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., codified at et. seq. 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). Classification decisions are required to be made on criteria including potential for abuse (an undefined term), currently accepted medical use in treatment in the United States, and international treaties.
History
The nation first outlawed addictive drugs in the early 1900s, and the International Opium Convention helped lead international agreements regulating trade. The Pure Food and Drug Act (1906) was the beginning of over 200 laws concerning public health and consumer protections. Others were the Federal Food, Drug, and Cosmetic Act (1938), and the Kefauver Harris Amendment of 1962.
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.
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. 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. 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.
King notes that the rehabilitation clauses were added as a compromise to Senator Harold 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.
Amendments, 1970–2018 Since its enactment in 1970, the Act has been amended numerous times: The 1976 Medical Device Regulation Act. The Psychotropic Substances Act of 1978 added provisions implementing the Convention on Psychotropic Substances. The Controlled Substances Penalties Amendments Act of 1984. The 1986 Federal Analog Act for chemicals "substantially similar" in Schedule I and II to be listed The 1988 Chemical Diversion and Trafficking Act (implemented August 1, 1989, as Article 12) added provisions implementing the United Nations Convention Against Illicit Traffic in Narcotic Drugs and Psychotropic Substances that went into force on November 11, 1990. The 1990 Anabolic Steroids Control Act, passed as part of the Crime Control Act of 1990, which placed anabolic steroids into Schedule IIISteven B. Karch. Pathology, Toxicogenetics, and Criminalistics of Drug Abuse. CRC Press, 2007 The 1993 Domestic Chemical Diversion and Control Act (effective on April 16, 1994) in response to methamphetamine trafficking. The Hillory J. Farias and Samantha Reid Date-Rape Prevention Act of 2000 placed gamma hydroxybutyrate (GHB) in Schedule I and sodium oxybate (the isolated sodium salt in GHB) in Schedule III when used under an FDA NDA or IND. The 2008 Ryan Haight Online Pharmacy Consumer Protection Act The 2010 Electronic Prescriptions for Controlled Substances (EPCS). The 2012 Synthetic Drug Abuse Prevention Act Subtitle D - synthetic drugs, added several Markush like statements that describes synthetic cannabinoid chemical space that are also controlled as Schedule 1 substances. However, since then many new synthetic cannabinoids not covered by this act have emerged The 2010 Secure and Responsible Drug Disposal Act (effective on October 12, 2010), to allow pharmacies to operate take-back programs for controlled substance medications in response to the US opioid epidemic. The 2017 Protecting Patient Access to Emergency Medications Act (PPAEMA) amended Section 33 of the CSA to include DEA registration for Emergency Medical Service (EMS) agencies, approved uses of standing orders, and requirements for the maintenance and administration of controlled substances used by EMS agencies. In 2018 the act was also amended to describe and control all chemical space related to Fentanyl like chemicals using Markush like notation, the first time Markush like statement were directly used in the act itself.
Statute content 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.
Enforcement authority
The Drug Enforcement Administration was established in 1973, combining the Bureau of Narcotics and Dangerous Drugs (BNDD) and Customs' drug agents. 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, 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 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 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.
Treaty obligations 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: