Controlled Substances Act
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.
Long title
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.
CSA
May 1, 1971
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.
Statute content[edit]
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.[22]
Regulation of precursors[edit]
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[58] customer signature of a "log-book" and presentation of valid photo ID in order to purchase PSE-containing products from all retailers.[59]
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.
Research exemptions[edit]
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 stereo isomers 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.[60] 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.
Analogues vs Markush descriptions[edit]
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[61]
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,[62] 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[60] are used to flag likely regulated chemicals.
Similar legislation outside of the United States: