H.R. 3797 — what changed

changed This Act may be cited as the “Medical Marijuana Research Act of 2019”.Act”.

added “(2) Registration applications”

added “(4) Article 7”

added “(3)

added “(A) The Attorney General shall register a practitioner to conduct research with marijuana if—

added “(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;

added “(ii) the applicant’s research protocol has been reviewed and approved by the Secretary under section 505(i) of the Federal Food, Drug, and Cosmetic Act; and

added “(iii) the Secretary has determined the applicant is qualified to conduct bona fide research.

added “(B)

added “(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.

added “(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.

added “(iii) In the case of a denial under clause (i), the Attorney General shall provide a written explanation of the basis for the denial.

added “(C) 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:

added “(i) The applicant’s experience in dispensing, or conducting research with respect to, controlled substances.

added “(ii) The applicant’s conviction record under Federal or State laws relating to the manufacture, distribution, or dispensing of controlled substances.

added “(iii) Compliance with applicable State or local laws relating to controlled substance misuse or diversion.

added “(D)

added “(i) A qualified marijuana researcher shall store marijuana to be used in research in a securely locked, substantially constructed cabinet.

added “(ii) Except as provided in clause (i), any security measures required by the Attorney General for practitioners conducting research with marijuana pursuant to a registration under this paragraph shall be consistent with the security measures for practitioners conducting research on other controlled substances in schedule II that have a similar risk of diversion and abuse.

added “(E)

added “(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 change the type of marijuana, the source of the marijuana, or the conditions under which the marijuana is stored, tracked, or administered.

added “(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.

added “(iii)

added “(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 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 or new research protocol, as the case may be.

added “(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.

added “(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.

added “(F) If marijuana or a compound of 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 (E) of this paragraph.

added “(G) 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 (21 U.S.C. 355(i)) or over requirements related to research protocols, including changes in—

added “(i) the method of administration of marijuana;

added “(ii) the dosing of marijuana; and

added “(iii) the number of individuals or patients involved in research.”

added 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:

added “(l) Registration of persons to manufacture and distribute marijuana for use in legitimate, medical research

added “(1) Registration of manufacturers—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 manufacture 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), 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—

added “(A) maintenance of effective controls against diversion of marijuana and any controlled substance compounded therefrom into other than legitimate medical, scientific, or research channels;

added “(B) compliance with applicable State and local laws relating to controlled substance misuse and diversion; and

added “(C) prior conviction record of the applicant under Federal or State laws relating to the manufacture, distribution, or dispensing of such substances.

added “(2) Registration of distributors—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), unless the Attorney General determines that the issuance of such registration is inconsistent with the public interest.

added “(3) Public interest—In determining the public interest under paragraph (2), the Attorney General shall take into consideration—

added “(A) the factors specified in subparagraphs (A), (B), and (C) of such paragraph; and

added “(B) past experience in the distribution of controlled substances, and the existence of effective controls against diversion.

added “(4) 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).

added “(5) Requirement to verify use for legitimate, medical research—As a condition on registration under this section to manufacture or distribute marijuana, the Attorney General shall require the registrant—

added “(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);

added “(B) in the case of distribution, to complete, with respect to that distribution, the DEA Controlled substance order form in accordance with section 308 and to upload such forms to the system used by the Drug Enforcement Agency for such distribution;

added “(C) to include in the labeling of any marijuana so manufactured or distributed—

added “(i) the following statement: “This material is for biomedical and scientific research purposes only.”; and

added “(ii) the name of the requestor of the marijuana;

added “(D) to limit the transfer and sale of any marijuana manufactured under this subsection—

added “(i) to researchers who are registered under this Act to conduct research with marijuana; and

added “(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 (21 U.S.C. 355(i)); and

added “(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.

added “(6) 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—

added “(A) grant or deny the request; and

added “(B) in the case of a denial, provide a written explanation of the basis for the denial.

added “(7) 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.”

removed “(2) Registration applications”

removed “(4) Article 7”

removed “(3)

removed “(A) The Attorney General shall register a practitioner to conduct research with marijuana if—

removed “(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;

removed “(ii) the applicant is only using marijuana manufactured by a person registered under subsection (l);

removed “(iii) the applicant’s research protocol—

removed “(I) has been reviewed and allowed by—

removed “(aa) the Secretary under section 505(i) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(i)); or

removed “(bb) the National Institutes of Health or another Federal agency that funds scientific research; or

removed “(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

removed “(iv) 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).

removed “(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:

removed “(i) The applicant’s experience in dispensing, or conducting research with respect to, controlled substances.

removed “(ii) The applicant’s conviction record under Federal or State laws relating to the manufacture, distribution, or dispensing of controlled substances.

removed “(iii) Compliance with applicable State or local laws relating to controlled substance misuse or diversion.

removed “(C) Not later than 90 days after the date of enactment of the Medical Marijuana Research Act of 2019, for purposes of subparagraph (A)(ii)(II), the National Institutes of Health shall establish a process that—

removed “(i) allows a researcher to voluntarily submit the research protocol of the researcher for review and approval; and

removed “(ii) provides a researcher described in clause (i) with a decision not less than 30 days after the date on which the research protocol is submitted.

removed “(D)

removed “(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.

removed “(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.

removed “(iii) In the case of a denial under clause (i), the Attorney General shall provide a written explanation of the basis for the denial and a description of any curative steps that may be taken for such request to be approved.

removed “(E)

removed “(i) A researcher registered under this paragraph shall store marijuana to be used in research in a securely locked, substantially constructed cabinet.

removed “(ii) Except as provided in clause (i), any security measures required by the Attorney General for practitioners conducting research with marijuana pursuant to a registration under this paragraph shall be consistent with the security measures for practitioners conducting research on other controlled substances in schedule II that have a similar risk of diversion and abuse.

removed “(F)

removed “(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—

removed “(I) change the type of drug, the source of the drug, or the conditions under which the drug is stored, tracked, or administered; or

removed “(II) otherwise increase the risk of diversion.

removed “(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.

removed “(iii)

removed “(I) If an applicant amends or supplements a research protocol and the amendment or supplement 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 or new research protocol, as the case may be.

removed “(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.

removed “(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.

removed “(G) If marijuana or a compound of 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 (G) of this paragraph.”

changed Section 303 The Secretary of the Controlled Substances Act (21 U.S.C. 823), as amended by section 3, is further amended by adding at the end the following:Health and Human Services may not—

removed “(l) Registration of persons To manufacture and distribute marijuana for use in legitimate, medical research

removed “(1) Registration of manufacturers—Beginning not later than the day that is 1 year after the date of enactment of the Medical Marijuana Research Act of 2019, the Attorney General shall register an applicant to manufacture marijuana to the extent the marijuana will be used exclusively by qualified marijuana researchers for research pursuant to subsection (f)(3), 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—

removed “(A) take into consideration—

removed “(i) maintenance of effective controls against diversion of marijuana and any controlled substance compounded therefrom into other than legitimate medical, scientific, or research channels;

removed “(ii) compliance with applicable State and local laws relating to controlled substance misuse and diversion; and

removed “(iii) prior conviction record of the applicant under Federal or State laws relating to the manufacture, distribution, or dispensing of such substances; and

removed “(B) not take into consideration any factors other than the factors listed in subparagraph (A).

removed “(2) Registration of distributors—Beginning not later than the day that is 1 year after the date of enactment of the Medical Marijuana Research Act of 2019, the Attorney General shall register an applicant to distribute marijuana that is intended to be used exclusively by qualified medical marijuana researchers for research pursuant to subsection (f)(3), unless the Attorney General determines that the issuance of such registration is inconsistent with the public interest.

removed “(3) Public interest—In determining the public interest under paragraph (2), the Attorney General shall—

removed “(A) take into consideration—

removed “(i) maintenance of effective controls against diversion of marijuana and any controlled substance compounded therefrom into other than legitimate medical, scientific, or research channels;

removed “(ii) compliance with applicable State and local law;

removed “(iii) prior conviction record of the applicant under Federal or State laws relating to the manufacture, distribution, or dispensing of such substances; and

removed “(iv) past experience in the distribution of controlled substances, and the existence in the establishment of effective controls against diversion; and

removed “(B) not take into consideration any factors other than the factors listed in subparagraph (A).

removed “(4) 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).

removed “(5) Requirement to verify use for legitimate, medical research—As a condition on registration under this section to manufacture or distribute marijuana, the Attorney General shall require the registrant—

removed “(A) to require any person to whom the marijuana will be supplied to submit documentation demonstrating that the marijuana will be used exclusively by qualified medical marijuana researchers for research pursuant to subsection (f)(3);

removed “(B) in the case of distribution, to complete, with respect to that distribution, the DEA Controlled substance order form (DEA 222) (or a successor form) and the DEA Certificate of Registration (DEA Form 223) (or a successor form) and to upload such forms to the system used by the Drug Enforcement Agency for such distribution;

removed “(C) to include in the labeling of any marijuana so manufactured or distributed—

removed “(i) the following statement: “This material is for medical and scientific research purposes only.”; and

removed “(ii) the name of the requestor of the marijuana; and

removed “(D) not later than 30 days after receipt of such documentation, and before supplying the marijuana to such person, to review such documentation and verify that the marijuana will be so used.

removed “(6) Timing—Not later than 30 days after receipt of a request for registration under this subsection to manufacture or distribute marijuana, the Attorney General shall—

removed “(A) grant or deny the request; and

removed “(B) in the case of a denial, provide a written explanation of the basis for the denial and a description of any curative steps that may be taken for such request to be approved.

removed “(7) 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 30-day period referred to in paragraph (5), such request is deemed approved.

removed “(8) Definition—For purposes of this subsection, the term qualified medical marijuana researcher means a researcher who is registered to conduct research with marijuana under subsection (f)(3).”

changed The Immediately upon the approval by the Food and Drug Administration of an application for a drug that contains marijuana 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 may not—shall—

changed Immediately upon the approval by the Food and Drug Administration of an application for a marijuana-based drug under section 505 Section 306 of the Federal Food, Drug, and Cosmetic Controlled Substances Act (21 U.S.C. 355), and (irrespective of whether any such approval is granted) not later than the date that 826) is 5 years after amended by adding at the date of enactment of this Act, end the Secretary of Health and Human Services shall—following:

added “(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.”

changed Section 306 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. 826) is amended by adding at the end 801 et seq.), this Act, and the following:amendments made by this Act.

removed “(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 of 2019 that meets the changing medical, scientific, and industrial needs for marijuana (as defined by the National Institute on Drug Abuse).”

removed 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.