[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[H.R. 8454 Enrolled Bill (ENR)]
H.R.8454
One Hundred Seventeenth Congress
of the
United States of America
AT THE SECOND SESSION
Begun and held at the City of Washington on Monday,
the third day of January, two thousand and twenty-two
An Act
To expand research on cannabidiol and marijuana, and for other purposes.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE; TABLE OF CONTENTS.
(a) Short Title.--This Act may be cited as the ``Medical Marijuana
and Cannabidiol Research Expansion Act''.
(b) Table of Contents.--The table of contents for this Act is as
follows:
Sec. 1. Short title; table of contents.
Sec. 2. Definitions.
Sec. 3. Determination of budgetary effects.
TITLE I--REGISTRATIONS FOR MARIJUANA RESEARCH
Sec. 101. Marijuana research applications.
Sec. 102. Research protocols.
Sec. 103. Applications to manufacture marijuana for research.
Sec. 104. Adequate and uninterrupted supply.
Sec. 105. Security requirements.
Sec. 106. Prohibition against reinstating interdisciplinary review
process for non-NIH-funded researchers.
TITLE II--DEVELOPMENT OF FDA-APPROVED DRUGS USING CANNABIDIOL AND
MARIJUANA
Sec. 201. Medical research on cannabidiol.
Sec. 202. Registration for the commercial production and distribution of
Food and Drug Administration-approved drugs.
TITLE III--DOCTOR-PATIENT RELATIONSHIP
Sec. 301. Doctor-patient relationship.
TITLE IV--FEDERAL RESEARCH
Sec. 401. Federal research.
SEC. 2. DEFINITIONS.
(a) In General.--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 marijuana, as applicable;
(2) the term ``cannabidiol'' means--
(A) the substance, cannabidiol, as derived from marijuana
that has a 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'', ``marijuana'', 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 marijuana 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.
(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''.
SEC. 3. 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.
TITLE I--REGISTRATIONS FOR MARIJUANA RESEARCH
SEC. 101. MARIJUANA RESEARCH APPLICATIONS.
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)(A) Registration applications'';
(4) by striking ``Article 7'' and inserting the following:
``(3) Article 7''; and
(5) by inserting after paragraph (2)(A), as so designated, the
following:
``(B)(i) The Attorney General shall register a practitioner to
conduct research with marijuana (including any derivative, extract,
preparation, and compound thereof) if--
``(I) the applicant's research protocol has been reviewed and
allowed--
``(aa) by the Secretary of Health and Human Services under
section 505(i) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 355(i));
``(bb) by the National Institutes of Health or another
Federal agency that funds scientific research; or
``(cc) pursuant to sections 1301.18 and 1301.32 of title
21, Code of Federal Regulations, or any successors thereto; and
``(II) the applicant has demonstrated to the Attorney General
that there are effective procedures in place to adequately
safeguard against diversion of the controlled substance for
legitimate medical or scientific use pursuant to section 105 of the
Medical Marijuana and Cannabidiol Research Expansion Act, including
demonstrating that the security measures are adequate for storing
the quantity of marijuana the applicant would be authorized to
possess.
``(ii) The Attorney General may deny an application for
registration under this subparagraph only if the Attorney General
determines that the issuance of the registration would be inconsistent
with the public interest. In determining the public interest, the
Attorney General shall consider the factors listed in--
``(I) subparagraphs (B) through (E) of paragraph (1); and
``(II) subparagraph (A) of paragraph (1), if the applicable
State requires practitioners conducting research to register with a
board or authority described in such subparagraph (A).
``(iii)(I) Not later than 60 days after the date on which the
Attorney General receives a complete application for registration under
this subparagraph, the Attorney General shall--
``(aa) approve the application; or
``(bb) request supplemental information.
``(II) For purposes of subclause (I), an application shall be
deemed complete when the applicant has submitted documentation showing
that the requirements under clause (i) are satisfied.
``(iv) Not later than 30 days after the date on which the Attorney
General receives supplemental information as described in clause
(iii)(I)(bb) in connection with an application described in this
subparagraph, the Attorney General shall approve or deny the
application.
``(v) If an application described in this subparagraph is denied,
the Attorney General shall provide a written explanation of the basis
of denial to the applicant.''.
SEC. 102. RESEARCH PROTOCOLS.
