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Bill
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S. 2032 — what changed

Cannabidiol and Marihuana Research Expansion Act

From Introduced in Senate to Engrossed in Senate. 4 sections amended between Introduced in Senate and Engrossed in Senate.

2. Definitions

In this Act—

(1)
the term appropriately registered means that an individual or entity is registered under the Controlled Substances Act (21 U.S.C. 801 et seq.) to engage in the type of activity that is carried out by the individual or entity with respect to a controlled substance on the schedule that is applicable to cannabidiol or marihuana, as applicable;
(2)
the term cannabidiol means—
(A)
changed the substance, cannabidiol, as derived from marihuana that has a tet­ra­hy­dro­can­nabinol delta–9 tetrahydrocannabinol level that is greater than 0.3 percent; and
(B)
the synthetic equivalent of the substance described in subparagraph (A);
(3)
the terms controlled substance, dispense, distribute, manufacture, marihuana, and practitioner have the meanings given such terms in section 102 of the Controlled Substances Act (21 U.S.C. 802), as amended by this Act;
(4)
the term covered institution of higher education means an institution of higher education (as defined in section 101 of the Higher Education Act of 1965 (20 U.S.C. 1001)) that—
(A)
(i)
has highest or higher research activity, as defined by the Carnegie Classification of Institutions of Higher Education; or
(ii)
is an accredited medical school or an accredited school of osteopathic medicine; and
(B)
is appropriately registered under the Controlled Substances Act (21 U.S.C. 801 et seq.);
(5)
the term drug has the meaning given the term in section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(g)(1));
(6)
the term medical research for drug development means medical research that is—
(A)
a preclinical study or clinical investigation conducted in accordance with section 505(i) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(i)) or otherwise permitted by the Department of Health and Human Services to determine the potential medical benefits of marihuana or cannabidiol as a drug; and
(B)
conducted by a covered institution of higher education, practitioner, or manufacturer that is appropriately registered under the Controlled Substances Act (21 U.S.C. 801 et seq.); and
(7)
the term State means any State of the United States, the District of Columbia, and any territory of the United States.

102. Research protocols

(a)
changed In general— Paragraph (2)(B) of section 303 303(f) of the Controlled Substances Act (21 U.S.C. 823(f)), as amended by section 101 of this Act, is further amended by adding at the end the following:

“(vi)

“(I) If the Attorney General grants an application for registration under clause (i), the registrant may amend or supplement the research protocol without reapplying if the registrant does not change—

“(aa) the quantity or type of drug;

“(bb) the source of the drug; or

“(cc) the conditions under which the drug is stored, tracked, or administered.

“(II)

“(aa) If a registrant under clause (i) seeks to change the type of drug, the source of the drug, or conditions under which the drug is stored, tracked, or administered, the registrant shall notify the Attorney General via registered mail, or an electronic means permitted by the Attorney General, not later than 30 days before implementing an amended or supplemental research protocol.

“(bb) A registrant may proceed with an amended or supplemental research protocol described in item (aa) if the Attorney General does not explicitly object during the 30-day period beginning on the date on which the Attorney General receives the notice under item (aa).

“(cc) The Attorney General may only object to an amended or supplemental research protocol under this subclause if additional security measures are needed to safeguard against diversion or abuse.

“(dd) If a registrant under clause (i) seeks to address additional security measures identified by the Attorney General under item (cc), the registrant shall notify the Attorney General via registered mail, or an electronic means permitted by the Attorney General, not later than 30 days before implementing an amended or supplemental research protocol.

“(ee) A registrant may proceed with an amended or supplemental research protocol described in item (dd) if the Attorney General does not explicitly object during the 30-day period beginning on the date on which the Attorney General receives the notice under item (dd).

changed “(III) If a registrant under clause (i) seeks to change the quantity of marihuana needed for research, the change shall be deemed approved by the Attorney General on the date on which the registered mail return receipt is returned to the registrant, or the date on which the electronic notification, as permitted by the Attorney General, is received, if the registrant submits to the Attorney General—“(III)

changed “(aa) If a registrant under clause (i) seeks to change the Drug Enforcement Administration registration number quantity of marihuana needed for research and the registrant;change in quantity does not impact the factors described in item (bb) or (cc) of subclause (I) of this clause, the registrant shall notify the Attorney General via registered mail or using an electronic means permitted by the Attorney General.

changed “(bb) the quantity of marihuana already obtained; andA notification under item (aa) shall include—

changed “(cc) “(AA) the quantity Drug Enforcement Administration registration number of additional marihuana needed to complete the research.registrant;

added “(BB) the quantity of marihuana already obtained;

added “(CC) the quantity of additional marihuana needed to complete the research; and

added “(DD) an attestation that the change in quantity does not impact the source of the drug or the conditions under which the drug is stored, tracked, or administered.

added “(cc) The Attorney General shall ensure that—

added “(AA) any registered mail return receipt with respect to a notification under item (aa) is submitted for delivery to the registrant providing the notification not later than 3 days after receipt of the notification by the Attorney General; and

added “(BB) notice of receipt of a notification using an electronic means permitted under item (aa) is provided to the registrant providing the notification not later than 3 days after receipt of the notification by the Attorney General.

added “(dd)

added “(AA) On and after the date described in subitem (BB), a registrant that submits a notification in accordance with item (aa) may proceed with the research as if the change in quantity has been approved on such date, unless the Attorney General notifies the registrant of an objection described in item (ee).

added “(BB) The date described in this subitem is the date on which a registrant submitting a notification under item (aa) receives the registered mail return receipt with respect to the notification or the date on which the registrant receives notice that the notification using an electronic means permitted under item (aa) was received by the Attorney General, as the case may be.

added “(ee) A notification submitted under item (aa) shall be deemed to be approved unless the Attorney General, not later than 10 days after receiving the notification, explicitly objects based on a finding that the change in quantity—

added “(AA) does impact the source of the drug or the conditions under which the drug is stored, tracked, or administered; or

added “(BB) necessitates that the registrant implement additional security measures to safeguard against diversion or abuse.

“(IV) Nothing in this clause shall limit the authority of the Secretary of Health and Human Services over requirements related to research protocols, including changes in—

“(aa) the method of administration of marihuana;

“(bb) the dosing of marihuana; and

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

(b)
Regulations— Not later than 1 year after the date of enactment of this Act, the Attorney General shall promulgate regulations to carry out the amendment made by this section.

103. Applications to manufacture marihuana for research

(a)
In general— Section 303 of the Controlled Substances Act (21 U.S.C. 823) is amended—
(1)
by redesignating subsections (c) through (k) as subsections (d) through (l), respectively;
(2)
by inserting after subsection (b) the following:

“(c)

“(1)

“(A) As it relates to applications to manufacture marihuana for research purposes, if the Attorney General places a notice in the Federal Register to increase the number of entities registered under this Act to manufacture marihuana to supply appropriately registered researchers in the United States, the Attorney General shall, not later than 60 days after the date on which the Attorney General receives a completed application—

“(i) approve the application; or

“(ii) request supplemental information.

“(B) For purposes of subparagraph (A), an application shall be deemed complete when the applicant has submitted documentation showing each of the following:

“(i) The requirements designated in the notice in the Federal Register are satisfied.

“(ii) The requirements under this Act are satisfied.

“(iii) The applicant will limit the transfer and sale of any marihuana manufactured under this subsection—

“(I) to researchers who are registered under this Act to conduct research with controlled substances in schedule I; 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 (21 U.S.C. 355(i)).

“(iv) The applicant will transfer or sell any marihuana manufactured under this subsection only with prior, written consent for the transfer or sale by the Attorney General.

“(v) The applicant has completed the application and review process under subsection (a) for the bulk manufacture of controlled substances in schedule I.

“(vi) The applicant has established and begun operation of a process for storage and handling of controlled substances in schedule I, including for inventory control and monitoring security in accordance with section 105 of the Cannabidiol and Marihuana Research Expansion Act.

“(vii) The applicant is licensed by each State in which the applicant will conduct operations under this subsection, to manufacture marihuana, if that State requires such a license.

“(C) Not later than 30 days after the date on which the Attorney General receives supplemental information requested under subparagraph (A)(ii) with respect to an application, the Attorney General shall approve or deny the application.

“(2) If an application described in this subsection is denied, the Attorney General shall provide a written explanation of the basis of denial to the applicant.”

(3)
in subsection (h)(2), as so redesignated, by striking “subsection (f)” each place it appears and inserting “subsection (g)”;
(4)
in subsection (j)(1), as so redesignated, by striking “subsection (d)” and inserting “subsection (e)”; and
(5)
in subsection (k), as so redesignated, by striking “subsection (f)” each place it appears and inserting “subsection (g)”.
(b)
Technical and conforming amendments—
(1)
The Controlled Substances Act (21 U.S.C. 801 et seq.) is amended—
(A)
in section 102 (21 U.S.C. 802)—
(i)
in paragraph (16)(B)—
(I)
in clause (i), by striking “or” at the end;
(II)
by redesignating clause (ii) as (iii); and
(III)
by inserting after clause (i) the following:

“(ii) the synthetic equivalent of hemp-derived cannabidiol that contains less than 0.3 percent tetrahydrocannabinol; or”

(ii)
in paragraph (52)(B)—
(I)
by striking “303(f)” each place it appears and inserting “303(g)”; and
(II)
in clause (i), by striking “(d), or (e)” and inserting “(e), or (f)”; and
(iii)
in paragraph (54), by striking “303(f)” each place it appears and inserting “303(g)”;
(B)
added in section 302(g)(5)(A)(iii)(I)(bb) (21 U.S.C. 822(g)(5)(A)(iii)(I)(bb)), by striking “303(f)” and inserting “303(g)”;
(C)
renumbered was (3)(2)(3) in section 304 (21 U.S.C. 824), by striking “303(g)(1)” each place it appears and inserting “303(h)(1)”;
(D)
renumbered was (3)(2)(4) in section 307(d)(2) (21 U.S.C. 827(d)(2)), by striking “303(f)” and inserting “303(g)”;
(E)
added in section 309A(a)(2) (21 U.S.C. 829a(a)(2)), in the matter preceding subparagraph (A), by striking “303(g)(2)” and inserting “303(h)(2)”;
(F)
renumbered was (3)(2)(5) in section 311(h) (21 U.S.C. 831(h)), by striking “303(f)” each place it appears and inserting “303(g)”;
(G)
renumbered was (3)(2)(6) in section 401(h)(2) (21 U.S.C. 841(h)(2)), by striking “303(f)” each place it appears and inserting “303(g)”;
(H)
renumbered was (3)(2)(7) in section 403(c)(2)(B) (21 U.S.C. 843(c)(2)(B)), by striking “303(f)” and inserting “303(g)”; and
(I)
renumbered was (3)(2)(8) in section 512(c)(1) (21 U.S.C. 882(c)(1)) by striking “303(f)” and inserting “303(g)”.
(2)
Section 1008(c) of the Controlled Substances Import and Export Act (21 U.S.C. 958(c)) is amended—
(A)
in paragraph (1), by striking “303(d)” and inserting “303(e)”; and
(B)
in paragraph (2)(B), by striking “303(h)” and inserting “303(i)”.
(3)
Title V of the Public Health Service Act (42 U.S.C. 290aa et seq.) is amended—
(A)
in section 520E–4(c) (42 U.S.C. 290bb–36d(c)), by striking “303(g)(2)(B)” and inserting “303(h)(2)(B)”; and
(B)
in section 544(a)(3) (42 U.S.C. 290dd–3(a)(3)), by striking “303(g)” and inserting “303(h)”.
(4)
added Title XVIII of the Social Security Act (42 U.S.C. 1395 et seq.) is amended—
(A)
added in section 1833(bb)(3)(B) (42 U.S.C. 1395l(bb)(3)(B)), by striking “303(g)” and inserting “303(h)”;
(B)
added in section 1834(o)(3)(C)(ii) (42 U.S.C. 1395m(o)(3)(C)(ii)), by striking “303(g)” and inserting “303(h)”; and
(C)
added in section 1866F(c)(3)(C) (42 U.S.C. 1395cc–6(c)(3)(C)), by striking “303(g)” and inserting “303(h)”.
(5)
added Section 1903(aa)(2)(C)(ii) of the Social Security Act (42 U.S.C. 1396b(aa)(2)(C)(ii)) is amended by striking “303(g)” each place it appears and inserting “303(h)”.

301. Doctor-patient relationship

changed It shall not be unlawful a violation of the Controlled Substances Act (21 U.S.C. 801 et seq.) for a State-licensed physician to discuss—

(1)
the currently known potential harms and benefits of marihuana derivatives, including cannabidiol, as a treatment with the legal guardian of the patient of the physician if the patient is a child; or
(2)
the currently known potential harms and benefits of marihuana and marihuana derivatives, including cannabidiol, as a treatment with the patient or the legal guardian of the patient of the physician if the patient is a legal adult.