Editorial Notes

Amendments

2025⁠—Subsec. (c). Pub. L. 119-26 added schedule I(e).

2018⁠—Subsec. (c). Pub. L. 115-334 inserted “, except for tetrahydrocannabinols in hemp (as defined under section 1639o of title 7)” after “Tetrahydrocannabinols” in schedule I(c)(17).

2012⁠—Subsec. (c). Pub. L. 112-144, § 1152(b), added schedule I(c)(18) to (28).

Pub. L. 112-144, § 1152(a), added schedule I(d).

1990⁠—Subsec. (c). Pub. L. 101-647 added item (e) at end of schedule III.

1986⁠—Subsec. (c). Pub. L. 99-646 amended schedule II(a)(4) generally. Prior to amendment, schedule II(a)(4) read as follows: “Coca leaves (except coca leaves and extracts of coca leaves from which cocaine, ecgonine, and derivatives of ecgonine or their salts have been removed); cocaine, its salts, optical and geometric isomers, and salts of isomers; and ecgonine, its derivatives, their salts, isomers, and salts of isomers.”

Pub. L. 99-570 amended schedule II(a)(4) generally. Prior to amendment, schedule II(a)(4) read as follows: “Coca leaves and any salt, compound, derivative, or preparation of coca leaves (including cocaine and ecgonine and their salts, isomers, derivatives, and salts of isomers and derivatives), and any salt, compound, derivative, or preparation thereof which is chemically equivalent or identical with any of these substances, except that the substances shall not include decocainized coca leaves or extraction of coca leaves, which extractions do not contain cocaine or ecgonine.”

1984⁠—Subsec. (c). Pub. L. 98-473, § 507(c), in schedule II(a)(4) added applicability to cocaine and ecgonine and their salts, isomers, etc.

Subsec. (d). Pub. L. 98-473, § 509(b), struck out subsec. (d) which related to authority of Attorney General to except stimulants or depressants containing active medicinal ingredients.

1978⁠—Subsec. (d)(3). Pub. L. 95-633 added cl. (3).

Statutory Notes and Related Subsidiaries

Effective Date of 2025 Amendment

Pub. L. 119-26, § 7(a), July 16, 2025, 139 Stat. 418, provided that:

“Irrespective of the date on which the rules required by section 5 [of Pub. L. 119-26, set out as a note below] are finalized, the amendments made by this Act [see Short Title of 2025 Amendment note set out under section 801 of this title] apply beginning as of the date of enactment of this Act [July 16, 2025].”

Effective Date of 1990 Amendment

Amendment by Pub. L. 101-647 effective 90 days after Nov. 29, 1990, see section 1902(d) of Pub. L. 101-647, set out as a note under section 802 of this title.

Effective Date of 1978 Amendment

Amendment by Pub. L. 95-633 effective on date the Convention on Psychotropic Substances enters into force in the United States [July 15, 1980], see section 112 of Pub. L. 95-633, set out as an Effective Date note under section 801a of this title.

Amendment of Schedules of Controlled Substances

For updated and republished schedules of controlled substances established by this section, see Code of Federal Regulations, Part 1308 of Title 21, Food and Drugs.

Rulemaking

Pub. L. 119-26, § 5, July 16, 2025, 139 Stat. 417, provided that:

“(a)  Interim Final Rules.⁠—The Attorney General⁠—

“(1)  shall, not later than 6 months after the date of enactment of this Act [July 16, 2025], issue rules to implement this Act [see Short Title of 2025 Amendment note set out under section 801 of this title] and the amendments made by this Act; and

“(2)  may issue the rules under paragraph (1) as interim final rules.

“(b)  Procedure for Final Rule.⁠—

“(1)  Effectiveness of interim final rules.⁠—A rule issued by the Attorney General as an interim final rule under subsection (a) shall become immediately effective as an interim final rule without requiring the Attorney General to demonstrate good cause therefor, notwithstanding subparagraph (B) of the undesignated matter following paragraph (4) of section 553(b) of title 5, United States Code.

“(2)  Opportunity for comment and hearing.⁠—An interim final rule issued under subsection (a) shall give interested persons the opportunity to comment and to request a hearing.

“(3)  Final rule.⁠—After the conclusion of such proceedings, the Attorney General shall issue a final rule to implement this Act and the amendments made by this Act in accordance with section 553 of title 5, United States Code.”

Reviewing the Scheduling of Approved Products Containing a Combination of Buprenorphine and Naloxone

Pub. L. 119-44, title II, § 209, Dec. 1, 2025, 139 Stat. 682, provided that:

“(a)  Secretary of HHS.⁠—The Secretary of Health and Human Services shall, consistent with the requirements and procedures set forth in sections 201 and 202 of the Controlled Substances Act (21 U.S.C. 811, 812)⁠—

“(1)  review the relevant data pertaining to the scheduling of products containing a combination of buprenorphine and naloxone that have been approved under section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355); and

“(2)  if appropriate, request that the Attorney General initiate rulemaking proceedings to revise the schedules accordingly with respect to such products.

“(b)  Attorney General.⁠—The Attorney General shall review any request made by the Secretary of Health and Human Services under subsection (a)(2) and determine whether to initiate proceedings to revise the schedules in accordance with the criteria set forth in sections 201 and 202 of the Controlled Substances Act (21 U.S.C. 811, 812).”

Congressional Finding; Emergency Scheduling of GHB in Controlled Substances Act

Pub. L. 106-172, §§ 2, 3(a), Feb. 18, 2000, 114 Stat. 7, 8, provided that:

“SEC. 2. FINDINGS.

“Congress finds as follows:

“(1)  Gamma hydroxybutyric acid (also called G, Liquid X, Liquid Ecstasy, Grievous Bodily Harm, Georgia Home Boy, Scoop) has become a significant and growing problem in law enforcement. At least 20 States have scheduled such drug in their drug laws and law enforcement officials have been experiencing an increased presence of the drug in driving under the influence, sexual assault, and overdose cases especially at night clubs and parties.

“(2)  A behavioral depressant and a hypnotic, gamma hydroxybutyric acid (‘GHB’) is being used in conjunction with alcohol and other drugs with detrimental effects in an increasing number of cases. It is difficult to isolate the impact of such drug’s ingestion since it is so typically taken with an ever-changing array of other drugs and especially alcohol which potentiates its impact.

“(3)  GHB takes the same path as alcohol, processes via alcohol dehydrogenase, and its symptoms at high levels of intake and as impact builds are comparable to alcohol ingestion/intoxication. Thus, aggression and violence can be expected in some individuals who use such drug.

“(4)  If taken for human consumption, common industrial chemicals such as gamma butyrolactone and 1.4-butanediol are swiftly converted by the body into GHB. Illicit use of these and other GHB analogues and precursor chemicals is a significant and growing law enforcement problem.

“(5)  A human pharmaceutical formulation of gamma hydroxybutyric acid is being developed as a treatment for cataplexy, a serious and debilitating disease. Cataplexy, which causes sudden and total loss of muscle control, affects about 65 percent of the estimated 180,000 Americans with narcolepsy, a sleep disorder. People with cataplexy often are unable to work, drive a car, hold their children or live a normal life.

“(6)  Abuse of illicit GHB is an imminent hazard to public safety that requires immediate regulatory action under the Controlled Substances Act (21 U.S.C. 801 et seq.).

“SEC. 3. EMERGENCY SCHEDULING OF GAMMA HYDROXYBUTYRIC ACID AND LISTING OF GAMMA BUTYROLACTONE AS LIST I CHEMICAL.

“(a)  Emergency Scheduling of GHB.⁠—

“(1)  In general.⁠—The Congress finds that the abuse of illicit gamma hydroxybutyric acid is an imminent hazard to the public safety. Accordingly, the Attorney General, notwithstanding sections 201(a), 201(b), 201(c), and 202 of the Controlled Substances Act [21 U.S.C. 811(a)–(c), 812], shall issue, not later than 60 days after the date of the enactment of this Act [Feb. 18, 2000], a final order that schedules such drug (together with its salts, isomers, and salts of isomers) in the same schedule under section 202(c) of the Controlled Substances Act as would apply to a scheduling of a substance by the Attorney General under section 201(h)(1) of such Act (relating to imminent hazards to the public safety), except as follows:

“(A)  For purposes of any requirements that relate to the physical security of registered manufacturers and registered distributors, the final order shall treat such drug, when the drug is manufactured, distributed, or possessed in accordance with an exemption under section 505(i) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 355(i)] (whether the exemption involved is authorized before, on, or after the date of the enactment of this Act [Feb. 18, 2000]), as being in the same schedule as that recommended by the Secretary of Health and Human Services for the drug when the drug is the subject of an authorized investigational new drug application (relating to such section 505(i)). The recommendation referred to in the preceding sentence is contained in the first paragraph of the letter transmitted on May 19, 1999, by such Secretary (acting through the Assistant Secretary for Health) to the Attorney General (acting through the Deputy Administrator of the Drug Enforcement Administration), which letter was in response to the letter transmitted by the Attorney General (acting through such Deputy Administrator) on September 16, 1997. In publishing the final order in the Federal Register, the Attorney General shall publish a copy of the letter that was transmitted by the Secretary of Health and Human Services.

