlled Substances Act, as added by section 2(d) of this Act. (b) Updating term Section 102(16) of the Controlled Substances Act ( 21 U.S.C. 802(16) ) is amended— (1) in subparagraph (A), by striking the term marihuana means and inserting the terms marihuana and marijuana mean ; and (2) in subparagraph (B), by striking The term marihuana does not and inserting The terms marihuana and marijuana do not . 9. Determination of budgetary effects The budgetary effects of this Act, for the purpose of complying with the Statutory Pay-As-You-Go Act of 2010, shall be determined by reference to the latest statement titled Budgetary Effects of PAYGO Legislation for this Act, submitted for printing in the Congressional Record by the Chairman of the House Budget Committee, provided that such statement has been submitted prior to the vote on passage.

Passed the House of Representatives April 4, 2022. Cheryl L. Johnson, Clerk.