CHAPTER 13 —DRUG ABUSE PREVENTION AND CONTROL
SUBCHAPTER I—CONTROL AND ENFORCEMENT
Part A—Introductory Provisions
Part B—Authority To Control; Standards and Schedules
Part C—Registration of Manufacturers, Distributors, and Dispensers of Controlled Substances
Part D—Offenses and Penalties
Part E—Administrative and Enforcement Provisions
Part F—General Provisions
SUBCHAPTER II—IMPORT AND EXPORT
SUBCHAPTER I—CONTROL AND ENFORCEMENT
Part A—Introductory Provisions
§801. Congressional findings and declarations: controlled substances
The Congress makes the following findings and declarations:
(1) Many of the drugs included within this subchapter have a useful and legitimate medical purpose and are necessary to maintain the health and general welfare of the American people.
(2) The illegal importation, manufacture, distribution, and possession and improper use of controlled substances have a substantial and detrimental effect on the health and general welfare of the American people.
(3) A major portion of the traffic in controlled substances flows through interstate and foreign commerce. Incidents of the traffic which are not an integral part of the interstate or foreign flow, such as manufacture, local distribution, and possession, nonetheless have a substantial and direct effect upon interstate commerce because—
(A) after manufacture, many controlled substances are transported in interstate commerce,
(B) controlled substances distributed locally usually have been transported in interstate commerce immediately before their distribution, and
(C) controlled substances possessed commonly flow through interstate commerce immediately prior to such possession.
(4) Local distribution and possession of controlled substances contribute to swelling the interstate traffic in such substances.
(5) Controlled substances manufactured and distributed intrastate cannot be differentiated from controlled substances manufactured and distributed interstate. Thus, it is not feasible to distinguish, in terms of controls, between controlled substances manufactured and distributed interstate and controlled substances manufactured and distributed intrastate.
(6) Federal control of the intrastate incidents of the traffic in controlled substances is essential to the effective control of the interstate incidents of such traffic.
(7) The United States is a party to the Single Convention on Narcotic Drugs, 1961, and other international conventions designed to establish effective control over international and domestic traffic in controlled substances.
(
Editorial Notes
References in Text
This subchapter, referred to in par. (1), was in the original "this title", meaning title II of
Statutory Notes and Related Subsidiaries
Effective Date
"(a) Except as otherwise provided in this section, this title [see Short Title note below] shall become effective on the first day of the seventh calendar month that begins after the day immediately preceding the date of enactment [Oct. 27, 1970].
"(b) Parts A, B, E, and F of this title [Parts A, B, E, and F of this subchapter], section 702 [set out as a note under
"(c) Sections 305 (relating to labels and labeling) [
Short Title of 2022 Amendment
Short Title of 2021 Amendment
Short Title of 2018 Amendment
Short Title of 2017 Amendment
Short Title of 2016 Amendment
Short Title of 2014 Amendment
Short Title of 2012 Amendment
Short Title of 2010 Amendment
Short Title of 2008 Amendment
Short Title of 2006 Amendment
Short Title of 2005 Amendment
Short Title of 2004 Amendment
Short Title of 2003 Amendment
Short Title of 2000 Amendments
Short Title of 1998 Amendment
Short Title of 1996 Amendments
Short Title of 1994 Amendment
Short Title of 1993 Amendment
Short Title of 1990 Amendment
Short Title of 1988 Amendment
Short Title of 1986 Amendment
Short Title of 1984 Amendment
Short Title of 1978 Amendment
Short Title of 1974 Amendment
Short Title
For short title and complete classification of title III of
Severability
Continuation of Orders, Rules, and Regulations
Doctor-Patient Relationship
"(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."
[For definitions of "State", "marijuana", and "cannabidiol" as used in section 301 of
Anti-Drug Messages on Federal Government Internet Sites
Protocols for Investigations and Prosecutions Relating to Date-Rape Drugs and Other Controlled Substances; Annual Report; National Awareness Campaign
"SEC. 6. DEVELOPMENT OF MODEL PROTOCOLS, TRAINING MATERIALS, FORENSIC FIELD TESTS, AND COORDINATION MECHANISM FOR INVESTIGATIONS AND PROSECUTIONS RELATING TO GAMMA HYDROXYBUTYRIC ACID, OTHER CONTROLLED SUBSTANCES, AND DESIGNER DRUGS.
"(a)
"(1) develop—
"(A) model protocols for the collection of toxicology specimens and the taking of victim statements in connection with investigations into and prosecutions related to possible violations of the Controlled Substances Act [
"(B) model training materials for law enforcement personnel involved in such investigations; and
"(2) make such protocols and training materials available to Federal, State, and local personnel responsible for such investigations.
"(b)
"(1)
"(2)
"(c)
"SEC. 7. ANNUAL REPORT REGARDING DATE-RAPE DRUGS; NATIONAL AWARENESS CAMPAIGN.
"(a)
"(b)
"(1)
"(A)
"(i) The dangers of date-rape drugs.
"(ii) The applicability of the Controlled Substances Act [
"(iii) Recognizing the symptoms that indicate an individual may be a victim of such drugs, including symptoms with respect to sexual assault.
"(iv) Appropriately responding when an individual has such symptoms.
"(B)
"(C)
"(2)
"(c)
Congressional Findings Regarding Methamphetamine Manufacture and Abuse
"(1) Methamphetamine is a very dangerous and harmful drug. It is highly addictive and is associated with permanent brain damage in long-term users.
"(2) The abuse of methamphetamine has increased dramatically since 1990. This increased use has led to devastating effects on individuals and the community, including—
"(A) a dramatic increase in deaths associated with methamphetamine ingestion;
"(B) an increase in the number of violent crimes associated with methamphetamine ingestion; and
"(C) an increase in criminal activity associated with the illegal importation of methamphetamine and precursor compounds to support the growing appetite for this drug in the United States.
"(3) Illegal methamphetamine manufacture and abuse presents an imminent public health threat that warrants aggressive law enforcement action, increased research on methamphetamine and other substance abuse, increased coordinated efforts to prevent methamphetamine abuse, and increased monitoring of the public health threat methamphetamine presents to the communities of the United States."
Support for International Efforts To Control Methamphetamine and Precursors
Interagency Methamphetamine Task Force
Suspicious Orders Task Force
Joint Federal Task Force on Illegal Drug Laboratories
"(a)
"(b)
"(c)
"(1) The volume of hazardous waste produced by illegal drug laboratories.
"(2) The cost of cleaning up and disposing of hazardous waste produced by illegal drug laboratories.
"(3) The effectiveness of the various methods of cleaning up and disposing of hazardous waste produced by illegal drug laboratories.
"(4) The coordination of the efforts of the Environmental Protection Agency and the Drug Enforcement Administration in cleaning up and disposing of hazardous waste produced by illegal drug laboratories.
"(5) The dissemination of information to law enforcement agencies that have responsibility for enforcement of drug laws.
"(d)
"(e)
"(1) The Attorney General shall make grants to, and enter into contracts with, State and local governments for demonstration projects to clean up and safely dispose of substances associated with illegal drug laboratories which may present a danger to public health or the environment.
"(2) The Attorney General may not under this subsection make a grant or enter into a contract unless the applicant for such assistance agrees to comply with the guidelines issued pursuant to subsection (d).
"(3) The Attorney General shall, through grant or contract, provide for independent evaluations of the activities carried out pursuant to this subsection and shall recommend appropriate legislation to the Congress.
"(f)
"(g)
"(1) transmit to the President and to each House of Congress not later than 270 days after the date of the enactment of this subtitle [Nov. 18, 1988] a report describing the program established by the Task Force under subsection (c) (including an analysis of the factors specified in paragraphs (1) through (5) of that subsection);
"(2) periodically transmit to the President and to each House of Congress reports describing the implementation of the program established by the Task Force under subsection (c) (including an analysis of the factors specified in paragraphs (1) through (5) of that subsection) and the progress made in the cleanup and disposal of hazardous waste produced by illegal drug laboratories; and
"(3) transmit to each House of Congress a report describing the findings made as a result of the evaluations referred to in subsection (e)(3)."
Great Lakes Drug Interdiction
"(a)
"(b)
[For transfer of authorities, functions, personnel, and assets of the Coast Guard, including the authorities and functions of the Secretary of Transportation relating thereto, to the Department of Homeland Security, and for treatment of related references, see
[For transfer of functions, personnel, assets, and liabilities of the United States Customs Service of the Department of the Treasury, including functions of the Secretary of the Treasury relating thereto, to the Secretary of Homeland Security, and for treatment of related references, see
GAO Study of Capabilities of United States To Control Drug Smuggling Into United States
Compliance With Budget Act
Drug Interdiction
"SEC. 3001. SHORT TITLE.
"This title [enacting
"SEC. 3002. FINDINGS.
"The Congress hereby finds that—
"(1) a balanced, coordinated, multifaceted strategy for combating the growing drug abuse and drug trafficking problem in the United States is essential in order to stop the flow and abuse of drugs within our borders;
"(2) a balanced, coordinated, multifaceted strategy for combating the narcotics drug abuse and trafficking in the United States should include—
"(A) increased investigations of large networks of drug smuggler organizations;
"(B) source country drug eradication;
"(C) increased emphasis on stopping narcotics traffickers in countries through which drugs are transshipped;
"(D) increased emphasis on drug education programs in the schools and workplace;
"(E) increased Federal Government assistance to State and local agencies, civic groups, school systems, and officials in their efforts to combat the drug abuse and trafficking problem at the local level; and
"(F) increased emphasis on the interdiction of drugs and drug smugglers at the borders of the United States, in the air, at sea, and on the land;
"(3) funds to support the interdiction of narcotics smugglers who threaten the transport of drugs through the air, on the sea, and across the land borders of the United States should be emphasized in the Federal Government budget process to the same extent as the other elements of a comprehensive antidrug effort are emphasized;
"(4) the Department of Defense and the use of its resources should be an integral part of a comprehensive, natonal [national] drug interdiction program;
"(5) the Federal Government civilian agencies engaged in drug interdiction, particularly the United States Customs Service and the Coast Guard, currently lack the aircraft, ships, radar, command, control, communications, and intelligence (C3I) system, and manpower resources necessary to mount a comprehensive attack on the narcotics traffickers who threaten the United States;
"(6) the civilian drug interdiction agencies of the United States are currently interdicting only a small percentage of the illegal, drug smuggler penetrations in the United States every year;
"(7) the budgets for our civilian drug interdiction agencies, primarily the United States Customs Service and the Coast Guard, have not kept pace with those of the traditional investigative law enforcement agencies of the Department of Justice; and
"(8) since the amendment of the Posse Comitatus Act (
"SEC. 3003. PURPOSES.
"It is the purpose of this title—
"(1) to increase the level of funding and resources available to civilian drug interdiction agencies of the Federal Government;
"(2) to increase the level of support from the Department of Defense as consistent with the Posse Comitatus Act [
"(3) to improve other drug interdiction programs of the Federal Government.
"SEC. 3301. ESTABLISHMENT OF A UNITED STATES-BAHAMAS DRUG INTERDICTION TASK FORCE
"(a)
"(1)
"(B) The Secretary of State, the Commandant of the Coast Guard, the Commissioner of Customs, the Attorney General, and the head of the National Narcotics Border Interdiction System (NNBIS), shall upon enactment of this Act [Oct. 27, 1986], immediately commence negotiations with the Government of the Bahamas to enter into a detailed agreement for the establishment and operation of a new drug interdiction task force, including plans for (i) the joint operation and maintenance of any drug interdiction assets authorized for the task force in this section and section 3141 [see
"(2)
"(A) $9,000,000 for 3 drug interdiction pursuit helicopters for use primarily for operations of the United States-Bahamas Drug Interdiction Task Force established under this section; and
"(B) $1,000,000 to enhance communications capabilities for the operation of a United States-Bahamas Drug Interdiction Task Force established under this section.
"(3)
"(B) The Commandant of the Coast Guard shall use such amounts appropriated pursuant to the authorization in this paragraph as may be necessary to establish a repair, maintenance, and boat lift facility to provide repair and maintenance services for both Coast Guard and Bahamian marine drug interdiction equipment, vessels, and related assets.
"(b)
Information on Drug Abuse at the Workplace
Interagency Coordination
"(a) The Secretary of Education, the Secretary of Health and Human Services, and the Secretary of Labor shall each designate an officer or employee of the Departments of Education, Health and Human Services, and Labor, respectively, to coordinate interagency drug abuse prevention activities to prevent duplication of effort.
"(b) Within one year after enactment of this Act [Oct. 27, 1986], a report shall be jointly submitted to the Congress by such Secretaries concerning the extent to which States and localities have been able to implement non-duplicative drug abuse prevention activities."
Substance Abuse Coverage Study
Health Insurance Coverage for Drug and Alcohol Treatment
"(a)
"(1) drug and alcohol abuse are problems of grave concern and consequence in American society;
"(2) over 500,000 individuals are known heroin addicts; 5 million individuals use cocaine; and at least 7 million individuals regularly use prescription drugs, mostly addictive ones, without medical supervision;
"(3) 10 million adults and 3 million children and adolescents abuse alcohol, and an additional 30 to 40 million people are adversely affected because of close family ties to alcoholics;
"(4) the total cost of drug abuse to the Nation in 1983 was over $60,000,000,000; and
"(5) the vast majority of health benefits plans provide only limited coverage for treatment of drug and alcohol addiction, which is a fact that can discourage the abuser from seeking treatment or, if the abuser does seek treatment, can cause the abuser to face significant out of pocket expenses for the treatment.
"(b)
"(1) all employers providing health insurance policies should ensure that the policies provide adequate coverage for treatment of drug and alcohol addiction in recognition that the health consequences and costs for individuals and society can be as formidable as those resulting from other diseases and illnesses for which insurance coverage is much more adequate; and
"(2) State insurance commissioners should encourage employers providing health benefits plans to ensure that the policies provide more adequate coverage for treatment of drug and alcohol addiction."
Commission on Marihuana and Drug Abuse
"(a)
"(1) two Members of the Senate appointed by the President of the Senate;
"(2) two Members of the House of Representatives appointed by the Speaker of the House of Representatives; and
"(3) nine members appointed by the President of the United States.
At no time shall more than one of the members appointed under paragraph (1), or more than one of the members appointed under paragraph (2), or more than five of the members appointed under paragraph (3) be members of the same political party.
"(b)
"(2) Members of the Commission who are Members of Congress or full-time officers or employees of the United States shall serve without additional compensation but shall be reimbursed for travel, subsistence, and other necessary expenses incurred in the performance of the duties vested in the Commission. Members of the Commission from private life shall receive $100 per diem while engaged in the actual performance of the duties vested in the Commission, plus reimbursement for travel, subsistence, and other necessary expenses incurred in the performance of such duties.
"(3) The Commission shall meet at the call of the Chairman or at the call of a majority of the members thereof.
"(c)
"(2) The Commission may procure, in accordance with the provisions of
"(3) The Commission may secure directly from any department or agency of the United States information necessary to enable it to carry out its duties under this section. Upon request of the Chairman of the Commission, such department or agency shall furnish such information to the Commission.
"(d)
"(A) the extent of use of marihuana in the United States to include its various sources of users, number of arrests, number of convictions, amount of marihuana seized, type of user, nature of use;
"(B) an evaluation of the efficacy of existing marihuana laws;
"(C) a study of the pharmacology of marihuana and its immediate and long-term effects, both physiological and psychological;
"(D) the relationship of marihuana use to aggressive behavior and crime;
"(E) the relationship between marihuana and the use of other drugs; and
"(F) the international control of marihuana.
"(2) Within one year after the date on which funds first become available to carry out this section, the Commission shall submit to the President and the Congress a comprehensive report on its study and investigation under this subsection which shall include its recommendations and such proposals for legislation and administrative action as may be necessary to carry out its recommendations.
"(e)
"(f)
Definitions
"(a)
"(1) the term 'appropriately registered' means that an individual or entity is registered under the Controlled Substances Act (
"(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 (
"(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 (
"(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 (
"(5) the term 'drug' has the meaning given the term in section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (
"(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 (
"(B) conducted by a covered institution of higher education, practitioner, or manufacturer that is appropriately registered under the Controlled Substances Act (
"(7) the term 'State' means any State of the United States, the District of Columbia, and any territory of the United States."
Executive Documents
Executive Order No. 11599
Ex. Ord. No. 11599, June 17, 1971, 36 F.R. 11793, which established the Special Action Office for Drug Abuse Prevention, was superseded. See Prior Provisions notes set out under
Executive Order No. 11641
Ex. Ord. No. 11641, Jan. 28, 1972, 37 F.R. 2421, which established the Office for Drug Abuse Law Enforcement, was revoked by Ex. Ord. No. 11727, July 6, 1973, 38 F.R. 18357, set out below.
Executive Order No. 11676
Ex. Ord. No. 11676, July 27, 1972, 37 F.R. 15125, which established the Office of National Narcotics Intelligence, was revoked by Ex. Ord. No. 11727, July 6, 1973, 38 F.R. 18357, set out below.
Ex. Ord. No. 11727. Drug Law Enforcement
Ex. Ord. No. 11727, July 6, 1973, 38 F.R. 18357, provided:
Reorganization Plan No. 2 of 1973 [set out in the Appendix to Title 5, Government Organization and Employees], which becomes effective on July 1, 1973, among other things establishes a Drug Enforcement Administration in the Department of Justice. In my message to the Congress transmitting that plan, I stated that all functions of the Office for Drug Abuse Law Enforcement (established pursuant to Executive Order No. 11641 of January 28, 1972) and the Office of National Narcotics Intelligence (established pursuant to Executive Order No. 11676 of July 27, 1972) would, together with other related functions, be merged in the new Drug Enforcement Administration.
NOW, THEREFORE, by virtue of the authority vested in me by the Constitution and laws of the United States, including
(1) "(6) Director, Office for Drug Abuse Law Enforcement, Department of Justice."; and
(2) "(7) Director, Office of National Narcotics Intelligence, Department of Justice."
Richard Nixon.
Combatting the National Drug Demand and Opioid Crisis
Memorandum of President of the United States, Oct. 26, 2017, 82 F.R. 50305, provided:
Memorandum for the Heads of Executive Departments and Agencies
By the authority vested in me as President by the Constitution and the laws of the United States of America, it is hereby directed as follows:
This crisis has devastated our communities. It has been particularly harmful for children affected by their parents' drug abuse. The number of infants born drug-dependent increased by nearly 500 percent from 2000 to 2012. The number of children being placed into foster care due, at least in part, to parental drug abuse is increasing, and accounted for almost a third of all child removals in Fiscal Year 2015. Serious drug users are also more likely to be arrested for crimes such as burglary, robbery, and handling stolen goods. Moreover, the drug trafficking that supplies illegal drugs to our country is associated with other illegal activities, including murder and other violent crimes. All of this devastates lives and harms communities in both the United States and foreign countries involved in the illegal drug supply chain. Federal, State, and local governments; law enforcement; first responders; the medical, public health, and substance abuse treatment community; and faith-based and community organizations are working tirelessly and have even expanded their efforts to combat the drug demand and opioid crisis.
Three factors are driving the opioid aspect of this crisis in particular. First, since the 1990s, there has been a dramatic rise in opioid pain medication prescriptions. Second, heroin from Mexico has flooded the country. Third, the illicit manufacture and illegal importation of fentanyl—an extremely deadly synthetic opioid—and its analogues and related compounds have proliferated. Fentanyl is currently manufactured almost exclusively in China, and it is either shipped into the United States or smuggled across the southern border by drug traffickers. Between 2013 and 2016, the amount of fentanyl seized by Customs and Border Protection at the border increased more than 200 times over. Dealers are increasingly lacing fentanyl into other drugs and pressing it into counterfeit opioid pills. Because fentanyl is lethal in even miniscule doses, this is an extremely deadly tactic, as it too often causes users to ingest a fatal amount unknowingly.
(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 memorandum shall be implemented consistent with applicable law and subject to the availability of appropriations.
(c) This memorandum 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 Secretary of Health and Human Services is hereby authorized and directed to publish this memorandum in the Federal Register.
Donald J. Trump.
§801a. Congressional findings and declarations: psychotropic substances
The Congress makes the following findings and declarations:
(1) The Congress has long recognized the danger involved in the manufacture, distribution, and use of certain psychotropic substances for nonscientific and nonmedical purposes, and has provided strong and effective legislation to control illicit trafficking and to regulate legitimate uses of psychotropic substances in this country. Abuse of psychotropic substances has become a phenomenon common to many countries, however, and is not confined to national borders. It is, therefore, essential that the United States cooperate with other nations in establishing effective controls over international traffic in such substances.
(2) The United States has joined with other countries in executing an international treaty, entitled the Convention on Psychotropic Substances and signed at Vienna, Austria, on February 21, 1971, which is designed to establish suitable controls over the manufacture, distribution, transfer, and use of certain psychotropic substances. The Convention is not self-executing, and the obligations of the United States thereunder may only be performed pursuant to appropriate legislation. It is the intent of the Congress that the amendments made by this Act, together with existing law, will enable the United States to meet all of its obligations under the Convention and that no further legislation will be necessary for that purpose.
(3) In implementing the Convention on Psychotropic Substances, the Congress intends that, consistent with the obligations of the United States under the Convention, control of psychotropic substances in the United States should be accomplished within the framework of the procedures and criteria for classification of substances provided in the Comprehensive Drug Abuse Prevention and Control Act of 1970 [
(
Editorial Notes
References in Text
This Act, referred to in par. (2), is
The Comprehensive Drug Abuse Prevention and Control Act of 1970, referred to in par. (3), is
Codification
Section was enacted as a part of the Psychotropic Substances Act of 1978, and not as a part of the Controlled Substances Act which comprises this subchapter.
Statutory Notes and Related Subsidiaries
Change of Name
"Secretary of Health and Human Services" substituted for "Secretary of Health, Education, and Welfare" in par. (3) pursuant to section 509(b) of
Effective Date
§802. Definitions
As used in this subchapter:
(1) The term "addict" means any individual who habitually uses any narcotic drug so as to endanger the public morals, health, safety, or welfare, or who is so far addicted to the use of narcotic drugs as to have lost the power of self-control with reference to his addiction.
(2) The term "administer" refers to the direct application of a controlled substance to the body of a patient or research subject by—
(A) a practitioner (or, in his presence, by his authorized agent), or
(B) the patient or research subject at the direction and in the presence of the practitioner,
whether such application be by injection, inhalation, ingestion, or any other means.
(3) The term "agent" means an authorized person who acts on behalf of or at the direction of a manufacturer, distributor, or dispenser; except that such term does not include a common or contract carrier, public warehouseman, or employee of the carrier or warehouseman, when acting in the usual and lawful course of the carrier's or warehouseman's business.
(4) The term "Drug Enforcement Administration" means the Drug Enforcement Administration in the Department of Justice.
(5) The term "control" means to add a drug or other substance, or immediate precursor, to a schedule under part B of this subchapter, whether by transfer from another schedule or otherwise.
(6) The term "controlled substance" means a drug or other substance, or immediate precursor, included in schedule I, II, III, IV, or V of part B of this subchapter. The term does not include distilled spirits, wine, malt beverages, or tobacco, as those terms are defined or used in subtitle E of the Internal Revenue Code of 1986.
(7) The term "counterfeit substance" means a controlled substance which, or the container or labeling of which, without authorization, bears the trademark, trade name, or other identifying mark, imprint, number, or device, or any likeness thereof, of a manufacturer, distributor, or dispenser other than the person or persons who in fact manufactured, distributed, or dispensed such substance and which thereby falsely purports or is represented to be the product of, or to have been distributed by, such other manufacturer, distributor, or dispenser.
(8) The terms "deliver" or "delivery" mean the actual, constructive, or attempted transfer of a controlled substance or a listed chemical, whether or not there exists an agency relationship.
(9) The term "depressant or stimulant substance" means—
(A) a drug which contains any quantity of barbituric acid or any of the salts of barbituric acid; or
(B) a drug which contains any quantity of (i) amphetamine or any of its optical isomers; (ii) any salt of amphetamine or any salt of an optical isomer of amphetamine; or (iii) any substance which the Attorney General, after investigation, has found to be, and by regulation designated as, habit forming because of its stimulant effect on the central nervous system; or
(C) lysergic acid diethylamide; or
(D) any drug which contains any quantity of a substance which the Attorney General, after investigation, has found to have, and by regulation designated as having, a potential for abuse because of its depressant or stimulant effect on the central nervous system or its hallucinogenic effect.
(10) The term "dispense" means to deliver a controlled substance to an ultimate user or research subject by, or pursuant to the lawful order of, a practitioner, including the prescribing and administering of a controlled substance and the packaging, labeling or compounding necessary to prepare the substance for such delivery. The term "dispenser" means a practitioner who so delivers a controlled substance to an ultimate user or research subject.
(11) The term "distribute" means to deliver (other than by administering or dispensing) a controlled substance or a listed chemical. The term "distributor" means a person who so delivers a controlled substance or a listed chemical.
(12) The term "drug" has the meaning given that term by
(13) The term "felony" means any Federal or State offense classified by applicable Federal or State law as a felony.
(14) The term "isomer" means the optical isomer, except as used in schedule I(c) and schedule II(a)(4). As used in schedule I(c), the term "isomer" means any optical, positional, or geometric isomer. As used in schedule II(a)(4), the term "isomer" means any optical or geometric isomer.
(15) The term "manufacture" means the production, preparation, propagation, compounding, or processing of a drug or other substance, either directly or indirectly or by extraction from substances of natural origin, or independently by means of chemical synthesis or by a combination of extraction and chemical synthesis, and includes any packaging or repackaging of such substance or labeling or relabeling of its container; except that such term does not include the preparation, compounding, packaging, or labeling of a drug or other substance in conformity with applicable State or local law by a practitioner as an incident to his administration or dispensing of such drug or substance in the course of his professional practice. The term "manufacturer" means a person who manufactures a drug or other substance.
(16)(A) Subject to subparagraph (B), the terms "marihuana" and "marijuana" mean all parts of 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.
(B) The terms "marihuana" and "marijuana" do not include—
(i) hemp, as defined in
(ii) the mature stalks of such plant, fiber produced from such stalks, oil or cake made from the seeds of such plant, any other compound, manufacture, salt, derivative, mixture, or preparation of such mature stalks (except the resin extracted therefrom), fiber, oil, or cake, or the sterilized seed of such plant which is incapable of germination.
(17) The term "narcotic drug" means any of the following whether produced directly or indirectly by extraction from substances of vegetable origin, or independently by means of chemical synthesis, or by a combination of extraction and chemical synthesis:
(A) Opium, opiates, derivatives of opium and opiates, including their isomers, esters, ethers, salts, and salts of isomers, esters, and ethers, whenever the existence of such isomers, esters, ethers, and salts is possible within the specific chemical designation. Such term does not include the isoquinoline alkaloids of opium.
(B) Poppy straw and concentrate of poppy straw.
(C) Coca leaves, except coca leaves and extracts of coca leaves from which cocaine, ecgonine, and derivatives of ecgonine or their salts have been removed.
(D) Cocaine, its salts, optical and geometric isomers, and salts of isomers.
(E) Ecgonine, its derivatives, their salts, isomers, and salts of isomers.
(F) Any compound, mixture, or preparation which contains any quantity of any of the substances referred to in subparagraphs (A) through (E).
(18) The term "opiate" or "opioid" means any drug or other substance having an addiction-forming or addiction-sustaining liability similar to morphine or being capable of conversion into a drug having such addiction-forming or addiction-sustaining liability.
(19) The term "opium poppy" means the plant of the species Papaver somniferum L., except the seed thereof.
(20) The term "poppy straw" means all parts, except the seeds, of the opium poppy, after mowing.
(21) The term "practitioner" means a physician, dentist, veterinarian, scientific investigator, pharmacy, hospital, or other person licensed, registered, or otherwise permitted, by the United States or the jurisdiction in which he practices or does research, to distribute, dispense, conduct research with respect to, administer, or use in teaching or chemical analysis, a controlled substance in the course of professional practice or research.
(22) The term "production" includes the manufacture, planting, cultivation, growing, or harvesting of a controlled substance.
(23) The term "immediate precursor" means a substance—
(A) which the Attorney General has found to be and by regulation designated as being the principal compound used, or produced primarily for use, in the manufacture of a controlled substance;
(B) which is an immediate chemical intermediary used or likely to be used in the manufacture of such controlled substance; and
(C) the control of which is necessary to prevent, curtail, or limit the manufacture of such controlled substance.
(24) The term "Secretary", unless the context otherwise indicates, means the Secretary of Health and Human Services.
(25) The term "serious bodily injury" means bodily injury which involves—
(A) a substantial risk of death;
(B) protracted and obvious disfigurement; or
(C) protracted loss or impairment of the function of a bodily member, organ, or mental faculty.
(26) The term "State" means a State of the United States, the District of Columbia, and any commonwealth, territory, or possession of the United States.
(27) The term "ultimate user" means a person who has lawfully obtained, and who possesses, a controlled substance for his own use or for the use of a member of his household or for an animal owned by him or by a member of his household.
(28) The term "United States", when used in a geographic sense, means all places and waters, continental or insular, subject to the jurisdiction of the United States.
(29) The term "maintenance treatment" means the dispensing, for a period in excess of twenty-one days, of a narcotic drug in the treatment of an individual for dependence upon heroin or other morphine-like drugs.
(30) The term "detoxification treatment" means the dispensing, for a period not in excess of one hundred and eighty days, of a narcotic drug in decreasing doses to an individual in order to alleviate adverse physiological or psychological effects incident to withdrawal from the continuous or sustained use of a narcotic drug and as a method of bringing the individual to a narcotic drug-free state within such period.
(31) The term "Convention on Psychotropic Substances" means the Convention on Psychotropic Substances signed at Vienna, Austria, on February 21, 1971; and the term "Single Convention on Narcotic Drugs" means the Single Convention on Narcotic Drugs signed at New York, New York, on March 30, 1961.
(32)(A) Except as provided in subparagraph (C), the term "controlled substance analogue" means a substance—
(i) the chemical structure of which is substantially similar to the chemical structure of a controlled substance in schedule I or II;
(ii) which has a stimulant, depressant, or hallucinogenic effect on the central nervous system that is substantially similar to or greater than the stimulant, depressant, or hallucinogenic effect on the central nervous system of a controlled substance in schedule I or II; or
(iii) with respect to a particular person, which such person represents or intends to have a stimulant, depressant, or hallucinogenic effect on the central nervous system that is substantially similar to or greater than the stimulant, depressant, or hallucinogenic effect on the central nervous system of a controlled substance in schedule I or II.
(B) The designation of gamma butyrolactone or any other chemical as a listed chemical pursuant to paragraph (34) or (35) does not preclude a finding pursuant to subparagraph (A) of this paragraph that the chemical is a controlled substance analogue.
(C) Such term does not include—
(i) a controlled substance;
(ii) any substance for which there is an approved new drug application;
(iii) with respect to a particular person any substance, if an exemption is in effect for investigational use, for that person, under
(iv) any substance to the extent not intended for human consumption before such an exemption takes effect with respect to that substance.
(33) The term "listed chemical" means any list I chemical or any list II chemical.
(34) The term "list I chemical" means a chemical specified by regulation of the Attorney General as a chemical that is used in manufacturing a controlled substance in violation of this subchapter and is important to the manufacture of the controlled substances, and such term includes (until otherwise specified by regulation of the Attorney General, as considered appropriate by the Attorney General or upon petition to the Attorney General by any person) the following:
(A) Anthranilic acid, its esters, and its salts.
(B) Benzyl cyanide.
(C) Ephedrine, its salts, optical isomers, and salts of optical isomers.
(D) Ergonovine and its salts.
(E) Ergotamine and its salts.
(F) N-Acetylanthranilic acid, its esters, and its salts.
(G) Norpseudoephedrine, its salts, optical isomers, and salts of optical isomers.
(H) Phenylacetic acid, its esters, and its salts.
(I) Phenylpropanolamine, its salts, optical isomers, and salts of optical isomers.
(J) Piperidine and its salts.
(K) Pseudoephedrine, its salts, optical isomers, and salts of optical isomers.
(L) 3,4-Methylenedioxyphenyl-2-propanone.
(M) Methylamine.
(N) Ethylamine.
(O) Propionic anhydride.
(P) Isosafrole.
(Q) Safrole.
(R) Piperonal.
(S) N-Methylephedrine.
(T) N-methylpseudoephedrine.
(U) Hydriodic acid.
(V) Benzaldehyde.
(W) Nitroethane.
(X) Gamma butyrolactone.
(Y) Any salt, optical isomer, or salt of an optical isomer of the chemicals listed in subparagraphs (M) through (U) of this paragraph.
(35) The term "list II chemical" means a chemical (other than a list I chemical) specified by regulation of the Attorney General as a chemical that is used in manufacturing a controlled substance in violation of this subchapter, and such term includes (until otherwise specified by regulation of the Attorney General, as considered appropriate by the Attorney General or upon petition to the Attorney General by any person) the following chemicals:
(A) Acetic anhydride.
(B) Acetone.
(C) Benzyl chloride.
(D) Ethyl ether.
(E) Repealed.
(F) Potassium permanganate.
(G) 2-Butanone (or Methyl Ethyl Ketone).
(H) Toluene.
(I) Iodine.
(J) Hydrochloric gas.
(36) The term "regular customer" means, with respect to a regulated person, a customer with whom the regulated person has an established business relationship that is reported to the Attorney General.
(37) The term "regular importer" means, with respect to a listed chemical, a person that has an established record as an importer of that listed chemical that is reported to the Attorney General.
(38) The term "regulated person" means a person who manufactures, distributes, imports, or exports a listed chemical, a tableting machine, or an encapsulating machine or who acts as a broker or trader for an international transaction involving a listed chemical, a tableting machine, or an encapsulating machine.
(39) The term "regulated transaction" means—
(A) a distribution, receipt, sale, importation, or exportation of, or an international transaction involving shipment of, a listed chemical, or if the Attorney General establishes a threshold amount for a specific listed chemical, a threshold amount, including a cumulative threshold amount for multiple transactions (as determined by the Attorney General, in consultation with the chemical industry and taking into consideration the quantities normally used for lawful purposes), of a listed chemical, except that such term does not include—
(i) a domestic lawful distribution in the usual course of business between agents or employees of a single regulated person;
(ii) a delivery of a listed chemical to or by a common or contract carrier for carriage in the lawful and usual course of the business of the common or contract carrier, or to or by a warehouseman for storage in the lawful and usual course of the business of the warehouseman, except that if the carriage or storage is in connection with the distribution, importation, or exportation of a listed chemical to a third person, this clause does not relieve a distributor, importer, or exporter from compliance with
(iii) any category of transaction or any category of transaction for a specific listed chemical or chemicals specified by regulation of the Attorney General as excluded from this definition as unnecessary for enforcement of this subchapter or subchapter II;
(iv) any transaction in a listed chemical that is contained in a drug that may be marketed or distributed lawfully in the United States under the Federal Food, Drug, and Cosmetic Act [
(I) the Attorney General has determined under
(II) the quantity of the listed chemical contained in the drug included in the transaction or multiple transactions equals or exceeds the threshold established for that chemical by the Attorney General;
(v) any transaction in a scheduled listed chemical product that is a sale at retail by a regulated seller or a distributor required to submit reports under
(vi) any transaction in a chemical mixture which the Attorney General has by regulation designated as exempt from the application of this subchapter and subchapter II based on a finding that the mixture is formulated in such a way that it cannot be easily used in the illicit production of a controlled substance and that the listed chemical or chemicals contained in the mixture cannot be readily recovered; and
(B) a distribution, importation, or exportation of a tableting machine or encapsulating machine.
(40) The term "chemical mixture" means a combination of two or more chemical substances, at least one of which is not a list I chemical or a list II chemical, except that such term does not include any combination of a list I chemical or a list II chemical with another chemical that is present solely as an impurity.
(41)(A) The term "anabolic steroid" means any drug or hormonal substance, chemically and pharmacologically related to testosterone (other than estrogens, progestins, corticosteroids, and dehydroepiandrosterone), and includes—
(i) androstanediol—
(I) 3β,17β-dihydroxy-5α-androstane; and
(II) 3α,17β-dihydroxy-5α-androstane;
(ii) androstanedione (5α-androstan-3,17-dione);
(iii) androstenediol—
(I) 1-androstenediol (3β,17β-dihydroxy-5α-androst-1-ene);
(II) 1-androstenediol (3α,17β-dihydroxy-5α-androst-1-ene);
(III) 4-androstenediol (3β,17β-dihydroxy-androst-4-ene); and
(IV) 5-androstenediol (3β,17β-dihydroxy-androst-5-ene);
(iv) androstenedione—
(I) 1-androstenedione ([5α]-androst-1-en-3,17-dione);
(II) 4-androstenedione (androst-4-en-3,17-dione); and
(III) 5-androstenedione (androst-5-en-3,17-dione);
(v) bolasterone (7α,17α-dimethyl-17β-hydroxyandrost-4-en-3-one);
(vi) boldenone (17β-hydroxyandrost-1,4,-diene-3-one);
(vii) calusterone (7β,17α-dimethyl-17β-hydroxyandrost-4-en-3-one);
(viii) clostebol (4-chloro-17β-hydroxyandrost-4-en-3-one);
(ix) dehydrochloromethyltestosterone (4-chloro-17β-hydroxy-17α-methyl-androst-1,4-dien-3-one);
(x) Δ1-dihydrotestosterone (a.k.a. "1-testosterone") (17β-hydroxy-5α-androst-1-en-3-one);
(xi) 4-dihydrotestosterone (17β-hydroxy-androstan-3-one);
(xii) drostanolone (17β-hydroxy-2α-methyl-5α-androstan-3-one);
(xiii) ethylestrenol (17α-ethyl-17β-hydroxyestr-4-ene);
(xiv) fluoxymesterone (9-fluoro-17α-methyl-11β,17β-dihydroxyandrost-4-en-3-one);
(xv) formebolone (2-formyl-17α-methyl-11α,17β-dihydroxyandrost-1,4-dien-3-one);
(xvi) furazabol (17α-methyl-17β-hydroxyandrostano[2,3-c]-furazan);
(xvii) 13β-ethyl-17β-hydroxygon-4-en-3-one;
(xviii) 4-hydroxytestosterone (4,17β-dihydroxy-androst-4-en-3-one);
(xix) 4-hydroxy-19-nortestosterone (4,17β-dihydroxy-estr-4-en-3-one);
(xx) mestanolone (17α-methyl-17β-hydroxy-5α-androstan-3-one);
(xxi) mesterolone (1α-methyl-17β-hydroxy-[5α]-androstan-3-one);
(xxii) methandienone (17α-methyl-17β-hydroxyandrost-1,4-dien-3-one);
(xxiii) methandriol (17α-methyl-3β,17β-dihydroxyandrost-5-ene);
(xxiv) methenolone (1-methyl-17β-hydroxy-5α-androst-1-en-3-one);
(xxv) 17α-methyl-3β, 17β-dihydroxy-5α-androstane;
(xxvi) 17α-methyl-3α,17β-dihydroxy-5α-androstane;
(xxvii) 17α-methyl-3β,17β-dihydroxyandrost-4-ene.
(xxviii) 17α-methyl-4-hydroxynandrolone (17α-methyl-4-hydroxy-17β-hydroxyestr-4-en-3-one);
(xxix) methyldienolone (17α-methyl-17β-hydroxyestra-4,9(10)-dien-3-one);
(xxx) methyltrienolone (17α-methyl-17β-hydroxyestra-4,9-11-trien-3-one);
(xxxi) methyltestosterone (17α-methyl-17β-hydroxyandrost-4-en-3-one);
(xxxii) mibolerone (7α,17α-dimethyl-17β-hydroxyestr-4-en-3-one);
(xxxiii) 17α-methyl-Δ1-dihydrotestosterone (17β-hydroxy-17α-methyl-5α-androst-1-en-3-one) (a.k.a. "17-α-methyl-1-testosterone");
(xxxiv) nandrolone (17β-hydroxyestr-4-en-3-one);
(xxxv) norandrostenediol—
(I) 19-nor-4-androstenediol (3β, 17β-dihydroxyestr-4-ene);
(II) 19-nor-4-androstenediol (3α, 17β-dihydroxyestr-4-ene);
(III) 19-nor-5-androstenediol (3β, 17β-dihydroxyestr-5-ene); and
(IV) 19-nor-5-androstenediol (3α, 17β-dihydroxyestr-5-ene);
(xxxvi) norandrostenedione—
(I) 19-nor-4-androstenedione (estr-4-en-3,17-dione); and
(II) 19-nor-5-androstenedione (estr-5-en-3,17-dione;
(xxxvii) norbolethone (13β,17α-diethyl-17β-hydroxygon-4-en-3-one);
(xxxviii) norclostebol (4-chloro-17β-hydroxyestr-4-en-3-one);
(xxxix) norethandrolone (17α-ethyl-17β-hydroxyestr-4-en-3-one);
(xl) normethandrolone (17α-methyl-17β-hydroxyestr-4-en-3-one);
(xli) oxandrolone (17α-methyl-17β-hydroxy-2-oxa-[5α]-androstan-3-one);
(xlii) oxymesterone (17α-methyl-4,17β-dihydroxyandrost-4-en-3-one);
(xliii) oxymetholone (17α-methyl-2-hydroxymethylene-17β-hydroxy-[5α]-androstan-3-one);
(xliv) stanozolol (17α-methyl-17β-hydroxy-[5α]-androst-2-eno[3,2-c]-pyrazole);
(xlv) stenbolone (17β-hydroxy-2-methyl-[5α]-androst-1-en-3-one);
(xlvi) testolactone (13-hydroxy-3-oxo-13,17-secoandrosta-1,4-dien-17-oic acid lactone);
(xlvii) testosterone (17β-hydroxyandrost-4-en-3-one);
(xlviii) tetrahydrogestrinone (13β,17α-diethyl-17β-hydroxygon-4,9,11-trien-3-one);
(xlix) trenbolone (17β-hydroxyestr-4,9,11-trien-3-one);
(l) 5α-Androstan-3,6,17-trione;
(li) 6-bromo-androstan-3,17-dione;
(lii) 6-bromo-androsta-1,4-diene-3,17-dione;
(liii) 4-chloro-17α-methyl-androsta-1,4-diene-3,17β-diol;
(liv) 4-chloro-17α-methyl-androst-4-ene-3β,17β-diol;
(lv) 4-chloro-17α-methyl-17β-hydroxy-androst-4-en-3-one;
(lvi) 4-chloro-17α-methyl-17β-hydroxy-androst-4-ene-3,11-dione;
(lvii) 4-chloro-17α-methyl-androsta-1,4-diene-3,17β-diol;
(lviii) 2α,17α-dimethyl-17β-hydroxy-5α-androstan-3-one;
(lix) 2α,17α-dimethyl-17β-hydroxy-5β-androstan-3-one;
(lx) 2α,3α-epithio-17α-methyl-5α-androstan-17β-ol;
(lxi) [3,2-c]-furazan-5α-androstan-17β-ol;
(lxii) 3β-hydroxy-estra-4,9,11-trien-17-one;
(lxiii) 17α-methyl-androst-2-ene-3,17β-diol;
(lxiv) 17α-methyl-androsta-1,4-diene-3,17β-diol;
(lxv) Estra-4,9,11-triene-3,17-dione;
(lxvi) 18a-Homo-3-hydroxy-estra-2,5(10)-dien-17-one;
(lxvii) 6α-Methyl-androst-4-ene-3,17-dione;
(lxviii) 17α-Methyl-androstan-3-hydroxyimine-17β-ol;
(lxix) 17α-Methyl-5α-androstan-17β-ol;
(lxx) 17β-Hydroxy-androstano[2,3-d]isoxazole;
(lxxi) 17β-Hydroxy-androstano[3,2-c]isoxazole;
(lxxii) 4-Hydroxy-androst-4-ene-3,17-dione[3,2-c]pyrazole-5α-androstan-17β-ol;
(lxxiii) [3,2-c]pyrazole-androst-4-en-17β-ol;
(lxxiv) [3,2-c]pyrazole-5α-androstan-17β-ol; and
(lxxv) any salt, ester, or ether of a drug or substance described in this paragraph.
The substances excluded under this subparagraph may at any time be scheduled by the Attorney General in accordance with the authority and requirements of subsections (a) through (c) of
(B)(i) Except as provided in clause (ii), such term does not include an anabolic steroid which is expressly intended for administration through implants to cattle or other nonhuman species and which has been approved by the Secretary of Health and Human Services for such administration.
(ii) If any person prescribes, dispenses, or distributes such steroid for human use, such person shall be considered to have prescribed, dispensed, or distributed an anabolic steroid within the meaning of subparagraph (A).
(C)(i) Subject to clause (ii), a drug or hormonal substance (other than estrogens, progestins, corticosteroids, and dehydroepiandrosterone) that is not listed in subparagraph (A) and is derived from, or has a chemical structure substantially similar to, 1 or more anabolic steroids listed in subparagraph (A) shall be considered to be an anabolic steroid for purposes of this chapter if—
(I) the drug or substance has been created or manufactured with the intent of producing a drug or other substance that either—
(aa) promotes muscle growth; or
(bb) otherwise causes a pharmacological effect similar to that of testosterone; or
(II) the drug or substance has been, or is intended to be, marketed or otherwise promoted in any manner suggesting that consuming it will promote muscle growth or any other pharmacological effect similar to that of testosterone.
(ii) A substance shall not be considered to be a drug or hormonal substance for purposes of this subparagraph if it—
(I) is—
(aa) an herb or other botanical;
(bb) a concentrate, metabolite, or extract of, or a constituent isolated directly from, an herb or other botanical; or
(cc) a combination of 2 or more substances described in item (aa) or (bb);
(II) is a dietary ingredient for purposes of the Federal Food, Drug, and Cosmetic Act (
(III) is not anabolic or androgenic.
(iii) In accordance with
(42) The term "international transaction" means a transaction involving the shipment of a listed chemical across an international border (other than a United States border) in which a broker or trader located in the United States participates.
(43) The terms "broker" and "trader" mean a person that assists in arranging an international transaction in a listed chemical by—
(A) negotiating contracts;
(B) serving as an agent or intermediary; or
(C) bringing together a buyer and seller, a buyer and transporter, or a seller and transporter.
(44) The term "felony drug offense" means an offense that is punishable by imprisonment for more than one year under any law of the United States or of a State or foreign country that prohibits or restricts conduct relating to narcotic drugs, marihuana, anabolic steroids, or depressant or stimulant substances.
(45)(A) The term "scheduled listed chemical product" means, subject to subparagraph (B), a product that—
(i) contains ephedrine, pseudoephedrine, or phenylpropanolamine; and
(ii) may be marketed or distributed lawfully in the United States under the Federal, Food, Drug, and Cosmetic Act [
Each reference in clause (i) to ephedrine, pseudoephedrine, or phenylpropanolamine includes each of the salts, optical isomers, and salts of optical isomers of such chemical.
(B) Such term does not include a product described in subparagraph (A) if the product contains a chemical specified in such subparagraph that the Attorney General has under
(46) The term "regulated seller" means a retail distributor (including a pharmacy or a mobile retail vendor), except that such term does not include an employee or agent of such distributor.
(47) The term "mobile retail vendor" means a person or entity that makes sales at retail from a stand that is intended to be temporary, or is capable of being moved from one location to another, whether the stand is located within or on the premises of a fixed facility (such as a kiosk at a shopping center or an airport) or whether the stand is located on unimproved real estate (such as a lot or field leased for retail purposes).
(48) The term "at retail", with respect to the sale or purchase of a scheduled listed chemical product, means a sale or purchase for personal use, respectively.
(49)(A) The term "retail distributor" means a grocery store, general merchandise store, drug store, or other entity or person whose activities as a distributor relating to ephedrine, pseudoephedrine, or phenylpropanolamine products are limited almost exclusively to sales for personal use, both in number of sales and volume of sales, either directly to walk-in customers or in face-to-face transactions by direct sales.
(B) For purposes of this paragraph, entities are defined by reference to the Standard Industrial Classification (SIC) code, as follows:
(i) A grocery store is an entity within SIC code 5411.
(ii) A general merchandise store is an entity within SIC codes 5300 through 5399 and 5499.
(iii) A drug store is an entity within SIC code 5912.
(50) The term "Internet" means collectively the myriad of computer and telecommunications facilities, including equipment and operating software, which comprise the interconnected worldwide network of networks that employ the Transmission Control Protocol/Internet Protocol, or any predecessor or successor protocol to such protocol, to communicate information of all kinds by wire or radio.
(51) The term "deliver, distribute, or dispense by means of the Internet" refers, respectively, to any delivery, distribution, or dispensing of a controlled substance that is caused or facilitated by means of the Internet.
(52) The term "online pharmacy"—
(A) means a person, entity, or Internet site, whether in the United States or abroad, that knowingly or intentionally delivers, distributes, or dispenses, or offers or attempts to deliver, distribute, or dispense, a controlled substance by means of the Internet; and
(B) does not include—
(i) manufacturers or distributors registered under subsection (a), (b), (e), or (f) of
(ii) nonpharmacy practitioners who are registered under
(iii) any hospital or other medical facility that is operated by an agency of the United States (including the Armed Forces), provided such hospital or other facility is registered under
(iv) a health care facility owned or operated by an Indian tribe or tribal organization, only to the extent such facility is carrying out a contract or compact under the Indian Self-Determination and Education Assistance Act [
(v) any agent or employee of any hospital or facility referred to in clause (iii) or (iv), provided such agent or employee is lawfully acting in the usual course of business or employment, and within the scope of the official duties of such agent or employee, with such hospital or facility, and, with respect to agents or employees of health care facilities specified in clause (iv), only to the extent such individuals are furnishing services pursuant to the contracts or compacts described in such clause;
(vi) mere advertisements that do not attempt to facilitate an actual transaction involving a controlled substance;
(vii) a person, entity, or Internet site that is not in the United States and does not facilitate the delivery, distribution, or dispensing of a controlled substance by means of the Internet to any person in the United States;
(viii) a pharmacy registered under
(I) refilling prescriptions for controlled substances in schedule III, IV, or V, as defined in paragraph (55); or
(II) filling new prescriptions for controlled substances in schedule III, IV, or V, as defined in paragraph (56); or
(ix) any other persons for whom the Attorney General and the Secretary have jointly, by regulation, found it to be consistent with effective controls against diversion and otherwise consistent with the public health and safety to exempt from the definition of an "online pharmacy".
(53) The term "homepage" means the opening or main page or screen of the website of an online pharmacy that is viewable on the Internet.
(54) The term "practice of telemedicine" means, for purposes of this subchapter, the practice of medicine in accordance with applicable Federal and State laws by a practitioner (other than a pharmacist) who is at a location remote from the patient and is communicating with the patient, or health care professional who is treating the patient, using a telecommunications system referred to in
(A) is being conducted—
(i) while the patient is being treated by, and physically located in, a hospital or clinic registered under
(ii) by a practitioner—
(I) acting in the usual course of professional practice;
(II) acting in accordance with applicable State law; and
(III) registered under
(aa) is exempted from such registration in all States under
(bb) is—
(AA) an employee or contractor of the Department of Veterans Affairs who is acting in the scope of such employment or contract; and
(BB) registered under
(B) is being conducted while the patient is being treated by, and in the physical presence of, a practitioner—
(i) acting in the usual course of professional practice;
(ii) acting in accordance with applicable State law; and
(iii) registered under
(I) is exempted from such registration in all States under
(II) is—
(aa) an employee or contractor of the Department of Veterans Affairs who is acting in the scope of such employment or contract; and
(bb) registered under
(C) is being conducted by a practitioner—
(i) who is an employee or contractor of the Indian Health Service, or is working for an Indian tribe or tribal organization under its contract or compact with the Indian Health Service under the Indian Self-Determination and Education Assistance Act [
(ii) acting within the scope of the employment, contract, or compact described in clause (i); and
(iii) who is designated as an Internet Eligible Controlled Substances Provider by the Secretary under
(D)(i) is being conducted during a public health emergency declared by the Secretary under
(ii) involves patients located in such areas, and such controlled substances, as the Secretary, with the concurrence of the Attorney General, designates, provided that such designation shall not be subject to the procedures prescribed by subchapter II of
(E) is being conducted by a practitioner who has obtained from the Attorney General a special registration under
(F) is being conducted—
(i) in a medical emergency situation—
(I) that prevents the patient from being in the physical presence of a practitioner registered under
(II) that prevents the patient from being physically present at a hospital or clinic operated by the Department of Veterans Affairs registered under
(III) during which the primary care practitioner of the patient or a practitioner otherwise practicing telemedicine within the meaning of this paragraph is unable to provide care or consultation; and
(IV) that requires immediate intervention by a health care practitioner using controlled substances to prevent what the practitioner reasonably believes in good faith will be imminent and serious clinical consequences, such as further injury or death; and
(ii) by a practitioner that—
(I) is an employee or contractor of the Veterans Health Administration acting within the scope of that employment or contract;
(II) is registered under
(III) issues a controlled substance prescription in this emergency context that is limited to a maximum of a 5-day supply which may not be extended or refilled; or
(G) is being conducted under any other circumstances that the Attorney General and the Secretary have jointly, by regulation, determined to be consistent with effective controls against diversion and otherwise consistent with the public health and safety.
(55) The term "refilling prescriptions for controlled substances in schedule III, IV, or V"—
(A) means the dispensing of a controlled substance in schedule III, IV, or V in accordance with refill instructions issued by a practitioner as part of a valid prescription that meets the requirements of subsections (b) and (c) of
(B) does not include the issuance of a new prescription to an individual for a controlled substance that individual was previously prescribed.
(56) The term "filling new prescriptions for controlled substances in schedule III, IV, or V" means filling a prescription for an individual for a controlled substance in schedule III, IV, or V, if—
(A) the pharmacy dispensing that prescription has previously dispensed to the patient a controlled substance other than by means of the Internet and pursuant to the valid prescription of a practitioner that meets the applicable requirements of subsections (b) and (c) of
(B) the pharmacy contacts the practitioner who issued the original prescription at the request of that individual to determine whether the practitioner will authorize the issuance of a new prescription for that individual for the controlled substance described in subparagraph (A); and
(C) the practitioner, acting in the usual course of professional practice, determines there is a legitimate medical purpose for the issuance of the new prescription.
(57) 1 The term "suspicious order" may include, but is not limited to—
(A) an order of a controlled substance of unusual size;
(B) an order of a controlled substance deviating substantially from a normal pattern; and
(C) orders of controlled substances of unusual frequency.
(57) 1 The term "serious drug felony" means an offense described in
(A) the offender served a term of imprisonment of more than 12 months; and
(B) the offender's release from any term of imprisonment was within 15 years of the commencement of the instant offense.
(58) The term "serious violent felony" means—
(A) an offense described in
(B) any offense that would be a felony violation of
(
Editorial Notes
References in Text
Schedules I, II, III, IV, and V, referred to in pars. (6), (14), (32)(A), (52)(B)(viii), (55), and (56), are set out in
This subchapter, referred to in introductory provisions and in pars. (34), (35), (39)(A)(iii), (vi), and (54), was in the original "this title", meaning title II of
Subchapter II, referred to in par. (39)(A)(iii), (vi), was in the original "title III", meaning title III of
The Federal Food, Drug, and Cosmetic Act, referred to in pars. (39)(A)(iv), (41)(C)(ii)(II), and (45)(A)(ii), is act June 25, 1938, ch. 675,
This chapter, referred to in par. (41)(C)(i), was in the original "this Act", meaning
The Indian Self-Determination and Education Assistance Act, referred to in pars. (52)(B)(iv) and (54)(C)(i), is
Amendments
2022—Par. (16)(A).
Par. (16)(B).
Par. (52)(B).
Par. (52)(B)(i).
Par. (54).
2018—Par. (16).
Par. (24).
Par. (57).
Par. (58).
2016—Par. (18).
2014—Par. (41)(A)(l) to (lxxv).
Par. (41)(C).
2008—Pars. (50) to (56).
2006—Par. (39)(A)(iv).
Par. (39)(A)(v), (vi).
Par. (41)(A)(xvii).
Par. (41)(A)(xliv).
Par. (45).
Pars. (46) to (48).
Par. (49).
2004—Par. (41).
Par. (44).
2002—Pars. (43), (44).
2000—Par. (32)(A).
Par. (32)(B), (C).
Par. (34)(X), (Y).
Par. (39)(A)(iv)(II).
1997—Par. (9)(A).
1996—Par. (26).
Par. (34)(P), (S), (U).
Par. (35)(G).
Par. (35)(I), (J).
Par. (39)(A)(iv)(I)(aa).
Par. (39)(A)(iv)(II).
Pars. (43), (44).
Pars. (45), (46).
1994—Par. (34)(V), (W).
Par. (35).
Par. (39)(A)(iv)(II).
Par. (43).
1993—Par. (33).
Par. (34).
Par. (34)(A), (F), (H).
Par. (34)(O).
Par. (34)(P) to (S).
Par. (34)(T).
Par. (34)(U).
Par. (34)(V).
Par. (34)(W).
Par. (34)(X).
Par. (34)(Y).
Par. (35).
Par. (37).
Par. (38).
Par. (39)(A).
Par. (39)(A)(iii).
Par. (39)(A)(iv).
Par. (39)(A)(v).
Par. (40).
Pars. (42), (43).
1990—Par. (32)(A).
Par. (34)(M) to (Y).
Par. (35)(E).
Par. (41).
1988—Par. (8).
Par. (11).
Pars. (33) to (40).
1986—Par. (6).
Par. (14).
Par. (25).
Pars. (26) to (31).
Par. (32).
1984—Pars. (14) to (16).
Par. (17).
Pars. (18) to (28).
Par. (29).
Par. (30).
1979—Par. (4).
1978—Par. (29).
1974—Pars. (27), (28).
Statutory Notes and Related Subsidiaries
Effective Date of 2018 Amendment
Effective Date of 2008 Amendment
"(1)
"(2)
"(A)
"(i) the definition of the term 'practice of telemedicine' in subparagraph (B) of this paragraph shall apply for purposes of the Controlled Substances Act [
"(ii) the definition of the term 'practice of telemedicine' in section 102(54) of the Controlled Substances Act [
"(B)
"(C)
Effective Date of 2004 Amendment
Effective Date of 2002 Amendment
Effective Date of 2000 Amendment
Effective Date of 1997 Amendment
Amendment by
Effective Date of 1996 Amendments
Amendment by section 604(b)(4) of
Effective Date of 1994 Amendment
Effective Date of 1993 Amendment
Effective Date of 1990 Amendment
Effective Date of 1988 Amendment
Effective Date of 1978 Amendment
Amendment by
Regulations
Construction of 2008 Amendment
Preservation of State Authority To Regulate Scheduled Listed Chemicals
Report on Diversion of Ordinary, Over-the-Counter Pseudoephedrine and Phenylpropanolamine Products
"(a)
"(1) Information from Federal, State, and local clandestine laboratory seizures and related investigations identifying the source, type, or brand of drug products being utilized and how they were obtained for the illicit production of methamphetamine and amphetamine.
"(2) Information submitted voluntarily from the pharmaceutical and retail industries involved in the manufacture, distribution, and sale of drug products containing ephedrine, pseudoephedrine, and phenylpropanolamine, including information on changes in the pattern, volume, or both, of sales of ordinary, over-the-counter pseudoephedrine and phenylpropanolamine products.
"(b)
"(1)
"(2)
"(A) the findings of the Attorney General as a result of the study; and
"(B) such recommendations on the need to establish additional measures to prevent diversion of ordinary, over-the-counter pseudoephedrine and phenylpropanolamine (such as a threshold on ordinary, over-the-counter pseudoephedrine and phenylpropanolamine products) as the Attorney General considers appropriate.
"(3)
"(c)
"(1)
"(A) there is a significant number of instances (as set forth in paragraph (3)(A) of such section 401(d) for purposes of such section) where ordinary, over-the-counter pseudoephedrine products, phenylpropanolamine products, or both such products that were purchased from retail distributors were widely used in the clandestine production of illicit drugs; and
"(B) the best practical method of preventing such use is the establishment of single-transaction limits for retail distributors of either or both of such products.
"(2)
Regulation of Retail Sales of Certain Precursor Chemicals; Effect on Thresholds; Combination Ephedrine Products
Exemption for Substances in Paragraph (41)
"(a)
"(1) approved by the Food and Drug Administration as an accepted treatment for a rare disease or condition, as defined in section 526 of the Federal Food, Drug, and Cosmetic Act (
"(2) does not have a significant potential for abuse, the Attorney General may exempt such drug from any production regulations otherwise issued under the Controlled Substances Act as may be necessary to ensure adequate supplies of such drug for medical purposes.
"(b)
1 So in original. Two pars. (57) have been enacted.
§803. Repealed. Pub. L. 95–137, §1(b), Oct. 18, 1977, 91 Stat. 1169
Section,
Part B—Authority To Control; Standards and Schedules
§811. Authority and criteria for classification of substances
(a) Rules and regulations of Attorney General; hearing
The Attorney General shall apply the provisions of this subchapter to the controlled substances listed in the schedules established by
(1) add to such a schedule or transfer between such schedules any drug or other substance if he—
(A) finds that such drug or other substance has a potential for abuse, and
(B) makes with respect to such drug or other substance the findings prescribed by subsection (b) of
(2) remove any drug or other substance from the schedules if he finds that the drug or other substance does not meet the requirements for inclusion in any schedule.
Rules of the Attorney General under this subsection shall be made on the record after opportunity for a hearing pursuant to the rulemaking procedures prescribed by subchapter II of
(b) Evaluation of drugs and other substances
The Attorney General shall, before initiating proceedings under subsection (a) to control a drug or other substance or to remove a drug or other substance entirely from the schedules, and after gathering the necessary data, request from the Secretary a scientific and medical evaluation, and his recommendations, as to whether such drug or other substance should be so controlled or removed as a controlled substance. In making such evaluation and recommendations, the Secretary shall consider the factors listed in paragraphs (2), (3), (6), (7), and (8) of subsection (c) and any scientific or medical considerations involved in paragraphs (1), (4), and (5) of such subsection. The recommendations of the Secretary shall include recommendations with respect to the appropriate schedule, if any, under which such drug or other substance should be listed. The evaluation and the recommendations of the Secretary shall be made in writing and submitted to the Attorney General within a reasonable time. The recommendations of the Secretary to the Attorney General shall be binding on the Attorney General as to such scientific and medical matters, and if the Secretary recommends that a drug or other substance not be controlled, the Attorney General shall not control the drug or other substance. If the Attorney General determines that these facts and all other relevant data constitute substantial evidence of potential for abuse such as to warrant control or substantial evidence that the drug or other substance should be removed entirely from the schedules, he shall initiate proceedings for control or removal, as the case may be, under subsection (a).
(c) Factors determinative of control or removal from schedules
In making any finding under subsection (a) of this section or under subsection (b) of
(1) Its actual or relative potential for abuse.
(2) Scientific evidence of its pharmacological effect, if known.
(3) The state of current scientific knowledge regarding the drug or other substance.
(4) Its history and current pattern of abuse.
(5) The scope, duration, and significance of abuse.
(6) What, if any, risk there is to the public health.
(7) Its psychic or physiological dependence liability.
(8) Whether the substance is an immediate precursor of a substance already controlled under this subchapter.
(d) International treaties, conventions, and protocols requiring control; procedures respecting changes in drug schedules of Convention on Psychotropic Substances
(1) If control is required by United States obligations under international treaties, conventions, or protocols in effect on October 27, 1970, 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 subsection (a) of this section or
(2)(A) Whenever the Secretary of State receives notification from the Secretary-General of the United Nations that information has been transmitted by or to the World Health Organization, pursuant to article 2 of the Convention on Psychotropic Substances, which may justify adding a drug or other substance to one of the schedules of the Convention, transferring a drug or substance from one schedule to another, or deleting it from the schedules, the Secretary of State shall immediately transmit the notice to the Secretary of Health and Human Services who shall publish it in the Federal Register and provide opportunity to interested persons to submit to him comments respecting the scientific and medical evaluations which he is to prepare respecting such drug or substance. The Secretary of Health and Human Services shall prepare for transmission through the Secretary of State to the World Health Organization such medical and scientific evaluations as may be appropriate regarding the possible action that could be proposed by the World Health Organization respecting the drug or substance with respect to which a notice was transmitted under this subparagraph.
(B) Whenever the Secretary of State receives information that the Commission on Narcotic Drugs of the United Nations proposes to decide whether to add a drug or other substance to one of the schedules of the Convention, transfer a drug or substance from one schedule to another, or delete it from the schedules, the Secretary of State shall transmit timely notice to the Secretary of Health and Human Services of such information who shall publish a summary of such information in the Federal Register and provide opportunity to interested persons to submit to him comments respecting the recommendation which he is to furnish, pursuant to this subparagraph, respecting such proposal. The Secretary of Health and Human Services shall evaluate the proposal and furnish a recommendation to the Secretary of State which shall be binding on the representative of the United States in discussions and negotiations relating to the proposal.
(3) When the United States receives notification of a scheduling decision pursuant to article 2 of the Convention on Psychotropic Substances that a drug or other substance has been added or transferred to a schedule specified in the notification or receives notification (referred to in this subsection as a "schedule notice") that existing legal controls applicable under this subchapter to a drug or substance and the controls required by the Federal Food, Drug, and Cosmetic Act [
(A) If such requirements are met by such existing controls but the Secretary of Health and Human Services nonetheless believes that more stringent controls should be applied to the drug or substance, the Secretary shall recommend to the Attorney General that he initiate proceedings for scheduling the drug or substance, pursuant to subsections (a) and (b) of this section, to apply to such controls.
(B) If such requirements are not met by such existing controls and the Secretary of Health and Human Services concurs in the scheduling decision or schedule notice transmitted by the notification, the Secretary shall recommend to the Attorney General that he initiate proceedings for scheduling the drug or substance under the appropriate schedule pursuant to subsections (a) and (b) of this section.
(C) If such requirements are not met by such existing controls and the Secretary of Health and Human Services does not concur in the scheduling decision or schedule notice transmitted by the notification, the Secretary shall—
(i) if he deems that additional controls are necessary to protect the public health and safety, recommend to the Attorney General that he initiate proceedings for scheduling the drug or substance pursuant to subsections (a) and (b) of this section, to apply such additional controls;
(ii) request the Secretary of State to transmit a notice of qualified acceptance, within the period specified in the Convention, pursuant to paragraph 7 of article 2 of the Convention, to the Secretary-General of the United Nations;
(iii) request the Secretary of State to transmit a notice of qualified acceptance as prescribed in clause (ii) and request the Secretary of State to ask for a review by the Economic and Social Council of the United Nations, in accordance with paragraph 8 of article 2 of the Convention, of the scheduling decision; or
(iv) in the case of a schedule notice, request the Secretary of State to take appropriate action under the Convention to initiate proceedings to remove the drug or substance from the schedules under the Convention or to transfer the drug or substance to a schedule under the Convention different from the one specified in the schedule notice.
(4)(A) If the Attorney General determines, after consultation with the Secretary of Health and Human Services, that proceedings initiated under recommendations made under paragraph 1 (B) or (C)(i) of paragraph (3) will not be completed within the time period required by paragraph 7 of article 2 of the Convention, the Attorney General, after consultation with the Secretary and after providing interested persons opportunity to submit comments respecting the requirements of the temporary order to be issued under this sentence, shall issue a temporary order controlling the drug or substance under schedule IV or V, whichever is most appropriate to carry out the minimum United States obligations under paragraph 7 of article 2 of the Convention. As a part of such order, the Attorney General shall, after consultation with the Secretary, except such drug or substance from the application of any provision of part C of this subchapter which he finds is not required to carry out the United States obligations under paragraph 7 of article 2 of the Convention. In the case of proceedings initiated under subparagraph (B) of paragraph (3), the Attorney General, concurrently with the issuance of such order, shall request the Secretary of State to transmit a notice of qualified acceptance to the Secretary-General of the United Nations pursuant to paragraph 7 of article 2 of the Convention. A temporary order issued under this subparagraph controlling a drug or other substance subject to proceedings initiated under subsections (a) and (b) of this section shall expire upon the effective date of the application to the drug or substance of the controls resulting from such proceedings.
(B) After a notice of qualified acceptance of a scheduling decision with respect to a drug or other substance is transmitted to the Secretary-General of the United Nations in accordance with clause (ii) or (iii) of paragraph (3)(C) or after a request has been made under clause (iv) of such paragraph with respect to a drug or substance described in a schedule notice, the Attorney General, after consultation with the Secretary of Health and Human Services and after providing interested persons opportunity to submit comments respecting the requirements of the order to be issued under this sentence, shall issue an order controlling the drug or substance under schedule IV or V, whichever is most appropriate to carry out the minimum United States obligations under paragraph 7 of article 2 of the Convention in the case of a drug or substance for which a notice of qualified acceptance was transmitted or whichever the Attorney General determines is appropriate in the case of a drug or substance described in a schedule notice. As a part of such order, the Attorney General shall, after consultation with the Secretary, except such drug or substance from the application of any provision of part C of this subchapter which he finds is not required to carry out the United States obligations under paragraph 7 of article 2 of the Convention. If, as a result of a review under paragraph 8 of article 2 of the Convention of the scheduling decision with respect to which a notice of qualified acceptance was transmitted in accordance with clause (ii) or (iii) of paragraph (3)(C)—
(i) the decision is reversed, and
(ii) the drug or substance subject to such decision is not required to be controlled under schedule IV or V to carry out the minimum United States obligations under paragraph 7 of article 2 of the Convention,
the order issued under this subparagraph with respect to such drug or substance shall expire upon receipt by the United States of the review decision. If, as a result of action taken pursuant to action initiated under a request transmitted under clause (iv) of paragraph (3)(C), the drug or substance with respect to which such action was taken is not required to be controlled under schedule IV or V, the order issued under this paragraph with respect to such drug or substance shall expire upon receipt by the United States of a notice of the action taken with respect to such drug or substance under the Convention.
(C) An order issued under subparagraph (A) or (B) may be issued without regard to the findings required by subsection (a) of this section or by
(5) Nothing in the amendments made by the Psychotropic Substances Act of 1978 or the regulations or orders promulgated thereunder shall be construed to preclude requests by the Secretary of Health and Human Services or the Attorney General through the Secretary of State, pursuant to article 2 or other applicable provisions of the Convention, for review of scheduling decisions under such Convention, based on new or additional information.
(e) Immediate precursors
The Attorney General may, without regard to the findings required by subsection (a) of this section or
(f) Abuse potential
If, at the time a new-drug application is submitted to the Secretary for any drug having a stimulant, depressant, or hallucinogenic effect on the central nervous system, it appears that such drug has an abuse potential, such information shall be forwarded by the Secretary to the Attorney General.
(g) Exclusion of non-narcotic substances sold over the counter without a prescription; dextromethorphan; exemption of substances lacking abuse potential
(1) The Attorney General shall by regulation exclude any non-narcotic drug which contains a controlled substance from the application of this subchapter and subchapter II of this chapter if such drug may, under the Federal Food, Drug, and Cosmetic Act [
(2) Dextromethorphan shall not be deemed to be included in any schedule by reason of enactment of this subchapter unless controlled after October 27, 1970 pursuant to the foregoing provisions of this section.
(3) The Attorney General may, by regulation, exempt any compound, mixture, or preparation containing a controlled substance from the application of all or any part of this subchapter if he finds such compound, mixture, or preparation meets the requirements of one of the following categories:
(A) A mixture, or preparation containing a nonnarcotic controlled substance, which mixture or preparation is approved for prescription use, and which contains one or more other active ingredients which are not listed in any schedule and which are included therein in such combinations, quantity, proportion, or concentration as to vitiate the potential for abuse.
(B) A compound, mixture, or preparation which contains any controlled substance, which is not for administration to a human being or animal, and which is packaged in such form or concentration, or with adulterants or denaturants, so that as packaged it does not present any significant potential for abuse.
(C) Upon the recommendation of the Secretary of Health and Human Services, a compound, mixture, or preparation which contains any anabolic steroid, which is intended for administration to a human being or an animal, and which, because of its concentration, preparation, formulation or delivery system, does not present any significant potential for abuse.
(h) Temporary scheduling to avoid imminent hazards to public safety
(1) If the Attorney General finds that the scheduling of a substance in schedule I on a temporary basis is necessary to avoid an imminent hazard to the public safety, he may, by order and without regard to the requirements of subsection (b) relating to the Secretary of Health and Human Services, schedule such substance in schedule I if the substance is not listed in any other schedule in
(A) the date of the publication by the Attorney General of a notice in the Federal Register of the intention to issue such order and the grounds upon which such order is to be issued, and
(B) the date the Attorney General has transmitted the notice required by paragraph (4).
(2) The scheduling of a substance under this subsection shall expire at the end of 2 years from the date of the issuance of the order scheduling such substance, except that the Attorney General may, during the pendency of proceedings under subsection (a)(1) with respect to the substance, extend the temporary scheduling for up to 1 year.
(3) When issuing an order under paragraph (1), the Attorney General shall be required to consider, with respect to the finding of an imminent hazard to the public safety, only those factors set forth in paragraphs (4), (5), and (6) of subsection (c), including actual abuse, diversion from legitimate channels, and clandestine importation, manufacture, or distribution.
(4) The Attorney General shall transmit notice of an order proposed to be issued under paragraph (1) to the Secretary of Health and Human Services. In issuing an order under paragraph (1), the Attorney General shall take into consideration any comments submitted by the Secretary in response to a notice transmitted pursuant to this paragraph.
(5) An order issued under paragraph (1) with respect to a substance shall be vacated upon the conclusion of a subsequent rulemaking proceeding initiated under subsection (a) with respect to such substance.
(6) An order issued under paragraph (1) is not subject to judicial review.
(i) Temporary and permanent scheduling of recently emerged anabolic steroids
(1) The Attorney General may issue a temporary order adding a drug or other substance to the definition of anabolic steroids if the Attorney General finds that—
(A) the drug or other substance satisfies the criteria for being considered an anabolic steroid under
(B) adding such drug or other substance to the definition of anabolic steroids will assist in preventing abuse or misuse of the drug or other substance.
(2) An order issued under paragraph (1) shall not take effect until 30 days after the date of the publication by the Attorney General of a notice in the Federal Register of the intention to issue such order and the grounds upon which such order is to be issued. The order shall expire not later than 24 months after the date it becomes effective, except that the Attorney General may, during the pendency of proceedings under paragraph (6), extend the temporary scheduling order for up to 6 months.
(3) The Attorney General shall transmit notice of an order proposed to be issued under paragraph (1) to the Secretary of Health and Human Services. In issuing an order under paragraph (1), the Attorney General shall take into consideration any comments submitted by the Secretary in response to a notice transmitted pursuant to this paragraph.
(4) A temporary scheduling order issued under paragraph (1) shall be vacated upon the issuance of a permanent scheduling order under paragraph (6).
(5) An order issued under paragraph (1) is not subject to judicial review.
(6) The Attorney General may, by rule, issue a permanent order adding a drug or other substance to the definition of anabolic steroids if such drug or other substance satisfies the criteria for being considered an anabolic steroid under
(j) Interim final rule; date of issuance; procedure for final rule
(1) With respect to a drug referred to in subsection (f), if the Secretary of Health and Human Services recommends that the Attorney General control the drug in schedule II, III, IV, or V pursuant to subsections (a) and (b), the Attorney General shall, not later than 90 days after the date described in paragraph (2), issue an interim final rule controlling the drug in accordance with such subsections and
(2) The date described in this paragraph shall be the later of—
(A) the date on which the Attorney General receives the scientific and medical evaluation and the scheduling recommendation from the Secretary of Health and Human Services in accordance with subsection (b); or
(B) the date on which the Attorney General receives notification from the Secretary of Health and Human Services that the Secretary has approved an application under section 505(c), 512, or 571 of the Federal Food, Drug, and Cosmetic Act [
(3) A rule issued by the Attorney General under paragraph (1) shall become immediately effective as an interim final rule without requiring the Attorney General to demonstrate good cause therefor. The interim final rule shall give interested persons the opportunity to comment and to request a hearing. After the conclusion of such proceedings, the Attorney General shall issue a final rule in accordance with the scheduling criteria of subsections (b), (c), and (d) of this section and
(
Editorial Notes
References in Text
This subchapter, referred to in subsecs. (a), (c)(8), (d)(3), (4)(A), (B), and (g)(2), (3), was in the original "this title", meaning title II of
The Federal Food, Drug, and Cosmetic Act, referred to in subsecs. (d)(3) and (g)(1), is act June 25, 1938, ch. 675,
Schedules I, II, III, IV, and V, referred to in subsecs. (d)(4)(A), (B), (h)(1), and (j)(1), are set out in
The Psychotropic Substances Act of 1978, referred to in subsec. (d)(5), is
This subchapter and subchapter II of this chapter, referred to in subsec. (g)(1), was in the original "titles II and III of the Comprehensive Drug Abuse Prevention and Control Act", which was translated as meaning titles II and III of the Comprehensive Drug Abuse Prevention and Control Act of 1970,
Amendments
2015—Subsec. (j).
2014—Subsec. (i).
2012—Subsec. (h)(2).
2004—Subsec. (g)(1).
Subsec. (g)(3)(C).
1984—Subsec. (g)(3).
Subsec. (h).
1978—Subsec. (d).
Statutory Notes and Related Subsidiaries
Change of Name
"Secretary of Health and Human Services" substituted for "Secretary of Health, Education, and Welfare" in subsec. (d)(2), (3), (4)(A), (B), (5) pursuant to section 509(b) of
Effective Date of 2004 Amendment
Amendment by
Effective Date of 1978 Amendment
Amendment by
1 So in original. Probably should be "subparagraph".
§812. Schedules of controlled substances
(a) Establishment
There are established five schedules of controlled substances, to be known as schedules I, II, III, IV, and V. Such schedules shall initially consist of the substances listed in this section. The schedules established by this section shall be updated and republished on a semiannual basis during the two-year period beginning one year after October 27, 1970, and shall be updated and republished on an annual basis thereafter.1
(b) Placement on schedules; findings required
Except where control is required by United States obligations under an international treaty, convention, or protocol, in effect on October 27, 1970, and except in the case of an immediate precursor, a drug or other substance may not be placed in any schedule unless the findings required for such schedule are made with respect to such drug or other substance. The findings required for each of the schedules are as follows:
(1)
(A) The drug or other substance has a high potential for abuse.
(B) The drug or other substance has no currently accepted medical use in treatment in the United States.
(C) There is a lack of accepted safety for use of the drug or other substance under medical supervision.
(2)
(A) The drug or other substance has a high potential for abuse.
(B) The drug or other substance has a currently accepted medical use in treatment in the United States or a currently accepted medical use with severe restrictions.
(C) Abuse of the drug or other substances may lead to severe psychological or physical dependence.
(3)
(A) The drug or other substance has a potential for abuse less than the drugs or other substances in schedules I and II.
(B) The drug or other substance has a currently accepted medical use in treatment in the United States.
(C) Abuse of the drug or other substance may lead to moderate or low physical dependence or high psychological dependence.
(4)
(A) The drug or other substance has a low potential for abuse relative to the drugs or other substances in schedule III.
(B) The drug or other substance has a currently accepted medical use in treatment in the United States.
(C) Abuse of the drug or other substance may lead to limited physical dependence or psychological dependence relative to the drugs or other substances in schedule III.
(5)
(A) The drug or other substance has a low potential for abuse relative to the drugs or other substances in schedule IV.
(B) The drug or other substance has a currently accepted medical use in treatment in the United States.
(C) Abuse of the drug or other substance may lead to limited physical dependence or psychological dependence relative to the drugs or other substances in schedule IV.
(c) Initial schedules of controlled substances
Schedules I, II, III, IV, and V shall, unless and until amended pursuant to
Schedule I
(a) Unless specifically excepted or unless listed in another schedule, any of the following opiates, including their isomers, esters, ethers, salts, and salts of isomers, esters, and ethers, whenever the existence of such isomers, esters, ethers, and salts is possible within the specific chemical designation:
(1) Acetylmethadol.
(2) Allylprodine.
(3) Alphacetylmathadol.2
(4) Alphameprodine.
(5) Alphamethadol.
(6) Benzethidine.
(7) Betacetylmethadol.
(8) Betameprodine.
(9) Betamethadol.
(10) Betaprodine.
(11) Clonitazene.
(12) Dextromoramide.
(13) Dextrorphan.
(14) Diampromide.
(15) Diethylthiambutene.
(16) Dimenoxadol.
(17) Dimepheptanol.
(18) Dimethylthiambutene.
(19) Dioxaphetyl butyrate.
(20) Dipipanone.
(21) Ethylmethylthiambutene.
(22) Etonitazene.
(23) Etoxeridine.
(24) Furethidine.
(25) Hydroxypethidine.
(26) Ketobemidone.
(27) Levomoramide.
(28) Levophenacylmorphan.
(29) Morpheridine.
(30) Noracymethadol.
(31) Norlevorphanol.
(32) Normethadone.
(33) Norpipanone.
(34) Phenadoxone.
(35) Phenampromide.
(36) Phenomorphan.
(37) Phenoperidine.
(38) Piritramide.
(39) Proheptazine.
(40) Properidine.
(41) Racemoramide.
(42) Trimeperidine.
(b) Unless specifically excepted or unless listed in another schedule, any of the following opium derivatives, their salts, isomers, and salts of isomers whenever the existence of such salts, isomers, and salts of isomers is possible within the specific chemical designation:
(1) Acetorphine.
(2) Acetyldihydrocodeine.
(3) Benzylmorphine.
(4) Codeine methylbromide.
(5) Codeine-N-Oxide.
(6) Cyprenorphine.
(7) Desomorphine.
(8) Dihydromorphine.
(9) Etorphine.
(10) Heroin.
(11) Hydromorphinol.
(12) Methyldesorphine.
(13) Methylhydromorphine.
(14) Morphine methylbromide.
(15) Morphine methylsulfonate.
(16) Morphine-N-Oxide.
(17) Myrophine.
(18) Nicocodeine.
(19) Nicomorphine.
(20) Normorphine.
(21) Pholcodine.
(22) Thebacon.
(c) Unless specifically excepted or unless listed in another schedule, any material, compound, mixture, or preparation, which contains any quantity of the following hallucinogenic substances, or which contains any of their salts, isomers, and salts of isomers whenever the existence of such salts, isomers, and salts of isomers is possible within the specific chemical designation:
(1) 3,4-methylenedioxy amphetamine.
(2) 5-methoxy-3,4-methylenedioxy amphetamine.
(3) 3,4,5-trimethoxy amphetamine.
(4) Bufotenine.
(5) Diethyltryptamine.
(6) Dimethyltryptamine.
(7) 4-methyl-2,5-dimethoxyamphetamine.
(8) Ibogaine.
(9) Lysergic acid diethylamide.
(10) Marihuana.
(11) Mescaline.
(12) Peyote.
(13) N-ethyl-3-piperidyl benzilate.
(14) N-methyl-3-piperidyl benzilate.
(15) Psilocybin.
(16) Psilocyn.
(17) Tetrahydrocannabinols, except for tetrahydrocannabinols in hemp (as defined under
(18) 4-methylmethcathinone (Mephedrone).
(19) 3,4-methylenedioxypyrovalerone (MDPV).
(20) 2-(2,5-Dimethoxy-4-ethylphenyl)ethanamine (2C–E).
(21) 2-(2,5-Dimethoxy-4-methylphenyl)ethanamine (2C–D).
(22) 2-(4-Chloro-2,5-dimethoxyphenyl)ethanamine (2C–C).
(23) 2-(4-Iodo-2,5-dimethoxyphenyl)ethanamine (2C–I).
(24) 2-[4-(Ethylthio)-2,5-dimethoxyphenyl]ethanamine (2C–T–2).
(25) 2-[4-(Isopropylthio)-2,5-dimethoxyphenyl]ethanamine (2C–T–4).
(26) 2-(2,5-Dimethoxyphenyl)ethanamine (2C–H).
(27) 2-(2,5-Dimethoxy-4-nitro-phenyl)ethanamine (2C–N).
(28) 2-(2,5-Dimethoxy-4-(n)-propylphenyl)ethanamine (2C–P).
(d)(1) Unless specifically exempted or unless listed in another schedule, any material, compound, mixture, or preparation which contains any quantity of cannabimimetic agents, or which contains their salts, isomers, and salts of isomers whenever the existence of such salts, isomers, and salts of isomers is possible within the specific chemical designation.
(2) In paragraph (1):
(A) The term "cannabimimetic agents" means any substance that is a cannabinoid receptor type 1 (CB1 receptor) agonist as demonstrated by binding studies and functional assays within any of the following structural classes:
(i) 2-(3-hydroxycyclohexyl)phenol with substitution at the 5-position of the phenolic ring by alkyl or alkenyl, whether or not substituted on the cyclohexyl ring to any extent.
(ii) 3-(1-naphthoyl)indole or 3-(1-naphthylmethane)indole by substitution at the nitrogen atom of the indole ring, whether or not further substituted on the indole ring to any extent, whether or not substituted on the naphthoyl or naphthyl ring to any extent.
(iii) 3-(1-naphthoyl)pyrrole by substitution at the nitrogen atom of the pyrrole ring, whether or not further substituted in the pyrrole ring to any extent, whether or not substituted on the naphthoyl ring to any extent.
(iv) 1-(1-naphthylmethylene)indene by substitution of the 3-position of the indene ring, whether or not further substituted in the indene ring to any extent, whether or not substituted on the naphthyl ring to any extent.
(v) 3-phenylacetylindole or 3-benzoylindole by substitution at the nitrogen atom of the indole ring, whether or not further substituted in the indole ring to any extent, whether or not substituted on the phenyl ring to any extent.
(B) Such term includes—
(i) 5-(1,1-dimethylheptyl)-2-[(1R,3S)-3-hydroxycyclohexyl]-phenol (CP–47,497);
(ii) 5-(1,1-dimethyloctyl)-2-[(1R,3S)-3-hydroxycyclohexyl]-phenol (cannabicyclohexanol or CP–47,497 C8-homolog);
(iii) 1-pentyl-3-(1-naphthoyl)indole (JWH–018 and AM678);
(iv) 1-butyl-3-(1-naphthoyl)indole (JWH–073);
(v) 1-hexyl-3-(1-naphthoyl)indole (JWH–019);
(vi) 1-[2-(4-morpholinyl)ethyl]-3-(1-naphthoyl)indole (JWH–200);
(vii) 1-pentyl-3-(2-methoxyphenylacetyl)indole (JWH–250);
(viii) 1-pentyl-3-[1-(4-methoxynaphthoyl)]indole (JWH–081);
(ix) 1-pentyl-3-(4-methyl-1-naphthoyl)indole (JWH–122);
(x) 1-pentyl-3-(4-chloro-1-naphthoyl)indole (JWH–398);
(xi) 1-(5-fluoropentyl)-3-(1-naphthoyl)indole (AM2201);
(xii) 1-(5-fluoropentyl)-3-(2-iodobenzoyl)indole (AM694);
(xiii) 1-pentyl-3-[(4-methoxy)-benzoyl]indole (SR–19 and RCS–4);
(xiv) 1-cyclohexylethyl-3-(2-methoxyphenylacetyl)indole (SR–18 and RCS–8); and
(xv) 1-pentyl-3-(2-chlorophenylacetyl)indole (JWH–203).
Schedule II
(a) Unless specifically excepted or unless listed in another schedule, any of the following substances whether produced directly or indirectly by extraction from substances of vegetable origin, or independently by means of chemical synthesis, or by a combination of extraction and chemical synthesis:
(1) Opium and opiate, and any salt, compound, derivative, or preparation of opium or opiate.
(2) Any salt, compound, derivative, or preparation thereof which is chemically equivalent or identical with any of the substances referred to in clause (1), except that these substances shall not include the isoquinoline alkaloids of opium.
(3) Opium poppy and poppy straw.
(4) coca 3 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; ecgonine, its derivatives, their salts, isomers, and salts of isomers; or any compound, mixture, or preparation which contains any quantity of any of the substances referred to in this paragraph.
(b) Unless specifically excepted or unless listed in another schedule, any of the following opiates, including their isomers, esters, ethers, salts, and salts of isomers, esters and ethers, whenever the existence of such isomers, esters, ethers, and salts is possible within the specific chemical designation:
(1) Alphaprodine.
(2) Anileridine.
(3) Bezitramide.
(4) Dihydrocodeine.
(5) Diphenoxylate.
(6) Fentanyl.
(7) Isomethadone.
(8) Levomethorphan.
(9) Levorphanol.
(10) Metazocine.
(11) Methadone.
(12) Methadone-Intermediate, 4-cyano-2-dimethylamino-4,4-diphenyl butane.
(13) Moramide-Intermediate, 2-methyl-3-morpholino-1, 1-diphenylpropane-carboxylic acid.
(14) Pethidine.
(15) Pethidine-Intermediate-A, 4-cyano-1-methyl-4-phenylpiperidine.
(16) Pethidine-Intermediate-B, ethyl-4-phenylpiperidine-4-carboxylate.
(17) Pethidine-Intermediate-C, 1-methyl-4-phenylpiperidine-4-carboxylic acid.
(18) Phenazocine.
(19) Piminodine.
(20) Racemethorphan.
(21) Racemorphan.
(c) Unless specifically excepted or unless listed in another schedule, any injectable liquid which contains any quantity of methamphetamine, including its salts, isomers, and salts of isomers.
Schedule III
(a) Unless specifically excepted or unless listed in another schedule, any material, compound, mixture, or preparation which contains any quantity of the following substances having a stimulant effect on the central nervous system:
(1) Amphetamine, its salts, optical isomers, and salts of its optical isomers.
(2) Phenmetrazine and its salts.
(3) Any substance (except an injectable liquid) which contains any quantity of methamphetamine, including its salts, isomers, and salts of isomers.
(4) Methylphenidate.
(b) Unless specifically excepted or unless listed in another schedule, any material, compound, mixture, or preparation which contains any quantity of the following substances having a depressant effect on the central nervous system:
(1) Any substance which contains any quantity of a derivative of barbituric acid, or any salt of a derivative of barbituric acid.
(2) Chorhexadol. 4
(3) Glutethimide.
(4) Lysergic acid.
(5) Lysergic acid amide.
(6) Methyprylon.
(7) Phencyclidine.
(8) Sulfondiethylmethane.
(9) Sulfonethylmethane.
(10) Sulfonmethane.
(c) Nalorphine.
(d) Unless specifically excepted or unless listed in another schedule, any material, compound, mixture, or preparation containing limited quantities of any of the following narcotic drugs, or any salts thereof:
(1) Not more than 1.8 grams of codeine per 100 milliliters or not more than 90 milligrams per dosage unit, with an equal or greater quantity of an isoquinoline alkaloid of opium.
(2) Not more than 1.8 grams of codeine per 100 milliliters or not more than 90 milligrams per dosage unit, with one or more active, non-narcotic ingredients in recognized therapeutic amounts.
(3) Not more than 300 milligrams of dihydrocodeinone per 100 milliliters or not more than 15 milligrams per dosage unit, with a fourfold or greater quantity of an isoquinoline alkaloid of opium.
(4) Not more than 300 milligrams of dihydrocodeinone per 100 milliliters or not more than 15 milligrams per dosage unit, with one or more active, nonnarcotic ingredients in recognized therapeutic amounts.
(5) Not more than 1.8 grams of dihydrocodeine per 100 milliliters or not more than 90 milligrams per dosage unit, with one or more active, nonnarcotic ingredients in recognized therapeutic amounts.
(6) Not more than 300 milligrams of ethylmorphine per 100 milliliters or not more than 15 milligrams per dosage unit, with one or more active, nonnarcotic ingredients in recognized therapeutic amounts.
(7) Not more than 500 milligrams of opium per 100 milliliters or per 100 grams, or not more than 25 milligrams per dosage unit, with one or more active, nonnarcotic ingredients in recognized therapeutic amounts.
(8) Not more than 50 milligrams of morphine per 100 milliliters or per 100 grams with one or more active, nonnarcotic ingredients in recognized therapeutic amounts.
(e) Anabolic steroids.
Schedule IV
(1) Barbital.
(2) Chloral betaine.
(3) Chloral hydrate.
(4) Ethchlorvynol.
(5) Ethinamate.
(6) Methohexital.
(7) Meprobamate.
(8) Methylphenobarbital.
(9) Paraldehyde.
(10) Petrichloral.
(11) Phenobarbital.
Schedule V
Any compound, mixture, or preparation containing any of the following limited quantities of narcotic drugs, which shall include one or more nonnarcotic active medicinal ingredients in sufficient proportion to confer upon the compound, mixture, or preparation valuable medicinal qualities other than those possessed by the narcotic drug alone:
(1) Not more than 200 milligrams of codeine per 100 milliliters or per 100 grams.
(2) Not more than 100 milligrams of dihydrocodeine per 100 milliliters or per 100 grams.
(3) Not more than 100 milligrams of ethylmorphine per 100 milliliters or per 100 grams.
(4) Not more than 2.5 milligrams of diphenoxylate and not less than 25 micrograms of atropine sulfate per dosage unit.
(5) Not more than 100 milligrams of opium per 100 milliliters or per 100 grams.
(
Editorial Notes
Amendments
2018—Subsec. (c).
2012—Subsec. (c).
1990—Subsec. (c).
1986—Subsec. (c).
1984—Subsec. (c).
Subsec. (d).
1978—Subsec. (d)(3).
Statutory Notes and Related Subsidiaries
Effective Date of 1990 Amendment
Amendment by
Effective Date of 1978 Amendment
Amendment by
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.
Congressional Finding; Emergency Scheduling of GHB in Controlled Substances Act
"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 (
"SEC. 3. EMERGENCY SCHEDULING OF GAMMA HYDROXYBUTYRIC ACID AND LISTING OF GAMMA BUTYROLACTONE AS LIST I CHEMICAL.
"(a)
"(1)
"(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 [
"(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 [
"(2)
Placement of Pipradrol and SPA in Schedule IV To Carry Out Obligation Under Convention on Psychotropic Substances
Provision of section 102(c) of
1 See Amendment of Schedules of Controlled Substances note below.
2 So in original. Probably should be "Alphacetylmethadol."
3 So in original. Probably should be capitalized.
4 So in original. Probably should be "Chlorhexadol."
§813. Treatment of controlled substance analogues
(a) In general
A controlled substance analogue shall, to the extent intended for human consumption, be treated, for the purposes of any Federal law as a controlled substance in schedule I.
(b) Determination
In determining whether a controlled substance analogue was intended for human consumption under subsection (a), the following factors may be considered, along with any other relevant factors:
(1) The marketing, advertising, and labeling of the substance.
(2) The known efficacy or usefulness of the substance for the marketed, advertised, or labeled purpose.
(3) The difference between the price at which the substance is sold and the price at which the substance it is purported to be or advertised as is normally sold.
(4) The diversion of the substance from legitimate channels and the clandestine importation, manufacture, or distribution of the substance.
(5) Whether the defendant knew or should have known the substance was intended to be consumed by injection, inhalation, ingestion, or any other immediate means.
(6) Any controlled substance analogue that is manufactured, formulated, sold, distributed, or marketed with the intent to avoid the provisions of existing drug laws.
(c) Limitation
For purposes of this section, evidence that a substance was not marketed, advertised, or labeled for human consumption, by itself, shall not be sufficient to establish that the substance was not intended for human consumption.
(
Editorial Notes
References in Text
Schedule I, referred to in subsec. (a), is set out in
Amendments
2018—
1988—
§814. Removal of exemption of certain drugs
(a) Removal of exemption
The Attorney General shall by regulation remove from exemption under
(b) Factors to be considered
In removing a drug or group of drugs from exemption under subsection (a), the Attorney General shall consider, with respect to a drug or group of drugs that is proposed to be removed from exemption—
(1) the scope, duration, and significance of the diversion;
(2) whether the drug or group of drugs is formulated in such a way that it cannot be easily used in the illicit production of a controlled substance; and
(3) whether the listed chemical can be readily recovered from the drug or group of drugs.
(c) Specificity of designation
The Attorney General shall limit the designation of a drug or a group of drugs removed from exemption under subsection (a) to the most particularly identifiable type of drug or group of drugs for which evidence of diversion exists unless there is evidence, based on the pattern of diversion and other relevant factors, that the diversion will not be limited to that particular drug or group of drugs.
(d) Reinstatement of exemption with respect to particular drug products
(1) Reinstatement
On application by a manufacturer of a particular drug product that has been removed from exemption under subsection (a), the Attorney General shall by regulation reinstate the exemption with respect to that particular drug product if the Attorney General determines that the particular drug product is manufactured and distributed in a manner that prevents diversion.
(2) Factors to be considered
In deciding whether to reinstate the exemption with respect to a particular drug product under paragraph (1), the Attorney General shall consider—
(A) the package sizes and manner of packaging of the drug product;
(B) the manner of distribution and advertising of the drug product;
(C) evidence of diversion of the drug product;
(D) any actions taken by the manufacturer to prevent diversion of the drug product; and
(E) such other factors as are relevant to and consistent with the public health and safety, including the factors described in subsection (b) as applied to the drug product.
(3) Status pending application for reinstatement
A transaction involving a particular drug product that is the subject of a bona fide pending application for reinstatement of exemption filed with the Attorney General not later than 60 days after a regulation removing the exemption is issued pursuant to subsection (a) shall not be considered to be a regulated transaction if the transaction occurs during the pendency of the application and, if the Attorney General denies the application, during the period of 60 days following the date on which the Attorney General denies the application, unless—
(A) the Attorney General has evidence that, applying the factors described in subsection (b) to the drug product, the drug product is being diverted; and
(B) the Attorney General so notifies the applicant.
(4) Amendment and modification
A regulation reinstating an exemption under paragraph (1) may be modified or revoked with respect to a particular drug product upon a finding that—
(A) applying the factors described in subsection (b) to the drug product, the drug product is being diverted; or
(B) there is a significant change in the data that led to the issuance of the regulation.
(
Editorial Notes
Amendments
2006—Subsec. (e).
1996—Subsec. (e).
Statutory Notes and Related Subsidiaries
Effective Date of 1996 Amendment
Amendment by
Effective Date
Section effective on date that is 120 days after Dec. 17, 1993, see section 11 of
Part C—Registration of Manufacturers, Distributors, and Dispensers of Controlled Substances
§821. Rules and regulations
The Attorney General is authorized to promulgate rules and regulations and to charge reasonable fees relating to the registration and control of the manufacture, distribution, and dispensing of controlled substances and to listed chemicals.
(
Editorial Notes
Amendments
2004—
1993—
Statutory Notes and Related Subsidiaries
Effective Date of 1993 Amendment
Amendment by
Effective Date
Section effective on first day of seventh calendar month that begins after Oct. 26, 1970, see section 704 of
§822. Persons required to register
(a) Period of registration
(1) Every person who manufactures or distributes any controlled substance or list I chemical, or who proposes to engage in the manufacture or distribution of any controlled substance or list I chemical, shall obtain annually a registration issued by the Attorney General in accordance with the rules and regulations promulgated by him.
(2) Every person who dispenses, or who proposes to dispense, any controlled substance, shall obtain from the Attorney General a registration issued in accordance with the rules and regulations promulgated by him. The Attorney General shall, by regulation, determine the period of such registrations. In no event, however, shall such registrations be issued for less than one year nor for more than three years.
(3)(A) Except as provided in subparagraph (C), the registration of any registrant under this subchapter to manufacture, distribute, or dispense controlled substances or list I chemicals terminates if and when such registrant—
(i) dies;
(ii) ceases legal existence;
(iii) discontinues business or professional practice; or
(iv) surrenders such registration.
(B) In the case of such a registrant who ceases legal existence or discontinues business or professional practice, such registrant shall promptly notify the Attorney General in writing of such fact.
(C) No registration under this subchapter to manufacture, distribute, or dispense controlled substances or list I chemicals, and no authority conferred thereby, may be assigned or otherwise transferred except upon such conditions as the Attorney General may specify and then only pursuant to written consent. A registrant to whom a registration is assigned or transferred pursuant to the preceding sentence may not manufacture, distribute, or dispense controlled substances or list I chemicals pursuant to such registration until the Attorney General receives such written consent.
(D) In the case of a registrant under this subchapter to manufacture, distribute, or dispense controlled substances or list I chemicals desiring to discontinue business or professional practice altogether or with respect to controlled substances and list I chemicals (without assigning or transferring such business or professional practice to another entity), such registrant shall return to the Attorney General for cancellation—
(i) the registrant's certificate of registration;
(ii) any unexecuted order forms in the registrant's possession; and
(iii) any other documentation that the Attorney General may require.
(b) Authorized activities
Persons registered by the Attorney General under this subchapter to manufacture, distribute, or dispense controlled substances or list I chemicals are authorized to possess, manufacture, distribute, or dispense such substances or chemicals (including any such activity in the conduct of research) to the extent authorized by their registration and in conformity with the other provisions of this subchapter.
(c) Exceptions
The following persons shall not be required to register and may lawfully possess any controlled substance or list I chemical under this subchapter:
(1) An agent or employee of any registered manufacturer, distributor, or dispenser of any controlled substance or list I chemical if such agent or employee is acting in the usual course of his business or employment.
(2) A common or contract carrier or warehouseman, or an employee thereof, whose possession of the controlled substance or list I chemical is in the usual course of his business or employment.
(3) An ultimate user who possesses such substance for a purpose specified in section 802(25) 1 of this title.
(d) Waiver
The Attorney General may, by regulation, waive the requirement for registration of certain manufacturers, distributors, or dispensers if he finds it consistent with the public health and safety.
(e) Separate registration
(1) A separate registration shall be required at each principal place of business or professional practice where the applicant manufactures, distributes, or dispenses controlled substances or list I chemicals.
(2) Notwithstanding paragraph (1), a registrant who is a veterinarian shall not be required to have a separate registration in order to transport and dispense controlled substances in the usual course of veterinary practice at a site other than the registrant's registered principal place of business or professional practice, so long as the site of transporting and dispensing is located in a State where the veterinarian is licensed to practice veterinary medicine and is not a principal place of business or professional practice.
(3) Notwithstanding paragraph (1), a registrant that is dispensing pursuant to section 823(g) 1 of this title narcotic drugs to individuals for maintenance treatment or detoxification treatment shall not be required to have a separate registration to incorporate one or more mobile medication units into the registrant's practice to dispense such narcotics at locations other than the registrant's principal place of business or professional practice described in paragraph (1), so long as the registrant meets such standards for operation of a mobile medication unit as the Attorney General may establish.
(f) Inspection
The Attorney General is authorized to inspect the establishment of a registrant or applicant for registration in accordance with the rules and regulations promulgated by him.
(g) Delivery of controlled substances by ultimate users for disposal
(1) An ultimate user who has lawfully obtained a controlled substance in accordance with this subchapter may, without being registered, deliver the controlled substance to another person for the purpose of disposal of the controlled substance if—
(A) the person receiving the controlled substance is authorized under this subchapter to engage in such activity; and
(B) the disposal takes place in accordance with regulations issued by the Attorney General to prevent diversion of controlled substances.
(2) In developing regulations under this subsection, the Attorney General shall take into consideration the public health and safety, as well as the ease and cost of program implementation and participation by various communities. Such regulations may not require any entity to establish or operate a delivery or disposal program.
(3) The Attorney General may, by regulation, authorize long-term care facilities, as defined by the Attorney General by regulation, to dispose of controlled substances on behalf of ultimate users who reside, or have resided, at such long-term care facilities in a manner that the Attorney General determines will provide effective controls against diversion and be consistent with the public health and safety.
(4) If a person dies while lawfully in possession of a controlled substance for personal use, any person lawfully entitled to dispose of the decedent's property may deliver the controlled substance to another person for the purpose of disposal under the same conditions as provided in paragraph (1) for an ultimate user.
(5)(A) In the case of a person receiving hospice care, an employee of a qualified hospice program, acting within the scope of employment, may handle, without being registered under this section, any controlled substance that was lawfully dispensed to the person receiving hospice care, for the purpose of disposal of the controlled substance so long as such disposal occurs onsite in accordance with all applicable Federal, State, Tribal, and local law and—
(i) the disposal occurs after the death of a person receiving hospice care;
(ii) the controlled substance is expired; or
(iii)(I) the employee is—
(aa) the physician of the person receiving hospice care; and
(bb) registered under
(II) the hospice patient no longer requires the controlled substance because the plan of care of the hospice patient has been modified.
(B) For the purposes of this paragraph:
(i) The terms "hospice care" and "hospice program" have the meanings given to those terms in
(ii) The term "employee of a qualified hospice program" means a physician, physician assistant, nurse, or other person who—
(I) is employed by, or pursuant to arrangements made by, a qualified hospice program;
(II)(aa) is licensed to perform medical or nursing services by the jurisdiction in which the person receiving hospice care was located; and
(bb) is acting within the scope of such employment in accordance with applicable State law; and
(III) has completed training through the qualified hospice program regarding the disposal of controlled substances in a secure and responsible manner so as to discourage abuse, misuse, or diversion.
(iii) The term "qualified hospice program" means a hospice program that—
(I) has written policies and procedures for assisting in the disposal of the controlled substances of a person receiving hospice care after the person's death;
(II) at the time when the controlled substances are first ordered—
(aa) provides a copy of the written policies and procedures to the patient or patient representative and family;
(bb) discusses the policies and procedures with the patient or representative and the family in a language and manner that they understand to ensure that these parties are educated regarding the safe disposal of controlled substances; and
(cc) documents in the patient's clinical record that the written policies and procedures were provided and discussed; and
(III) at the time following the disposal of the controlled substances—
(aa) documents in the patient's clinical record the type of controlled substance, dosage, route of administration, and quantity so disposed; and
(bb) the time, date, and manner in which that disposal occurred.
(
Editorial Notes
References in Text
This subchapter, referred to in subsecs. (a)(3), (b), (c), and (g)(1), was in the original "this title", meaning title II of
Amendments
2022—Subsec. (e)(3).
Subsec. (g)(5)(A)(iii)(I)(bb).
2021—Subsec. (a)(3).
2018—Subsec. (g)(5).
2014—Subsec. (e).
2010—Subsec. (g).
1993—Subsec. (a)(1).
Subsec. (b).
Subsec. (c).
Subsec. (e).
1984—Subsec. (a).
Statutory Notes and Related Subsidiaries
Effective Date of 1993 Amendment
Amendment by
Effective Date
Section effective on first day of seventh calendar month that begins after Oct. 26, 1970, see section 704 of
Rule of Construction Relating to State and Local Law
Guidance
Findings
"(1) The nonmedical use of prescription drugs is a growing problem in the United States, particularly among teenagers.
"(2) According to the Department of Justice's 2009 National Prescription Drug Threat Assessment—
"(A) the number of deaths and treatment admissions for controlled prescription drugs (CPDs) has increased significantly in recent years;
"(B) unintentional overdose deaths involving prescription opioids, for example, increased 114 percent from 2001 to 2005, and the number of treatment admissions for prescription opioids increased 74 percent from 2002 to 2006; and
"(C) violent crime and property crime associated with abuse and diversion of CPDs has increased in all regions of the United States over the past 5 years.
"(3) According to the Office of National Drug Control Policy's 2008 Report 'Prescription for Danger', prescription drug abuse is especially on the rise for teens—
"(A) one-third of all new abusers of prescription drugs in 2006 were 12- to 17-year-olds;
"(B) teens abuse prescription drugs more than any illicit drug except marijuana—more than cocaine, heroin, and methamphetamine combined; and
"(C) responsible adults are in a unique position to reduce teen access to prescription drugs because the drugs often are found in the home.
"(4)(A) Many State and local law enforcement agencies have established drug disposal programs (often called 'take-back' programs) to facilitate the collection and destruction of unused, unwanted, or expired medications. These programs help get outdated or unused medications off household shelves and out of the reach of children and teenagers.
"(B) However, take-back programs often cannot dispose of the most dangerous pharmaceutical drugs—controlled substance medications—because Federal law does not permit take-back programs to accept controlled substances unless they get specific permission from the Drug Enforcement Administration and arrange for full-time law enforcement officers to receive the controlled substances directly from the member of the public who seeks to dispose of them.
"(C) Individuals seeking to reduce the amount of unwanted controlled substances in their household consequently have few disposal options beyond discarding or flushing the substances, which may not be appropriate means of disposing of the substances. Drug take-back programs are also a convenient and effective means for individuals in various communities to reduce the introduction of some potentially harmful substances into the environment, particularly into water.
"(D) Long-term care facilities face a distinct set of obstacles to the safe disposal of controlled substances due to the increased volume of controlled substances they handle.
"(5) This Act [see Short Title of 2010 Amendment note set out under
"(6) The goal of this Act is to encourage the Attorney General to set controlled substance diversion prevention parameters that will allow public and private entities to develop a variety of methods of collection and disposal of controlled substances, including some pharmaceuticals, in a secure, convenient, and responsible manner. This will also serve to reduce instances of diversion and introduction of some potentially harmful substances into the environment."
Provisional Registration
"(a)(1) Any person who—
"(A) is engaged in manufacturing, distributing, or dispensing any controlled substance on the day before the effective date of section 302 [this section], and
"(B) is registered on such day under section 510 of the Federal Food, Drug, and Cosmetic Act [
shall, with respect to each establishment for which such registration is in effect under any such section, be deemed to have a provisional registration under section 303 [
"(2) During the period his provisional registration is in effect under this section, the registration number assigned such person under such section 510 [
"(b) The provisions of section 304 [
"(c) Unless sooner suspended or revoked under subsection (b), a provisional registration of a person under subsection (a)(1) of this section shall be in effect until—
"(1) the date on which such person has registered with the Attorney General under section 303 [
"(2) such date as may be prescribed by the Attorney General for registration of manufacturers, distributors, or dispensers, as the case may be,
whichever occurs first."
1 See References in Text note below.
§822a. Prescription drug take back expansion
(a) Definition of covered entity
In this section, the term "covered entity" means—
(1) a State, local, or tribal law enforcement agency;
(2) a manufacturer, distributor, or reverse distributor of prescription medications;
(3) a retail pharmacy;
(4) a registered narcotic treatment program;
(5) a hospital or clinic with an onsite pharmacy;
(6) an eligible long-term care facility; or
(7) any other entity authorized by the Drug Enforcement Administration to dispose of prescription medications.
(b) Program authorized
The Attorney General, in coordination with the Administrator of the Drug Enforcement Administration, the Secretary of Health and Human Services, and the Director of the Office of National Drug Control Policy, shall coordinate with covered entities in expanding or making available disposal sites for unwanted prescription medications.
(
Editorial Notes
Codification
Section was enacted as part of the Comprehensive Addiction and Recovery Act of 2016, and not as part of the Controlled Substances Act which comprises this subchapter.
Statutory Notes and Related Subsidiaries
Access to Increased Drug Disposal
"SEC. 3251. SHORT TITLE.
"This chapter may be cited as the 'Access to Increased Drug Disposal Act of 2018'.
"SEC. 3252. DEFINITIONS.
"In this chapter—
"(1) the term 'Attorney General' means the Attorney General, acting through the Assistant Attorney General for the Office of Justice Programs;
"(2) the term 'authorized collector' means a narcotic treatment program, a hospital or clinic with an on-site pharmacy, a retail pharmacy, or a reverse distributor, that is authorized as a collector under section 1317.40 of title 21, Code of Federal Regulations (or any successor regulation);
"(3) the term 'covered grant' means a grant awarded under section 3003 [probably means section 3253; no section 3003 of
"(4) the term 'eligible collector' means a person who is eligible to be an authorized collector.
"SEC. 3253. AUTHORITY TO MAKE GRANTS.
"The Attorney General shall award grants to States to enable the States to increase the participation of eligible collectors as authorized collectors.
"SEC. 3254. APPLICATION.
"A State desiring a covered grant shall submit to the Attorney General an application that, at a minimum—
"(1) identifies the single State agency that oversees pharmaceutical care and will be responsible for complying with the requirements of the grant;
"(2) details a plan to increase participation rates of eligible collectors as authorized collectors; and
"(3) describes how the State will select eligible collectors to be served under the grant.
"SEC. 3255. USE OF GRANT FUNDS.
"A State that receives a covered grant, and any subrecipient of the grant, may use the grant amounts only for the costs of installation, maintenance, training, purchasing, and disposal of controlled substances associated with the participation of eligible collectors as authorized collectors.
"SEC. 3256. ELIGIBILITY FOR GRANT.
"The Attorney General shall award a covered grant to 5 States, not less than 3 of which shall be States in the lowest quartile of States based on the participation rate of eligible collectors as authorized collectors, as determined by the Attorney General.
"SEC. 3257. DURATION OF GRANTS.
"The Attorney General shall determine the period of years for which a covered grant is made to a State.
"SEC. 3258. ACCOUNTABILITY AND OVERSIGHT.
"A State that receives a covered grant shall submit to the Attorney General a report, at such time and in such manner as the Attorney General may reasonably require, that—
"(1) lists the ultimate recipients of the grant amounts;
"(2) describes the activities undertaken by the State using the grant amounts; and
"(3) contains performance measures relating to the effectiveness of the grant, including changes in the participation rate of eligible collectors as authorized collectors.
"SEC. 3259. DURATION OF PROGRAM.
"The Attorney General may award covered grants for each of the first 5 fiscal years beginning after the date of enactment of this Act [Oct. 24, 2018].
"SEC. 3260. AUTHORIZATION OF APPROPRIATIONS.
"There is authorized to be appropriated to the Attorney General such sums as may be necessary to carry out this chapter."
§823. Registration requirements
(a) Manufacturers of controlled substances in schedule I or II
The Attorney General shall register an applicant to manufacture controlled substances in schedule I or II if he determines that such registration is consistent with the public interest and with United States obligations under international treaties, conventions, or protocols in effect on May 1, 1971. In determining the public interest, the following factors shall be considered:
(1) maintenance of effective controls against diversion of particular controlled substances and any controlled substance in schedule I or II compounded therefrom into other than legitimate medical, scientific, research, or industrial channels, by limiting the importation and bulk manufacture of such controlled substances to a number of establishments which can produce an adequate and uninterrupted supply of these substances under adequately competitive conditions for legitimate medical, scientific, research, and industrial purposes;
(2) compliance with applicable State and local law;
(3) promotion of technical advances in the art of manufacturing these substances and the development of new substances;
(4) prior conviction record of applicant under Federal and State laws relating to the manufacture, distribution, or dispensing of such substances;
(5) past experience in the manufacture of controlled substances, and the existence in the establishment of effective control against diversion; and
(6) such other factors as may be relevant to and consistent with the public health and safety.
(b) Distributors of controlled substances in schedule I or II
The Attorney General shall register an applicant to distribute a controlled substance in schedule I or II unless he determines that the issuance of such registration is inconsistent with the public interest. In determining the public interest, the following factors shall be considered:
(1) maintenance of effective control against diversion of particular controlled substances into other than legitimate medical, scientific, and industrial channels;
(2) compliance with applicable State and local law;
(3) prior conviction record of applicant under Federal or State laws relating to the manufacture, distribution, or dispensing of such substances;
(4) past experience in the distribution of controlled substances; and
(5) such other factors as may be relevant to and consistent with the public health and safety.
(c) Manufacturers of marijuana for research purposes
(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 chapter 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 chapter 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 chapter 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 355(i) 1 of this title.
(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.
(d) Limits of authorized activities
Registration granted under subsections (a) and (b) of this section shall not entitle a registrant to (1) manufacture or distribute controlled substances in schedule I or II other than those specified in the registration, or (2) manufacture any quantity of those controlled substances in excess of the quota assigned pursuant to
(e) Manufacturers of controlled substances in schedule III, IV, or V
The Attorney General shall register an applicant to manufacture controlled substances in schedule III, IV, or V, unless he determines that the issuance of such registration is inconsistent with the public interest. In determining the public interest, the following factors shall be considered:
(1) maintenance of effective controls against diversion of particular controlled substances and any controlled substance in schedule III, IV, or V compounded therefrom into other than legitimate medical, scientific, or industrial channels;
(2) compliance with applicable State and local law;
(3) promotion of technical advances in the art of manufacturing these substances and the development of new substances;
(4) prior conviction record of applicant under Federal or State laws relating to the manufacture, distribution, or dispensing of such substances;
(5) past experience in the manufacture, distribution, and dispensing of controlled substances, and the existence in the establishment of effective controls against diversion; and
(6) such other factors as may be relevant to and consistent with the public health and safety.
(f) Distributors of controlled substances in schedule III, IV, or V
The Attorney General shall register an applicant to distribute controlled substances in schedule III, IV, or V, unless he determines that the issuance of such registration is inconsistent with the public interest. In determining the public interest, the following factors shall be considered:
(1) maintenance of effective controls against diversion of particular controlled substances into other than legitimate medical, scientific, and industrial channels;
(2) compliance with applicable State and local law;
(3) prior conviction record of applicant under Federal or State laws relating to the manufacture, distribution, or dispensing of such substances;
(4) past experience in the distribution of controlled substances; and
(5) such other factors as may be relevant to and consistent with the public health and safety.
(g) Research by practitioners; pharmacies; research applications; construction of Article 7 of the Convention on Psychotropic Substances
(1) The Attorney General shall register practitioners (including pharmacies, as distinguished from pharmacists) to dispense, or conduct research with, controlled substances in schedule II, III, IV, or V and shall modify the registrations of pharmacies so registered to authorize them to dispense controlled substances by means of the Internet, if the applicant is authorized to dispense, or conduct research with respect to, controlled substances under the laws of the State in which he practices. The Attorney General may deny an application for such registration or such modification of registration if the Attorney General determines that the issuance of such registration or modification would be inconsistent with the public interest. In determining the public interest, the following factors shall be considered:
(A) The recommendation of the appropriate State licensing board or professional disciplinary authority.
(B) The applicant's experience in dispensing, or conducting research with respect to controlled substances.
(C) The applicant's conviction record under Federal or State laws relating to the manufacture, distribution, or dispensing of controlled substances.
(D) Compliance with applicable State, Federal, or local laws relating to controlled substances.
(E) Such other conduct which may threaten the public health and safety.
Separate registration under this part for practitioners engaging in research with controlled substances in schedule II, III, IV, or V, who are already registered under this part in another capacity, shall not be required.
(2)(A) Registration applications by practitioners wishing to conduct research with controlled substances in schedule I shall be referred to the Secretary, who shall determine the qualifications and competency of each practitioner requesting registration, as well as the merits of the research protocol. The Secretary, in determining the merits of each research protocol, shall consult with the Attorney General as to effective procedures to adequately safeguard against diversion of such controlled substances from legitimate medical or scientific use. Registration for the purpose of bona fide research with controlled substances in schedule I by a practitioner deemed qualified by the Secretary may be denied by the Attorney General only on a ground specified in
(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
(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.
(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.
(3) Article 7 of the Convention on Psychotropic Substances shall not be construed to prohibit, or impose additional restrictions upon, research involving drugs or other substances scheduled under the convention which is conducted in conformity with this subsection and other applicable provisions of this subchapter.
(h) Practitioners dispensing narcotic drugs for narcotic treatment; annual registration; separate registration; qualifications
Practitioners who dispense narcotic drugs (other than narcotic drugs in schedule III, IV, or V) to individuals for maintenance treatment or detoxification treatment shall obtain annually a separate registration for that purpose. The Attorney General shall register an applicant to dispense narcotic drugs to individuals for maintenance treatment or detoxification treatment (or both)—
(1) if the applicant is a practitioner who is determined by the Secretary to be qualified (under standards established by the Secretary) to engage in the treatment with respect to which registration is sought;
(2) if the Attorney General determines that the applicant will comply with standards established by the Attorney General respecting (A) security of stocks of narcotic drugs for such treatment, and (B) the maintenance of records (in accordance with
(3) if the Secretary determines that the applicant will comply with standards established by the Secretary (after consultation with the Attorney General) respecting the quantities of narcotic drugs which may be provided for unsupervised use by individuals in such treatment.
(i) Applicants for distribution of list I chemicals
The Attorney General shall register an applicant to distribute a list I chemical unless the Attorney General determines that registration of the applicant is inconsistent with the public interest. Registration under this subsection shall not be required for the distribution of a drug product that is exempted under clause (iv) or (v) of
(1) maintenance by the applicant of effective controls against diversion of listed chemicals into other than legitimate channels;
(2) compliance by the applicant with applicable Federal, State, and local law;
(3) any prior conviction record of the applicant under Federal or State laws relating to controlled substances or to chemicals controlled under Federal or State law;
(4) any past experience of the applicant in the manufacture and distribution of chemicals; and
(5) such other factors as are relevant to and consistent with the public health and safety.
(j) Registration to manufacture certain controlled substances for use only in a clinical trial
(1) For purposes of registration to manufacture a controlled substance under subsection (e) for use only in a clinical trial, the Attorney General shall register the applicant, or serve an order to show cause upon the applicant in accordance with
(2) For purposes of registration to manufacture a controlled substance under subsection (a) for use only in a clinical trial, the Attorney General shall, in accordance with the regulations issued by the Attorney General, issue a notice of application not later than 90 days after the application is accepted for filing. Not later than 90 days after the date on which the period for comment pursuant to such notice ends, the Attorney General shall register the applicant, or serve an order to show cause upon the applicant in accordance with
(k) Emergency medical services that administer controlled substances
(1) Registration
For the purpose of enabling emergency medical services professionals to administer controlled substances in schedule II, III, IV, or V to ultimate users receiving emergency medical services in accordance with the requirements of this subsection, the Attorney General—
(A) shall register an emergency medical services agency if the agency submits an application demonstrating it is authorized to conduct such activity under the laws of each State in which the agency practices; and
(B) may deny an application for such registration if the Attorney General determines that the issuance of such registration would be inconsistent with the requirements of this subsection or the public interest based on the factors listed in subsection (g).
(2) Option for single registration
In registering an emergency medical services agency pursuant to paragraph (1), the Attorney General shall allow such agency the option of a single registration in each State where the agency administers controlled substances in lieu of requiring a separate registration for each location of the emergency medical services agency.
(3) Hospital-based agency
If a hospital-based emergency medical services agency is registered under subsection (g), the agency may use the registration of the hospital to administer controlled substances in accordance with this subsection without being registered under this subsection.
(4) Administration outside physical presence of medical director or authorizing medical professional
Emergency medical services professionals of a registered emergency medical services agency may administer controlled substances in schedule II, III, IV, or V outside the physical presence of a medical director or authorizing medical professional in the course of providing emergency medical services if the administration is—
(A) authorized by the law of the State in which it occurs; and
(B) pursuant to—
(i) a standing order that is issued and adopted by one or more medical directors of the agency, including any such order that may be developed by a specific State authority; or
(ii) a verbal order that is—
(I) issued in accordance with a policy of the agency; and
(II) provided by a medical director or authorizing medical professional in response to a request by the emergency medical services professional with respect to a specific patient—
(aa) in the case of a mass casualty incident; or
(bb) to ensure the proper care and treatment of a specific patient.
(5) Delivery
A registered emergency medical services agency may deliver controlled substances from a registered location of the agency to an unregistered location of the agency only if the agency—
(A) designates the unregistered location for such delivery; and
(B) notifies the Attorney General at least 30 days prior to first delivering controlled substances to the unregistered location.
(6) Storage
A registered emergency medical services agency may store controlled substances—
(A) at a registered location of the agency;
(B) at any designated location of the agency or in an emergency services vehicle situated at a registered or designated location of the agency; or
(C) in an emergency medical services vehicle used by the agency that is—
(i) traveling from, or returning to, a registered or designated location of the agency in the course of responding to an emergency; or
(ii) otherwise actively in use by the agency under circumstances that provide for security of the controlled substances consistent with the requirements established by regulations of the Attorney General.
(7) No treatment as distribution
The delivery of controlled substances by a registered emergency medical services agency pursuant to this subsection shall not be treated as distribution for purposes of
(8) Restocking of emergency medical services vehicles at a hospital
Notwithstanding paragraph (13)(J), a registered emergency medical services agency may receive controlled substances from a hospital for purposes of restocking an emergency medical services vehicle following an emergency response, and without being subject to the requirements of
(A) The registered or designated location of the agency where the vehicle is primarily situated maintains a record of such receipt in accordance with paragraph (9).
(B) The hospital maintains a record of such delivery to the agency in accordance with
(C) If the vehicle is primarily situated at a designated location, such location notifies the registered location of the agency within 72 hours of the vehicle receiving the controlled substances.
(9) Maintenance of records
(A) In general
A registered emergency medical services agency shall maintain records in accordance with subsections (a) and (b) of
(B) Requirements
Such records—
(i) shall include records of deliveries of controlled substances between all locations of the agency; and
(ii) shall be maintained, whether electronically or otherwise, at each registered and designated location of the agency where the controlled substances involved are received, administered, or otherwise disposed of.
(10) Other requirements
A registered emergency medical services agency, under the supervision of a medical director, shall be responsible for ensuring that—
(A) all emergency medical services professionals who administer controlled substances using the agency's registration act in accordance with the requirements of this subsection;
(B) the recordkeeping requirements of paragraph (9) are met with respect to a registered location and each designated location of the agency;
(C) the applicable physical security requirements established by regulation of the Attorney General are complied with wherever controlled substances are stored by the agency in accordance with paragraph (6); and
(D) the agency maintains, at a registered location of the agency, a record of the standing orders issued or adopted in accordance with paragraph (9).
(11) Regulations
The Attorney General may issue regulations—
(A) specifying, with regard to delivery of controlled substances under paragraph (5)—
(i) the types of locations that may be designated under such paragraph; and
(ii) the manner in which a notification under paragraph (5)(B) must be made;
(B) specifying, with regard to the storage of controlled substances under paragraph (6), the manner in which such substances must be stored at registered and designated locations, including in emergency medical service vehicles; and
(C) addressing the ability of hospitals, emergency medical services agencies, registered locations, and designated locations to deliver controlled substances to each other in the event of—
(i) shortages of such substances;
(ii) a public health emergency; or
(iii) a mass casualty event.
(12) Rule of construction
Nothing in this subsection shall be construed—
(A) to limit the authority vested in the Attorney General by other provisions of this subchapter to take measures to prevent diversion of controlled substances; or
(B) to override the authority of any State to regulate the provision of emergency medical services consistent with this subsection.
(13) Definitions
In this section:
(A) The term "authorizing medical professional" means an emergency or other physician, or another medical professional (including an advanced practice registered nurse or physician assistant)—
(i) who is registered under this chapter;
(ii) who is acting within the scope of the registration; and
(iii) whose scope of practice under a State license or certification includes the ability to provide verbal orders.
(B) The term "designated location" means a location designated by an emergency medical services agency under paragraph (5).
(C) The term "emergency medical services" means emergency medical response and emergency mobile medical services provided outside of a fixed medical facility.
(D) The term "emergency medical services agency" means an organization providing emergency medical services, including such an organization that—
(i) is governmental (including fire-based and hospital-based agencies), nongovernmental (including hospital-based agencies), private, or volunteer-based;
(ii) provides emergency medical services by ground, air, or otherwise; and
(iii) is authorized by the State in which the organization is providing such services to provide emergency medical care, including the administering of controlled substances, to members of the general public on an emergency basis.
(E) The term "emergency medical services professional" means a health care professional (including a nurse, paramedic, or emergency medical technician) licensed or certified by the State in which the professional practices and credentialed by a medical director of the respective emergency medical services agency to provide emergency medical services within the scope of the professional's State license or certification.
(F) The term "emergency medical services vehicle" means an ambulance, fire apparatus, supervisor truck, or other vehicle used by an emergency medical services agency for the purpose of providing or facilitating emergency medical care and transport or transporting controlled substances to and from the registered and designated locations.
(G) The term "hospital-based" means, with respect to an agency, owned or operated by a hospital.
(H) The term "medical director" means a physician who is registered under subsection (g) and provides medical oversight for an emergency medical services agency.
(I) The term "medical oversight" means supervision of the provision of medical care by an emergency medical services agency.
(J) The term "registered emergency medical services agency" means—
(i) an emergency medical services agency that is registered pursuant to this subsection; or
(ii) a hospital-based emergency medical services agency that is covered by the registration of the hospital under subsection (g).
(K) The term "registered location" means a location that appears on the certificate of registration issued to an emergency medical services agency under this subsection or subsection (g), which shall be where the agency receives controlled substances from distributors.
(L) The term "specific State authority" means a governmental agency or other such authority, including a regional oversight and coordinating body, that, pursuant to State law or regulation, develops clinical protocols regarding the delivery of emergency medical services in the geographic jurisdiction of such agency or authority within the State that may be adopted by medical directors.
(M) The term "standing order" means a written medical protocol in which a medical director determines in advance the medical criteria that must be met before administering controlled substances to individuals in need of emergency medical services.
(N) The term "verbal order" means an oral directive that is given through any method of communication including by radio or telephone, directly to an emergency medical services professional, to contemporaneously administer a controlled substance to individuals in need of emergency medical services outside the physical presence of the medical director or authorizing medical professional.
(l) 2 "Factors as may be relevant to and consistent with the public health and safety" defined
In this section, the phrase "factors as may be relevant to and consistent with the public health and safety" means factors that are relevant to and consistent with the findings contained in
(l) 2 Required training for prescribers
(1) Training required
As a condition on registration under this section to dispense controlled substances in schedule II, III, IV, or V, the Attorney General shall require any qualified practitioner, beginning with the first applicable registration for the practitioner, to meet the following:
(A) If the practitioner is a physician (as defined under
(i) The physician holds a board certification in addiction psychiatry or addiction medicine from the American Board of Medical Specialties.
(ii) The physician holds a board certification from the American Board of Addiction Medicine.
(iii) The physician holds a board certification in addiction medicine from the American Osteopathic Association.
(iv) The physician has, with respect to the treatment and management of patients with opioid or other substance use disorders, or the safe pharmacological management of dental pain and screening, brief intervention, and referral for appropriate treatment of patients with or at risk of developing opioid or other substance use disorders, completed not less than 8 hours of training (through classroom situations, seminars at professional society meetings, electronic communications, or otherwise) that is provided by—
(I) the American Society of Addiction Medicine, the American Academy of Addiction Psychiatry, the American Medical Association, the American Osteopathic Association, the American Dental Association, the American Association of Oral and Maxillofacial Surgeons, the American Psychiatric Association, or any other organization accredited by the Accreditation Council for Continuing Medical Education (ACCME) or the Commission for Continuing Education Provider Recognition (CCEPR);
(II) any organization accredited by a State medical society accreditor that is recognized by the ACCME or the CCEPR;
(III) any organization accredited by the American Osteopathic Association to provide continuing medical education; or
(IV) any organization approved by the Assistant Secretary for Mental Health and Substance Use, the ACCME, or the CCEPR.
(v) The physician graduated in good standing from an accredited school of allopathic medicine, osteopathic medicine, dental surgery, or dental medicine in the United States during the 5-year period immediately preceding the date on which the physician first registers or renews under this section and has successfully completed a comprehensive allopathic or osteopathic medicine curriculum or accredited medical residency or dental surgery or dental medicine curriculum that included not less than 8 hours of training on—
(I) treating and managing patients with opioid or other substance use disorders, including the appropriate clinical use of all drugs approved by the Food and Drug Administration for the treatment of a substance use disorder; or
(II) the safe pharmacological management of dental pain and screening, brief intervention, and referral for appropriate treatment of patients with or at risk of developing opioid and other substance use disorders.
(B) If the practitioner is not a physician (as defined under
(i) The practitioner has completed not fewer than 8 hours of training with respect to the treatment and management of patients with opioid or other substance use disorders (through classroom situations, seminars at professional society meetings, electronic communications, or otherwise) provided by the American Society of Addiction Medicine, the American Academy of Addiction Psychiatry, the American Medical Association, the American Osteopathic Association, the American Nurses Credentialing Center, the American Psychiatric Association, the American Association of Nurse Practitioners, the American Academy of Physician Associates, or any other organization approved or accredited by the Assistant Secretary for Mental Health and Substance Use or the Accreditation Council for Continuing Medical Education.
(ii) The practitioner has graduated in good standing from an accredited physician assistant school or accredited school of advanced practice nursing in the United States during the 5-year period immediately preceding the date on which the practitioner first registers or renews under this section and has successfully completed a comprehensive physician assistant or advanced practice nursing curriculum that included not fewer than 8 hours of training on treating and managing patients with opioid and other substance use disorders, including the appropriate clinical use of all drugs approved by the Food and Drug Administration for the treatment of a substance use disorder.
(2) One-time training
(A) In general
The Attorney General shall not require any qualified practitioner to complete the training described in clause (iv) or (v) of paragraph (1)(A) or clause (i) or (ii) of paragraph (1)(B) more than once.
(B) Notification
Not later than 90 days after December 29, 2022, the Attorney General shall provide to qualified practitioners a single written, electronic notification of the training described in clauses (iv) and (v) of paragraph (1)(A) or clauses (i) and (ii) of paragraph (1)(B).
(3) Rule of construction
Nothing in this subsection shall be construed—
(A) to preclude the use, by a qualified practitioner, of training received pursuant to this subsection to satisfy registration requirements of a State or for some other lawful purpose; or
(B) to preempt any additional requirements by a State related to the dispensing of controlled substances under schedule II, III, IV, or V.
(4) Definitions
In this section:
(A) First applicable registration
The term "first applicable registration" means the first registration or renewal of registration by a qualified practitioner under this section that occurs on or after the date that is 180 days after December 29, 2022.
(B) Qualified practitioner
In this subsection, the term "qualified practitioner" means a practitioner who—
(i) is licensed under State law to prescribe controlled substances; and
(ii) is not solely a veterinarian.
(
Editorial Notes
References in Text
Schedules I, II, III, IV, and V, referred to in subsecs. (a) to (g)(2), (k)(1), (4), and (l)(1), (3)(B), are set out in
This chapter, referred to in subsecs. (c)(1)(A), (B) and (k)(13)(A)(i), was in the original "this Act", meaning
Section 105 of the Medical Marijuana and Cannabidiol Research Expansion Act, referred to in subsecs. (c)(1)(B)(vi) and (g)(2)(B)(i)(II), is section 105 of
This subchapter, referred to in subsecs. (g)(3) and (k)(12)(A), was in the original "this title", meaning title II of
Amendments
2022—Subsecs. (c) to (e).
Subsec. (f).
Subsec. (f)(2)(B)(vi).
Subsec. (g).
Subsec. (h).
Subsec. (h)(2).
Subsec. (i).
Subsec. (j).
Subsec. (j)(1).
Subsec. (k).
Subsec. (l).
2018—Subsec. (g)(2)(B)(iii)(II).
Subsec. (g)(2)(G)(ii)(VIII).
Subsec. (g)(2)(G)(iii)(II).
Subsec. (g)(2)(G)(iii)(III).
Subsec. (g)(2)(G)(iv).
2017—Subsecs. (j), (k).
2016—Subsec. (g)(2)(B).
"(i) The practitioner is a qualifying physician (as defined in subparagraph (G)).
"(ii) With respect to patients to whom the practitioner will provide such drugs or combinations of drugs, the practitioner has the capacity to refer the patients for appropriate counseling and other appropriate ancillary services.
"(iii) The total number of such patients of the practitioner at any one time will not exceed the applicable number. For purposes of this clause, the applicable number is 30, unless, not sooner than 1 year after the date on which the practitioner submitted the initial notification, the practitioner submits a second notification to the Secretary of the need and intent of the practitioner to treat up to 100 patients. A second notification under this clause shall contain the certifications required by clauses (i) and (ii) of this subparagraph. The Secretary may by regulation change such total number."
Subsec. (g)(2)(D)(ii).
Subsec. (g)(2)(D)(iii).
Subsec. (g)(2)(G)(ii)(I).
Subsec. (g)(2)(G)(ii)(II).
Subsec. (g)(2)(G)(ii)(III).
Subsec. (g)(2)(G)(ii)(IV).
Subsec. (g)(2)(G)(iii), (iv).
Subsec. (g)(2)(H)(i)(III).
Subsec. (g)(2)(H)(ii).
Subsec. (g)(2)(I), (J).
Subsec. (j).
2015—Subsec. (i).
2008—Subsec. (f).
2006—Subsec. (g)(2)(B)(iii).
Subsec. (g)(2)(J)(i).
Subsec. (g)(2)(J)(ii).
Subsec. (g)(2)(J)(iii).
Subsec. (h).
2005—Subsec. (g)(2)(B)(iii).
Subsec. (g)(2)(B)(iv).
2002—Subsec. (g)(2)(I).
Subsec. (g)(2)(J)(i).
2000—Subsec. (g).
1993—Subsec. (h).
1984—Subsec. (f).
1978—Subsec. (f).
1974—Subsec. (g).
Statutory Notes and Related Subsidiaries
Effective Date of 2008 Amendment
Amendment by
Effective Date of 2005 Amendment
Effective Date of 1993 Amendment
Amendment by
Effective Date of 1978 Amendment
Amendment by
Effective Date
Section effective on first day of seventh calendar month that begins after Oct. 26, 1970, see section 704 of
Regulations
Update Regulations
Adequate and Uninterrupted Supply
"(a)
"(b)
"(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."
[For definition of "marijuana" as used in section 104 of
Security Requirements
"(a)
"(b)
[For definitions of "marijuana", "controlled substances", and "practitioners" as used in section 105 of
Development of Food and Drug Administration-Approved Drugs Using Cannabidiol and Marijuana
"SEC. 201. MEDICAL RESEARCH ON CANNABIDIOL.
"Notwithstanding any provision of the Controlled Substances Act (
"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 (
[For definitions of terms used in title II of
Treatment for Children
Grants To Enhance Access to Substance Use Disorder Treatment
"(a)
"(b)
Reports to Congress
"(A)
"(i) perform a thorough review of the provision of opioid use disorder treatment services in the United States, including services provided in opioid treatment programs and other specialty and nonspecialty settings; and
"(ii) submit a report to the Congress on the findings and conclusions of such review.
"(B)
"(i) compliance with the requirements of [former] section 303(g)(2) of the Controlled Substances Act (
"(ii) the measures taken by the Secretary of Health and Human Services to ensure such compliance;
"(iii) whether there is further need to increase or decrease the number of patients a practitioner, pursuant to a waiver under [former] section 303(g)(2) of the Controlled Substances Act (
"(iv) the extent to which, and proportions with which, the full range of Food and Drug Administration-approved treatments for opioid use disorder are used in routine health care settings and specialty substance use disorder treatment settings;
"(v) access to, and use of, counseling and recovery support services, including the percentage of patients receiving such services;
"(vi) changes in State or local policies and legislation relating to opioid use disorder treatment;
"(vii) the use of prescription drug monitoring programs by practitioners who are permitted to dispense narcotic drugs to individuals pursuant to a waiver described in clause (iii);
"(viii) the findings resulting from inspections by the Drug Enforcement Administration of practitioners described in clause (vii); and
"(ix) the effectiveness of cross-agency collaboration between [the] Department of Health and Human Services and the Drug Enforcement Administration for expanding effective opioid use disorder treatment."
Provisional Registration
For provisional registration of persons engaged in manufacturing, distributing, or dispensing of controlled substances on the day before the effective date of
1 So in original. Probably should be preceded by "section".
2 So in original. Two subsecs. (l) have been enacted.
§824. Denial, revocation, or suspension of registration
(a) Grounds
A registration pursuant to
(1) has materially falsified any application filed pursuant to or required by this subchapter or subchapter II;
(2) has been convicted of a felony under this subchapter or subchapter II or any other law of the United States, or of any State, relating to any substance defined in this subchapter as a controlled substance or a list I chemical;
(3) has had his State license or registration suspended, revoked, or denied by competent State authority and is no longer authorized by State law to engage in the manufacturing, distribution, or dispensing of controlled substances or list I chemicals or has had the suspension, revocation, or denial of his registration recommended by competent State authority;
(4) has committed such acts as would render his registration under
(5) has been excluded (or directed to be excluded) from participation in a program pursuant to
A registration pursuant to section 823(h)(1) 1 of this title to dispense a narcotic drug for maintenance treatment or detoxification treatment may be suspended or revoked by the Attorney General upon a finding that the registrant has failed to comply with any standard referred to in section 823(h)(1) 1 of this title.
(b) Limits of revocation or suspension
The Attorney General may limit revocation or suspension of a registration to the particular controlled substance or list I chemical with respect to which grounds for revocation or suspension exist.
(c) Service of show cause order; proceedings
(1) Before taking action pursuant to this section, or pursuant to a denial of registration under
(2) An order to show cause under paragraph (1) shall—
(A) contain a statement of the basis for the denial, revocation, or suspension, including specific citations to any laws or regulations alleged to be violated by the applicant or registrant;
(B) direct the applicant or registrant to appear before the Attorney General at a time and place stated in the order, but not less than 30 days after the date of receipt of the order; and
(C) notify the applicant or registrant of the opportunity to submit a corrective action plan on or before the date of appearance.
(3) Upon review of any corrective action plan submitted by an applicant or registrant pursuant to paragraph (2), the Attorney General shall determine whether denial, revocation, or suspension proceedings should be discontinued, or deferred for the purposes of modification, amendment, or clarification to such plan.
(4) Proceedings to deny, revoke, or suspend shall be conducted pursuant to this section in accordance with subchapter II of
(5) The requirements of this subsection shall not apply to the issuance of an immediate suspension order under subsection (d).
(d) Suspension of registration in cases of imminent danger
(1) The Attorney General may, in his discretion, suspend any registration simultaneously with the institution of proceedings under this section, in cases where he finds that there is an imminent danger to the public health or safety. A failure to comply with a standard referred to in section 823(h)(1) 1 of this title may be treated under this subsection as grounds for immediate suspension of a registration granted under such section. A suspension under this subsection shall continue in effect until the conclusion of such proceedings, including judicial review thereof, unless sooner withdrawn by the Attorney General or dissolved by a court of competent jurisdiction.
(2) In this subsection, the phrase "imminent danger to the public health or safety" means that, due to the failure of the registrant to maintain effective controls against diversion or otherwise comply with the obligations of a registrant under this subchapter or subchapter II, there is a substantial likelihood of an immediate threat that death, serious bodily harm, or abuse of a controlled substance will occur in the absence of an immediate suspension of the registration.
(e) Suspension and revocation of quotas
The suspension or revocation of a registration under this section shall operate to suspend or revoke any quota applicable under
(f) Disposition of controlled substances or list I chemicals
In the event the Attorney General suspends or revokes a registration granted under
(g) Seizure or placement under seal of controlled substances or list I chemicals
The Attorney General may, in his discretion, seize or place under seal any controlled substances or list I chemicals owned or possessed by a registrant whose registration has expired or who has ceased to practice or do business in the manner contemplated by his registration. Such controlled substances or list I chemicals shall be held for the benefit of the registrant, or his successor in interest. The Attorney General shall notify a registrant, or his successor in interest, who has any controlled substance or list I chemical seized or placed under seal of the procedures to be followed to secure the return of the controlled substance or list I chemical and the conditions under which it will be returned. The Attorney General may not dispose of any controlled substance or list I chemical seized or placed under seal under this subsection until the expiration of one hundred and eighty days from the date such substance or chemical was seized or placed under seal.
(h) Order to prohibit registration based on prior history
The Attorney General may issue an order to prohibit, conditionally or unconditionally, and permanently or for such period as the Attorney General may determine, any person from being registered under this subchapter to manufacture, distribute, or dispense a controlled substance or a list I chemical, if the Attorney General finds that—
(1) such person meets or has met any of the conditions for suspension or revocation of registration under subsection (a); and
(2) such person has a history of prior suspensions or revocations of registration.
(
Editorial Notes
References in Text
This subchapter, referred to in subsecs. (a)(1), (2), (c)(4), (d)(2), and (h), was in the original "this title", meaning title II of
Subchapter II, referred to in subsecs. (a)(1), (2) and (d)(2), was in the original "title III", meaning title III of
Amendments
2022—Subsec. (a).
Subsec. (d)(1).
2021—Subsec. (h).
2016—Subsec. (c).
Subsec. (d).
2000—Subsec. (a).
Subsec. (d).
1994—Subsec. (g).
1993—Subsec. (a).
Subsec. (b).
Subsec. (f).
Subsec. (g).
1987—Subsec. (a)(5).
1984—Subsec. (a)(3).
Subsec. (a)(4).
Subsec. (f).
Subsec. (g).
1974—Subsec. (a).
Subsec. (d).
Statutory Notes and Related Subsidiaries
Effective Date of 1994 Amendment
Amendment by
Effective Date of 1993 Amendment
Amendment by
Effective Date of 1987 Amendment
Amendment by
Effective Date
Section effective on first day of seventh calendar month that begins after Oct. 26, 1970, see section 704 of
Provisional Registration
Applicability of this section to provisional registrations, see section 703 of
1 See References in Text note below.
§825. Labeling and packaging
(a) Symbol
It shall be unlawful to distribute a controlled substance in a commercial container unless such container, when and as required by regulations of the Attorney General, bears a label (as defined in
(b) Unlawful distribution without identifying symbol
It shall be unlawful for the manufacturer of any controlled substance to distribute such substance unless the labeling (as defined in
(c) Warning on label
The Secretary shall prescribe regulations under
(d) Containers to be securely sealed
It shall be unlawful to distribute controlled substances in schedule I or II, and narcotic drugs in schedule III or IV, unless the bottle or other container, stopper, covering, or wrapper thereof is securely sealed as required by regulations of the Attorney General.
(e) False labeling of anabolic steroids
(1) It shall be unlawful to import, export, manufacture, distribute, dispense, or possess with intent to manufacture, distribute, or dispense, an anabolic steroid or product containing an anabolic steroid, unless the steroid or product bears a label clearly identifying an anabolic steroid or product containing an anabolic steroid by the nomenclature used by the International Union of Pure and Applied Chemistry (IUPAC).
(2)(A) A product described in subparagraph (B) is exempt from the International Union of Pure and Applied Chemistry nomenclature requirement of this subsection if such product is labeled in the manner required under the Federal Food, Drug, and Cosmetic Act [
(B) A product is described in this subparagraph if the product—
(i) is the subject of an approved application as described in section 505(b) or (j) of the Federal Food, Drug, and Cosmetic Act [
(ii) is exempt from the provisions of section 505 of such Act relating to new drugs because—
(I) it is intended solely for investigational use as described in section 505(i) of such Act; and
(II) such product is being used exclusively for purposes of a clinical trial that is the subject of an effective investigational new drug application.
(
Editorial Notes
References in Text
Schedules I, II, III, and IV, referred to in subsecs. (c) and (d), are set out in
The Federal Food, Drug, and Cosmetic Act, referred to in subsec. (e)(2)(A), is act June 25, 1938, ch. 675,
Amendments
2014—Subsec. (e).
Statutory Notes and Related Subsidiaries
Effective Date
Section effective on first day of seventh calendar month that begins after Oct. 26, 1970, but with Attorney General authorized to postpone such effective date for such period as he might determine to be necessary for the efficient administration of this subchapter, see section 704(c) of
Identification and Publication of List of Products Containing Anabolic Steroids
"(a)
"(b)
§826. Production quotas for controlled substances
(a) Establishment of total annual needs
(1) The Attorney General shall determine the total quantity and establish production quotas for each basic class of controlled substance in schedules I and II and for ephedrine, pseudoephedrine, and phenylpropanolamine to be manufactured each calendar year to provide for the estimated medical, scientific, research, and industrial needs of the United States, for lawful export requirements, and for the establishment and maintenance of reserve stocks. Except as provided in paragraph (2), production quotas shall be established in terms of quantities of each basic class of controlled substance and not in terms of individual pharmaceutical dosage forms prepared from or containing such a controlled substance.
(2) The Attorney General may, if the Attorney General determines it will assist in avoiding the overproduction, shortages, or diversion of a controlled substance, establish an aggregate or individual production quota under this subsection, or a procurement quota established by the Attorney General by regulation, in terms of pharmaceutical dosage forms prepared from or containing the controlled substance.
(b) Individual manufacturing quotas; revised quotas
The Attorney General shall limit or reduce individual manufacturing quotas to the extent necessary to prevent the aggregate of individual quotas from exceeding the amount determined necessary each year by the Attorney General under subsection (a). The quota of each registered manufacturer for each basic class of controlled substance in schedule I or II or for ephedrine, pseudoephedrine, or phenylpropanolamine shall be revised in the same proportion as the limitation or reduction of the aggregate of the quotas. However, if any registrant, before the issuance of a limitation or reduction in quota, has manufactured in excess of his revised quota, the amount of the excess shall be subtracted from his quota for the following year.
(c) Manufacturing quotas for registered manufacturers
On or before December 1 of each year, upon application therefor by a registered manufacturer, the Attorney General shall fix a manufacturing quota for the basic classes of controlled substances in schedules I and II and for ephedrine, pseudoephedrine, and phenylpropanolamine that the manufacturer seeks to produce. The quota shall be subject to the provisions of subsections (a) and (b) of this section. In fixing such quotas, the Attorney General shall determine the manufacturer's estimated disposal, inventory, and other requirements for the calendar year; and, in making his determination, the Attorney General shall consider the manufacturer's current rate of disposal, the trend of the national disposal rate during the preceding calendar year, the manufacturer's production cycle and inventory position, the economic availability of raw materials, yield and stability problems, emergencies such as strikes and fires, and other factors.
(d) Quotas for registrants who have not manufactured controlled substance during one or more preceding years
The Attorney General shall, upon application and subject to the provisions of subsections (a) and (b) of this section, fix a quota for a basic class of controlled substance in schedule I or II for any registrant who has not manufactured that basic class of controlled substance or ephedrine, pseudoephedrine, or phenylpropanolamine during one or more preceding calendar years. In fixing such quota, the Attorney General shall take into account the registrant's reasonably anticipated requirements for the current year; and, in making his determination of such requirements, he shall consider such factors specified in subsection (c) of this section as may be relevant.
(e) Quota increases
At any time during the year any registrant who has applied for or received a manufacturing quota for a basic class of controlled substance in schedule I or II or for ephedrine, pseudoephedrine, or phenylpropanolamine may apply for an increase in that quota to meet his estimated disposal, inventory, and other requirements during the remainder of that year. In passing upon the application the Attorney General shall take into consideration any occurrences since the filing of the registrant's initial quota application that may require an increased manufacturing rate by the registrant during the balance of the year. In passing upon the application the Attorney General may also take into account the amount, if any, by which the determination of the Attorney General under subsection (a) of this section exceeds the aggregate of the quotas of all registrants under this section.
(f) Incidental production exception
Notwithstanding any other provisions of this subchapter, no registration or quota may be required for the manufacture of such quantities of controlled substances in schedules I and II or ephedrine, pseudoephedrine, or phenylpropanolamine as incidentally and necessarily result from the manufacturing process used for the manufacture of a controlled substance or of ephedrine, pseudoephedrine, or phenylpropanolamine with respect to which its manufacturer is duly registered under this subchapter. The Attorney General may, by regulation, prescribe restrictions on the retention and disposal of such incidentally produced substances or chemicals.
(g) Reference to ephedrine, pseudoephedrine, or phenylpropanolamine
Each reference in this section to ephedrine, pseudoephedrine, or phenylpropanolamine includes each of the salts, optical isomers, and salts of optical isomers of such chemical.
(h) Quotas applicable to drugs in shortage
(1) Not later than 30 days after the receipt of a request described in paragraph (2), the Attorney General shall—
(A) complete review of such request; and
(B)(i) as necessary to address a shortage of a controlled substance, increase the aggregate and individual production quotas under this section applicable to such controlled substance and any ingredient therein to the level requested; or
(ii) if the Attorney General determines that the level requested is not necessary to address a shortage of a controlled substance, the Attorney General shall provide a written response detailing the basis for the Attorney General's determination.
The Secretary shall make the written response provided under subparagraph (B)(ii) available to the public on the Internet Web site of the Food and Drug Administration.
(2) A request is described in this paragraph if—
(A) the request pertains to a controlled substance on the list of drugs in shortage maintained under
(B) the request is submitted by the manufacturer of the controlled substance; and
(C) the controlled substance is in schedule II.
(i) Strengthening considerations for DEA opioid quotas
(1)(A) In establishing any quota under this section, or any procurement quota established by the Attorney General by regulation, for fentanyl, oxycodone, hydrocodone, oxymorphone, or hydromorphone (in this subsection referred to as a "covered controlled substance"), the Attorney General shall estimate the amount of diversion of the covered controlled substance that occurs in the United States.
(B) In estimating diversion under this paragraph, the Attorney General—
(i) shall consider information the Attorney General, in consultation with the Secretary of Health and Human Services, determines reliable on rates of overdose deaths and abuse and overall public health impact related to the covered controlled substance in the United States; and
(ii) may take into consideration whatever other sources of information the Attorney General determines reliable.
(C) After estimating the amount of diversion of a covered controlled substance, the Attorney General shall make appropriate quota reductions, as determined by the Attorney General, from the quota the Attorney General would have otherwise established had such diversion not been considered.
(2)(A) For any year for which the approved aggregate production quota for a covered controlled substance is higher than the approved aggregate production quota for the covered controlled substance for the previous year, the Attorney General, in consultation with the Secretary of Health and Human Services, shall include in the final order an explanation of why the public health benefits of increasing the quota clearly outweigh the consequences of having an increased volume of the covered controlled substance available for sale, and potential diversion, in the United States.
(B) Not later than 1 year after October 24, 2018, and every year thereafter, the Attorney General shall submit to the Committee on the Judiciary, the Committee on Health, Education, Labor, and Pensions, and the Committee on Appropriations of the Senate and the Committee on the Judiciary, the Committee on Energy and Commerce, and the Committee on Appropriations of the House of Representatives the following information with regard to each covered controlled substance:
(i) An anonymized count of the total number of manufacturers issued individual manufacturing quotas that year for the covered controlled substance.
(ii) An anonymized count of how many such manufacturers were issued an approved manufacturing quota that was higher than the quota issued to that manufacturer for the covered controlled substance in the previous year.
(3) Not later than 1 year after October 24, 2018, the Attorney General shall submit to Congress a report on how the Attorney General, when fixing and adjusting production and manufacturing quotas under this section for covered controlled substances, will—
(A) take into consideration changes in the accepted medical use of the covered controlled substances; and
(B) work with the Secretary of Health and Human Services on methods to appropriately and anonymously estimate the type and amount of covered controlled substances that are submitted for collection from approved drug collection receptacles, mail-back programs, and take-back events.
(
Editorial Notes
References in Text
Schedules I and II, referred to in text, are set out in
Amendments
2018—Subsec. (a).
Subsec. (b).
Subsec. (c).
Subsec. (i).
2012—Subsec. (h).
2006—Subsec. (a).
Subsec. (b).
Subsec. (c).
Subsec. (d).
Subsec. (e).
Subsec. (f).
Subsec. (g).
1976—Subsec. (c).
Statutory Notes and Related Subsidiaries
Effective Date
Section effective on first day of seventh calendar month that begins after Oct. 26, 1970, but with Attorney General authorized to postpone such effective date for such period as he might determine to be necessary for the efficient administration of this subchapter, see section 704(c) of
Change to Editorial Heading in United States Code
Coordination With United States Trade Representative
§826a. Attorney General report on drug shortages
Not later than 6 months after July 9, 2012, and annually thereafter, the Attorney General shall submit to the Committee on Energy and Commerce of the House of Representatives and the Committee on the Judiciary of the Senate a report on drug shortages that—
(1) identifies the number of requests received under
(2) describes the coordination between the Drug Enforcement Administration and Food and Drug Administration on efforts to prevent or alleviate drug shortages; and
(3) identifies drugs containing a controlled substance subject to
(
Editorial Notes
References in Text
Section 1005 of this Act, referred to in par. (1), means section 1005 of
Codification
Section was enacted as part of the Food and Drug Administration Safety and Innovation Act, and not as part of the Controlled Substances Act which comprises this subchapter.
Statutory Notes and Related Subsidiaries
Definition of "Secretary"
The term "Secretary" as meaning the Secretary of Health and Human Services, see section 1001(b) of
§827. Records and reports of registrants
(a) Inventory
Except as provided in subsection (c)—
(1) every registrant under this subchapter shall, on May 1, 1971, or as soon thereafter as such registrant first engages in the manufacture, distribution, or dispensing of controlled substances, and every second year thereafter, make a complete and accurate record of all stocks thereof on hand, except that the regulations prescribed under this section shall permit each such biennial inventory (following the initial inventory required by this paragraph) to be prepared on such registrant's regular general physical inventory date (if any) which is nearest to and does not vary by more than six months from the biennial date that would otherwise apply;
(2) on the effective date of each regulation of the Attorney General controlling a substance that immediately prior to such date was not a controlled substance, each registrant under this subchapter manufacturing, distributing, or dispensing such substance shall make a complete and accurate record of all stocks thereof on hand; and
(3) on and after May 1, 1971, every registrant under this subchapter manufacturing, distributing, or dispensing a controlled substance or substances shall maintain, on a current basis, a complete and accurate record of each such substance manufactured, received, sold, delivered, or otherwise disposed of by him, except that this paragraph shall not require the maintenance of a perpetual inventory.
(b) Availability of records
Every inventory or other record required under this section (1) shall be in accordance with, and contain such relevant information as may be required by, regulations of the Attorney General, (2) shall (A) be maintained separately from all other records of the registrant, or (B) alternatively, in the case of nonnarcotic controlled substances, be in such form that information required by the Attorney General is readily retrievable from the ordinary business records of the registrant, and (3) shall be kept and be available, for at least two years, for inspection and copying by officers or employees of the United States authorized by the Attorney General.
(c) Nonapplicability
The foregoing provisions of this section shall not apply—
(1)(A) to the prescribing of controlled substances in schedule II, III, IV, or V by practitioners acting in the lawful course of their professional practice unless such substance is prescribed in the course of maintenance or detoxification treatment of an individual; or
(B) to the administering of a controlled substance in schedule II, III, IV, or V unless the practitioner regularly engages in the dispensing or administering of controlled substances and charges his patients, either separately or together with charges for other professional services, for substances so dispensed or administered or unless such substance is administered in the course of maintenance treatment or detoxification treatment of an individual;
(2)(A) to the use of controlled substances, at establishments registered under this subchapter which keep records with respect to such substances, in research conducted in conformity with an exemption granted under
(B) to the use of controlled substances, at establishments registered under this subchapter which keep records with respect to such substances, in preclinical research or in teaching; or
(3) to the extent of any exemption granted to any person, with respect to all or part of such provisions, by the Attorney General by or pursuant to regulation on the basis of a finding that the application of such provisions (or part thereof) to such person is not necessary for carrying out the purposes of this subchapter.
Nothing in the Convention on Psychotropic Substances shall be construed as superseding or otherwise affecting the provisions of paragraph (1)(B), (2), or (3) of this subsection.
(d) Periodic reports to Attorney General
(1) Every manufacturer registered under
(2) Each pharmacy with a modified registration under
(A) 100 or more prescriptions dispensed.
(B) 5,000 or more dosage units of all controlled substances combined.
(e) Reporting and recordkeeping requirements of drug conventions
In addition to the reporting and recordkeeping requirements under any other provision of this subchapter, each manufacturer registered under
(f) Records and reports of registrants
(1) The Attorney General shall, not less frequently than quarterly, make the following information available to manufacturer and distributor registrants through the Automated Reports and Consolidated Orders System, or any subsequent automated system developed by the Drug Enforcement Administration to monitor selected controlled substances:
(A) The total number of distributor registrants that distribute controlled substances to a pharmacy or practitioner registrant, aggregated by the name and address of each pharmacy and practitioner registrant.
(B) The total quantity and type of opioids distributed, listed by Administration Controlled Substances Code Number, to each pharmacy and practitioner registrant described in subparagraph (A).
(2) The information required to be made available under paragraph (1) shall be made available not later than the 30th day of the first month following the quarter to which the information relates.
(3)(A) All registered manufacturers and distributors shall be responsible for reviewing the information made available by the Attorney General under this subsection.
(B) In determining whether to initiate proceedings under this subchapter against a registered manufacturer or distributor based on the failure of the registrant to maintain effective controls against diversion or otherwise comply with the requirements of this subchapter or the regulations issued thereunder, the Attorney General may take into account that the information made available under this subsection was available to the registrant.
(g) Investigational uses of drugs; procedures
Regulations under
(h) Change of address
Every registrant under this subchapter shall be required to report any change of professional or business address in such manner as the Attorney General shall by regulation require.
(i) Reporting requirements for GHB
In the case of a drug product containing gamma hydroxybutyric acid for which an application has been approved under
(1) That every person who is registered as a manufacturer of bulk or dosage form, as a packager, repackager, labeler, relabeler, or distributor shall report acquisition and distribution transactions quarterly, not later than the 15th day of the month succeeding the quarter for which the report is submitted, and annually report end-of-year inventories.
(2) That all annual inventory reports shall be filed no later than January 15 of the year following that for which the report is submitted and include data on the stocks of the drug product, drug substance, bulk drug, and dosage forms on hand as of the close of business December 31, indicating whether materials reported are in storage or in process of manufacturing.
(3) That every person who is registered as a manufacturer of bulk or dosage form shall report all manufacturing transactions both inventory increases, including purchases, transfers, and returns, and reductions from inventory, including sales, transfers, theft, destruction, and seizure, and shall provide data on material manufactured, manufactured from other material, use in manufacturing other material, and use in manufacturing dosage forms.
(4) That all reports under this section must include the registered person's registration number as well as the registration numbers, names, and other identifying information of vendors, suppliers, and customers, sufficient to allow the Attorney General to track the receipt and distribution of the drug.
(5) That each dispensing practitioner shall maintain for each prescription the name of the prescribing practitioner, the prescribing practitioner's Federal and State registration numbers, with the expiration dates of these registrations, verification that the prescribing practitioner possesses the appropriate registration to prescribe this controlled substance, the patient's name and address, the name of the patient's insurance provider and documentation by a medical practitioner licensed and registered to prescribe the drug of the patient's medical need for the drug. Such information shall be available for inspection and copying by the Attorney General.
(6) That
(j) Electronic reporting format
All of the reports required under this section shall be provided in an electronic format.
(
Editorial Notes
References in Text
Schedules II, III, IV, and V, referred to in subsec. (c), are set out in
Amendments
2022—Subsec. (d)(2).
2018—Subsecs. (f) to (i).
Subsec. (j).
2008—Subsec. (d).
2000—Subsec. (h).
1984—Subsec. (c)(1)(A).
Subsec. (c)(1)(B).
Subsec. (g).
1978—Subsec. (c).
Subsecs. (e), (f).
1974—Subsec. (c)(1)(A).
Statutory Notes and Related Subsidiaries
Effective Date of 2008 Amendment
Amendment by
Effective Date of 1978 Amendment
Amendment by
Effective Date
Section effective on first day of seventh calendar month that begins after Oct. 26, 1970, see section 704 of
Purpose
"(a)
"(b)
"(1) identify, stop, and report suspicious orders; or
"(2) maintain effective controls against diversion in accordance with section 303 of the Controlled Substances Act (
§828. Order forms
(a) Unlawful distribution of controlled substances
It shall be unlawful for any person to distribute a controlled substance in schedule I or II to another except in pursuance of a written order of the person to whom such substance is distributed, made on a form to be issued by the Attorney General in blank in accordance with subsection (d) and regulations prescribed by him pursuant to this section.
(b) Nonapplicability of provisions
Nothing in subsection (a) shall apply to—
(1) the exportation of such substances from the United States in conformity with subchapter II;
(2) the delivery of such a substance to or by a common or contract carrier for carriage in the lawful and usual course of its business, or to or by a warehouseman for storage in the lawful and usual course of its business; but where such carriage or storage is in connection with the distribution by the owner of the substance to a third person, this paragraph shall not relieve the distributor from compliance with subsection (a); or
(3) the delivery of such a substance for the purpose of disposal by an ultimate user, long-term care facility, or other person acting in accordance with
(c) Preservation and availability
(1) Every person who in pursuance of an order required under subsection (a) distributes a controlled substance shall preserve such order for a period of two years, and shall make such order available for inspection and copying by officers and employees of the United States duly authorized for that purpose by the Attorney General, and by officers or employees of States or their political subdivisions who are charged with the enforcement of State or local laws regulating the production, or regulating the distribution or dispensing, of controlled substances and who are authorized under such laws to inspect such orders.
(2) Every person who gives an order required under subsection (a) shall, at or before the time of giving such order, make or cause to be made a duplicate thereof on a form to be issued by the Attorney General in blank in accordance with subsection (d) and regulations prescribed by him pursuant to this section, and shall, if such order is accepted, preserve such duplicate for a period of two years and make it available for inspection and copying by the officers and employees mentioned in paragraph (1) of this subsection.
(d) Issuance
(1) The Attorney General shall issue forms pursuant to subsections (a) and (c)(2) only to persons validly registered under
(2) The Attorney General may charge reasonable fees for the issuance of such forms in such amounts as he may prescribe for the purpose of covering the cost to the United States of issuing such forms, and other necessary activities in connection therewith.
(e) Unlawful acts
It shall be unlawful for any person to obtain by means of order forms issued under this section controlled substances for any purpose other than their use, distribution, dispensing, or administration in the conduct of a lawful business in such substances or in the course of his professional practice or research.
(
Editorial Notes
References in Text
Schedules I and II, referred to in subsec. (a), are set out in
Amendments
2010—Subsec. (b)(3).
Statutory Notes and Related Subsidiaries
Effective Date
Section effective on first day of seventh calendar month that begins after Oct. 26, 1970, see section 704 of
§829. Prescriptions
(a) Schedule II substances
Except when dispensed directly by a practitioner, other than a pharmacist, to an ultimate user, no controlled substance in schedule II, which is a prescription drug as determined under the Federal Food, Drug, and Cosmetic Act [
(b) Schedule III and IV substances
Except when dispensed directly by a practitioner, other than a pharmacist, to an ultimate user, no controlled substance in schedule III or IV, which is a prescription drug as determined under the Federal Food, Drug, and Cosmetic Act [
(c) Schedule V substances
No controlled substance in schedule V which is a drug may be distributed or dispensed other than for a medical purpose.
(d) Non-prescription drugs with abuse potential
Whenever it appears to the Attorney General that a drug not considered to be a prescription drug under the Federal Food, Drug, and Cosmetic Act [
(e) Controlled substances dispensed by means of the Internet
(1) No controlled substance that is a prescription drug as determined under the Federal Food, Drug, and Cosmetic Act [
(2) As used in this subsection:
(A) The term "valid prescription" means a prescription that is issued for a legitimate medical purpose in the usual course of professional practice by—
(i) a practitioner who has conducted at least 1 in-person medical evaluation of the patient; or
(ii) a covering practitioner.
(B)(i) The term "in-person medical evaluation" means a medical evaluation that is conducted with the patient in the physical presence of the practitioner, without regard to whether portions of the evaluation are conducted by other health professionals.
(ii) Nothing in clause (i) shall be construed to imply that 1 in-person medical evaluation demonstrates that a prescription has been issued for a legitimate medical purpose within the usual course of professional practice.
(C) The term "covering practitioner" means, with respect to a patient, a practitioner who conducts a medical evaluation (other than an in-person medical evaluation) at the request of a practitioner who—
(i) has conducted at least 1 in-person medical evaluation of the patient or an evaluation of the patient through the practice of telemedicine, within the previous 24 months; and
(ii) is temporarily unavailable to conduct the evaluation of the patient.
(3) Nothing in this subsection shall apply to—
(A) the delivery, distribution, or dispensing of a controlled substance by a practitioner engaged in the practice of telemedicine; or
(B) the dispensing or selling of a controlled substance pursuant to practices as determined by the Attorney General by regulation, which shall be consistent with effective controls against diversion.
(f) Partial fills of schedule II controlled substances
(1) Partial fills
A prescription for a controlled substance in schedule II may be partially filled if—
(A) it is not prohibited by State law;
(B) the prescription is written and filled in accordance with this subchapter, regulations prescribed by the Attorney General, and State law;
(C) the partial fill is requested by the patient or the practitioner that wrote the prescription; and
(D) the total quantity dispensed in all partial fillings does not exceed the total quantity prescribed.
(2) Remaining portions
(A) In general
Except as provided in subparagraph (B), remaining portions of a partially filled prescription for a controlled substance in schedule II—
(i) may be filled; and
(ii) shall be filled not later than 30 days after the date on which the prescription is written.
(B) Emergency situations
In emergency situations, as described in subsection (a), the remaining portions of a partially filled prescription for a controlled substance in schedule II—
(i) may be filled; and
(ii) shall be filled not later than 72 hours after the prescription is issued.
(3) Currently lawful partial fills
Notwithstanding paragraph (1) or (2), in any circumstance in which, as of the day before July 22, 2016, a prescription for a controlled substance in schedule II may be lawfully partially filled, the Attorney General may allow such a prescription to be partially filled.
(
Editorial Notes
References in Text
The Federal Food, Drug, and Cosmetic Act, referred to in subsecs. (a), (b), (d), and (e)(1), is act June 25, 1938, ch. 675,
Schedules II, III, IV, and V, referred to in subsecs. (a) to (c), are set out in
Amendments
2016—Subsec. (f).
2008—Subsec. (e).
Statutory Notes and Related Subsidiaries
Effective Date of 2008 Amendment
Amendment by
Effective Date
Section effective on first day of seventh calendar month that begins after Oct. 26, 1970, see section 704 of
Construction of 2016 Amendment
Dispensation of Narcotic Drugs for the Purpose of Relieving Acute Withdrawal Symptoms From Opioid Use Disorder
Programs and Materials for Training on Certain Circumstances Under Which a Pharmacist May Decline To Fill a Prescription
"(a)
"(1) circumstances under which a pharmacist may, consistent with section 309 of the Controlled Substances Act (
"(2) other Federal requirements pertaining to declining to fill a prescription under such circumstances, including the partial fill of prescriptions for certain controlled substances.
"(b)
"(1) pharmacists on how to verify the identity of the patient;
"(2) pharmacists on how to decline to fill a prescription and actions to take after declining to fill a prescription; and
"(3) other health care practitioners and the public on a pharmacist's ability to decline to fill prescriptions in certain circumstances and a description of those circumstances (as described in the materials developed under subsection (a)(1)).
"(c)
"(d)
"(1) update the materials developed under subsection (a) to include information for pharmacists on how to verify the identity of the patient; and
"(2) disseminate, as appropriate, the updated materials."
Effect of Scheduling on Prescriptions
§829a. Delivery of a controlled substance by a pharmacy to an administering practitioner
(a) In general
Notwithstanding
(1) the controlled substance is delivered by the pharmacy to the prescribing practitioner or the practitioner administering the controlled substance, as applicable, at the location listed on the practitioner's certificate of registration issued under this subchapter;
(2) the controlled substance is a narcotic drug in schedule III, IV, or V to be administered for the purpose of maintenance or detoxification treatment and is to be administered by injection or implantation;
(3) the pharmacy and the practitioner are authorized to conduct the activities specified in this section under the law of the State in which such activities take place;
(4) the prescription is not issued to supply any practitioner with a stock of controlled substances for the purpose of general dispensing to patients;
(5) except as provided in subsection (b), the controlled substance is to be administered only to the patient named on the prescription not later than 45 days after the date of receipt of the controlled substance by the practitioner; and
(6) notwithstanding any exceptions under
(b) Modification of number of days before which controlled substance shall be administered
(1) Initial 2-year period
During the 2-year period beginning on October 24, 2018, the Attorney General, in coordination with the Secretary, may reduce the number of days described in subsection (a)(5) if the Attorney General determines that such reduction will—
(A) reduce the risk of diversion; or
(B) protect the public health.
(2) Modifications after submission of report
After the date on which the report described in section 3204(b) of the SUPPORT for Patients and Communities Act is submitted, the Attorney General, in coordination with the Secretary, may modify the number of days described in subsection (a)(5).
(3) Minimum number of days
Any modification under this subsection shall be for a period of not less than 7 days.
(
Editorial Notes
References in Text
Par. (2) of
Section 3204(b) of the SUPPORT for Patients and Communities Act, referred to in subsec. (b)(2), is section 3204(b) of
Amendments
2022—Subsec. (a)(2).
"(A) the practitioner who issued the prescription is a qualifying practitioner authorized under, and acting within the scope of that section; and
"(B) the controlled substance is to be administered by injection or implantation;"
was executed by making the substitution for "the controlled substance is to be administered for the purpose of maintenance or detoxification treatment under section 823(h)(2) and—" and subpars. (A) and (B), to reflect the probable intent of Congress and the intervening amendment by
Subsec. (a)(5).
§830. Regulation of listed chemicals and certain machines
(a) Record of regulated transactions
(1) Each regulated person who engages in a regulated transaction involving a listed chemical, a tableting machine, or an encapsulating machine shall keep a record of the transaction for two years after the date of the transaction.
(2) A record under this subsection shall be retrievable and shall include the date of the regulated transaction, the identity of each party to the regulated transaction, a statement of the quantity and form of the listed chemical, a description of the tableting machine or encapsulating machine, and a description of the method of transfer. Such record shall be available for inspection and copying by the Attorney General.
(3) It is the duty of each regulated person who engages in a regulated transaction to identify each other party to the transaction. It is the duty of such other party to present proof of identity to the regulated person. The Attorney General shall specify by regulation the types of documents and other evidence that constitute proof of identity for purposes of this paragraph.
(b) Reports to Attorney General
(1) Each regulated person shall report to the Attorney General, in such form and manner as the Attorney General shall prescribe by regulation—
(A) any regulated transaction involving an extraordinary quantity of a listed chemical, an uncommon method of payment or delivery, or any other circumstance that the regulated person believes may indicate that the listed chemical will be used in violation of this subchapter;
(B) any proposed regulated transaction with a person whose description or other identifying characteristic the Attorney General furnishes in advance to the regulated person;
(C) any unusual or excessive loss or disappearance of a listed chemical under the control of the regulated person; and
(D) any regulated transaction in a tableting machine or an encapsulating machine.
Each report under subparagraph (A) shall be made at the earliest practicable opportunity after the regulated person becomes aware of the circumstance involved. A regulated person may not complete a transaction with a person whose description or identifying characteristic is furnished to the regulated person under subparagraph (B) unless the transaction is approved by the Attorney General. The Attorney General shall make available to regulated persons guidance documents describing transactions and circumstances for which reports are required under subparagraph (A) and subparagraph (C).
(2) A regulated person that manufactures a listed chemical shall report annually to the Attorney General, in such form and manner and containing such specific data as the Attorney General shall prescribe by regulation, information concerning listed chemicals manufactured by the person. The requirement of the preceding sentence shall not apply to the manufacture of a drug product that is exempted under
(3)
(i) The term "drug product" means an active ingredient in dosage form that has been approved or otherwise may be lawfully marketed under the Food, Drug, and Cosmetic Act 1 [
(ii) The term "valid prescription" means a prescription which is issued for a legitimate medical purpose by an individual practitioner licensed by law to administer and prescribe the drugs concerned and acting in the usual course of the practitioner's professional practice.
(B) Each regulated person who engages in a transaction with a nonregulated person or who engages in an export transaction which—
(i) involves ephedrine, pseudoephedrine, or phenylpropanolamine (including drug products containing these chemicals); and
(ii) uses or attempts to use the Postal Service or any private or commercial carrier;
shall, on a monthly basis, submit a report of each such transaction conducted during the previous month to the Attorney General in such form, containing such data, and at such times as the Attorney General shall establish by regulation.
(C) The data required for such reports shall include—
(i) the name of the purchaser;
(ii) the quantity and form of the ephedrine, pseudoephedrine, or phenylpropanolamine purchased; and
(iii) the address to which such ephedrine, pseudoephedrine, or phenylpropanolamine was sent.
(D) Except as provided in subparagraph (E), the following distributions to a nonregulated person, and the following export transactions, shall not be subject to the reporting requirement in subparagraph (B):
(i) Distributions of sample packages of drug products when such packages contain not more than two solid dosage units or the equivalent of two dosage units in liquid form, not to exceed 10 milliliters of liquid per package, and not more than one package is distributed to an individual or residential address in any 30-day period.
(ii) Distributions of drug products by retail distributors that may not include face-to-face transactions to the extent that such distributions are consistent with the activities authorized for a retail distributor as specified in
(iii) Distributions of drug products to a resident of a long term care facility (as that term is defined in regulations prescribed by the Attorney General) or distributions of drug products to a long term care facility for dispensing to or for use by a resident of that facility.
(iv) Distributions of drug products pursuant to a valid prescription.
(v) Exports which have been reported to the Attorney General pursuant to
(vi) Any quantity, method, or type of distribution or any quantity, method, or type of distribution of a specific listed chemical (including specific formulations or drug products) or of a group of listed chemicals (including specific formulations or drug products) which the Attorney General has excluded by regulation from such reporting requirement on the basis that such reporting is not necessary for the enforcement of this subchapter or subchapter II.
(E) The Attorney General may revoke any or all of the exemptions listed in subparagraph (D) for an individual regulated person if he finds that drug products distributed by the regulated person are being used in violation of this subchapter or subchapter II. The regulated person shall be notified of the revocation, which will be effective upon receipt by the person of such notice, as provided in
(c) Confidentiality of information obtained by Attorney General; non-disclosure; exceptions
(1) Except as provided in paragraph (2), any information obtained by the Attorney General under this section which is exempt from disclosure under
(2) Information referred to in paragraph (1) may be disclosed only—
(A) to an officer or employee of the United States engaged in carrying out this subchapter, subchapter II, or the customs laws;
(B) when relevant in any investigation or proceeding for the enforcement of this subchapter, subchapter II, or the customs laws;
(C) when necessary to comply with an obligation of the United States under a treaty or other international agreement; or
(D) to a State or local official or employee in conjunction with the enforcement of controlled substances laws or chemical control laws.
