Регулируемые вещества и наркотические средства: международное и национальное законодательство.

Drug whose manufacture, possession and use is regulated by an organization

A controlled substance is generally a drug or chemical whose manufacture, possession and use is regulated by a government, such as illicitly used drugs or prescription medications that are designated by law. Some treaties, notably the Single Convention on Narcotic Drugs, the Convention on Psychotropic Substances, and the United Nations Convention Against Illicit Traffic in Narcotic Drugs and Psychotropic Substances, provide internationally agreed upon "schedules" of controlled substances, which have been incorporated into national laws; however, national laws usually significantly expand on these international conventions. Some precursor chemicals used for the production of illegal drugs are also controlled substances in many countries, even though they may lack the pharmacological effects of the drugs themselves. Substances are classified according to schedules and consist primarily of potentially psychoactive substances and anabolic steroids. The controlled substances do not include many prescription items such as antibiotics.

In the United States, the Drug Enforcement Administration is the federal government agency responsible for suppressing illegal drug use and distribution by enforcing the Controlled Substances Act, which regulates both the drugs themselves and certain precursors. Some U. S. states have additional restrictions for substances which might or might not be regulated by the federal government. During the Obama Administration, the federal government also voluntarily suspended enforcement of federal laws restricting marijuana where people were operating in compliance with state law. Some states in the U. S. have statutes against health care providers self prescribing and/or administering substances listed in the Controlled Substance Act schedules. This does not forbid licensed providers from self prescribing medications not on the schedules. The term Controlled Drug in the United Kingdom (CD) is used for substances governed by the Misuse of Drugs Act 1971. Other national drug prohibition laws include the Controlled Drugs and Substances Act (Canada) and the Misuse of Drugs Act 1975 (New Zealand), among many others. Within Europe controlled substance laws are legislated at the national rather than by the EU itself, with significant variation between countries in which and how chemicals are classified as controlled. Only drug precursor laws are legislated for at the European level.

A common misunderstanding amongst researchers is that most national laws allow the use of small amounts of a controlled substance for non clinical / non in vivo research without licences. A typical use case might be having a few milligrams or microlitres of a controlled substance within larger chemical collections (often 10K's of chemicals) for in vitro screening. 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 controlled substances laws simply list 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 most countries enact “generic statement" or “chemical space” laws, which aim to control all chemicals similar to the “named” substance. These either provide detailed descriptions similar to Markushes, or simply state analogues are also controlled. In addition, control of most named substances is extended to control of all of their ethers, esters, salts and stereoisomers. Due to this complexity in legislation the identification of controlled chemicals in research is often carried out computationally, either by in house systems maintained a company's sample logistics department or by the use commercial software solutions. Automated systems are often required as many research operations can often have chemical collections running into 10Ks of molecules at the 1–5 mg scale, which are likely to include controlled substances, especially within medicinal chemistry research. These may not have been controlled when created, but they have subsequently been declared controlled.