Federal Register, Volume 91 Issue 81 (Tuesday, April 28, 2026)

[Federal Register Volume 91, Number 81 (Tuesday, April 28, 2026)]
[Rules and Regulations]
[Pages 22714-22723]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2026-08176]

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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Parts 1300, 1301, 1308, and 1312

[AG Order No. 6754-2026]

Schedules of Controlled Substances: Rescheduling of Food and Drug
Administration Approved Products Containing Marijuana From Schedule I
to Schedule III; Corresponding Change to Permit Requirements

AGENCY: Drug Enforcement Administration, Department of Justice.

ACTION: Final rule.

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SUMMARY: With the issuance of this final rule, which constitutes a
final order, the Acting Attorney General of the U.S. Department of
Justice places drug products containing marijuana that have been
approved by the Food and Drug Administration (FDA) in schedule III of
the Controlled Substances Act (``CSA''). This action is required to
satisfy the responsibility of the Administrator under the CSA to place
a drug in the schedule he deems most appropriate to carry out United
States obligations under the Single Convention on Narcotic Drugs, 1961.
In general, this final rule applies to marijuana as defined in the CSA,
marijuana extracts, and delta-9-tetrahydrocannabinol and other
compounds derived from the marijuana plant (other than the mature
stalks and seeds) that falls outside the definition of hemp, to the
extent that any of these are included in an FDA-approved drug product
or are subject to

[[Page 22715]]

a state-issued license to manufacture, distribute, and/or dispense
marijuana or products containing marijuana for medical purposes
(``state medical marijuana license''). Also consistent therewith, this
final rule adds such drugs to the list of substances that may only be
imported or exported pursuant to a permit. This final rule also
establishes an expedited registration process under 21 CFR part 1301
for entities holding state medical marijuana licenses, enabling such
entities to engage in the manufacture, distribution, and/or dispensing
of marijuana for medical purposes under federal law consistent with the
requirements of the Single Convention.

DATES: Effective April 28, 2026.

ADDRESSES: 8701 Morrissette Drive, Springfield, Virginia 22152.

FOR FURTHER INFORMATION CONTACT: Dr. Clara Hellickson, Drug and
Chemical Evaluation Section, Diversion Control Division, Drug
Enforcement Administration; Telephone: (571) 362-3249.

SUPPLEMENTARY INFORMATION:

Background and Legal Authority

The United States' Treaty Obligations

The United States is a party to the United Nations Single
Convention on Narcotic Drugs, Mar. 30, 1961, 18 U.S.T. 1407, 520
U.N.T.S. 151 (``Single Convention''), as amended by the 1972 Protocol.
The Single Convention entered into force for the United States on June
24, 1967, after the Senate gave its advice and consent to the United
States' accession.\1\ The enactment and enforcement of the CSA are the
primary means by which the United States carries out its obligations
under the Single Convention.\2\ Various provisions of the CSA directly
reference the Single Convention. One such provision is 21 U.S.C.
811(d)(1), which relates to scheduling of controlled substances.
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\1\ See Single Convention, 18 U.S.T. 1407.
\2\ See S. Rep. No. 91-613, at 4 (1969) (``The United States has
international commitments to help control the worldwide drug
traffic. To honor those commitments, principally those established
by the Single Convention on Narcotic Drugs of 1961, is clearly a
Federal responsibility.''); Office of Legal Counsel, Control of
Papaver Bracteatum, 1 Op. O.L.C. 93, 95 (1977) (``[A] number of the
provisions of [the CSA] reflect Congress' intent to comply with the
obligations imposed by the Single Convention.'').
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Under 21 U.S.C. 811(d)(1), if control of a substance is required
``by United States obligations under international treaties,
conventions, or protocols in effect on October 27, 1970''--which
includes the Single Convention--the Attorney General shall issue an
order controlling such drug under the schedule he deems most
appropriate to carry out such obligations, without regard to the
findings required by [21 U.S.C. 811(a) or 812(b)] and without regard to
the procedures prescribed by [21 U.S.C. 811(a) and (b)].'' \3\ This
provision is consistent with the Supremacy Clause of the U.S.
Constitution, which provides that all treaties made under the authority
of the United States ``shall be the supreme Law of the Land.'' \4\ In
accordance with this constitutional mandate, under section 811(d)(1),
Congress directed the Attorney General to ensure that compliance by the
United States with our nation's obligations under the Single Convention
is given top consideration when it comes to scheduling
determinations.\5\ Importantly, the Department of Justice's Office of
Legal Counsel (OLC) concluded in a 1972 opinion that 21 U.S.C.
811(d)(1) is not limited to those instances where a substance is newly
added to an international schedule.\6\
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\3\ See also 21 CFR 1308.46.
\4\ U.S. Const., art. VI, sec. 2.
\5\ The Attorney General has delegated scheduling authority
under 21 U.S.C. 811 to the Administrator of the Drug Enforcement
Administration. 28 CFR 0.100.
\6\ Petition to Decontrol Marijuana; Interpretation of Section
201 of the Controlled Substances Act of 1970, Op. O.L.C. at 7-8
(Aug. 21, 1972) (recognizing that the House Report ``clearly shows
that a much broader application was intended''). Consistent with
this understanding of the CSA and the Single Convention, on
September 28, 2018, DEA issued a final rule under 21 U.S.C.
811(d)(1) placing FDA-approved drug products that contain
cannabidiol (CBD) derived from the cannabis plant and no more than
0.1 percent tetrahydrocannabinols (THC) into schedule V of the CSA.
See Schedules of Controlled Substances: Placement in Schedule V of
Certain FDA-Approved Drugs Containing Cannabidiol; Corresponding
Change to Permit Requirements, 83 FR 48950 (Sept. 28, 2018).
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Parties to the Single Convention are required to impose several
control measures regarding drugs listed in Schedule I of the
Convention.\7\ These include the following:
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\7\ The text of the Single Convention capitalizes schedules
(e.g., ``Schedule I''). In contrast, the text of the CSA generally
refers to schedules in lower case. This document will follow this
approach of using capitalization or lower case depending on whether
the schedule is under the Single Convention or the CSA. It should
also be noted that the schedules of the Single Convention operate
somewhat differently than the schedules of the CSA. Unlike the CSA,
the Single Convention imposes additional restrictions on drugs
listed in Schedule IV that go beyond those applicable to drugs
listed in Schedule I. All drugs in Schedule IV of the Single
Convention are also in Schedule I of the Convention. Cannabis and
cannabis resin are among the drugs were also listed in Schedule IV
of the Single Convention, but the U.N. Commission on Narcotic Drugs
removed cannabis from Schedule IV in 2020.
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Limiting exclusively to medical and scientific purposes
the production, manufacture, export, import, distribution of, trade in,
use and possession of such drugs. Article 4.
Furnishing to the International Narcotics Control Board
(INCB) annual estimates of, among other things, quantities of such
drugs to be consumed for medical and scientific purposes, utilized for
the manufacture of other drugs, and held in stock. Article 19.
Furnishing to the INCB statistical returns on the actual
production, utilization, consumption, imports and exports, seizures,
and stocks of such drugs during the prior year. Article 20.
Requiring that licensed manufacturers of such drugs obtain
quotas specifying the amounts of such drugs they may manufacture to
prevent excessive production and accumulation beyond that necessary to
satisfy legitimate needs. Articles 21 & 29.
Requiring manufacturers and distributors of such drugs to
be licensed. Articles 29 & 30.
Requiring medical prescriptions for the dispensing of such
drugs to patients. Article 30.
Requiring importers and exporters of such drugs to be
licensed and requiring each individual importation or exportation to be
predicated on the issuance of a permit. Article 31.
Prohibiting the possession of such drugs except under
legal authority. Article 33.
Requiring those in the legitimate distribution chain
(manufacturers, distributors, scientists, and those who lawfully
dispense such drugs) to keep records that show the quantities of such
drugs manufactured, distributed, dispensed, acquired, or otherwise
disposed of during the prior two years. Article 34.
Because the CSA was enacted in large part to satisfy United States
obligations under the Single Convention, many of the CSA's provisions
directly implement the foregoing treaty requirements.
Under the Single Convention, cannabis, cannabis resin, and extracts
and tinctures of cannabis are listed in Schedule I.\8\ The CSA, in
implementing

[[Page 22716]]

these requirements, generally defines marijuana to mean ``the plant
Cannabis sativa L., whether growing or not; the seeds thereof; the
resin extracted from any part of such plant; and every compound,
manufacture, salt, derivative, mixture, or preparation of such plant,
its seeds or resin.'' \9\ In 2018, Congress amended the CSA to remove
``(i) hemp, as defined in section [1639o of title 7 of the U.S. Code]''
from the definition of marijuana.\10\ Section 1639o(1) of title 7, in
turn, defines hemp as ``the plant Cannabis sativa L. and any part of
that plant, including the seeds thereof and all derivatives, extracts,
cannabinoids, isomers, acids, salts, and salts of isomers, whether
growing or not, with a delta-9-tetrahydrocannabinol concentration of
not more than 0.3 percent on a dry weight basis.'' \11\ Delta-9-
tetrahydrocannabinol ([Delta]9-THC) is the major psychoactive
intoxicating cannabinoid in marijuana. This exclusion of hemp from the
definition of marijuana had the effect of removing many products
containing predominantly cannabidiol (``CBD'') derived from hemp and
containing no more than 0.3 percent [Delta]9-THC on a dry weight basis
from control as marijuana. Effective November 12, 2026, the definition
of hemp in 7 U.S.C. 1639o(1) is being amended, with corresponding
impact on the definition of marijuana in 21 U.S.C. 802(16)(A).
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\8\ Under the Single Convention, ```[c]annabis plant' means any
plant of the genus Cannabis.'' Single Convention art. 1(1)(c). The
Single Convention defines ``cannabis'' to mean ``the flowering or
fruiting tops of the cannabis plant (excluding the seeds and leaves
when not accompanied by the tops) from which the resin has not been
extracted, by whatever name they may be designated.'' Id. art.
1(1)(b). This definition of ``cannabis'' under the Single Convention
is slightly less inclusive in certain respects than the CSA
definition of ``marijuana,'' which includes all parts of the
cannabis plant except for the mature stalks, sterilized seeds, oil
from the seeds, and certain derivatives thereof. See 21 U.S.C.
802(16). Cannabis and cannabis resin are included in the list of
drugs in Schedule I of the Single Convention, and cannabis is
subject to the same controls as Schedule I drugs as well as
additional controls. See Single Convention art. 2(6); id. art. 28.
\9\ 21 U.S.C. 802(16)(A).
\10\ Agricultural Improvement Act of 2018, Public Law 115-334,
sec. 12619; 132 Stat. 4490, 5018.
\11\ As of November 12, 2026, this definition is revised to
refer to a ``total a total tetrahydrocannabinols concentration
(including tetrahydrocannabinolic acid) of not more than 0.3 percent
on a dry weight basis,'' rather than the current reference to the
concentration of [Delta]9-THC. Public Law 119-37, sec. 781.
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In addition to the requirements for drugs in Schedule I discussed
above, the Single Convention requires the United States to take the
following additional measures specific to the growing of marijuana
plants within the United States:
Register and regulate growers, including by designating
the land upon which they may grow marijuana plants;
Limit growing of the marijuana plant to that required for
legitimate domestic scientific, medical, and industrial needs, and for
legitimate exports;
Establish the upper limit of marijuana that each grower
may grow in a calendar year, as well as the total amount of marijuana
that can be grown in the United States annually for legitimate needs;
Purchase all harvested crops of marijuana and monopolize
the wholesale trade in harvested marijuana.\12\
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\12\ DEA implemented the requirement to purchase harvested crops
of marijuana and to monopolize the wholesale trade in marijuana
through regulations pursuant to a 2018 OLC opinion. See Office of
Legal Counsel, Licensing Marijuana Cultivation in Compliance with
the Single Convention on Narcotic Drugs, 42 Op. O.L.C. 1 (June 6,
2018), https://www.justice.gov/olc/file/1272131/dl?inline (``2018
OLC Opinion'').
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Moreover, the CSA also recognizes that the United States is also a
party to the Convention on Psychotropic Substances, Feb. 21, 1971, 32
U.S.T. 543, 1019 U.N.T.S. 175 (Convention on Psychotropic
Substances).\13\ As with the Single Convention, parties to the
Convention on Psychotropic Substances are obligated to take various
control measures related to the drugs that are covered by the
treaty.\14\ Congress implemented the additional authority necessary to
comply with the Convention on Psychotropic Substances through various
amendments to the CSA.\15\ [Delta]9-THC is a substance covered by
schedule II of the Convention on Psychotropic Substances, in addition
to being covered by Schedule I of the Single Convention if it is
extracted from the cannabis plant. This final rule places in schedule
III (i) those FDA-approved drug products that contain [Delta]9-THC
falling within the CSA's definition of marijuana, specifically FDA-
approved drug products containing [Delta]9-THC derived from the plant
Cannabis sativa L., other than the mature stalks and seeds; and (ii)
marijuana subject to a state medical marijuana license.
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\13\ See also 21 U.S.C. 801a(2).
\14\ Id.
\15\ Id. 801a(2)-(3).
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Existing State Regulatory Systems

Over the last three decades, forty U.S. states have legalized the
sale and use of marijuana for medical purposes as a matter of state law
and have established systems to regulate that activity. States that
have authorized medical marijuana have done so through a licensing
regime that restricts cultivation, manufacture, and distribution to
entities approved by a designated state agency--typically a department
of health, department of agriculture, or a dedicated cannabis
regulatory authority. These agencies conduct application review,
perform inspections, and maintain ongoing oversight of licensees. State
licensees are required to maintain detailed records of plant counts,
harvested quantities, inventory levels, and sales or transfers, and to
report that information to state regulators on a periodic basis. State
medical licensing regimes oversee permissible uses of medical
marijuana, confining distribution to registered patients or caregivers
through approved dispensaries or other authorized channels. Registered
and licensed physicians oversee patient qualification for medical
marijuana based on state specific criteria and qualifying conditions.

Authority To Place Certain Marijuana Products in Schedule III

The Administrator has the authority under Section 811(d)(1) of the
CSA to move FDA-approved drug products containing marijuana and
marijuana subject to state-issued licenses to Schedule III.
Based on a 2024 OLC opinion, if marijuana is listed in schedule
III, most of the Single Convention's obligations noted above will
continue to be met by CSA statutory authorities and associated
regulations.\16\ Similarly, the controls available under schedule III
are also sufficient to comply with the requirements of the Convention
on Psychotropic Substances with respect to [Delta]9-THC. As discussed
in more detail below, this final rule ensures that the United States
will continue to meet these obligations without delay or disruption.
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\16\ See Office of Legal Counsel, Memorandum for Merrick B.
Garland Attorney General Re: Questions Related to the Potential
Rescheduling of Marijuana, 45 Op. O.L.C., at *33-34 (Apr. 11, 2024).
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As indicated above, Article 31 of the Single Convention obligates
parties to require a permit for the importation and exportation of
drugs listed in Schedule I of the Convention. This permit requirement
applies to drug products containing marijuana because, as further
indicated above, such a product is a Schedule I drug under the Single
Convention. However, under the CSA \17\ and DEA regulations, the
import/export permit requirement does not apply to all controlled
substances. Rather, a permit is required to import or export any
controlled substance in schedule I and II as well as certain controlled
substances in schedules III, IV, and V.\18\ Thus, in order to control
FDA-approved drug products containing marijuana and

[[Page 22717]]

marijuana subject to state-issued licenses in schedule III, DEA must
simultaneously amend the regulations to require a permit to import or
export such products.
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\17\ The provisions of federal law relating to the import and
export of controlled substances--those found in 21 U.S.C. 951
through 971--are more precisely referred to as the Controlled
Substances Import and Export Act. However, federal courts and DEA
often use the term ``CSA'' to refer collectively to all provisions
from 21 U.S.C. 801 through 971 and, for ease of exposition, this
document will do likewise.
\18\ See 21 U.S.C. 952 and 953; 21 CFR 1312.11, 1312.12,
1312.21, 1312.22.
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It bears emphasis that where, as here, control of a drug is
required by the Single Convention, an order under 21 U.S.C. 811(d)(1)
must be issued ``without regard to the findings required by [21 U.S.C.
811 (a) or 812(b)] and without regard to the procedures prescribed by
[21 U.S.C. 811 (a) or (b)].'' Thus, in such circumstances, the plain
and unambiguous statutory language does not require the Administrator
to request a medical and scientific evaluation or scheduling
recommendation from the Department of Health and Human Services (HHS),
as is normally done pursuant to rulemaking under section 811(b).\19\
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\19\ In the House Report to the bill that would become the CSA,
this issue is explained as follows:
Under subsection [811(d)], where control of a drug or other
substance by the United States is required by reason of its
obligations under [the Single Convention], the bill does not require
that the Attorney General seek an evaluation and recommendation by
the Secretary of Health, Education, and Welfare, or pursue the
procedures for control prescribed by the bill but he may include the
drug or other substance under any of the five schedules of the bill
which he considers most appropriate to carry out the obligations of
the United States under the international instrument, and he may do
so without making the specific findings otherwise required for
inclusion of a drug or other substance in that schedule.
H. Rep. No. 91-1444, at 36 (1970). See also Schedules of
Controlled Substances: Placement in Schedule V of Certain FDA-
Approved Drugs Containing Cannabidiol; Corresponding Change to
Permit Requirements, 83 FR 48950, 48952 & n.8 (Sept. 28, 2018). Of
note, a 1977 D.C. Circuit decision considered not the plain text of
the statute, but rather certain aspects of the legislative history,
to conclude that 21 U.S.C. 811(d)(1) still requires DEA to request a
scientific and medical evaluation and scheduling recommendation from
HHS in certain circumstances, such as when a substance can be placed
in more than one schedule under the CSA and still satisfy
obligations under the Single Convention. Nat'l Org. for Reform of
Marijuana Laws (NORML) v. Drug Enforcement Admin., 559 F.2d 735,
746-47 (D.C. Cir. 1977) (stating that the ``language of Section
201(d) is consistent with the clear import of the Act's legislative
history,'' including certain floor debates and comments by various
congressmen, and ``must be read against this backdrop of intense
concern with establishing and preserving [HHS's] avenue of input
into scheduling decisions''). Because HHS has provided DEA with a
medical and scientific evaluation and scheduling recommendation for
marijuana, DEA has met this additional procedural requirement.
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Nonetheless, in a letter dated August 29, 2023, HHS provided DEA
with a medical and scientific evaluation and scheduling recommendation
that marijuana be controlled in schedule III of the CSA.\20\ HHS found,
inter alia, that marijuana has a potential for abuse less than the
drugs or other substances in schedules I and II, and that the abuse of
marijuana may lead to moderate or low physical dependence or high
psychological dependence.\21\ These findings would correspond to the
criteria for placement of a substance in schedule III.\22\ While each
of these findings are discussed briefly below, HHS's scientific and
medical evaluation entitled, ``Basis for the Recommendation to
Reschedule Marijuana Into Schedule III of the Controlled Substances
Act,'' is available in its entirety under the ``Supporting and Related
Material'' of the public docket for this final rule at https://www.regulations.gov under docket number DEA-1362.
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\20\ See Letter for Anne Milgram, Administrator, DEA, from
Rachel L. Levine, M.D., Assistant Secretary for Health, HHS (Aug.
29, 2023) (``August 2023 Letter''); see also Memorandum for DEA,
from HHS, Re: Basis for the Recommendation to Reschedule Marijuana
to Schedule III of the Controlled Substances Act (``HHS Basis for
Rec.'').
\21\ HHS Basis for Rec. at 62-65.
\22\ See 21 U.S.C. 812(b)(3).
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First, HHS found that marijuana has a potential for abuse less than
the drugs or other substances in schedules I and II. As noted above,
marijuana contains [Delta]9-THC, the substance responsible for the
abuse potential of marijuana. [Delta]9-THC has agonist properties at
CB1 cannabinoid receptors and produces rewarding responses
in animals, as evidenced by its ability to produce self-administration
and CPP. When marijuana is administered to humans under experimental
conditions, it produces a wide range of positive subjective responses
in addition to certain negative subjective responses. Common responses
to marijuana when it is used by individuals for nonmedical purposes
include euphoria and other positive subjective responses, as well as
perceptual changes, sedative responses, anxiety responses, psychiatric,
social, and cognitive changes, and physiological changes.\23\
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\23\ HHS Basis for Rec. at 62.
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HHS noted that epidemiological data from the 2022 National Survey
on Drug Use and Health (NSDUH) show that marijuana is the most
frequently used federally illicit drug in the United States on a past-
year and past-month basis among the illicit comparator drugs
considered. Although 50 percent of respondents in NSDUH reported using
marijuana nonmedically fewer than 5 days per month, another 30 percent
reported using it nonmedically for 20 days or more per month.\24\
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\24\ Id.
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Despite the high prevalence of nonmedical use of marijuana, HHS
observed that an overall evaluation of epidemiological indicators
suggests that it does not produce serious outcomes compared to drugs in
schedules I or II. HHS found this especially notable given the
availability of marijuana and marijuana-derived products that contain
extremely high levels of [Delta]9-THC. Due to such availability, the
epidemiological data described in HHS's evaluation inherently include
the outcomes from individuals who use marijuana and marijuana-derived
products that have doses of [Delta]9-THC that range from low to very
high, and yet the data demonstrate that these products overall are
producing fewer negative outcomes than drugs in schedules I or II.\25\
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\25\ Id.
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HHS compared the rank ordering of selected drugs that are abused
for various epidemiological measures and observed that marijuana was
among the drugs at the very lowest ranking for a number of measures,
including poison center (PC) abuse cases, likelihood that any use would
lead to a PC call, accidental or unintentional poisoning, utilization-
adjusted rates of unintentional exposure, utilization-adjusted and
population-adjusted rates for emergency department visits and
hospitalizations, likelihood of being diagnosed with a serious
substance abuse disorder, deaths reported to PCs, and overdose deaths
when used with other drugs or as a single substance (as total numbers
and when utilization-adjusted). In contrast, comparators such as heroin
(schedule I), oxycodone (schedule II), and cocaine (schedule II)
typically were in the highest rank ordering on these measures.\26\
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\26\ Id.
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For the various epidemiological measures evaluated above, HHS noted
that marijuana was also compared to controlled substances in schedule
III (ketamine) and schedule IV (benzodiazepines, zolpidem, and
tramadol), as well as to other schedule II substances (fentanyl and
hydrocodone). The analyses were conducted in this manner to provide a
comprehensive assessment of the relative abuse potential of marijuana.
However, the rank order of these substances regarding harms does not
consistently align with the relative scheduling placement of these
drugs in the CSA due to the pharmacological differences between various
classes of drugs.\27\
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\27\ Id. at 63.
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There are a number of confounding factors that likely influence the
adverse outcomes measured in various epidemiological databases and
account for the rank ordering of the drugs evaluated on these measures.
For example, a different population abuses each substance, and each
substance has

[[Page 22718]]

a different prevalence of abuse and a different profile of severe
adverse outcomes in a setting of nonmedical use and abuse. Thus, it is
challenging to reconcile the ranking of relative harms associated with
the comparators used in this evaluation when the rankings differ across
various epidemiological databases and when these rankings often do not
align with the scheduling placement of these comparators under the
CSA.\28\
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\28\ Id.
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To address these challenges, HHS evaluated the totality of the
available data and concluded that it supports the placement of
marijuana in schedule III. Overall, these data demonstrate that,
according to HHS, although marijuana is associated with a high
prevalence of abuse, the profile of and propensity for serious outcomes
related to that abuse lead to a conclusion that marijuana is most
appropriately controlled in schedule III under the CSA.\29\
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\29\ Id.
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Second, HHS found that abuse of marijuana may lead to moderate or
low physical dependence or high psychological dependence.\30\ Regarding
physical dependence, as evidenced by its associated withdrawal
symptomology upon abrupt discontinuation of use, the most commonly
reported marijuana withdrawal symptoms in clinical investigations are
sleep difficulties, decreased appetite and weight loss, craving,
irritability, anger, anxiety or nervousness, and restlessness.
Marijuana withdrawal symptoms typically peak within two to six days and
decline over one to two weeks as [Delta]9-THC is eliminated. Similarly,
the drug labels for the FDA-approved drug products Marinol and Syndros
state that, following chronic administration of dronabinol, drug
discontinuation leads to irritability, insomnia, and restlessness at 12
hours, and by 24 hours the withdrawal symptoms can include hot flashes,
sweating, rhinorrhea, diarrhea, and anorexia.\31\
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\30\ Id. at 65.
\31\ Id. at 64.
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HHS observed that marijuana withdrawal syndrome has been reported
in individuals with heavy, chronic marijuana use, but its occurrence in
occasional users of marijuana has not been established. Marijuana
withdrawal syndrome appears to be relatively mild compared to the
withdrawal syndrome associated with alcohol, which can include more
serious symptoms such as agitation, paranoia, seizures and even death.
Multiple studies comparing the withdrawal symptoms associated with
marijuana and tobacco demonstrate that the magnitude and time course of
the two withdrawal syndromes are similar.\32\
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\32\ Id.
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Based on the evidence, HHS determined that the abuse of marijuana
may lead to moderate or low physical dependence, depending on frequency
and degree of marijuana exposure. HHS further concluded that marijuana
can produce psychic dependence in some individuals, but that the
likelihood of serious outcomes is low, suggesting that high
psychological dependence does not occur in most individuals who use
marijuana.\33\
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\33\ Id. at 65.
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Although I am not required to consider this HHS recommendation when
issuing an order under section 811(d)(1), because I believe there are
several legally viable scheduling options that would satisfy the United
States' obligations under the Single Convention based on OLC's 2024
opinion discussed above, I exercise my discretion in determining the
most appropriate schedule by choosing the option that most closely
aligns to HHS's findings and best positions the United States to carry
out its obligations under the Single Convention with regard to
marijuana crops and other marijuana that has not yet been manufactured
into an FDA-approved product or subject to a state medical marijuana
license. Namely, I am hereby ordering that FDA-approved drug products
containing marijuana, as well marijuana in any form covered by a state
medical marijuana license, be placed in schedule III of the CSA.\34\
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\34\ Article 5 of the Single Convention requires parties to take
legislative and administrative measures ``to limit exclusively to
medical and scientific purposes the production, manufacture, export,
import, distribution of, trade in, use and possession of'' the
substances covered by the treaty. In this order, DEA is carrying out
this obligation by limiting the rescheduling to FDA-approved drug
products and marijuana covered by licenses issued under state-
medical-marijuana regulatory regimes.
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Additionally, maintaining unlicensed bulk marijuana in schedule I
allows the United States to continue to meet two of its obligations
under the Single Convention without disruption. First, as indicated
above, for drugs listed in Schedule I of the Single Convention, parties
are obligated to require that licensed manufacturers of such drugs
obtain quotas specifying the amounts of such drugs they may
manufacture. The purpose of this treaty requirement is to prevent
excessive production and accumulation beyond that necessary to satisfy
legitimate needs. Under this scheduling order, the United States will
continue to meet this obligation without disruption or delay because
unlicensed bulk marijuana, marijuana extract, and [Delta]9-THC material
used to make FDA-approved drug products will remain in schedule I of
the CSA and thus be subject to all applicable quota provisions under 21
U.S.C. 826; and because state-licensed marijuana will be required to
meet the quota requirements of the Single Convention.
Second, as also discussed above, pursuant to a 2018 OLC opinion,
DEA must buy marijuana crops from registered manufacturers, be the
seller of that marijuana to any eligible registered purchaser, and
establish prices for such purchase and sale.\35\ Marijuana growers must
pay DEA an administrative fee for such transactions.\36\ These actions
are necessary for the United States to meet its obligations under
articles 23 and 28 of the Single Convention.\37\ By maintaining in
schedule I all unlicensed marijuana crops, bulk marijuana, and any
marijuana or marijuana extract that has not yet been incorporated into
a FDA-approved drug product, and by requiring that state-licensed
marijuana satisfy the requirements relating to the purchase and sale of
marijuana by DEA, the United States will continue to meet these
obligations without disruption or delay.
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\35\ See 2018 OLC Opinion, supra n.12. See also 21 CFR
1318.06(b).
\36\ 21 CFR 1318.06.
\37\ 2018 OLC Opinion, supra n.12. See also Single Convention
arts. 23, 28.
---------------------------------------------------------------------------

Placing only FDA-approved products containing marijuana and state-
licensed marijuana in schedule III also is consistent with articles 23
and 28 of the Single Convention and 21 CFR 1318.04(b), which specify
that the requirement to monopolize the wholesale trade in marijuana
does not extend to ``medicinal cannabis.'' Medicinal cannabis is
defined in 21 CFR 1318.02(b) to mean ``a drug product made from the
cannabis plant, or derivatives thereof, that can be legally marketed
under the Federal Food, Drug, and Cosmetic Act [(FD&C Act)].'' The
final rule exempts marijuana subject to state medical marijuana
licenses from the requirement to monopolize the wholesale trade in
marijuana.
This final rule rescheduling marijuana contained in FDA-approved
products or subject to a state medical marijuana license applies to
marijuana as listed in 21 CFR 1308.11(d)(23), as well as marijuana
extracts as defined in 21 CFR 1308.11(d)(58) because they meet the
statutory definition of marijuana and, prior to 2017, were included in
21 CFR 1308.11(d)(23).\38\ In addition, this final

[[Page 22719]]

rule applies to [Delta]9-THC derived from the marijuana plant (other
than the mature stalks and seeds) that falls outside the definition of
hemp, because it meets the statutory definition of marijuana.
---------------------------------------------------------------------------

\38\ See Establishment of a New Drug Code for Marijuana Extract,
81 FR 90194 (Dec. 14, 2016).
---------------------------------------------------------------------------

This final rule does not apply to synthetically derived THC, which
is outside the CSA's definition of marijuana. Tetrahydrocannabinols
that can be derived only through a process of artificial synthesis
(e.g., delta-10-tetrahydrocannabinol) are excluded. HHS provided a
scientific and medical evaluation only relating to ``marijuana'' as
defined in the CSA. That definition is limited to the plant (other than
the mature stalks and seeds) and derivatives of the plant. Therefore,
synthetic THC remains in schedule I.
This final rule also does not affect the status of hemp (as defined
in 7 U.S.C. 1639o), because hemp is excluded from the definition of
marijuana. This final rule is not rescheduling any drug product
containing marijuana or THC that previously has been rescheduled out of
schedule I (e.g., Marinol and Syndros). Nor does it impact the status
of any previously scheduled synthetic cannabinoids.
As noted, this order placing FDA-approved drug products containing
marijuana and state-licensed medical marijuana in schedule III will
only comport with 21 U.S.C. 811(d)(1) if all importations and
exportations of products containing marijuana remain subject to the
permit requirement. Until now, since all marijuana has been a schedule
I controlled substance, any importation has been subject to the permit
requirement. To ensure this requirement remains in place (and thus to
prevent any lapse in compliance with the requirements of the Single
Convention), this order amends the DEA regulations (21 CFR 1312.30) to
add FDA-approved drug products containing marijuana and state-licensed
medical marijuana to the list of nonnarcotic schedule III through V
controlled substances that are subject to the import and export permit
requirement.\39\
---------------------------------------------------------------------------

\39\ It is DEA's intention that the provisions of this final
rule shall operate independently of each other. If this final rule,
or any portion of this final rule, is ultimately declared invalid or
stayed as to a particular provision, it is DEA's intent that the
final rule nonetheless be severable and remain valid with respect to
those provisions not affected by a declaration of invalidity or
stayed. DEA concludes it would separately adopt all of the
provisions contained in this final rule.
---------------------------------------------------------------------------

Tax Implications

The Acting Attorney General further notes that, as a consequence of
this rule, state licensees will no longer be subject to the deduction
disallowance imposed by Section 280E of the Internal Revenue Code,
which applies only to businesses engaged in ``trafficking in controlled
substances . . . in a schedule I or II,'' 26 U.S.C. 280E. Nothing in
this rule constitutes a determination regarding federal tax liability,
and qualifying state licensees should consult with tax counsel
regarding the applicability of Section 280E to their specific
circumstances.

Requirements for Handling FDA-Approved Drug Products Containing
Marijuana

Preliminarily, it should be noted that any form of marijuana other
than in an FDA-approved drug product or marijuana subject to a state
medical marijuana license remains a schedule I controlled substance,
and those who handle such material remain subject to the regulatory
controls, and administrative, civil, and criminal sanctions, applicable
to schedule I controlled substances set forth in the CSA and DEA
regulations.
However, for those who handle marijuana exclusively in the form of
an FDA-approved drug product, the following is a summary of the
schedule III regulatory requirements that will apply upon the effective
date of this final rule:
1. Registration. Any person who handles (e.g., manufactures,
distributes, dispenses, imports, exports, engages in research, reverse
distributes, or conducts instructional activities or chemical analysis
with) FDA-approved drug products containing marijuana must be
registered with DEA to conduct such activities.\40\ That is, persons
and entities wishing to distribute or dispense (including prescribe)
marijuana in an FDA-approved product must first obtain a DEA
registration applicable to schedule III controlled substances. Entities
that transfer marijuana to patients, including dispensaries, must
register with DEA as ``practitioners'' under 21 U.S.C. 823(g).
Registration under that provision does not allow the practitioner to
possess or dispense (including prescribe) schedule I controlled
substances, including marijuana and marijuana extracts that are in a
form other than an FDA-approved drug product or marijuana subject to a
state medical marijuana license.
---------------------------------------------------------------------------

\40\ 21 U.S.C. 822, 823, 957, and 958, and in accordance with 21
CFR parts 1301, 1312, and 1318.
---------------------------------------------------------------------------

2. Disposal of stocks. Schedule III FDA-approved drug products
containing marijuana must be disposed of in accordance with 21 CFR part
1317, in addition to all other applicable federal, state, local, and
tribal laws.
3. Fees. Each applicant for registration, other than those employed
by state or Federal governments, must pay a registration fee. Current
fees are: (1) Manufacturers: $3,699 annually; (2) Distributors: $1,850
annually; and (3) Dispensers, including pharmacies: $888 for a
registration valid for 3 years.
4. Prescriptions. Prescriptions for FDA-approved drug products
containing marijuana are required prior to dispensing, except when
dispensed directly by a DEA-registered practitioner, such as a
physician, dentist, veterinarian, or hospital.\41\ Prescriptions must
be ``issued for a legitimate medical purpose by an individual
practitioner acting in the usual course of professional practice.''
\42\ Prescriptions must include ``the drug name, strength, dosage form,
quantity prescribed, directions for use,'' among other items.\43\ Under
DEA's regulations, both the prescribing practitioner and the pharmacist
who fills the prescription have responsibility for the proper
prescribing and/or dispensing of controlled substances.\44\
---------------------------------------------------------------------------

\41\ 21 U.S.C. 829(a), (b); 21 CFR 290.1. See also Single
Convention, art. 30. Dispensing generally refers to the lawful
delivery of marijuana by a DEA registrant to an ultimate user. See
21 U.S.C. 802(10).
\42\ 21 CFR 1306.04(a).
\43\ 21 CFR 1306.05(a).
\44\ Id. 1306.04(a).
---------------------------------------------------------------------------

5. Records and Reports. All DEA registrants must maintain records
and submit reports with respect to FDA-approved drug products
containing marijuana.\45\
---------------------------------------------------------------------------

\45\ 21 U.S.C. 827 and 832(a); 21 CFR 1301.74(b) and (c), and
parts 1304, 1312, and 1317.
---------------------------------------------------------------------------

6. Security. All DEA registrants must comply with regulatory
security requirements.\46\
---------------------------------------------------------------------------

\46\ 21 U.S.C. 821, 823; 21 CFR 1301.71-1301.76; 1301.90-
1301.93.
---------------------------------------------------------------------------

7. Labeling and Packaging. All labels, labeling, and packaging for
commercial containers of FDA-approved drug products containing
marijuana must meet all applicable schedule III labeling and packaging
requirements.\47\
---------------------------------------------------------------------------

\47\ 21 U.S.C. 825 and 958(e); 21 CFR part 1302.
---------------------------------------------------------------------------

8. Inventory. Any person registered with DEA to handle FDA-approved
drug products containing marijuana must make an initial inventory of
all stocks of controlled substances (including these substances) on
hand on the date the registrant first engages in the handling of
controlled substances. After the initial inventory, every DEA
registrant must take a new inventory of all stocks of controlled
substances (including

[[Page 22720]]

FDA-approved drug products containing marijuana) on hand every two
years.\48\
---------------------------------------------------------------------------

\48\ 21 U.S.C. 827 and 958(e); 21 CFR 1304.03, 1304.04, and
1304.11.
---------------------------------------------------------------------------

9. Manufacturing and Distributing. In addition to the general
requirements of the CSA and DEA regulations that are applicable to
manufacturers and distributors of schedule III controlled substances,
such registrants should be advised that (consistent with the foregoing
considerations) any manufacturing or distribution of FDA-approved
products containing marijuana may only be for the legitimate purposes
authorized by the FD&C Act and the CSA.
10. Liability. Any activity involving FDA-approved drug products
containing marijuana not authorized by, or in violation of the CSA or
its implementing regulations, is unlawful, and may subject the person
to administrative, civil, and/or criminal sanctions

Registration of State Licensees

State medical marijuana regulatory systems have matured
significantly since California first authorized medical use in 1996,
and today the vast majority of States maintain comprehensive licensing
frameworks governing cultivation, processing, distribution, and
dispensing of marijuana for medical purposes. These state regimes have
developed robust infrastructure for preventing diversion, ensuring
product safety, maintaining records, and conducting facility
inspections--functions that fulfill the objectives of federal
registration and recordkeeping requirements. The Attorney General has
reviewed the operation of these state systems and finds that, taken as
a whole, they demonstrate a sustained capacity to achieve the public-
interest objectives that underlie the CSA's registration framework,
including protecting public health and safety and preventing the
diversion of controlled substances into illicit channels.
In light of that record, the Attorney General has determined that
incorporating state licensing systems into the federal registration
framework represents the most effective and efficient means of
achieving the CSA's objectives with respect to medical marijuana while
promoting the medical benefits of marijuana and causing the least
disruption for patients and existing state systems. The rule
accordingly leverages existing regulatory infrastructure while
preserving the Administrator's authority to deny or revoke registration
where specific public-interest concerns arise and to ensure compliance
with the Single Convention. This approach reflects the Attorney
General's considered judgment that cooperative federalism best serves
the statutory purposes of the CSA in the context of a well-regulated
medical marijuana market.
The proposed amendments to part 1301 establish a new registration
pathway for state-licensed medical marijuana entities seeking federal
DEA registration as manufacturers, distributors, and/or dispensers. The
regulation creates an expedited review process under which applicants
holding state medical marijuana licenses may submit their existing
state credentials as conclusive evidence of state-law authorization.
The Administrator must grant registration unless doing so would be
inconsistent with the public interest under the 21 U.S.C. 823 factors
or with the requirements of the Single Convention. A DEA registration
automatically suspends upon suspension, revocation, or expiration of
the underlying state-issued license, ensuring that federal
authorization tracks state authorization. To facilitate a prompt
transition, the Administrator is directed to process applications
submitted within 60 days of publication within six months, and early
applicants may lawfully operate under their state-issued licenses
during the pendency of review.
The rule contains several provisions designed to reduce regulatory
burden on compliant state-licensed entities. Reporting, recordkeeping,
and order-form requirements are limited to what is strictly necessary
to satisfy federal statutory and treaty obligations, with state-
required records accepted to the maximum extent permissible. State-
authorized medical marijuana certifications or similar documents are
sufficient to permit the dispensing of medical marijuana to users,
provided they include the user's name and address, are dated and signed
on the day of issuance, and identify the issuing practitioner.
Similarly, registrants may rely on state-law labeling, packaging,
disposal, and physical-security requirements in lieu of the otherwise-
applicable federal requirements, subject to inclusion of the statutory
warning label required by 21 U.S.C. 825(c).
To address Single Convention compliance under Article 23, the rule
establishes a nominal-price purchase-and-resale mechanism through which
the Administration acquires and resells registered manufacturers'
marijuana crops, thereby satisfying the Convention's requirement that a
government agency serve as the exclusive purchaser of cannabis
production. Registered manufacturers must store crops in a facility to
which DEA maintains access until that transaction is complete, and each
manufacturer registration must specify the areas in which cultivation
is permitted. The Administrator is also authorized to require record-
keeping and reporting necessary to comply with the Single Convention,
and the Administrator must take into account the requirements of the
Single Convention, including any quota requirements, in evaluating
applications.
Out of an abundance of caution, the Administrator clarifies that
researchers who obtain marijuana or marijuana-derived products from a
state licensee for use in scientific research shall incur no civil or
criminal liability under the Controlled Substances Act solely by reason
of having obtained such products from a state-licensed source rather
than a separately DEA-registered bulk manufacturer, provided that the
researcher is registered with the Administration to conduct research
with marijuana under 21 CFR. 1301.13 and the state licensee from whom
the researcher obtained the marijuana held a valid federal registration
at the time of the transfer. The Administrator shall not treat the use
of state-licensed marijuana products in federally registered research
as a basis for adverse action against a researcher's registration.
The Administrator further notes that, as a consequence of this
rule, holders of state medical marijuana licenses will no longer be
subject to the deduction disallowance imposed by Section 280E of the
Internal Revenue Code, which applies only to businesses engaged in
``trafficking in controlled substances . . . in a schedule I or II,''
26 U.S.C. 280E. The Administrator encourages the Secretary of the
Treasury to consider providing retrospective relief from Section 280E
liability for taxable years in which a state licensee operated under a
state medical marijuana license. Nothing in this rule constitutes a
determination regarding federal tax liability, and state licensees
should consult with tax counsel regarding the applicability of Section
280E to their specific circumstances.

Regulatory Analyses

Administrative Procedure Act

The CSA provides for an expedited scheduling action where control
is required by the United States' obligations under international
treaties, conventions, or protocols.\49\ If control is required
pursuant to such international

[[Page 22721]]

treaty, convention, or protocol, the Attorney General, as delegated to
the Administrator, must issue an order controlling such drug under the
schedule he deems most appropriate to carry out such obligations, and
``without regard to'' the findings and rulemaking procedures otherwise
required for scheduling actions in 21 U.S.C. 811(a) and (b).\50\
---------------------------------------------------------------------------

\49\ 21 U.S.C. 811(d)(1).
\50\ Id.
---------------------------------------------------------------------------

In accordance with 21 U.S.C. 811(d)(1), scheduling actions for
drugs that are required to be controlled by the United States'
obligations under international treaties, conventions, or protocols in
effect on October 27, 1970, shall be issued by order, as opposed to
scheduling by rule pursuant to 21 U.S.C. 811(a). Therefore, DEA
believes that the notice-and-comment requirements of the Administrative
Procedure Act (APA), 5 U.S.C. 553, do not apply to this scheduling
action.

Executive Orders 12866, 13563, 14192, and 14294

This action is not a significant regulatory action as defined by
Executive Order (E.O.) 12866, Regulatory Planning and Review, and the
principles reaffirmed in E.O. 13563, Improving Regulation and
Regulatory Review. DEA scheduling actions are not subject to E.O.
14192, Unleashing Prosperity Through Deregulation, or E.O. 14294,
Fighting Overcriminalization in Federal Regulations.
While this scheduling action is exempt from review under E.O.
12866, DEA recognizes this action may have unique economic impacts.
Marijuana is subject to a number of State laws that have allowed a
multibillion-dollar industry to develop. DEA acknowledges that there
may be large impacts related to Federal taxes and research and
development investment for the pharmaceutical industry, among other
things.

Executive Order 12988, Civil Justice Reform

This action meets the applicable standards set forth in sections
3(a) and 3(b)(2) of E.O. 12988 to eliminate drafting errors and
ambiguity, minimize litigation, provide a clear legal standard for
affected conduct, and promote simplification and burden reduction.

Executive Order 13132, Federalism

This action does not have federalism implications warranting the
application of E.O. 13132. This action does not have substantial direct
effects on the States, on the relationship between the national
government and the States, or on the distribution of power and
responsibilities among the various levels of government.

Executive Order 13175, Consultation and Coordination With Indian Tribal
Governments

This action does not have tribal implications warranting the
application of E.O. 13175. It does not have substantial direct effects
on one or more Indian tribes, on the relationship between the Federal
government and Indian tribes, or on the distribution of power and
responsibilities between the Federal government and Indian tribes.

Regulatory Flexibility Act

The Regulatory Flexibility Act (RFA) \51\ applies to rules that are
subject to notice and comment under the APA or any other law. As
explained above, this final rule is not subject to the notice-and-
comment procedures of the APA. Consequently, the RFA does not apply to
this action.
---------------------------------------------------------------------------

\51\ 5 U.S.C. 601 et seq.
---------------------------------------------------------------------------

Paperwork Reduction Act of 1995

This action does not impose a new or revised ``collection[s] of
information'' as defined by the Paperwork Reduction Act of 1995.\52\
---------------------------------------------------------------------------

\52\ 44 U.S.C. 3502(3).
---------------------------------------------------------------------------

Unfunded Mandates Reform Act of 1995

DEA has determined pursuant to the Unfunded Mandates Reform Act
(UMRA) of 1995 \53\ that this final rule would not result in any
Federal mandate that may result ``in the expenditure by State, local,
and tribal governments, in the aggregate, or by the private sector, of
$100,000,000 or more (adjusted annually for inflation) in any 1 year .
. . .'' Therefore, neither a Small Government Agency Plan nor any other
action is required under UMRA of 1995.
---------------------------------------------------------------------------

\53\ 2 U.S.C. 1501 et seq.
---------------------------------------------------------------------------

Congressional Review Act

This order is not a major rule as defined by the Congressional
Review Act (CRA).\54\ However, DEA is submitting reports under the CRA
to both Houses of Congress and to the Comptroller General.
---------------------------------------------------------------------------

\54\ 5 U.S.C. 804.
---------------------------------------------------------------------------

List of Subjects

21 CFR Part 1300

Definitions, Drug traffic control.

21 CFR Part 1301

Administrative practice and procedure, Drug traffic control,
Registration requirements.

21 CFR Part 1308

Administrative practice and procedure, Drug traffic control,
Reporting and recordkeeping requirements.

21 CFR Part 1312

Administrative practice and procedure, Drug traffic control,
Exports, Imports, Reporting requirement.
For the reasons set out above, DEA amends 21 CFR parts 1300, 1301,
1308, and 1312 as follows:

PART 1300--DEFINITIONS

0
1. The authority citation for part 1300 continues to read as follows:

Authority: 21 U.S.C. 802, 821, 822, 829, 871(b), 951, 958(f).

0
2. Amend Sec. 1300.01 by adding the definitions of ``Marijuana''and
''State medical marijuana license'' in alphabetical order to read as
follows:

Sec. 1300.01 Definitions relating to controlled substances.

* * * * *
Marijuana shall have the meaning set forth at 21 U.S.C. 802(16)(A).
* * * * *
State medical marijuana license means a license issued by a state
entity (or by a District of Columbia entity or a federal territorial
entity) authorizing the licensee to manufacture, distribute, and/or
dispense marijuana or products that contain marijuana for medical
purposes.
* * * * *

PART 1301--REGISTRATION OF MANUFACTURERS, DISTRIBUTORS, AND
DISPENSERS OF CONTROLLED SUBSTANCES

0
3. The authority citation for part 1301 continues to read as follows:

Authority: 21 U.S.C. 821, 822, 823, 824, 831, 871(b), 875, 877,
886a, 951, 952, 956, 957, 958, 965.

0
4. Amend Sec. 1301.13 by adding paragraph (k) to read as follows.

Sec. 1301.13 Application for registration; time for application;
expiration date; registration for independent activities; application
forms, fees, contents and signature; coincident activities.

* * * * *
(k) Medical marijuana registrations. The Administration shall
establish an expedited review process for entities holding state
medical marijuana licenses who seek registration as a marijuana
manufacturer, distributor, or dispenser. Such applicants shall submit,
along with the applicable DEA form or forms, proof of a state medical

[[Page 22722]]

marijuana license in the form specified by the Administrator. The
Administrator shall register an applicant under this subsection unless
the Administrator determines that the issuance of such registration is
inconsistent with the public interest, taking into account the factors
set forth at 21 U.S.C. 823(e) through (g), as applicable, and the
requirements of the Single Convention on Narcotic Drugs, including any
quota requirement. In general, registration of an applicant that
complies with a state-law regime that contains robust protections
against diversion, requirements for record-keeping and reporting, and
safety and inspection measures will not be inconsistent with the public
interest so long as registration is consistent with the Single
Convention.
(1) Types of registrations. (i) A registered marijuana manufacturer
may cultivate, produce, process, package, label, and transfer marijuana
and products containing marijuana to registered distributors or other
registered manufacturers, subject to the limitations of its state
license.
(ii) A registered distributor may receive marijuana and products
containing marijuana from registered manufacturers and transfer
marijuana and products containing marijuana to registered dispensers or
other registered distributors, subject to the limitations of its state
license.
(iii) A registered dispenser may dispense marijuana and products
containing marijuana to individuals authorized by state law to possess
marijuana and products containing marijuana for medical purposes,
subject to the limitations of its state license.
(iv) Registrations under this subpart do not authorize the
manufacture, distribution, dispensing, or use of marijuana or products
containing marijuana for non-medical purposes.
(v) A single entity may be granted multiple types of registrations.
(2) State licenses as evidence of State authorization. For purposes
of 21 U.S.C. 823(e) through (g), and for any other purpose, a state
license shall constitute conclusive evidence that the applicant is
authorized under state law to engage in the activity for which
registration is sought.
(3) Suspension, revocation, or expiration of State license. A
registration issued under this section shall not exceed the scope of
the holder's state medical marijuana license. If the state medical
marijuana license is suspended, revoked, or expires, the DEA
registration is automatically suspended.
(4) Reports, records, and order forms. Notwithstanding any other
provision of this part, the Administrator shall require registrants
under this subsection to submit only such reports and records, and to
use only such order forms, as the Administrator concludes are necessary
to comply with federal statutory and treaty obligations. The
Administrator shall accept state-required reports, records, and forms
to the maximum extent permissible.
(5) Prescriptions. Notwithstanding part 1306 of this chapter or any
other provision of these rules, a certification or other document
(including an electronic document) that state law deems sufficient for
a user to obtain marijuana or products containing marijuana for medical
purposes shall be sufficient to permit dispensing of marijuana or
products containing marijuana to a user so long as the certification or
other document is dated as of, and signed on, the day when issued;
bears the full name and address of the user; and contains the name,
address, and state license number of the practitioner who signed the
certification or other document and is authorized to do so under state
law.
(6) Compliance with Article 23 of the Single Convention on Narcotic
Drugs. Part 1318 of this chapter shall not apply to entities holding
valid licenses under this paragraph (k)(6).
(i) All manufacturers registered under this subsection shall
establish a nominal price for the purchase of their marijuana crops.
The Administration shall then purchase the entity's crops at that price
and sell the crops back to the entity, or a related or subsidiary
entity, at the same price with the addition of the administrative fee
as calculated under Sec. 1318.06(a) of this chapter.
(ii) All registered manufacturers shall store marijuana crops in a
facility to which the Administration maintains access until the
transaction set forth in paragraph (k)(6)(i) of this section is
complete. The Administration shall have the right to inspect such
facilities on demand.
(iii) A registration for a manufacturer under this subsection shall
specify the areas in which marijuana cultivation is permitted.
(7) Expedition. The Administrator shall make every effort to
process all applications submitted within 60 days of the publication of
this regulation in the Federal Register within six months.
Notwithstanding paragraph (a) of this section, any applicant that
submits an application within 60 days of the publication of this rule
in the Federal Register may engage in the manufacture, distribution,
and/or dispensing of marijuana or products containing marijuana for
medical purposes in conformity with a state-issued license during the
pendency of the application.
(8) Labeling, packaging, and sealing. A registrant under this
subsection is exempt from the labeling, packaging, and sealing
requirements under part 1302 of this chapter, and other provisions of
these rules so long as they label, package, and seal marijuana and
products containing marijuana in conformity with state law and so long
as the label includes the warning required by 21 U.S.C. 825(c), where
applicable.
(9) Disposal. Notwithstanding part 1317 of this chapter. or any
other provision of these rules, a registrant under this paragraph may
dispose of marijuana and products containing marijuana in conformity
with state law.
(10) Security Requirements. Notwithstanding any other provision of
these rules, a registrant under this paragraph has sufficient physical-
security requirements if the registrant meets the requirements of state
law.

PART 1308--SCHEDULES OF CONTROLLED SUBSTANCES

0
5. The authority citation for part 1308 continues to read as follows:

Authority: 21 U.S.C. 811, 812, 871(b), 956(b), unless otherwise
noted.

0
6. Amend Sec. 1308.13 by adding new paragraphs (g)(2) through (5) to
read as follows.

Sec. 1308.13 Schedule III.

* * * * *
(g) * * *

* * * * * * *
(2) Marijuana, as defined in 21 U.S.C. 802(16), in a U.S. Food XXXX
and Drug Administration approved product or subject to a state
medical marijuana license.....................................
(3) Marijuana extract, as defined in 21 CFR 1308.11(d)(58), in XXXX
a U.S. Food and Drug Administration approved product or
subject to a state medical marijuana license..................
(4) Naturally derived delta-9-tetrahydrocannabinols in a U.S. XXXX
Food and Drug Administration approved product or in marijuana
subject to a state medical marijuana license..................

[[Page 22723]]

(i) Naturally derived delta-9-tetrahydrocannabinols means those
delta-9-tetrahydrocannabinols, except as in paragraphs (g)(2)
and (3) of this section, that are naturally contained in a
plant of the genus Cannabis (cannabis plant)..................
(ii) Naturally derived delta-9-tetrahydrocannabinols do not
include any material, compound, mixture, or preparation that
falls within the definition of hemp set forth in 7 U.S.C.
1639o.........................................................
(iii) Naturally derived delta-9-tetrahydrocannabinols do not
include any delta-9-tetrahydrocannabinols contained in
substances excluded from the definition of marijuana as set
forth in 21 U.S.C. 802(16)(B)(ii).............................
(5) [Reserved]................................................. XXXX

* * * * * * *

* * * * *

PART 1312--IMPORTATION AND EXPORTATION OF CONTROLLED SUBSTANCES

0
7. The authority citation for part 1312 continues to read as follows:

Authority: 21 U.S.C. 821, 871(b), 952, 953, 954, 957, 958.

0
8. Amend Sec. 1312.30 by:
0
a. Redesignating paragraph (b) as paragraph (e); and
0
b. Adding new paragraphs (b), (c), and (d).
The additions to read as follows:

Sec. 1312.30 Schedule III, IV, and V non-narcotic controlled
substances requiring an import and export permit.

* * * * *
(b) Marijuana, as defined in 21 U.S.C. 802(16), in a U.S. Food and
Drug Administration approved product or subject to a state medical
marijuana license.
(c) Marijuana extract, as defined in 21 CFR 1308.11(d)(58), in a
U.S. Food and Drug Administration approved product or subject to a
state medical marijuana license.
(d) Naturally derived delta-9-tetrahydrocannabinols in a U.S. Food
and Drug Administration approved product or subject to a state medical
marijuana license.
(1) Naturally derived delta-9-tetrahydrocannabinols means those
delta-9-tetrahydrocannabinols, except as in paragraphs (g)(2) and (3)
of this section, that are naturally contained in a plant of the genus
Cannabis (cannabis plant).
(2) Naturally derived delta-9-tetrahydrocannabinols do not include
any material, compound, mixture, or preparation that falls within the
definition of hemp set forth in 7 U.S.C. 1639o.
(3) Naturally derived delta-9-tetrahydrocannabinols do not include
any delta-9-tetrahydrocannabinols contained in substances excluded from
the definition of marijuana as set forth in 21 U.S.C. 802(16)(B)(ii).
* * * * *

Dated: April 22, 2026.
Todd Blanche,
Acting Attorney General.
[FR Doc. 2026-08176 Filed 4-27-26; 8:45 am]
BILLING CODE 4410-09-P