(3) The Attorney General shall—
(A) take such action as may be necessary to prevent unauthorized disclosure of information by any person to whom such information is disclosed under paragraph (2); and
(B) issue guidelines that limit, to the maximum extent feasible, the disclosure of proprietary business information, including the names or identities of United States exporters of listed chemicals, to any person to whom such information is disclosed under paragraph (2).
(4) Any person who is aggrieved by a disclosure of information in violation of this section may bring a civil action against the violator for appropriate relief.
(5) Notwithstanding paragraph (4), a civil action may not be brought under such paragraph against investigative or law enforcement personnel of the Drug Enforcement Administration.
(d) Scheduled listed chemicals; restrictions on sales quantity; requirements regarding nonliquid forms
With respect to ephedrine base, pseudoephedrine base, or phenylpropanolamine base in a scheduled listed chemical product—
(1) the quantity of such base sold at retail in such a product by a regulated seller, or a distributor required to submit reports by subsection (b)(3) may not, for any purchaser, exceed a daily amount of 3.6 grams, without regard to the number of transactions; and
(2) such a seller or distributor may not sell such a product in nonliquid form (including gel caps) at retail unless the product is packaged in blister packs, each blister containing not more than 2 dosage units, or where the use of blister packs is technically infeasible, the product is packaged in unit dose packets or pouches.
(e) Scheduled listed chemicals; behind-the-counter access; logbook requirement; training of sales personnel; privacy protections
(1) Requirements regarding retail transactions
(A) In general
Each regulated seller shall ensure that, subject to subparagraph (F), sales by such seller of a scheduled listed chemical product at retail are made in accordance with the following:
(i) In offering the product for sale, the seller places the product such that customers do not have direct access to the product before the sale is made (in this paragraph referred to as "behind-the-counter" placement). For purposes of this paragraph, a behind-the-counter placement of a product includes circumstances in which the product is stored in a locked cabinet that is located in an area of the facility involved to which customers do have direct access.
(ii) The seller delivers the product directly into the custody of the purchaser.
(iii) The seller maintains, in accordance with criteria issued by the Attorney General, a written or electronic list of such sales that identifies the products by name, the quantity sold, the names and addresses of purchasers, and the dates and times of the sales (which list is referred to in this subsection as the "logbook"), except that such requirement does not apply to any purchase by an individual of a single sales package if that package contains not more than 60 milligrams of pseudoephedrine.
(iv) In the case of a sale to which the requirement of clause (iii) applies, the seller does not sell such a product unless the sale is made in accordance with the following:
(I) The prospective purchaser—
(aa) presents an identification card that provides a photograph and is issued by a State or the Federal Government, or a document that, with respect to identification, is considered acceptable for purposes of sections 274a.2(b)(1)(v)(A) and 274a.2(b)(1)(v)(B) of title 8, Code of Federal Regulations (as in effect on or after March 9, 2006); and
(bb) signs the written logbook and enters in the logbook his or her name, address, and the date and time of the sale, or for transactions involving an electronic logbook, the purchaser provides a signature using one of the following means:
(AA) Signing a device presented by the seller that captures signatures in an electronic format. Such device shall display the notice described in clause (v). Any device used shall preserve each signature in a manner that clearly links that signature to the other electronically-captured logbook information relating to the prospective purchaser providing that signature.
(BB) Signing a bound paper book. Such bound paper book shall include, for such purchaser, either (aaa) a printed sticker affixed to the bound paper book at the time of sale which either displays the name of each product sold, the quantity sold, the name and address of the purchaser, and the date and time of the sale, or a unique identifier which can be linked to that electronic information, or (bbb) a unique identifier which can be linked to that information and which is written into the book by the seller at the time of sale. The purchaser shall sign adjacent to the printed sticker or written unique identifier related to that sale. Such bound paper book shall display the notice described in clause (v).
(CC) Signing a printed document that includes, for such purchaser, the name of each product sold, the quantity sold, the name and address of the purchaser, and the date and time of the sale. Such document shall be printed by the seller at the time of the sale. Such document shall contain a clearly identified signature line for a purchaser to sign. Such printed document shall display the notice described in clause (v). Each signed document shall be inserted into a binder or other secure means of document storage immediately after the purchaser signs the document.
(II) The seller enters in the logbook the name of the product and the quantity sold. Such information may be captured through electronic means, including through electronic data capture through bar code reader or similar technology.
(III) The logbook maintained by the seller includes the prospective purchaser's name, address, and the date and time of the sale, as follows:
(aa) If the purchaser enters the information, the seller must determine that the name entered in the logbook corresponds to the name provided on such identification and that the date and time entered are correct.
(bb) If the seller enters the information, the prospective purchaser must verify that the information is correct.
(cc) Such information may be captured through electronic means, including through electronic data capture through bar code reader or similar technology.
(v) The written or electronic logbook includes, in accordance with criteria of the Attorney General, a notice to purchasers that entering false statements or misrepresentations in the logbook, or supplying false information or identification that results in the entry of false statements or misrepresentations, may subject the purchasers to criminal penalties under
(vi) Regardless of whether the logbook entry is written or electronic, the seller maintains each entry in the logbook for not fewer than 2 years after the date on which the entry is made.
(vii) In the case of individuals who are responsible for delivering such products into the custody of purchasers or who deal directly with purchasers by obtaining payments for the products, the seller has submitted to the Attorney General a self-certification that all such individuals have, in accordance with criteria under subparagraph (B)(ii), undergone training provided by the seller to ensure that the individuals understand the requirements that apply under this subsection and subsection (d).
(viii) The seller maintains a copy of such certification and records demonstrating that individuals referred to in clause (vii) have undergone the training.
(ix) If the seller is a mobile retail vendor:
(I) The seller complies with clause (i) by placing the product in a locked cabinet.
(II) The seller does not sell more than 7.5 grams of ephedrine base, pseudoephedrine base, or phenylpropanolamine base in such products per customer during a 30-day period.
(B) Additional provisions regarding certifications and training
(i) In general
A regulated seller may not sell any scheduled listed chemical product at retail unless the seller has submitted to the Attorney General the self-certification referred to in subparagraph (A)(vii). The certification is not effective for purposes of the preceding sentence unless, in addition to provisions regarding the training of individuals referred to in such subparagraph, the certification includes a statement that the seller understands each of the requirements that apply under this paragraph and under subsection (d) and agrees to comply with the requirements.
(ii) Issuance of criteria; self-certification
The Attorney General shall by regulation establish criteria for certifications under this paragraph. The criteria shall—
(I) provide that the certifications are self-certifications provided through the program under clause (iii);
(II) provide that a separate certification is required for each place of business at which a regulated seller sells scheduled listed chemical products at retail; and
(III) include criteria for training under subparagraph (A)(vii).
(iii) Program for regulated sellers
The Attorney General shall establish a program regarding such certifications and training in accordance with the following:
(I) The program shall be carried out through an Internet site of the Department of Justice and such other means as the Attorney General determines to be appropriate.
(II) The program shall inform regulated sellers that
(III) The program shall make available to such sellers an explanation of the criteria under clause (ii).
(IV) The program shall be designed to permit the submission of the certifications through such Internet site.
(V) The program shall be designed to automatically provide the explanation referred to in subclause (III), and an acknowledgement that the Department has received a certification, without requiring direct interactions of regulated sellers with staff of the Department (other than the provision of technical assistance, as appropriate).
(iv) Availability of certification to State and local officials
Promptly after receiving a certification under subparagraph (A)(vii), the Attorney General shall make available a copy of the certification to the appropriate State and local officials.
(v) Publication of list of self-certified persons
The Attorney General shall develop and make available a list of all persons who are currently self-certified in accordance with this section. This list shall be made publicly available on the website of the Drug Enforcement Administration in an electronically downloadable format.
(C) Privacy protections
In order to protect the privacy of individuals who purchase scheduled listed chemical products, the Attorney General shall by regulation establish restrictions on disclosure of information in logbooks under subparagraph (A)(iii). Such regulations shall—
(i) provide for the disclosure of the information as appropriate to the Attorney General and to State and local law enforcement agencies; and
(ii) prohibit accessing, using, or sharing information in the logbooks for any purpose other than to ensure compliance with this subchapter or to facilitate a product recall to protect public health and safety.
(D) False statements or misrepresentations by purchasers
For purposes of
(E) Good faith protection
A regulated seller who in good faith releases information in a logbook under subparagraph (A)(iii) to Federal, State, or local law enforcement authorities is immune from civil liability for such release unless the release constitutes gross negligence or intentional, wanton, or willful misconduct.
(F) Inapplicability of requirements to certain sales
Subparagraph (A) does not apply to the sale at retail of a scheduled listed chemical product if a report on the sales transaction is required to be submitted to the Attorney General under subsection (b)(3).
(G) Certain measures regarding theft and diversion
A regulated seller may take reasonable measures to guard against employing individuals who may present a risk with respect to the theft and diversion of scheduled listed chemical products, which may include, notwithstanding State law, asking applicants for employment whether they have been convicted of any crime involving or related to such products or controlled substances.
(2) Mail-order reporting; verification of identity of purchaser; 30-day restriction on quantities for individual purchasers
Each regulated person who makes a sale at retail of a scheduled listed chemical product and is required under subsection (b)(3) to submit a report of the sales transaction to the Attorney General is subject to the following:
(A) The person shall, prior to shipping the product, confirm the identity of the purchaser in accordance with procedures established by the Attorney General. The Attorney General shall by regulation establish such procedures.
(B) The person may not sell more than 7.5 grams of ephedrine base, pseudoephedrine base, or phenylpropanolamine base in such products per customer during a 30-day period.
(C) Each regulated person who makes a sale at retail of a scheduled listed chemical product and is required under subsection (b)(3) to submit a report of the sales transaction to the Attorney General may not sell any scheduled listed chemical product at retail unless such regulated person has submitted to the Attorney General a self-certification including a statement that the seller understands each of the requirements that apply under this paragraph and under subsection (d) and agrees to comply with the requirements. The Attorney General shall by regulation establish criteria for certifications of mail-order distributors that are consistent with the criteria established for the certifications of regulated sellers under paragraph (1)(B).
(3) Exemptions for certain products
Upon the application of a manufacturer of a scheduled listed chemical product, the Attorney General may by regulation provide that the product is exempt from the provisions of subsection (d) and paragraphs (1) and (2) of this subsection if the Attorney General determines that the product cannot be used in the illicit manufacture of methamphetamine.
(
Editorial Notes
References in Text
The Food, Drug, and Cosmetic Act, referred to in subsec. (b)(3)(A)(i), probably means the Federal Food, Drug, and Cosmetic Act, act June 25, 1938, ch. 675,
This subchapter, referred to in subsecs. (b)(3)(D)(vi), (E) and (e)(1)(C)(ii), was in the original "this title", meaning title II of
Subchapter II, referred to in subsecs. (b)(3)(D)(iv), (E) and (c)(2)(A), (B), was in the original "title III", meaning title III of
Amendments
2010—Subsec. (e)(1)(B)(v).
Subsec. (e)(2)(C).
2008—Subsec. (e)(1)(A)(iv) to (vi).
2006—Subsec. (b)(3)(D)(ii).
Subsec. (b)(3)(D)(v).
Subsec. (d).
Subsec. (e)(1).
Subsec. (e)(2).
Subsec. (e)(3).
2000—Subsec. (b)(3).
1996—Subsec. (a)(1).
"(A) for 4 years after the date of the transaction, if the listed chemical is a list I chemical or if the transaction involves a tableting machine or an encapsulating machine; and
"(B) for 2 years after the date of the transaction, if the listed chemical is a list II chemical."
Subsec. (b)(3).
1993—Subsec. (a)(1).
Subsec. (b).
Subsec. (c)(2)(D).
1988—
Statutory Notes and Related Subsidiaries
Effective Date of 2010 Amendment
Effective Date of 2006 Amendment
"(A) Such subsection (d) applies on and after the expiration of the 30-day period beginning on the date of the enactment of this Act [Mar. 9, 2006].
"(B) Such subsection (e)(1) applies on and after September 30, 2006."
Effective Date of 1993 Amendment
Amendment by
Effective Date of 1988 Amendment
Amendment by
Effective Date; Time To Submit Piperidine Report; Required Information
"(1) Except as provided under paragraph (2), the amendments made by this title [enacting this section and amending
"(2) Any person required to submit a report under section 310(a)(1) of the Controlled Substances Act [subsec. (a)(1) of this section] respecting a distribution, sale, or importation of piperidine during the 90 days after the date of the enactment of this Act [Nov. 10, 1978] may submit such report any time up to 97 days after such date of enactment.
"(3) Until otherwise provided by the Attorney General by regulation, the information required to be reported by a person under section 310(a)(1) of the Controlled Substances Act (as added by
"(A) be the information described in subparagraphs (A) and (B) of such section, and
"(B) except as provided in paragraph (2) of this subsection, be reported not later than seven days after the date of such distribution, sale, or importation."
Repeals
Regulations
Report to President and Congress on Effectiveness of Title II of Pub. L. 95–633
1 See References in Text note below.
§831. Additional requirements relating to online pharmacies and telemedicine
(a) In general
An online pharmacy shall display in a visible and clear manner on its homepage a statement that it complies with the requirements of this section with respect to the delivery or sale or offer for sale of controlled substances and shall at all times display on the homepage of its Internet site a declaration of compliance in accordance with this section.
(b) Licensure
Each online pharmacy shall comply with the requirements of State law concerning the licensure of pharmacies in each State from which it, and in each State to which it, delivers, distributes, or dispenses or offers to deliver, distribute, or dispense controlled substances by means of the Internet, pursuant to applicable licensure requirements, as determined by each such State.
(c) Internet pharmacy site disclosure information
Each online pharmacy shall post in a visible and clear manner on the homepage of each Internet site it operates, or on a page directly linked thereto in which the hyperlink is also visible and clear on the homepage, the following information for each pharmacy that delivers, distributes, or dispenses controlled substances pursuant to orders made on, through, or on behalf of, that website:
(1) The name and address of the pharmacy as it appears on the pharmacy's Drug Enforcement Administration certificate of registration.
(2) The pharmacy's telephone number and email address.
(3) The name, professional degree, and States of licensure of the pharmacist-in-charge, and a telephone number at which the pharmacist-in-charge can be contacted.
(4) A list of the States in which the pharmacy is licensed to dispense controlled substances.
(5) A certification that the pharmacy is registered under this part to deliver, distribute, or dispense by means of the Internet controlled substances.
(6) The name, address, telephone number, professional degree, and States of licensure of any practitioner who has a contractual relationship to provide medical evaluations or issue prescriptions for controlled substances, through referrals from the website or at the request of the owner or operator of the website, or any employee or agent thereof.
(7) The following statement, unless revised by the Attorney General by regulation: "This online pharmacy will only dispense a controlled substance to a person who has a valid prescription issued for a legitimate medical purpose based upon a medical relationship with a prescribing practitioner. This includes at least one prior in-person medical evaluation or medical evaluation via telemedicine in accordance with applicable requirements of section 309.".
(d) Notification
(1) In general
Thirty days prior to offering a controlled substance for sale, delivery, distribution, or dispensing, the online pharmacy shall notify the Attorney General, in such form and manner as the Attorney General shall determine, and the State boards of pharmacy in any States in which the online pharmacy offers to sell, deliver, distribute, or dispense controlled substances.
(2) Contents
The notification required under paragraph (1) shall include—
(A) the information required to be posted on the online pharmacy's Internet site under subsection (c) and shall notify the Attorney General and the applicable State boards of pharmacy, under penalty of perjury, that the information disclosed on its Internet site under subsection (c) is true and accurate;
(B) the online pharmacy's Internet site address and a certification that the online pharmacy shall notify the Attorney General of any change in the address at least 30 days in advance; and
(C) the Drug Enforcement Administration registration numbers of any pharmacies and practitioners referred to in subsection (c), as applicable.
(3) Existing online pharmacies
An online pharmacy that is already operational as of the effective date of this section, shall notify the Attorney General and applicable State boards of pharmacy in accordance with this subsection not later than 30 days after such date.
(e) Declaration of compliance
On and after the date on which it makes the notification under subsection (d), each online pharmacy shall display on the homepage of its Internet site, in such form as the Attorney General shall by regulation require, a declaration that it has made such notification to the Attorney General.
(f) Reports
Any statement, declaration, notification, or disclosure required under this section shall be considered a report required to be kept under this part.
(g) Notice and designations concerning Indian tribes
(1) In general
For purposes of
(2) Designations
(A) In general
The Secretary may designate a practitioner described in subparagraph (B) as an Internet Eligible Controlled Substances Provider. Such designations shall be made only in cases where the Secretary has found that there is a legitimate need for the practitioner to be so designated because the population served by the practitioner is in a sufficiently remote location that access to medical services is limited.
(B) Practitioners
A practitioner described in this subparagraph is a practitioner who is an employee or contractor of the Indian Health Service, or is working for an Indian tribe or tribal organization under its contract or compact under the Indian Self-Determination and Education Assistance Act [
(h) Special registration for telemedicine
(1) In general
The Attorney General may issue to a practitioner a special registration to engage in the practice of telemedicine for purposes of
(A) demonstrates a legitimate need for the special registration; and
(B) is registered under
(i) is exempted from such registration in all States under
(ii) is an employee or contractor of the Department of Veterans Affairs who is acting in the scope of such employment or contract and is registered under
(2) Regulations
Not later than 1 year after October 24, 2018, in consultation with the Secretary, the Attorney General shall promulgate final regulations specifying—
(A) the limited circumstances in which a special registration under this subsection may be issued; and
(B) the procedure for obtaining a special registration under this subsection.
(3) Denials
Proceedings to deny an application for registration under this subsection shall be conducted in accordance with
(i) Reporting of telemedicine by VHA during medical emergency situations
(1) In general
Any practitioner issuing a prescription for a controlled substance under the authorization to conduct telemedicine during a medical emergency situation described in
(2) To Attorney General
Not later than 30 days after the date that a prescription described in subparagraph (A) is issued, the Secretary of Veterans Affairs shall report to the Attorney General the authorization of that emergency prescription.
(j) Clarification concerning prescription transfers
Any transfer between pharmacies of information relating to a prescription for a controlled substance shall meet the applicable requirements under regulations promulgated by the Attorney General under this chapter.
(
Editorial Notes
References in Text
Section 309, referred to in subsec. (c)(7), is section 309 of
For effective date of this section, referred to in subsec. (d)(3), see Effective Date note below.
The Indian Self-Determination and Education Assistance Act, referred to in subsec. (g)(1), (2)(B), is
This chapter, referred to in subsec. (j), was in the original "this Act", meaning
Amendments
2022—Subsec. (h)(1)(B).
2018—Subsec. (h)(2).
Statutory Notes and Related Subsidiaries
Effective Date
Section effective 180 days after Oct. 15, 2008, except as otherwise provided, see section 3(j) of
§832. Suspicious orders
(a) Reporting
Each registrant shall—
(1) design and operate a system to identify suspicious orders for the registrant;
(2) ensure that the system designed and operated under paragraph (1) by the registrant complies with applicable Federal and State privacy laws; and
(3) upon discovering a suspicious order or series of orders, notify the Administrator of the Drug Enforcement Administration and the Special Agent in Charge of the Division Office of the Drug Enforcement Administration for the area in which the registrant is located or conducts business.
(b) Suspicious order database
(1) In general
Not later than 1 year after October 24, 2018, the Attorney General shall establish a centralized database for collecting reports of suspicious orders.
(2) Satisfaction of reporting requirements
If a registrant reports a suspicious order to the centralized database established under paragraph (1), the registrant shall be considered to have complied with the requirement under subsection (a)(3) to notify the Administrator of the Drug Enforcement Administration and the Special Agent in Charge of the Division Office of the Drug Enforcement Administration for the area in which the registrant is located or conducts business.
(c) Sharing information with the States
(1) In general
The Attorney General shall prepare and make available information regarding suspicious orders in a State, including information in the database established under subsection (b)(1), to the point of contact for purposes of administrative, civil, and criminal oversight relating to the diversion of controlled substances for the State, as designated by the Governor or chief executive officer of the State.
(2) Timing
The Attorney General shall provide information in accordance with paragraph (1) within a reasonable period of time after obtaining the information.
(3) Coordination
In establishing the process for the provision of information under this subsection, the Attorney General shall coordinate with States to ensure that the Attorney General has access to information, as permitted under State law, possessed by the States relating to prescriptions for controlled substances that will assist in enforcing Federal law.
(
Part D—Offenses and Penalties
§841. Prohibited acts A
(a) Unlawful acts
Except as authorized by this subchapter, it shall be unlawful for any person knowingly or intentionally—
(1) to manufacture, distribute, or dispense, or possess with intent to manufacture, distribute, or dispense, a controlled substance; or
(2) to create, distribute, or dispense, or possess with intent to distribute or dispense, a counterfeit substance.
(b) Penalties
Except as otherwise provided in
(1)(A) In the case of a violation of subsection (a) of this section involving—
(i) 1 kilogram or more of a mixture or substance containing a detectable amount of heroin;
(ii) 5 kilograms or more of a mixture or substance containing a detectable amount of—
(I) coca leaves, except coca leaves and extracts of coca leaves from which cocaine, ecgonine, and derivatives of ecgonine or their salts have been removed;
(II) cocaine, its salts, optical and geometric isomers, and salts of isomers;
(III) ecgonine, its derivatives, their salts, isomers, and salts of isomers; or
(IV) any compound, mixture, or preparation which contains any quantity of any of the substances referred to in subclauses (I) through (III);
(iii) 280 grams or more of a mixture or substance described in clause (ii) which contains cocaine base;
(iv) 100 grams or more of phencyclidine (PCP) or 1 kilogram or more of a mixture or substance containing a detectable amount of phencyclidine (PCP);
(v) 10 grams or more of a mixture or substance containing a detectable amount of lysergic acid diethylamide (LSD);
(vi) 400 grams or more of a mixture or substance containing a detectable amount of N-phenyl-N- [ 1- ( 2-phenylethyl ) -4-piperidinyl ] propanamide or 100 grams or more of a mixture or substance containing a detectable amount of any analogue of N-phenyl-N-[1-(2-phenylethyl)-4-piperidinyl] propanamide;
(vii) 1000 kilograms or more of a mixture or substance containing a detectable amount of marihuana, or 1,000 or more marihuana plants regardless of weight; or
(viii) 50 grams or more of methamphetamine, its salts, isomers, and salts of its isomers or 500 grams or more of a mixture or substance containing a detectable amount of methamphetamine, its salts, isomers, or salts of its isomers;
such person shall be sentenced to a term of imprisonment which may not be less than 10 years or more than life and if death or serious bodily injury results from the use of such substance shall be not less than 20 years or more than life, a fine not to exceed the greater of that authorized in accordance with the provisions of title 18 or $10,000,000 if the defendant is an individual or $50,000,000 if the defendant is other than an individual, or both. If any person commits such a violation after a prior conviction for a serious drug felony or serious violent felony has become final, such person shall be sentenced to a term of imprisonment of not less than 15 years and not more than life imprisonment and if death or serious bodily injury results from the use of such substance shall be sentenced to life imprisonment, a fine not to exceed the greater of twice that authorized in accordance with the provisions of title 18 or $20,000,000 if the defendant is an individual or $75,000,000 if the defendant is other than an individual, or both. If any person commits a violation of this subparagraph or of
(B) In the case of a violation of subsection (a) of this section involving—
(i) 100 grams or more of a mixture or substance containing a detectable amount of heroin;
(ii) 500 grams or more of a mixture or substance containing a detectable amount of—
(I) coca leaves, except coca leaves and extracts of coca leaves from which cocaine, ecgonine, and derivatives of ecgonine or their salts have been removed;
(II) cocaine, its salts, optical and geometric isomers, and salts of isomers;
(III) ecgonine, its derivatives, their salts, isomers, and salts of isomers; or
(IV) any compound, mixture, or preparation which contains any quantity of any of the substances referred to in subclauses (I) through (III);
(iii) 28 grams or more of a mixture or substance described in clause (ii) which contains cocaine base;
(iv) 10 grams or more of phencyclidine (PCP) or 100 grams or more of a mixture or substance containing a detectable amount of phencyclidine (PCP);
(v) 1 gram or more of a mixture or substance containing a detectable amount of lysergic acid diethylamide (LSD);
(vi) 40 grams or more of a mixture or substance containing a detectable amount of N-phenyl-N- [ 1- ( 2-phenylethyl ) -4-piperidinyl ] propanamide or 10 grams or more of a mixture or substance containing a detectable amount of any analogue of N-phenyl-N-[1-(2-phenylethyl)-4-piperidinyl] propanamide;
(vii) 100 kilograms or more of a mixture or substance containing a detectable amount of marihuana, or 100 or more marihuana plants regardless of weight; or
(viii) 5 grams or more of methamphetamine, its salts, isomers, and salts of its isomers or 50 grams or more of a mixture or substance containing a detectable amount of methamphetamine, its salts, isomers, or salts of its isomers;
such person shall be sentenced to a term of imprisonment which may not be less than 5 years and not more than 40 years and if death or serious bodily injury results from the use of such substance shall be not less than 20 years or more than life, a fine not to exceed the greater of that authorized in accordance with the provisions of title 18 or $5,000,000 if the defendant is an individual or $25,000,000 if the defendant is other than an individual, or both. If any person commits such a violation after a prior conviction for a serious drug felony or serious violent felony has become final, such person shall be sentenced to a term of imprisonment which may not be less than 10 years and not more than life imprisonment and if death or serious bodily injury results from the use of such substance shall be sentenced to life imprisonment, a fine not to exceed the greater of twice that authorized in accordance with the provisions of title 18 or $8,000,000 if the defendant is an individual or $50,000,000 if the defendant is other than an individual, or both. Notwithstanding
(C) In the case of a controlled substance in schedule I or II, gamma hydroxybutyric acid (including when scheduled as an approved drug product for purposes of section 3(a)(1)(B) of the Hillory J. Farias and Samantha Reid Date-Rape Drug Prohibition Act of 2000), or 1 gram of flunitrazepam, except as provided in subparagraphs (A), (B), and (D), such person shall be sentenced to a term of imprisonment of not more than 20 years and if death or serious bodily injury results from the use of such substance shall be sentenced to a term of imprisonment of not less than twenty years or more than life, a fine not to exceed the greater of that authorized in accordance with the provisions of title 18 or $1,000,000 if the defendant is an individual or $5,000,000 if the defendant is other than an individual, or both. If any person commits such a violation after a prior conviction for a felony drug offense has become final, such person shall be sentenced to a term of imprisonment of not more than 30 years and if death or serious bodily injury results from the use of such substance shall be sentenced to life imprisonment, a fine not to exceed the greater of twice that authorized in accordance with the provisions of title 18 or $2,000,000 if the defendant is an individual or $10,000,000 if the defendant is other than an individual, or both. Notwithstanding
(D) In the case of less than 50 kilograms of marihuana, except in the case of 50 or more marihuana plants regardless of weight, 10 kilograms of hashish, or one kilogram of hashish oil, such person shall, except as provided in paragraphs (4) and (5) of this subsection, be sentenced to a term of imprisonment of not more than 5 years, a fine not to exceed the greater of that authorized in accordance with the provisions of title 18 or $250,000 if the defendant is an individual or $1,000,000 if the defendant is other than an individual, or both. If any person commits such a violation after a prior conviction for a felony drug offense has become final, such person shall be sentenced to a term of imprisonment of not more than 10 years, a fine not to exceed the greater of twice that authorized in accordance with the provisions of title 18 or $500,000 if the defendant is an individual or $2,000,000 if the defendant is other than an individual, or both. Notwithstanding
(E)(i) Except as provided in subparagraphs (C) and (D), in the case of any controlled substance in schedule III, such person shall be sentenced to a term of imprisonment of not more than 10 years and if death or serious bodily injury results from the use of such substance shall be sentenced to a term of imprisonment of not more than 15 years, a fine not to exceed the greater of that authorized in accordance with the provisions of title 18 or $500,000 if the defendant is an individual or $2,500,000 if the defendant is other than an individual, or both.
(ii) If any person commits such a violation after a prior conviction for a felony drug offense has become final, such person shall be sentenced to a term of imprisonment of not more than 20 years and if death or serious bodily injury results from the use of such substance shall be sentenced to a term of imprisonment of not more than 30 years, a fine not to exceed the greater of twice that authorized in accordance with the provisions of title 18 or $1,000,000 if the defendant is an individual or $5,000,000 if the defendant is other than an individual, or both.
(iii) Any sentence imposing a term of imprisonment under this subparagraph shall, in the absence of such a prior conviction, impose a term of supervised release of at least 2 years in addition to such term of imprisonment and shall, if there was such a prior conviction, impose a term of supervised release of at least 4 years in addition to such term of imprisonment.
(2) In the case of a controlled substance in schedule IV, such person shall be sentenced to a term of imprisonment of not more than 5 years, a fine not to exceed the greater of that authorized in accordance with the provisions of title 18 or $250,000 if the defendant is an individual or $1,000,000 if the defendant is other than an individual, or both. If any person commits such a violation after a prior conviction for a felony drug offense has become final, such person shall be sentenced to a term of imprisonment of not more than 10 years, a fine not to exceed the greater of twice that authorized in accordance with the provisions of title 18 or $500,000 if the defendant is an individual or $2,000,000 if the defendant is other than an individual, or both. Any sentence imposing a term of imprisonment under this paragraph shall, in the absence of such a prior conviction, impose a term of supervised release of at least one year in addition to such term of imprisonment and shall, if there was such a prior conviction, impose a term of supervised release of at least 2 years in addition to such term of imprisonment.
(3) In the case of a controlled substance in schedule V, such person shall be sentenced to a term of imprisonment of not more than one year, a fine not to exceed the greater of that authorized in accordance with the provisions of title 18 or $100,000 if the defendant is an individual or $250,000 if the defendant is other than an individual, or both. If any person commits such a violation after a prior conviction for a felony drug offense has become final, such person shall be sentenced to a term of imprisonment of not more than 4 years, a fine not to exceed the greater of twice that authorized in accordance with the provisions of title 18 or $200,000 if the defendant is an individual or $500,000 if the defendant is other than an individual, or both. Any sentence imposing a term of imprisonment under this paragraph may, if there was a prior conviction, impose a term of supervised release of not more than 1 year, in addition to such term of imprisonment.
(4) Notwithstanding paragraph (1)(D) of this subsection, any person who violates subsection (a) of this section by distributing a small amount of marihuana for no remuneration shall be treated as provided in
(5) Any person who violates subsection (a) of this section by cultivating or manufacturing a controlled substance on Federal property shall be imprisoned as provided in this subsection and shall be fined any amount not to exceed—
(A) the amount authorized in accordance with this section;
(B) the amount authorized in accordance with the provisions of title 18;
(C) $500,000 if the defendant is an individual; or
(D) $1,000,000 if the defendant is other than an individual;
or both.
(6) Any person who violates subsection (a), or attempts to do so, and knowingly or intentionally uses a poison, chemical, or other hazardous substance on Federal land, and, by such use—
(A) creates a serious hazard to humans, wildlife, or domestic animals,
(B) degrades or harms the environment or natural resources, or
(C) pollutes an aquifer, spring, stream, river, or body of water,
shall be fined in accordance with title 18 or imprisoned not more than five years, or both.
(7)
(A)
(B)
(c) Offenses involving listed chemicals
Any person who knowingly or intentionally—
(1) possesses a listed chemical with intent to manufacture a controlled substance except as authorized by this subchapter;
(2) possesses or distributes a listed chemical knowing, or having reasonable cause to believe, that the listed chemical will be used to manufacture a controlled substance except as authorized by this subchapter; or
(3) with the intent of causing the evasion of the recordkeeping or reporting requirements of
shall be fined in accordance with title 18 or imprisoned not more than 20 years in the case of a violation of paragraph (1) or (2) involving a list I chemical or not more than 10 years in the case of a violation of this subsection other than a violation of paragraph (1) or (2) involving a list I chemical, or both.
(d) Boobytraps on Federal property; penalties; "boobytrap" defined
(1) Any person who assembles, maintains, places, or causes to be placed a boobytrap on Federal property where a controlled substance is being manufactured, distributed, or dispensed shall be sentenced to a term of imprisonment for not more than 10 years or fined under title 18, or both.
(2) If any person commits such a violation after 1 or more prior convictions for an offense punishable under this subsection, such person shall be sentenced to a term of imprisonment of not more than 20 years or fined under title 18, or both.
(3) For the purposes of this subsection, the term "boobytrap" means any concealed or camouflaged device designed to cause bodily injury when triggered by any action of any unsuspecting person making contact with the device. Such term includes guns, ammunition, or explosive devices attached to trip wires or other triggering mechanisms, sharpened stakes, and lines or wires with hooks attached.
(e) Ten-year injunction as additional penalty
In addition to any other applicable penalty, any person convicted of a felony violation of this section relating to the receipt, distribution, manufacture, exportation, or importation of a listed chemical may be enjoined from engaging in any transaction involving a listed chemical for not more than ten years.
(f) Wrongful distribution or possession of listed chemicals
(1) Whoever knowingly distributes a listed chemical in violation of this subchapter (other than in violation of a recordkeeping or reporting requirement of
(2) Whoever possesses any listed chemical, with knowledge that the recordkeeping or reporting requirements of
(g) Internet sales of date rape drugs
(1) Whoever knowingly uses the Internet to distribute a date rape drug to any person, knowing or with reasonable cause to believe that—
(A) the drug would be used in the commission of criminal sexual conduct; or
(B) the person is not an authorized purchaser;
shall be fined under this subchapter or imprisoned not more than 20 years, or both.
(2) As used in this subsection:
(A) The term "date rape drug" means—
(i) gamma hydroxybutyric acid (GHB) or any controlled substance analogue of GHB, including gamma butyrolactone (GBL) or 1,4–butanediol;
(ii) ketamine;
(iii) flunitrazepam; or
(iv) any substance which the Attorney General designates, pursuant to the rulemaking procedures prescribed by
The Attorney General is authorized to remove any substance from the list of date rape drugs pursuant to the same rulemaking authority.
(B) The term "authorized purchaser" means any of the following persons, provided such person has acquired the controlled substance in accordance with this chapter:
(i) A person with a valid prescription that is issued for a legitimate medical purpose in the usual course of professional practice that is based upon a qualifying medical relationship by a practitioner registered by the Attorney General. A "qualifying medical relationship" means a medical relationship that exists when the practitioner has conducted at least 1 medical evaluation with the authorized purchaser in the physical presence of the practitioner, without regard to whether portions of the evaluation are conducted by other heath 1 professionals. The preceding sentence shall not be construed to imply that 1 medical evaluation demonstrates that a prescription has been issued for a legitimate medical purpose within the usual course of professional practice.
(ii) Any practitioner or other registrant who is otherwise authorized by their registration to dispense, procure, purchase, manufacture, transfer, distribute, import, or export the substance under this chapter.
(iii) A person or entity providing documentation that establishes the name, address, and business of the person or entity and which provides a legitimate purpose for using any "date rape drug" for which a prescription is not required.
(3) The Attorney General is authorized to promulgate regulations for record-keeping and reporting by persons handling 1,4–butanediol in order to implement and enforce the provisions of this section. Any record or report required by such regulations shall be considered a record or report required under this chapter.
(h) Offenses involving dispensing of controlled substances by means of the Internet
(1) In general
It shall be unlawful for any person to knowingly or intentionally—
(A) deliver, distribute, or dispense a controlled substance by means of the Internet, except as authorized by this subchapter; or
(B) aid or abet (as such terms are used in
(2) Examples
Examples of activities that violate paragraph (1) include, but are not limited to, knowingly or intentionally—
(A) delivering, distributing, or dispensing a controlled substance by means of the Internet by an online pharmacy that is not validly registered with a modification authorizing such activity as required by
(B) writing a prescription for a controlled substance for the purpose of delivery, distribution, or dispensation by means of the Internet in violation of
(C) serving as an agent, intermediary, or other entity that causes the Internet to be used to bring together a buyer and seller to engage in the dispensing of a controlled substance in a manner not authorized by sections 2 823(g) or 829(e) of this title;
(D) offering to fill a prescription for a controlled substance based solely on a consumer's completion of an online medical questionnaire; and
(E) making a material false, fictitious, or fraudulent statement or representation in a notification or declaration under subsection (d) or (e), respectively, of
(3) Inapplicability
(A) This subsection does not apply to—
(i) the delivery, distribution, or dispensation of controlled substances by nonpractitioners to the extent authorized by their registration under this subchapter;
(ii) the placement on the Internet of material that merely advocates the use of a controlled substance or includes pricing information without attempting to propose or facilitate an actual transaction involving a controlled substance; or
(iii) except as provided in subparagraph (B), any activity that is limited to—
(I) the provision of a telecommunications service, or of an Internet access service or Internet information location tool (as those terms are defined in
(II) the transmission, storage, retrieval, hosting, formatting, or translation (or any combination thereof) of a communication, without selection or alteration of the content of the communication, except that deletion of a particular communication or material made by another person in a manner consistent with
(B) The exceptions under subclauses (I) and (II) of subparagraph (A)(iii) shall not apply to a person acting in concert with a person who violates paragraph (1).
(4) Knowing or intentional violation
Any person who knowingly or intentionally violates this subsection shall be sentenced in accordance with subsection (b).
(
Editorial Notes
References in Text
This subchapter, referred to in subsecs. (a), (b)(1), (c)(1), (2), (f)(1), (g)(1), and (h)(1), (3)(A)(i), was in the original "this title", meaning title II of
Schedules I, II, III, IV, and V, referred to in subsec. (b), are set out in
Section 3(a)(1)(B) of the Hillory J. Farias and Samantha Reid Date-Rape Prohibition Act of 2000, referred to in subsec. (b)(1)(C), is section 3(a)(1)(B) of
This chapter, referred to in subsec. (g)(2)(B), (3), was in the original "this Act", meaning
Amendments
2022—Subsec. (h)(2).
2018—Subsec. (b)(1)(A).
Subsec. (b)(1)(B).
2010—Subsec. (b)(1)(A).
Subsec. (b)(1)(A)(iii).
Subsec. (b)(1)(B).
Subsec. (b)(1)(B)(iii).
2008—Subsec. (b)(1)(D).
Subsec. (b)(1)(E).
Subsec. (b)(2).
Subsec. (b)(3).
Subsec. (h).
2006—Subsec. (b)(5).
Subsec. (f)(1).
Subsec. (g).
2002—Subsec. (b)(1)(A), (B).
Subsec. (b)(1)(C), (D).
Subsec. (d)(1).
Subsec. (d)(2).
2000—Subsec. (b)(1)(C).
Subsec. (b)(1)(D).
Subsec. (b)(7)(A).
Subsecs. (c) to (g).
1998—Subsec. (b)(1).
1996—Subsec. (b)(1)(C).
Subsec. (b)(1)(D).
Subsec. (b)(7).
Subsec. (d).
Subsec. (f).
1994—Subsec. (b).
Subsec. (b)(1)(A).
Subsec. (b)(1)(B).
Subsec. (b)(1)(C).
Subsec. (b)(1)(D).
1990—Subsec. (b).
Subsec. (b)(1)(A).
Subsec. (b)(1)(A)(ii)(IV).
Subsec. (b)(1)(A)(viii).
Subsec. (b)(1)(B)(ii)(IV).
Subsec. (c).
1988—Subsec. (b)(1)(A).
Subsec. (b)(1)(B).
Subsec. (b)(1)(D).
Subsec. (b)(6).
Subsec. (d).
"(1) possesses any piperidine with intent to manufacture phencyclidine except as authorized by this subchapter, or
"(2) possesses any piperidine knowing, or having reasonable cause to believe, that the piperidine will be used to manufacture phencyclidine except as authorized by this subchapter,
shall be sentenced to a term of imprisonment of not more than 5 years, a fine not to exceed the greater of that authorized in accordance with the provisions of title 18 or $250,000 if the defendant is an individual or $1,000,000 if the defendant is other than an individual, or both."
Subsecs. (f), (g).
1986—
Subsec. (b).
Subsec. (b)(1)(A).
"(i) 100 grams or more of a controlled substance in schedule I or II which is a mixture or substance containing a detectable amount of a narcotic drug other than a narcotic drug consisting of—
"(I) coca leaves;
"(II) a compound, manufacture, salt, derivative, or preparation of coca leaves; or
"(III) a substance chemically identical thereto;
"(ii) a kilogram or more of any other controlled substance in schedule I or II which is a narcotic drug;
"(iii) 500 grams or more of phencyclidine (PCP); or
"(iv) 5 grams or more of lysergic acid diethylamide (LSD);
such person shall be sentenced to a term of imprisonment of not more than 20 years, a fine of not more than $250,000, or both. If any person commits such a violation after one or more prior convictions of him for an offense punishable under this paragraph, or for a felony under any other provision of this subchapter or subchapter II of this chapter or other law of a State, the United States, or a foreign country relating to narcotic drugs, marihuana, or depressant or stimulant substances, have become final, such person shall be sentenced to a term of imprisonment of not more than 40 years, a fine of not more than $500,000, or both".
Subsec. (b)(1)(B).
Subsec. (b)(1)(C).
Subsec. (b)(1)(D).
Subsec. (b)(2).
Subsec. (b)(3).
Subsec. (b)(4).
Subsec. (b)(5).
"(A) $500,000 if such person is an individual; and
"(B) $1,000,000 if such person is not an individual."
Subsec. (c).
Subsec. (d).
Subsec. (e).
1984—Subsec. (b).
Subsec. (b)(1)(A).
Subsec. (b)(1)(B).
Subsec. (b)(1)(C).
Subsec. (b)(2).
Subsec. (b)(3).
Subsec. (b)(4).
Subsec. (b)(5).
Subsec. (b)(6).
Subsec. (c).
1980—Subsec. (b)(1)(B).
Subsec. (b)(6).
1978—Subsec. (b)(1)(B).
Subsec. (b)(5).
Subsec. (d).
Statutory Notes and Related Subsidiaries
Effective Date of 2018 Amendment
Amendment by
Effective Date of 2008 Amendment
Amendment by
Effective Date of 1988 Amendment
Amendment by section 6055 of
Effective Date of 1986 Amendment
Effective Date of 1984 Amendment
Amendment by section 224(a) of
Effective Date of 1978 Amendment
Amendment by
Effective Date
Section effective on first day of seventh calendar month that begins after Oct. 26, 1970, see section 704 of
Repeals
Application of Fair Sentencing Act
"(a)
"(b)
"(c)
1 So in original. Probably should be "health".
2 So in original. Probably should be "section".
§842. Prohibited acts B
(a) Unlawful acts
It shall be unlawful for any person—
(1) who is subject to the requirements of part C to distribute or dispense a controlled substance in violation of
(2) who is a registrant to distribute or dispense a controlled substance not authorized by his registration to another registrant or other authorized person or to manufacture a controlled substance not authorized by his registration;
(3) who is a registrant to distribute a controlled substance in violation of
(4) to remove, alter, or obliterate a symbol or label required by
(5) to refuse or negligently fail to make, keep, or furnish any record, report, notification, declaration, order or order form, statement, invoice, or information required under this subchapter or subchapter II;
(6) to refuse any entry into any premises or inspection authorized by this subchapter or subchapter II;
(7) to remove, break, injure, or deface a seal placed upon controlled substances pursuant to
(8) to use, to his own advantage, or to reveal, other than to duly authorized officers or employees of the United States, or to the courts when relevant in any judicial proceeding under this subchapter or subchapter II, any information acquired in the course of an inspection authorized by this subchapter concerning any method or process which as a trade secret is entitled to protection, or to use to his own advantage or reveal (other than as authorized by
(9) who is a regulated person to engage in a regulated transaction without obtaining the identification required by 830(a)(3) of this title.1
(10) negligently to fail to keep a record or make a report under
(11) to distribute a laboratory supply to a person who uses, or attempts to use, that laboratory supply to manufacture a controlled substance or a listed chemical, in violation of this subchapter or subchapter II, with reckless disregard for the illegal uses to which such a laboratory supply will be put;
(12) who is a regulated seller, or a distributor required to submit reports under subsection (b)(3) of
(A) to sell at retail a scheduled listed chemical product in violation of paragraph (1) of subsection (d) of such section, knowing at the time of the transaction involved (independent of consulting the logbook under subsection (e)(1)(A)(iii) of such section) that the transaction is a violation; or
(B) to knowingly or recklessly sell at retail such a product in violation of paragraph (2) of such subsection (d);
(13) who is a regulated seller to knowingly or recklessly sell at retail a scheduled listed chemical product in violation of subsection (e) of such section;
(14) who is a regulated seller or an employee or agent of such seller to disclose, in violation of regulations under subparagraph (C) of
(15) to distribute a scheduled listed chemical product to a regulated seller, or to a regulated person referred to in
(16) to violate subsection (e) of
(17) in the case of a registered manufacturer or distributor of opioids, to fail to review the most recent information, directly related to the customers of the manufacturer or distributor, made available by the Attorney General in accordance with
As used in paragraph (11), the term "laboratory supply" means a listed chemical or any chemical, substance, or item on a special surveillance list published by the Attorney General, which contains chemicals, products, materials, or equipment used in the manufacture of controlled substances and listed chemicals. For purposes of paragraph (11), there is a rebuttable presumption of reckless disregard at trial if the Attorney General notifies a firm in writing that a laboratory supply sold by the firm, or any other person or firm, has been used by a customer of the notified firm, or distributed further by that customer, for the unlawful production of controlled substances or listed chemicals a firm distributes and 2 weeks or more after the notification the notified firm distributes a laboratory supply to the customer. For purposes of paragraph (15), if the distributor is temporarily unable to access the list of persons referred to under
(b) Manufacture
It shall be unlawful for any person who is a registrant to manufacture a controlled substance in schedule I or II, or ephedrine, pseudoephedrine, or phenylpropanolamine or any of the salts, optical isomers, or salts of optical isomers of such chemical, which is—
(1) not expressly authorized by his registration and by a quota assigned to him pursuant to
(2) in excess of a quota assigned to him pursuant to
(c) Penalties
(1)(A) Except as provided in subparagraph (B), (C), or (D) of this paragraph and paragraph (2), any person who violates this section shall, with respect to any such violation, be subject to a civil penalty of not more than $25,000. The district courts of the United States (or, where there is no such court in the case of any territory or possession of the United States, then the court in such territory or possession having the jurisdiction of a district court of the United States in cases arising under the Constitution and laws of the United States) shall have jurisdiction in accordance with
(B)(i) Except as provided in clause (ii), in the case of a violation of paragraph (5), (10), or (17) of subsection (a), the civil penalty shall not exceed $10,000.
(ii) In the case of a violation described in clause (i) committed by a registered manufacturer or distributor of opioids and related to the reporting of suspicious orders for opioids, failing to maintain effective controls against diversion of opioids, or failing to review the most recent information made available by the Attorney General in accordance with
(C) In the case of a violation of paragraph (16) of subsection (a) of this section by an importer, exporter, manufacturer, or distributor (other than as provided in subparagraph (D)), up to $500,000 per violation. For purposes of this subparagraph, a violation is defined as each instance of importation, exportation, manufacturing, distribution, or possession with intent to manufacture or distribute, in violation of paragraph (16) of subsection (a).
(D) In the case of a distribution, dispensing, or possession with intent to distribute or dispense in violation of paragraph (16) of subsection (a) of this section at the retail level, up to $1000 per violation. For purposes of this paragraph, the term "at the retail level" refers to products sold, or held for sale, directly to the consumer for personal use. Each package, container or other separate unit containing an anabolic steroid that is distributed, dispensed, or possessed with intent to distribute or dispense at the retail level in violation of such paragraph (16) of subsection (a) shall be considered a separate violation.
(2)(A) If a violation of this section is prosecuted by an information or indictment which alleges that the violation was committed knowingly and the trier of fact specifically finds that the violation was so committed, such person shall, except as otherwise provided in subparagraph (B) or (D) of this paragraph, be sentenced to imprisonment of not more than one year or a fine under title 18, or both.
(B) If a violation referred to in subparagraph (A) was committed after one or more prior convictions of the offender for an offense punishable under this paragraph (2), or for a crime under any other provision of this subchapter or subchapter II or other law of the United States relating to narcotic drugs, marihuana, or depressant or stimulant substances, have become final, such person shall be sentenced to a term of imprisonment of not more than 2 years, a fine under title 18, or both.
(C) In addition to the penalties set forth elsewhere in this subchapter or subchapter II, any business that violates paragraph (11) of subsection (a) shall, with respect to the first such violation, be subject to a civil penalty of not more than $250,000, but shall not be subject to criminal penalties under this section, and shall, for any succeeding violation, be subject to a civil fine of not more than $250,000 or double the last previously imposed penalty, whichever is greater.
(D) In the case of a violation described in subparagraph (A) that was a violation of paragraph (5), (10), or (17) of subsection (a) committed by a registered manufacturer or distributor of opioids that relates to the reporting of suspicious orders for opioids, failing to maintain effective controls against diversion of opioids, or failing to review the most recent information made available by the Attorney General in accordance with
(3) Except under the conditions specified in paragraph (2) of this subsection, a violation of this section does not constitute a crime, and a judgment for the United States and imposition of a civil penalty pursuant to paragraph (1) shall not give rise to any disability or legal disadvantage based on conviction for a criminal offense.
(4)(A) If a regulated seller, or a distributor required to submit reports under
(B) An order under subparagraph (A) may be imposed only through the same procedures as apply under
(
Editorial Notes
References in Text
Schedules I and II, referred to in subsec. (b), are set out in
Amendments
2018—Subsec. (a)(17).
Subsec. (c)(1)(B).
Subsec. (c)(2)(A).
Subsec. (c)(2)(D).
2014—Subsec. (a)(16).
Subsec. (c)(1)(A).
Subsec. (c)(1)(C), (D).
2010—Subsec. (a).
Subsec. (a)(10).
Subsec. (a)(15).
2006—Subsec. (a)(12) to (14).
Subsec. (b).
Subsec. (c)(4).
2002—Subsec. (c)(2)(A).
Subsec. (c)(2)(B).
Subsec. (c)(2)(C).
1998—Subsec. (a)(5).
Subsec. (a)(10).
Subsec. (c)(1).
1996—Subsec. (a).
Subsec. (c)(2)(C).
1988—Subsec. (a)(8).
Subsec. (a)(9).
Subsec. (a)(10).
Subsec. (c)(2)(C).
1978—Subsec. (a)(9).
Subsec. (c)(2)(C).
Statutory Notes and Related Subsidiaries
Effective Date of 2010 Amendment
Amendment by
Effective Date of 1988 Amendment
Amendment by
Effective Date of 1978 Amendment
Amendment by
Effective Date
Section effective on first day of seventh calendar month that begins after Oct. 26, 1970, see section 704 of
Repeals
1 So in original. Probably should be "
2 See References in Text note below.
§843. Prohibited acts C
(a) Unlawful acts
It shall be unlawful for any person knowingly or intentionally—
(1) who is a registrant to distribute a controlled substance classified in schedule I or II, in the course of his legitimate business, except pursuant to an order or an order form as required by
(2) to use in the course of the manufacture, distribution, or dispensing of a controlled substance, or to use for the purpose of acquiring or obtaining a controlled substance, a registration number which is fictitious, revoked, suspended, expired, or issued to another person;
(3) to acquire or obtain possession of a controlled substance by misrepresentation, fraud, forgery, deception, or subterfuge;
(4)(A) to furnish false or fraudulent material information in, or omit any material information from, any application, report, record, or other document required to be made, kept, or filed under this subchapter or subchapter II, or (B) to present false or fraudulent identification where the person is receiving or purchasing a listed chemical and the person is required to present identification under
(5) to make, distribute, or possess any punch, die, plate, stone, or other thing designed to print, imprint, or reproduce the trademark, trade name, or other identifying mark, imprint, or device of another or any likeness of any of the foregoing upon any drug or container or labeling thereof so as to render such drug a counterfeit substance;
(6) to possess any three-neck round-bottom flask, tableting machine, encapsulating machine, or gelatin capsule, or any equipment, chemical, product, or material which may be used to manufacture a controlled substance or listed chemical, knowing, intending, or having reasonable cause to believe, that it will be used to manufacture a controlled substance or listed chemical in violation of this subchapter or subchapter II;
(7) to manufacture, distribute, export, or import any three-neck round-bottom flask, tableting machine, encapsulating machine, or gelatin capsule, or any equipment, chemical, product, or material which may be used to manufacture a controlled substance or listed chemical, knowing, intending, or having reasonable cause to believe, that it will be used to manufacture a controlled substance or listed chemical in violation of this subchapter or subchapter II or, in the case of an exportation, in violation of this subchapter or subchapter II or of the laws of the country to which it is exported;
(8) to create a chemical mixture for the purpose of evading a requirement of
(9) to distribute, import, or export a list I chemical without the registration required by this subchapter or subchapter II.
(b) Communication facility
It shall be unlawful for any person knowingly or intentionally to use any communication facility in committing or in causing or facilitating the commission of any act or acts constituting a felony under any provision of this subchapter or subchapter II. Each separate use of a communication facility shall be a separate offense under this subsection. For purposes of this subsection, the term "communication facility" means any and all public and private instrumentalities used or useful in the transmission of writing, signs, signals, pictures, or sounds of all kinds and includes mail, telephone, wire, radio, and all other means of communication.
(c) Advertisement
(1) It shall be unlawful for any person to place in any newspaper, magazine, handbill, or other publications, any written advertisement knowing that it has the purpose of seeking or offering illegally to receive, buy, or distribute a Schedule 1 I controlled substance. As used in this section the term "advertisement" includes, in addition to its ordinary meaning, such advertisements as those for a catalog of Schedule 1 I controlled substances and any similar written advertisement that has the purpose of seeking or offering illegally to receive, buy, or distribute a Schedule 1 I controlled substance. The term "advertisement" does not include material which merely advocates the use of a similar material, which advocates a position or practice, and does not attempt to propose or facilitate an actual transaction in a Schedule 1 I controlled substance.
(2)(A) It shall be unlawful for any person to knowingly or intentionally use the Internet, or cause the Internet to be used, to advertise the sale of, or to offer to sell, distribute, or dispense, a controlled substance where such sale, distribution, or dispensing is not authorized by this subchapter or by the Controlled Substances Import and Export Act [
(B) Examples of activities that violate subparagraph (A) include, but are not limited to, knowingly or intentionally causing the placement on the Internet of an advertisement that refers to or directs prospective buyers to Internet sellers of controlled substances who are not registered with a modification under
(C) Subparagraph (A) does not apply to material that either—
(i) merely advertises the distribution of controlled substances by nonpractitioners to the extent authorized by their registration under this subchapter; or
(ii) merely advocates the use of a controlled substance or includes pricing information without attempting to facilitate an actual transaction involving a controlled substance.
(d) Penalties
(1) Except as provided in paragraph (2), any person who violates this section shall be sentenced to a term of imprisonment of not more than 4 years, a fine under title 18, or both; except that if any person commits such a violation after one or more prior convictions of him for violation of this section, or for a felony under any other provision of this subchapter or subchapter II or other law of the United States relating to narcotic drugs, marihuana, or depressant or stimulant substances, have become final, such person shall be sentenced to a term of imprisonment of not more than 8 years, a fine under title 18, or both.
(2) Any person who, with the intent to manufacture or to facilitate the manufacture of methamphetamine, violates paragraph (6) or (7) of subsection (a), shall be sentenced to a term of imprisonment of not more than 10 years, a fine under title 18, or both; except that if any person commits such a violation after one or more prior convictions of that person—
(A) for a violation of paragraph (6) or (7) of subsection (a);
(B) for a felony under any other provision of this subchapter or subchapter II of this chapter; 2 or
(C) under any other law of the United States or any State relating to controlled substances or listed chemicals,
has become final, such person shall be sentenced to a term of imprisonment of not more than 20 years, a fine under title 18, or both.
(e) Additional penalties
In addition to any other applicable penalty, any person convicted of a felony violation of this section relating to the receipt, distribution, manufacture, exportation, or importation of a listed chemical may be enjoined from engaging in any transaction involving a listed chemical for not more than ten years.
(f) Injunctions
(1) In addition to any penalty provided in this section, the Attorney General is authorized to commence a civil action for appropriate declaratory or injunctive relief relating to violations of this section,
(2) Any action under this subsection may be brought in the district court of the United States for the district in which the defendant is located or resides or is doing business.
(3) Any order or judgment issued by the court pursuant to this subsection shall be tailored to restrain violations of this section or
(4) The court shall proceed as soon as practicable to the hearing and determination of such an action. An action under this subsection is governed by the Federal Rules of Civil Procedure except that, if an indictment has been returned against the respondent, discovery is governed by the Federal Rules of Criminal Procedure.
(
Editorial Notes
References in Text
Schedules I and II, referred to in subsecs. (a)(1) and (c)(1), are set out in
This subchapter, referred to in subsec. (c)(2)(A), (C)(i), was in the original "this title", meaning title II of
The Controlled Substances Import and Export Act, referred to in subsec. (c)(2)(A), is title III of
This subchapter or subchapter II of this chapter, referred to in subsec. (d)(2)(B), was in the original a reference to "this subchapter or subchapter II of this chapter" but probably should be a reference to "this title or title III of this Act", meaning titles II and III, respectively, of
The Federal Rules of Civil Procedure, referred to in subsec. (f)(4), are set out in the Appendix to Title 28, Judiciary and Judicial Procedure.
The Federal Rules of Criminal Procedure, referred to in subsec. (f)(4), are set out in the Appendix to Title 18, Crimes and Criminal Procedure.
Amendments
2022—Subsec. (c)(2)(B).
2008—Subsec. (c).
2003—Subsec. (f)(1).
2002—Subsec. (d).
1996—Subsec. (d).
Subsec. (e).
Subsec. (f).
1994—Subsecs. (c) to (e).
1993—Subsec. (a)(6), (7).
"(6) to possess any three-neck round-bottom flask, tableting machine, encapsulating machine, gelatin capsule, or equipment specially designed or modified to manufacture a controlled substance, with intent to manufacture a controlled substance except as authorized by this subchapter;
"(7) to manufacture, distribute, or import any three-neck round-bottom flask, tableting machine, encapsulating machine, gelatin capsule, or equipment specially designed or modified to manufacture a controlled substance, knowing that it will be used to manufacture a controlled substance except as authorized by this subchapter; or".
Subsec. (a)(9).
1988—Subsec. (a)(4)(B).
Subsec. (a)(6) to (8).
Subsec. (d).
1986—Subsec. (a)(2).
1984—Subsec. (a)(2).
1978—Subsec. (a)(4).
Statutory Notes and Related Subsidiaries
Effective Date of 2008 Amendment
Amendment by
Effective Date of 1993 Amendment
Amendment by
Effective Date of 1988 Amendment
Amendment by
Effective Date of 1978 Amendment
Amendment by
Effective Date
Section effective on first day of seventh calendar month that begins after Oct. 26, 1970, see section 704 of
Repeals
1 So in original. Probably should not be capitalized.
2 See References in Text note below.
3 So in original. Probably should be preceded by "section".
§844. Penalties for simple possession
(a) Unlawful acts; penalties
It shall be unlawful for any person knowingly or intentionally to possess a controlled substance unless such substance was obtained directly, or pursuant to a valid prescription or order, from a practitioner, while acting in the course of his professional practice, or except as