| Shorttitle: | Controlled Substances |
| Longtitle: | An Act to amend the Public Health Service Act and other laws to provide increased research into, and prevention of, drug abuse and drug dependence; to provide for treatment and rehabilitation of drug abusers and drug dependent persons; and to strengthen existing law enforcement authority in the field of drug abuse. |
| Colloquialacronym: | CSA |
| Enacted By: | 91st |
| Effective Date: | May 1, 1971 |
| Public Law Url: | http://www.gpo.gov/fdsys/pkg/STATUTE-84/pdf/STATUTE-84-Pg1236.pdf |
| Cite Public Law: | 91-513 |
| Cite Statutes At Large: | a.k.a. 84 Stat. 1242 |
| Title Amended: | 21 U.S.C.: Food and Drugs |
| Sections Created: | § 801 et seq. |
| Introducedin: | House |
| Introducedby: | Harley O. Staggers (D–WV) |
| Introduceddate: | September 10, 1970 |
| Committees: | Interstate and Foreign Commerce Committee and Senate Judiciary Committee |
| Passedbody1: | House |
| Passeddate1: | September 24, 1970 |
| Passedvote1: | 341–6 |
| Passedbody2: | Senate |
| Passeddate2: | October 7, 1970 |
| Passedvote2: | 54–0 |
| Conferencedate: | October 13, 1970 |
| Passedbody3: | House |
| Passeddate3: | October 14, 1970 |
| Passedvote3: | passed |
| Passedbody4: | Senate |
| Passeddate4: | October 14, 1970 |
| Passedvote4: | passed |
| Signedpresident: | Richard Nixon |
| Signeddate: | October 27, 1970 |
| Amendments: | Hillory J. Farias and Samantha Reid Date-Rape Prevention Act of 2000 |
The Controlled Substances Act (CSA) is the statute establishing federal U.S. drug policy under which the manufacture, importation, possession, use, and distribution of certain substances is regulated. It was passed by the 91st United States Congress as Title II of the Comprehensive Drug Abuse Prevention and Control Act of 1970 and signed into law by President Richard Nixon.[1] The Act also served as the national implementing legislation for the Single Convention on Narcotic Drugs.
The legislation created five schedules (classifications), with varying qualifications for a substance to be included in each. Two federal agencies, the Drug Enforcement Administration (DEA) and the Food and Drug Administration (FDA), determine which substances are added to or removed from the various schedules, although the statute passed by Congress created the initial listing. Congress has sometimes scheduled other substances through legislation such as the Hillory J. Farias and Samantha Reid Date-Rape Prevention Act of 2000, which placed gamma hydroxybutyrate (GHB) in Schedule I and sodium oxybate (the isolated sodium salt in GHB) in Schedule III when used under an FDA New Drug Application (NDA) or Investigational New Drug (IND).[2] [3] Classification decisions are required to be made on criteria including potential for abuse (an undefined term),[4] currently accepted medical use in treatment in the United States, and international treaties.
The nation first outlawed addictive drugs in the early 1900s and the International Opium Convention helped lead international agreements regulating trade.[5] [6] [7] The Pure Food and Drug Act (1906) was the beginning of over 200 laws concerning public health and consumer protections.[8] Others were the Federal Food, Drug, and Cosmetic Act (1938), and the Kefauver Harris Amendment of 1962.[9]
In 1969, President Richard Nixon announced that the Attorney General, John N. Mitchell, was preparing a comprehensive new measure to more effectively meet the narcotic and dangerous drug problems at the federal level by combining all existing federal laws into a single new statute. With the help of White House Counsel head, John Dean; the Executive Director of the Shafer Commission, Michael Sonnenreich; and the Director of the BNDD, John Ingersoll creating and writing the legislation, Mitchell was able to present Nixon with the bill.[10]
The CSA not only combined existing federal drug laws and expanded their scope, but it also changed the nature of federal drug law policies and expanded federal law enforcement pertaining to controlled substances.Title II, Part F of the Comprehensive Drug Abuse Prevention and Control Act of 1970 established the National Commission on Marijuana and Drug Abuse—known as the Shafer Commission after its chairman, Raymond P. Shafer—to study cannabis abuse in the United States.[11] During his presentation of the commission's First Report to Congress, Sonnenreich and Shafer recommended the decriminalization of marijuana in small amounts, with Shafer stating,
Rufus King notes that this stratagem was similar to that used by Harry Anslinger when he consolidated the previous anti-drug treaties into the Single Convention and took the opportunity to add new provisions that otherwise might have been unpalatable to the international community.[12] According to David T. Courtwright, "the Act was part of an omnibus reform package designed to rationalize, and in some respects to liberalize, American drug policy." (Courtwright noted that the Act became, not libertarian, but instead repressionistic to the point of tyrannical in its intent; a cruel and/or arbitrary exercise of power). It eliminated mandatory minimum sentences and provided support for drug treatment and research.[13]
