H.R. 3797 — what changed

“(2) Registration applications”

“(4) Article 7”

“(3)

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

added “(i) the applicant is authorized to dispense, or conduct research with respect to, controlled substances in schedule I, II, III, IV, or V;

added “(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

added “(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.

added “(B) An applicant registered under subparagraph (A) shall be referred to in this section as a “qualified marijuana researcher”.

added “(C)

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

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

removed “(B)

“(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.

added “(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:

removed “(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:

“(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.

added “(iv) Such other conduct which may threaten the public health and safety.

removed “(D)

removed “(i) A qualified marijuana researcher 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.

“(E)

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 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.

added “(F)

added “(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.

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 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)

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, 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 “(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.

“(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.

added “(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.

added “(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—

removed “(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.

removed “(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—

“(i) the method of administration of marijuana;

“(ii) the dosing of marijuana; and

“(iii) the number of individuals or patients involved in 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:

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

changed “(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—manufacturers

changed “(A) maintenance In general—Beginning not later than the day that is 1 year after the date of effective controls against diversion enactment of marijuana 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 controlled substance compounded therefrom into other than legitimate medical, scientific, or research channels;derivative, extract, preparation, and compound thereof) that is intended for—

changed “(B) compliance with applicable State “(i) the ultimate and local laws relating exclusive use by qualified marijuana researchers for research pursuant to controlled substance misuse and diversion; andsubsection (f)(3); or

changed “(C) prior conviction record of “(ii) subsequent downstream manufacture by a duly registered manufacturer for the applicant under Federal or State laws relating ultimate and exclusive use by qualified marijuana researchers for research pursuant to the manufacture, distribution, or dispensing of such substances.subsection (f)(3).

changed “(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 “(B) Public interest—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), under subparagraph (A) unless the Attorney General determines that the issuance of such registration is inconsistent with the public interest.interest. In determining the public interest, the Attorney General shall take into consideration—

changed “(3) Public interest—In determining the public interest under paragraph (2), the Attorney General shall take “(i) maintenance of effective controls against diversion of marijuana and any controlled substance compounded therefrom into consideration—other than legitimate medical, scientific, or research channels;

changed “(A) the factors specified in subparagraphs (A), (B), “(ii) compliance with applicable State and (C) of such paragraph; andlocal laws relating to controlled substance misuse and diversion;

changed “(B) past experience in the distribution “(iii) prior conviction record of controlled substances, and the existence applicant under Federal or State laws relating to the manufacture, distribution, or dispensing of effective controls against diversion.such substances; and

changed “(4) No limit on number of manufacturers and distributors—Notwithstanding any “(iv) such other provision of law, the Attorney General shall not impose or implement any limit on conduct which may threaten the number of persons eligible to be registered to manufacture or distribute marijuana pursuant to paragraph (1) or (2).public health and safety.

changed “(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—“(2) Registration of distributors

changed “(A) to require any person to whom In general—Beginning not later than the marijuana will be supplied to submit documentation demonstrating 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) will be ultimately used exclusively that is intended for the ultimate and exclusive use by qualified marijuana researchers for research pursuant to subsection (f)(3);(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.

changed “(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 Public interest—In determining the system used by public interest under subparagraph (A), the Drug Enforcement Agency for such distribution;Attorney General shall take into consideration—

added “(i) the factors specified in clauses (i), (ii), (iii), and (iv) of paragraph (1)(B); and

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

added “(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).

added “(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—

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) or for subsequent downstream manufacture by a duly registered manufacturer for use by qualified marijuana researchers for research pursuant to such subsection;

added “(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;

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

added “(i) to researchers who are registered under this Act to conduct research with marijuana or to manufacturers duly registered under this subsection; 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 or for the purposes of further manufacturing of marijuana; and

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

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

removed “(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

“(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 “(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—

removed “(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—

“(A) grant or deny the request; and

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

added “(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.”

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 60-day period referred to in paragraph (5), such request is deemed approved.”

The Secretary of Health and Human Services may not—

changed 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—