“(B)  In the case of gamma hydroxybutyric acid that is contained in a drug product for which an application is approved under section 505 of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 355] (whether the application involved is approved before, on, or after the date of the enactment of this Act [Feb. 18, 2000]), the final order shall schedule such drug in the same schedule as that recommended by the Secretary of Health and Human Services for authorized formulations of the drug. The recommendation referred to in the preceding sentence is contained in the last sentence of the fourth paragraph of the letter referred to in subparagraph (A) with respect to May 19, 1999.

“(2)  Failure to issue order.⁠—If the final order is not issued within the period specified in paragraph (1), gamma hydroxybutyric acid (together with its salts, isomers, and salts of isomers) is deemed to be scheduled under section 202(c) of the Controlled Substances Act [21 U.S.C. 812(c)] in accordance with the policies described in paragraph (1), as if the Attorney General had issued a final order in accordance with such paragraph.”

Placement of Pipradrol and SPA in Schedule IV To Carry Out Obligation Under Convention on Psychotropic Substances

Pub. L. 95-633, title I, § 102(c), Nov. 10, 1978, 92 Stat. 3772, provided that:

“For the purpose of carrying out the minimum United States obligations under paragraph 7 of article 2 of the Convention on Psychotropic Substances, signed at Vienna, Austria, on February 21, 1971, with respect to pipradrol and SPA (also known as (-)-1-dimethyl­amino-1,2-diphenylethane), the Attorney General shall by order, made without regard to sections 201 and 202 of the Controlled Substances Act [this section and section 811 of this title], place such drugs in schedule IV of such Act [see subsec. (c) of this section].”

Provision of section 102(c) of Pub. L. 95-633, set out above, effective on the date the Convention on Psychotropic Substances enters into force in the United States [July 15, 1980], see section 112 of Pub. L. 95-633, set out as an Effective Date note under section 801a of this title.

Executive Documents

Ex. Ord. No. 14370. Increasing Medical Marijuana and Cannabidiol Research

Ex. Ord. No. 14370, Dec. 18, 2025, 90 F.R. 60541, provided:

By the authority vested in me as President by the Constitution and the laws of the United States of America, it is hereby ordered:

Section 1. Purpose and Policy. Americans deserve access to the best medical treatments and research infrastructure in the world. In 2023, the Food and Drug Administration (FDA) completed a review of the landscape of medical use of marijuana and found scientific support for its use to treat anorexia related to a medical condition, nausea and vomiting, and pain. Chronic pain affects nearly 1 in 4 United States adults and more than 1 in 3 United States seniors, and 6 in 10 people who use medical marijuana report doing so to manage pain. Forty States plus the District of Columbia have State- or locally-sanctioned, regulated medical marijuana programs. Yet decades of Federal drug control policy have neglected marijuana’s medical uses. That oversight has limited the ability of scientists and manufacturers to complete the necessary research on safety and efficacy to inform doctors and patients.

Marijuana is currently controlled under Schedule I of the Controlled Substances Act [Pub. L. 91-513; 21 U.S.C. 801 et seq.] (CSA). In 2023, the Department of Health and Human Services (HHS) recommended to the Drug Enforcement Agency that marijuana be controlled under Schedule III of the CSA. Schedule I drugs are defined as drugs with no currently accepted medical use, a high potential for abuse, and a lack of accepted safety for use of the drug under medical supervision. Schedule III drugs are classified as having a potential for abuse less than the drugs or other substances in Schedules I and II, a currently accepted medical use in treatment in the United States, and a potential for moderate or low physical dependence or high psychological dependence in the event of drug abuse.

The recommendation from HHS included a determination that medical marijuana has a currently accepted medical use. That determination was based in part on a finding by the HHS Office of the Assistant Secretary of Health that more than 30,000 licensed healthcare practitioners across 43 United States jurisdictions are authorized to recommend the medical use of marijuana for more than 6 million registered patients to treat at least 15 medical conditions. It was also based on a finding by the FDA of credible scientific support to substantiate the use of marijuana in the treatment of pain, anorexia related to certain medical conditions, and nausea and vomiting induced by chemotherapy. The National Institute on Drug Abuse concurred with the FDA’s recommendation that marijuana be rescheduled from Schedule I to Schedule III of the CSA. In May 2024, the Department of Justice issued a proposed rule to reschedule marijuana to Schedule III. The proposed rule received nearly 43,000 public comments and is currently awaiting an administrative law hearing.

The Federal Government’s long delay in recognizing the medical use of marijuana does not serve the Americans who report health benefits from the medical use of marijuana to ease chronic pain and other various medically recognized ailments. Americans who often seek alternative relief from chronic pain symptoms are particularly impacted. For example, in one research survey, 20 percent of participating United States veterans reported using fewer opioids as a result of their medical marijuana use. One in 10 seniors used marijuana in the last year and some evidence shows improvements in seniors’ health-related quality of life and pain with medical marijuana use. However, the current Schedule I position of marijuana has impeded research. The lack of appropriate research on medical marijuana and consequent lack of FDA approval leaves American patients and doctors without adequate guidance on appropriate prescribing and utilization. One patient survey showed that just 56 percent of older Americans using marijuana have discussed the usage with their healthcare provider. This places patients, especially seniors who may be on multiple medications, at increased risk of drug interactions or other adverse events. The Federal Government must improve the research infrastructure for medical marijuana to better serve Americans.

In addition to medical marijuana, which is primarily made up of two cannabinoids⁠—cannabidiol (CBD) and tetrahydracannabinol (THC)⁠—hemp-derived cannabinoid products, defined by section 297A of the Agricultural Marketing Act of 1946 (7 U.S.C. 1639o), have shown potential to improve patient symptoms for common ailments and are frequently used by Americans. One in 5 United States adults and nearly 15 percent of seniors reported using CBD in the past year, and chronic pain patients have reported improvements with CBD use in clinical studies. Furthermore, evidence suggests that the amount of THC in hemp-derived cannabinoid products can affect both pain treatment efficacy and adverse events. Hemp-derived cannabinoids, as defined in 7 U.S.C. 1639o, are not controlled substances under the CSA but are subject to the same authorities and requirements as FDA-regulated products containing any other substance. Adding complexity is the fact that some full-spectrum CBD products will once again be controlled as marijuana under the CSA when section 781 of Public Law 119–37 [amending section 1639o of Title 7, Agriculture] goes into effect because they contain THC levels above the per-container threshold set by that law. Further, a recent study found that some commercially available CBD products evaluated were inaccurately labeled regarding CBD isolate, broad-spectrum, or full-spectrum composition, posing safety risks for consumers. In short, the current legal landscape leaves American patients and doctors without adequate guidance or product safeguards for CBD.

It is the policy of my Administration to increase medical marijuana and CBD research to better inform patients and doctors. It is critical to close the gap between current medical marijuana and CBD use and medical knowledge of risks and benefits, including for specific populations and conditions. Research methods and models should include real-world evidence and should facilitate affordable access in order to rapidly assess the health outcomes of medical marijuana and legal CBD products while focusing on long-term health effects in vulnerable populations like adolescents and young adults.

Sec. 2. Rescheduling Medical Marijuana and Improving Access to Cannabidiol Products. (a) The Attorney General shall take all necessary steps to complete the rulemaking process related to rescheduling marijuana to Schedule III of the CSA in the most expeditious manner in accordance with Federal law, including 21 U.S.C. 811 [section 201 of Pub. L. 91-513].

(b) The Assistant to the President and Deputy Chief of Staff for Legislative, Political, and Public Affairs shall work with the Congress to update the statutory definition of final hemp-derived cannabinoid products to allow Americans to benefit from access to appropriate full-spectrum CBD products while preserving the Congress’s intent to restrict the sale of products that pose serious health risks. This will include consultation with appropriate executive departments and agencies and authorities to develop a regulatory framework for hemp-derived cannabinoid products, including development of guidance on an upper limit on milligrams of THC per serving with considerations on per container limits and CBD to THC ratio requirements. The Secretary of Health and Human Services, the Commissioner of Food and Drugs, the Administrator of the Centers for Medicare and Medicaid Services, and the Director of the National Institutes of Health shall develop research methods and models utilizing real-world evidence to improve accessto hemp-derived cannabinoid products in accordance with Federal law and to inform standards of care.

Sec. 3. General Provisions. (a) Nothing in this order shall be construed to impair or otherwise affect:

(i) the authority granted by law to an executive department or agency, or the head thereof; or

(ii) the functions of the Director of the Office of Management and Budget relating to budgetary, administrative, or legislative proposals.

(b) This order shall be implemented consistent with applicable law and subject to the availability of appropriations.

(c) This order is not intended to, and does not, create any right or benefit, substantive or procedural, enforceable at law or in equity by any party against the United States, its departments, agencies, or entities, its officers, employees, or agents, or any other person.

(d) The costs for publication of this order shall be borne by the Department of Health and Human Services.

Donald J. Trump.