King notes that the rehabilitation clauses were added as a compromise to Senator Jim Hughes, who favored a moderate approach. The bill, as introduced by Senator Everett Dirksen, ran to 91 pages. While it was being drafted, the Uniform Controlled Substances Act, to be passed by state legislatures, was also being drafted by the Department of Justice; its wording closely mirrored the Controlled Substances Act.[12]
Since its enactment in 1970, the Act has been amended numerous times:
The Controlled Substances Act consists of two subchapters. Subchapter I defines Schedules I–V, lists chemicals used in the manufacture of controlled substances, and differentiates lawful and unlawful manufacturing, distribution, and possession of controlled substances, including possession of Schedule I drugs for personal use; this subchapter also specifies the dollar amounts of fines and durations of prison terms for violations. Subchapter II describes the laws for exportation and importation of controlled substances, again specifying fines and prison terms for violations.[20]
The Drug Enforcement Administration was established in 1973, combining the Bureau of Narcotics and Dangerous Drugs (BNDD) and Customs' drug agents.[21] Proceedings to add, delete, or change the schedule of a drug or other substance may be initiated by the DEA, the Department of Health and Human Services (HHS), or by petition from any interested party, including the manufacturer of a drug, a medical society or association, a pharmacy association, a public interest group concerned with drug abuse, a state or local government agency, or an individual citizen. When a petition is received by the DEA, the agency begins its own investigation of the drug.
The DEA may begin an investigation of a drug at any time based upon information received from laboratories, state and local law enforcement and regulatory agencies, or other sources of information. Once the DEA has collected the necessary data, the Deputy Administrator of DEA,[22] requests from HHS a scientific and medical evaluation and recommendation as to whether the drug or other substance should be controlled or removed from control.
This request is sent to the Assistant Secretary of Health of HHS. Then, HHS solicits information from the Commissioner of the Food and Drug Administration and evaluations and recommendations from the National Institute on Drug Abuse and, on occasion, from the scientific and medical community at large. The Assistant Secretary, by authority of the Secretary, compiles the information and transmits back to the DEA a medical and scientific evaluation regarding the drug or other substance, a recommendation as to whether the drug should be controlled, and in what schedule it should be placed.
The HHS recommendation on scheduling is binding to the extent that if HHS recommends, based on its medical and scientific evaluation, that the substance not be controlled, then the DEA may not control the substance. Once the DEA has received the scientific and medical evaluation from HHS, the DEA Administrator evaluates all available data and makes a final decision whether to propose that a drug or other substance be controlled and into which schedule it should be placed. Under certain circumstances, the Government may temporarily schedule[23] a drug without following the normal procedure.
An example is when international treaties require control of a substance. allows the Attorney General to temporarily place a substance in Schedule I "to avoid an imminent hazard to the public safety". Thirty days' notice is required before the order can be issued, and the scheduling expires after a year. The period may be extended six months if rulemaking proceedings to permanently schedule the drug are in progress. In any case, once these proceedings are complete, the temporary order is automatically vacated. Unlike ordinary scheduling proceedings, such temporary orders are not subject to judicial review.
The CSA creates a closed system of distribution[24] for those authorized to handle controlled substances. The cornerstone of this system is the registration of all those authorized by the DEA to handle controlled substances. All individuals and firms that are registered are required to maintain complete and accurate inventories and records of all transactions involving controlled substances, as well as security for the storage of controlled substances.
The Congressional findings in 21 USC §§,, and state that a major purpose of the CSA is to "enable the United States to meet all of its obligations" under international treaties. The CSA bears many resemblances to these Conventions. Both the CSA and the treaties set out a system for classifying controlled substances in several schedules in accordance with the binding scientific and medical findings of a public health authority. Under of the CSA, that authority is the Secretary of Health and Human Services (HHS). Under Article 3 of the Single Convention and Article 2 of the Convention on Psychotropic Substances, the World Health Organization is that authority.
The domestic and international legal nature of these treaty obligations must be considered in light of the supremacy of the United States Constitution over treaties or acts and the equality of treaties and Congressional acts. In Reid v. Covert the Supreme Court of the United States addressed both these issues directly and clearly holding:
According to the Cato Institute, these treaties only bind (legally obligate) the United States to comply with them as long as that nation agrees to remain a state party to these treaties. The U.S. Congress and the President of the United States have the absolute sovereign right to withdraw from or abrogate at any time these two instruments, in accordance with said nation's Constitution, at which point these treaties will cease to bind that nation in any way, shape, or form.[25]
A provision for automatic compliance with treaty obligations is found at, which also establishes mechanisms for amending international drug control regulations to correspond with HHS findings on scientific and medical issues. If control of a substance is mandated by the Single Convention, the Attorney General is required to "issue an order controlling such drug under the schedule he deems most appropriate to carry out such obligations," without regard to the normal scheduling procedure or the findings of the HHS Secretary. However, the Secretary has great influence over any drug scheduling proposal under the Single Convention, because requires the Secretary the power to "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."
Similarly, if the United Nations Commission on Narcotic Drugs adds or transfers a substance to a schedule established by the Convention on Psychotropic Substances, so that current U.S. regulations on the drug do not meet the treaty's requirements, the Secretary is required to issue a recommendation on how the substance should be scheduled under the CSA. If the Secretary agrees with the Commission's scheduling decision, he can recommend that the Attorney General initiate proceedings to reschedule the drug accordingly.
If the HHS Secretary disagrees with the UN controls, the Attorney General must temporarily place the drug in Schedule IV or V (whichever meets the minimum requirements of the treaty) and exclude the substance from any regulations not mandated by the treaty. The Secretary is required to request that the Secretary of State take action, through the Commission or the UN Economic and Social Council, to remove the drug from international control or transfer it to a different schedule under the Convention. The temporary scheduling expires as soon as control is no longer needed to meet international treaty obligations.
This provision was invoked in 1984 to place Rohypnol (flunitrazepam) in Schedule IV. The drug did not then meet the Controlled Substances Act's criteria for scheduling; however, control was required by the Convention on Psychotropic Substances. In 1999, an FDA official explained to Congress:
The Cato Institute's Handbook for Congress calls for repealing the CSA, an action that would likely bring the United States into conflict with international law, were the United States not to exercise its sovereign right to withdraw from and/or abrogate the Single Convention on Narcotic Drugs and/or the 1971 Convention on Psychotropic Substances prior to repealing the Controlled Substances Act.[25] The exception would be if the U.S. were to claim that the treaty obligations violate the United States Constitution. Many articles in these treaties—such as Article 35 and Article 36 of the Single Convention—are prefaced with phrases such as "Having due regard to their constitutional, legal and administrative systems, the Parties shall . . ." or "Subject to its constitutional limitations, each Party shall . . ." According to former United Nations Drug Control Programme Chief of Demand Reduction Cindy Fazey, "This has been used by the USA not to implement part of article 3 of the 1988 Convention, which prevents inciting others to use narcotic or psychotropic drugs, on the basis that this would be in contravention of their constitutional amendment guaranteeing freedom of speech".[26]
There are five different schedules of controlled substances, numbered IV. The CSA describes the different schedules based on three factors:
The following table gives a summary of the different schedules.[27]
| Potential for Abuse | Accepted Medical Use? | Potential for Addiction | ||
|---|---|---|---|---|
| Schedule I | High | None | Drug is not safe to use, even under medical supervision | |
| Schedule II | High | Yes; sometimes allowed only with "severe restrictions" | Abusing the drug can cause severe physical and mental addiction | |
| Schedule III | Medium | Yes | Abusing the drug can cause severe mental addiction, or moderate physical addiction | |
| Schedule IV | Moderate | Yes | Abusing the drug may lead to moderate mental or physical addiction | |
| Schedule V | Lowest | Yes | Abusing the drug may lead to mild mental or physical addiction |
Placing a drug or other substance in a certain schedule or removing it from a certain schedule is primarily based on 21 USC §§,,,,,, and . Every schedule otherwise requires finding and specifying the "potential for abuse" before a substance can be placed in that schedule.[28] The specific classification of any given drug or other substance is usually a source of controversy, as is the purpose and effectiveness of the entire regulatory scheme.
Some have argued that this is an important exemption, since alcohol and tobacco are two of the most widely used drugs in the United States.[29] [30]
See main article: List of Schedule I drugs (US).
Schedule I substances are described as those that have all of the following findings:
No prescriptions may be written for Schedule I substances, and such substances are subject to production quotas which the DEA imposes.
Under the DEA's interpretation of the CSA, a drug does not necessarily have to have the same "high potential for abuse" as heroin, for example, to merit placement in Schedule I:
Drugs listed in this control schedule include:
In addition to the named substance, usually all possible ethers, esters, salts and stereoisomers of these substances are also controlled and also 'analogues', which are chemically similar chemicals.
See main article: List of Schedule II drugs (US).
Schedule II substances are those that have the following findings:
Except when dispensed directly to an ultimate user by a practitioner other than a pharmacist, no controlled substance in Schedule II, which is a prescription drug as determined under the Federal Food, Drug, and Cosmetic Act (21 USC 301 et seq.), may be dispensed without the written or electronically transmitted (21 CFR 1306.08) prescription of a practitioner, except that in emergency situations, as prescribed by the Secretary by regulation after consultation with the Attorney General, such drug may be dispensed upon oral prescription in accordance with section 503(b) of that Act (21 USC 353 (b)). With exceptions, an original prescription is always required even though faxing in a prescription in advance to a pharmacy by a prescriber is allowed.[39]
Prescriptions shall be retained in conformity with the requirements of section 827 of this title. No prescription for a controlled substance in Schedule II may be refilled.[40] Notably no emergency situation provisions exist outside the Controlled Substances Act's "closed system" although this closed system may be unavailable or nonfunctioning in the event of accidents in remote areas or disasters such as hurricanes and earthquakes. Acts which would widely be considered morally imperative remain offenses subject to heavy penalties.[41]
These drugs vary in potency: for example fentanyl is about 80 times as potent as morphine (heroin is roughly two times as potent). More significantly, they vary in nature. Pharmacology and CSA scheduling have a weak relationship.
Because refills of prescriptions for Schedule II substances are not allowed, it can be burdensome to both the practitioner and the patient if the substances are to be used on a long-term basis. To provide relief, in 2007, was amended (at) to allow practitioners to write up to three prescriptions at once, to provide up to a 90-day supply, specifying on each the earliest date on which it may be filled.[42]
Drugs in this schedule include:
See main article: List of Schedule III drugs (US).
Schedule III substances are those that have the following findings:
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 (21 USC 301 et seq.), may be dispensed without a written, electronically transmitted, or oral prescription in conformity with section 503(b) of that Act (21 USC 353 (b)). Such prescriptions may not be filled or refilled more than six months after the date thereof or be refilled more than five times after the date of the prescription unless renewed by the practitioner.[40]
A prescription for controlled substances in Schedules III, IV, and V issued by a practitioner, may be communicated either orally, in writing, electronically transmitted or by facsimile to the pharmacist, and may be refilled if so authorized on the prescription or by call-in.[39] Control of wholesale distribution is somewhat less stringent than Schedule II drugs. Provisions for emergency situations are less restrictive within the "closed system" of the Controlled Substances Act than for Schedule II though no schedule has provisions to address circumstances where the closed system is unavailable, nonfunctioning or otherwise inadequate.
Drugs in this schedule include:
See main article: List of Schedule IV drugs (US).
Placement on schedules; findings requiredSchedule IV substances are those that have the following findings:
Control measures are similar to Schedule III. Prescriptions for Schedule IV drugs may be refilled up to five times within a six-month period. A prescription for controlled substances in Schedules III, IV, and V issued by a practitioner, may be communicated either orally, in writing, electronically transmitted or by facsimile to the pharmacist, and may be refilled if so authorized on the prescription or by call-in.[39]
Drugs in this schedule include:
See main article: List of Schedule V drugs (US).
Schedule V substances are those that have the following findings:
No controlled substance in Schedule V which is a drug may be distributed or dispensed other than for a medical purpose.[40] A prescription for controlled substances in Schedules III, IV, and V issued by a practitioner, may be communicated either orally, in writing, electronically transmitted or by facsimile to the pharmacist, and may be refilled if so authorized on the prescription or by call-in.[39]
Drugs in this schedule include:
These psychoactive drugs are not controlled by the act, and are also allowed for sale intended for recreational use at the federal level (others are allowed for sale as dietary supplements, but not specifically regulated or intended for recreational use):
The Controlled Substances Act also provides for federal regulation of precursors used to manufacture some of the controlled substances. The DEA list of chemicals is actually modified when the United States Attorney General determines that illegal manufacturing processes have changed.