(a) In General.--Paragraph (2)(B) of section 303(f) of the
Controlled Substances Act (21 U.S.C. 823(f)), as added 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 notification to, or review by, the Drug
Enforcement Administration if the registrant does not change--
``(aa) the quantity or type of marijuana or cannabidiol
(including any derivative, extract, preparation, and compound
thereof);
``(bb) the source of such marijuana or cannabidiol; or
``(cc) the conditions under which such marijuana or cannabidiol
is stored, tracked, or administered.
``(II)(aa) If a registrant under clause (i) seeks to change the
type of marijuana or cannabidiol (including any derivative, extract,
preparation, and compound thereof), the source of such marijuana or
cannabidiol, or the conditions under which such marijuana or
cannabidiol 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).
``(III)(aa) If a registrant under clause (i) seeks to change the
quantity of marijuana needed for research and the 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.
``(bb) A notification under item (aa) shall include--
``(AA) the Drug Enforcement Administration registration number
of the registrant;
``(BB) the quantity of marijuana or cannabidiol already
obtained;
``(CC) the quantity of additional marijuana or cannabidiol
needed to complete the research; and
``(DD) an attestation that the change in quantity does not
impact the source of the marijuana or cannabidiol or the conditions
under which the marijuana or cannabidiol is stored, tracked, or
administered.
``(cc) The Attorney General shall ensure that--
``(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
``(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.
``(dd)(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).
``(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.
``(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--
``(AA) does impact the source of the marijuana or cannabidiol
or the conditions under which the marijuana or cannabidiol is
stored, tracked, or administered; or
``(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 marijuana or
cannabidiol;
``(bb) the dosing of marijuana or cannabidiol; 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.
SEC. 103. APPLICATIONS TO MANUFACTURE MARIJUANA FOR RESEARCH.
(a) In General.--Section 303 of the Controlled Substances Act (21
U.S.C. 823), as amended by sections 101 and 102 of this Act, is further
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 marijuana
for research purposes, when the Attorney General places a notice in the
Federal Register to increase the number of entities registered under
this Act to manufacture marijuana 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
marijuana 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 marijuana
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 Medical Marijuana and
Cannabidiol Research Expansion Act.
``(vii) The applicant is licensed by each State in which the
applicant will conduct operations under this subsection, to
manufacture marijuana, 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 (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
(ii) in paragraph (54), by striking ``303(f)'' each
place it appears and inserting ``303(g)'';
(B) 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) in section 304 (21 U.S.C. 824), by striking
``303(g)(1)'' each place it appears and inserting
``303(h)(1)'';
(D) in section 307(d)(2) (21 U.S.C. 827(d)(2)), by striking
``303(f)'' and inserting ``303(g)'';
(E) 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) in section 311(h) (21 U.S.C. 831(h)), by striking
``303(f)'' each place it appears and inserting ``303(g)'';
(G) 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) in section 403(c)(2)(B) (21 U.S.C. 843(c)(2)(B)), by
striking ``303(f)'' and inserting ``303(g)''; and
(I) 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) Title XVIII of the Social Security Act (42 U.S.C. 1395 et
seq.) is amended--
(A) in section 1833(bb)(3)(B) (42 U.S.C. 1395l(bb)(3)(B)),
by striking ``303(g)'' and inserting ``303(h)'';
(B) 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) in section 1866F(c)(3)(C) (42 U.S.C. 1395cc-
6(c)(3)(C)), by striking ``303(g)'' and inserting ``303(h)''.
(5) 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)''.
SEC. 104. ADEQUATE AND UNINTERRUPTED SUPPLY.
(a) In General.--On an annual basis, the Attorney General, in
consultation with the Secretary of Health and Human Services, shall
assess whether there is an adequate and uninterrupted supply of
marijuana, including of specific strains, for research purposes.
(b) Report to Congress.--If the Attorney General, in consultation
with the Secretary of Health and Human Services, determines there is an
inadequate or interrupted supply of marijuana, including of specific
strains for research purposes, the Attorney General shall report to
Congress within 60 days of the determination on at least--
(1) the factors contributing to the inadequate or interrupted
supply of marijuana;
(2) expected impacts of the inadequate or interrupted supply on
ongoing research protocols; and
(3) specific steps the Attorney General will take to restore an
adequate and uninterrupted supply of marijuana, including of
specific strains, for research purposes.
SEC. 105. SECURITY REQUIREMENTS.
(a) In General.--An individual or entity engaged in researching
marijuana or its components shall store it in a securely locked,
substantially constructed cabinet.
(b) Requirements for Other Measures.--Any other security measures
required by the Attorney General to safeguard against diversion shall
be consistent with those required for practitioners conducting research
on other controlled substances in schedules I and II in section 202(c)
of the Controlled Substances Act (21 U.S.C. 812(c)) that have a similar
risk of diversion and abuse.
SEC. 106. PROHIBITION AGAINST REINSTATING INTERDISCIPLINARY REVIEW
PROCESS FOR NON-NIH-FUNDED RESEARCHERS.
The Secretary of Health and Human Services may not--
(1) reinstate the Public Health Service interdisciplinary
review process described in the guidance entitled ``Guidance on
Procedures for the Provision of Marijuana for Medical Research''
(issued on May 21, 1999); or
(2) require another review of scientific protocols that is
applicable only to research on marijuana or its components.
TITLE II--DEVELOPMENT OF FDA-APPROVED DRUGS USING CANNABIDIOL AND
MARIJUANA
SEC. 201. MEDICAL RESEARCH ON CANNABIDIOL.
Notwithstanding any provision of the Controlled Substances Act (21
U.S.C. 801 et seq.), the Safe and Drug-Free Schools and Communities Act
(20 U.S.C. 7101 et seq.), chapter 81 of title 41, United States Code,
or any other Federal law, an appropriately registered covered
institution of higher education, practitioner, or manufacturer may
manufacture, distribute, dispense, or possess marijuana or cannabidiol
if the marijuana or cannabidiol is manufactured, distributed,
dispensed, or possessed, respectively, for purposes of medical research
for drug development or subsequent commercial production in accordance
with section 202.
SEC. 202. REGISTRATION FOR THE COMMERCIAL PRODUCTION AND
DISTRIBUTION OF FOOD AND DRUG ADMINISTRATION-APPROVED DRUGS.
The Attorney General shall register an applicant to manufacture or
distribute cannabidiol or marijuana for the purpose of commercial
production of a drug containing or derived from marijuana that is
approved by the Secretary of Health and Human Services under section
505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355), in
accordance with the applicable requirements under subsection (a) or (b)
of section 303 of the Controlled Substances Act (21 U.S.C. 823).
TITLE III--DOCTOR-PATIENT RELATIONSHIP
SEC. 301. DOCTOR-PATIENT RELATIONSHIP.
It shall not be 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
marijuana 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
marijuana and marijuana 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.
TITLE IV--FEDERAL RESEARCH
SEC. 401. FEDERAL RESEARCH.
(a) In General.--Not later than 1 year after the date of enactment
of this Act, the Secretary of Health and Human Services, in
coordination with the Director of the National Institutes of Health and
the heads of other relevant Federal agencies, shall submit to the
Caucus on International Narcotics Control, the Committee on the
Judiciary, and the Committee on Health, Education, Labor, and Pensions
of the Senate and the Committee on Energy and Commerce and the
Committee on the Judiciary of the House of Representatives a report
on--
(1) the potential therapeutic effects of cannabidiol or
marijuana on serious medical conditions, including intractable
epilepsy;
(2) the potential effects of marijuana, including--
(A) the effect of increasing delta-9-tetrahydrocannabinol
levels on the human body and developing adolescent brains; and
(B) the effect of various delta-9-tetrahydrocannabinol
levels on cognitive abilities, such as those that are required
to operate motor vehicles or other heavy equipment; and
(3) the barriers associated with researching marijuana or
cannabidiol in States that have legalized the use of such
substances, which shall include--
(A) recommendations as to how such barriers might be
overcome, including whether public-private partnerships or
Federal-State research partnerships may or should be
implemented to provide researchers with access to additional
strains of marijuana and cannabidiol; and
(B) recommendations as to what safeguards must be in place
to verify--
(i) the levels of tetrahydrocannabinol, cannabidiol, or
other cannabinoids contained in products obtained from such
States is accurate; and
(ii) that such products do not contain harmful or toxic
components.
(b) Activities.--To the extent practicable, the Secretary of Health
and Human Services, either directly or through awarding grants,
contacts, or cooperative agreements, shall expand and coordinate the
activities of the National Institutes of Health and other relevant
Federal agencies to better determine the effects of cannabidiol and
marijuana, as outlined in the report submitted under paragraphs (1) and
(2) of subsection (a).
Speaker of the House of Representatives.
Vice President of the United States and
President of the Senate.