In addition to the CSA, due to pseudoephedrine (PSE) and ephedrine being widely used in the manufacture of methamphetamine, the U.S. Congress passed the Methamphetamine Precursor Control Act which places restrictions on the sale of any medicine containing pseudoephedrine. That bill was then superseded by the Combat Methamphetamine Epidemic Act of 2005, which was passed as an amendment to the Patriot Act renewal and included wider and more comprehensive restrictions on the sale of PSE-containing products. This law requires[54] customer signature of a "log-book" and presentation of valid photo ID in order to purchase PSE-containing products from all retailers.[55]
Additionally, the law restricts an individual to the retail purchase of no more than three packages or 3.6 grams of such product per day per purchase – and no more than 9 grams in a single month. A violation of this statute constitutes a misdemeanor. Retailers now commonly require PSE-containing products to be sold behind the pharmacy or service counter. This affects many preparations which were previously available over-the-counter without restriction, such as Actifed and its generic equivalents.
A common misunderstanding amongst researchers is that most national laws (including the Controlled Substance Act) allows the supply/use of small amounts of a controlled substance for non-clinical / non-in vivo research without licenses. A typical use case might be having a few milligrams or microlitres of a controlled substance within larger chemical collections (often tens of thousands of chemicals) for in vitro screening or sale. Researchers often believe that there is some form of "research exemption" for such small amounts. This incorrect view may be further re-enforced by R&D chemical suppliers often stating and asking scientists to confirm that anything bought is for research use only.
A further misconception is that the Controlled Substances Act simply lists a few hundred substances (e.g. MDMA, Fentanyl, Amphetamine, etc.) and compliance can be achieved via checking a CAS number, chemical name or similar identifier. However, the reality is that in most cases all ethers, esters, salts and stereoisomers are also controlled and it is impossible to simply list all of these. The act contains several "generic statements" or "chemical space" laws, which aim to control all chemicals similar to the "named" substance, these provide detailed descriptions similar to Markushes, these include ones for Fentanyl and also synthetic cannabinoids.
Due to this complexity in legislation, the identification of controlled chemicals in research or chemical supply is often carried out computationally on the chemical structure, either by in-house systems maintained a company or by the use of commercial software solutions.[56] Automated systems are often required as many research operations can have collections of 10,000–100,000 different substances at the 1–5 milligram scale, which are likely to include controlled substances, especially within medicinal chemistry research, even if the core focus of the company is not narcotic or psychotropic drugs. These may not have been controlled when created, but they have subsequently been declared controlled, or fall within chemical space close to known controlled substances, or are used as tool compounds, precursors or synthetic intermediates to a controlled substance.
Historically, in an attempt to prevent psychoactive chemicals which are chemically similar to controlled substance, but not specifically controlled by it, the CSA also controls "analogues" of many listed controlled substances. The definition of what 'analogue' means is kept deliberately vague, presumably to make it harder to circumvent this rule, as it's not clear what is / is not controlled, thus placing an element of risk and deterrent in those performing the supply. It is up to the courts to then decide whether a specific chemical is an analogue, often via a 'battle of experts' for the defense and prosecution which can lead to extended and more uncertain prosecutions. The use of the 'analogue' definition also make it more difficult for companies involved in the legitimate supply of chemicals for research and industrial purposes to know whether a chemical is regulated under the CSA[57]
Starting in 2012, with the Synthetic drug abuse prevention act, and later an amendment to the CSA in 2018 defining fentanyl chemical space, the CSA started to use Markush descriptions to clearly define what analogues or chemical space is controlled. These chemical space, chemical family, generic statements or markush statements (depending on the legislation terminology) have been used for many years by other countries,[58] notably the UK in the Misuse of Drugs Act.
These have the advantage of clearly defining what is controlled, making prosecutions easier and compliance by legitimate companies simpler. However the downside is that these tend to be harder to understand for non-chemists and also give those wishing to supply for illegitimate reasons something to 'aim' for in terms of non-controlled chemical space. For both Markush and analogue type approaches, typically computational systems are used to flag likely regulated chemicals.
The CSA does not include a definition of "drug abuse".[59] [4] In addition, research shows certain substances on Schedule I, for drugs which have no accepted medical uses and high potential for abuse, actually have accepted medical uses, have low potential for abuse, or both.[60] [61] [62] One of those substances is cannabis, which is either decriminalized or legalized in 33 states of the United States.[63]
Similar legislation outside of the United States: