Controlled substance

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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.

Contents

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. [1]

Laws and enforcement

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. [2] 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.

Use in research

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. [3] 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.

Known research exemptions

Source: [4]

Switzerland

Has limited exemptions to some Directory E substances, but which substances are covered and what the exemption allows depends on the substance, for example compounds similar to Fentanyl allow for “Von der Kontrolle ausgenommen ist die industrielle und die wissenschaftliche Verwendung. Der private Gebrauch ist nicht von der Kontrolle ausgenommen” or “Excluded from the control is the industrial and scientific use. Private use is not exempt from the control.” The exemption wording for Cyclohexylphenols is “Cyclohexylphenole sind von der Kontrolle nach den Kapiteln 5 und 6 der Verordnung über die Betäubungsmittelkontrolle vom 25. Mai 2011 ausgenommen, wenn sie von Unternehmen mit einer Betriebsbewilligung für den Umgang mit kontrollierten Substanzen des Verzeichnisses e industriell eingesetzt werden. Für Substanzmengen bis zu 100 g benötigen diese Unternehmen keine Ein- oder Ausfuhrbewilligung.” or “Cyclohexylphenols are exempted from the control under Chapters 5 and 6 of the Narcotics Control Ordinance of 25 May 2011 if they are used industrially by undertakings holding an operating license for the handling of controlled substances in Inventory e. For substance quantities of up to 100g, these companies do not require an import or export license”. In addition, import or export authorization is not required in case of controlled substances for analytical purpose in concentrations up to 1 mg/ml. (Art 23, Abs. 2b, BetmKV) [5]

Further qualifications apply e.g. yearly limits as well individual shipment limits

United Kingdom

There are no specific research exemptions in the Misuse of Drugs Act 1971. However, the associated Misuse of Drugs Regulations 2001 [6] does exempt products containing less than 1 mg of a controlled substance (1 ug for lysergide and derivatives) so long as a number of requirements are met, including that it cannot be recovered by readily applicable means, does not pose a risk to human health and is not meant for administration to a human or animal.

Although this does at first seem to allow research use, in most circumstances the sample, by definition, is “recoverable” - in order to prepare it for use the sample is ‘recovered’ into an assay buffer or solvent such as DMSO or water. In 2017 the Home Office also confirmed that the 1 mg limit applies to the total of all preparations across the entire container in the case of sample microtitre plates.  Given this, most companies and researchers choose not to rely on this exemption.

According to Home Office licensing, "University research departments generally do not require licences to possess and supply drugs in schedule 2 drug, schedule 3 drug, schedule 4 drug part I, part II and schedule 5, but they do require licences to produce any of those drugs and to produce, possess and/or supply drugs in schedule 1". [7]

United States of America

In the US no general research exemptions are known to exist, at least at the federal level and the Controlled Substances Act.

Germany

The Gesetz über den Verkehr mit Betäubungsmitteln (Betäubungsmittelgesetz - BtMG) / (Law on the Traffic in Narcotic Drugs (Narcotics Act - BtMG) has a partial exemption that might apply to certain research areas.

For each schedule the act allows for

the preparations of the substances listed in this Appendix if they are not

a)      without being applied to or in the human or animal body, for diagnostic or analytical purposes only, and their content of one or more anesthetics not exceeding 0.001 per cent, or isotope-modified in the preparations, or

b)      are particularly excluded;

die Zubereitungen der in dieser Anlage aufgeführten Stoffe, wenn sie nicht

a)      ohne am oder im menschlichen oder tierischen Körper angewendet zu werden, ausschließlich diagnostischen oder analytischen Zwecken dienen und ihr Gehalt an einem oder mehreren Betäubungsmitteln jeweils 0,001 vom Hundert nicht übersteigt oder die Stoffe in den Zubereitungen isotopenmodifiziert oder

b)      besonders ausgenommen sind;

The exact percentage various for each schedule. Also whether the ‘0.001%’ allows the rest to be an assay solvent or medium, or whether a licence is needed if you have some solid, e.g. 1 mg of sample before its diluted is not clear.

Related Research Articles

<span class="mw-page-title-main">Controlled Substances Act</span> United States drug-regulating law

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. The Act also served as the national implementing legislation for the Single Convention on Narcotic Drugs.

<span class="mw-page-title-main">Misuse of Drugs Act 1971</span> United Kingdom legislation

The Misuse of Drugs Act 1971 is an Act of the Parliament of the United Kingdom. It represents action in line with treaty commitments under 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.

<span class="mw-page-title-main">Federal Analogue Act</span>

The Federal Analogue Act, 21 U.S.C. § 813, is a section of the United States Controlled Substances Act passed in 1986 which allows any chemical "substantially similar" to a controlled substance listed in Schedule I or II to be treated as if it were listed in Schedule I, but only if intended for human consumption. These similar substances are often called designer drugs. The law's broad reach has been used to successfully prosecute possession of chemicals openly sold as dietary supplements and naturally contained in foods. The law's constitutionality has been questioned by now Supreme Court Justice Neil Gorsuch.

<span class="mw-page-title-main">ALD-52</span> Chemical compound

ALD-52, also known as 1-acetyl-LSD, is a chemical analogue of lysergic acid diethylamide (LSD). It was originally discovered by Albert Hofmann in 1957 but was not widely studied until the rise in popularity of psychedelics in the 1960s.

<span class="mw-page-title-main">Etorphine</span> Semi-synthetic opioid

Etorphine (M99) is a semi-synthetic opioid possessing an analgesic potency approximately 1,000–3,000 times that of morphine. It was first prepared in 1960 from oripavine, which does not generally occur in opium poppy extract but rather the related plants Papaver orientale and Papaver bracteatum. It was later reproduced in 1963 by a research group at MacFarlan Smith in Gorgie, Edinburgh, led by Kenneth Bentley. It can also be produced from thebaine.

<span class="mw-page-title-main">Nimetazepam</span> Chemical compound

Nimetazepam is an intermediate-acting hypnotic drug which is a benzodiazepine derivative. It was first synthesized by a team at Hoffmann-La Roche in 1964. It possesses powerful hypnotic, anxiolytic, sedative, and skeletal muscle relaxant properties. Nimetazepam is also a particularly potent anticonvulsant. It is marketed in 5 mg tablets known as Erimin, which is the brand name manufactured and marketed by the large Japanese corporation Sumitomo. Japan is the sole manufacturer of nimetazepam in the world. Outside of Japan, Erimin is available in much of East and Southeast Asia and was widely prescribed for the short-term treatment of severe insomnia in patients who have difficulty falling asleep or maintaining sleep. Sumitomo has ceased manufacturing Erimin since November 2015. It is still available as a generic drug or as Lavol.

<span class="mw-page-title-main">AL-LAD</span> Chemical compound (psychedelic drug)

AL-LAD, also known as 6-allyl-6-nor-LSD, is a psychedelic drug and an analog of lysergic acid diethylamide (LSD). It is described by Alexander Shulgin in the book TiHKAL. It is synthesized starting from nor-LSD as a precursor, using allyl bromide as a reactant.

<span class="mw-page-title-main">Phenazepam</span> Chemical compound

Phenazepam is a benzodiazepine drug, which was developed in the Soviet Union in 1975, and now produced in Russia and some CIS countries.

<span class="mw-page-title-main">Federal drug policy of the United States</span> Nationwide framework regarding the abuse of drugs in the United States

The drug policy in the United States is the activity of the federal government relating to the regulation of drugs. Starting in the early 1900s the United States government began enforcing drug policies. These policies criminalized drugs such as opium, morphine, heroine, and cocaine outside of medical use. The drug policies put into place are enforced by the Food and Drug Administration and the Drug Enforcement Administration. Classification of Drugs are defined and enforced using the Controlled Substance Act, which lists different drugs into their respective substances based on its potential of abuse and potential for medical use. Four different categories of drugs are Alcohol, Cannabis, Opioids, and Stimulants.

<span class="mw-page-title-main">2-Fluoromethamphetamine</span> Chemical compound

2-Fluoromethamphetamine (2-FMA) is a stimulant drug of the amphetamine family which has been used as a designer drug. 2-FMA is commonly compared to lisdexamfetamine (Vyvanse), and dextroamphetamine due to its efficacy as a study or productivity aid. 2-FMA is purported to produce somewhat less euphoria than comparable amphetamines, likely due to its main mechanism of action consisting of norepinephrine reuptake inhibition.

βk-2C-B Chemical compound

βk-2C-B is a novel psychedelic substance. It is the beta (β) ketone structural analogue of 2C-B, a psychedelic drug of the 2C family. It is used as a recreational drug, usually taken orally. βk-2C-B is a controlled substance in Canada, Germany, Switzerland, and the United Kingdom.

<span class="mw-page-title-main">AB-CHMINACA</span> Chemical compound

AB-CHMINACA is an indazole-based synthetic cannabinoid. It is a potent agonist of the CB1 receptor (Ki = 0.78 nM) and CB2 receptor (Ki = 0.45 nM) and fully substitutes for Δ9-THC in rat discrimination studies, while being 16x more potent. Continuing the trend seen in other cannabinoids of this generation, such as AB-FUBINACA and AB-PINACA, it contains a valine amino acid amide residue as part of its structure, where older cannabinoids contained a naphthyl or adamantane residue.

<span class="mw-page-title-main">Flubromazolam</span> Triazolobenzodiazepine/Benzodiazepine derivative

Flubromazolam (JYI-73) is a triazolobenzodiazepine (TBZD), which are benzodiazepine (BZD) derivatives. Flubromazolam is reputed to be highly potent, and concerns have been raised that clonazolam and flubromazolam in particular may pose comparatively higher risks than other designer benzodiazepines, due to their ability to produce strong sedation and amnesia at oral doses of as little as 0.5 mg. Life-threatening adverse reactions have been observed at doses of only 3 mg of flubromazolam.

<span class="mw-page-title-main">ADB-CHMINACA</span> Chemical compound

ADB-CHMINACA (also known as MAB-CHMINACA) is an indazole-based synthetic cannabinoid. It is a potent agonist of the CB1 receptor with a binding affinity of Ki = 0.289 nM and was originally developed by Pfizer in 2009 as an analgesic medication. It was identified in cannabinoid blends in Japan in early 2015.

<span class="mw-page-title-main">5F-AMB</span> Chemical compound

5F-AMB (also known as 5F-MMB-PINACA and 5F-AMB-PINACA) is an indazole-based synthetic cannabinoid from the indazole-3-carboxamide family, which has been used as an active ingredient in synthetic cannabis products. It was first identified in Japan in early 2014. Although only very little pharmacological information about 5F-AMB itself exists, its 4-cyanobutyl analogue (instead of 5-fluoropentyl) has been reported to be a potent agonist for the CB1 receptor (KI = 0.7 nM).

<span class="mw-page-title-main">MDMB-CHMINACA</span> Chemical compound

MDMB-CHMINACA (also known as MDMB(N)-CHM) is an indazole-based synthetic cannabinoid that acts as a potent agonist of the CB1 receptor, and has been sold online as a designer drug. It was invented by Pfizer in 2008, and is one of the most potent cannabinoid agonists known, with a binding affinity of 0.0944 nM at CB1, and an EC50 of 0.330 nM. It is closely related to MDMB-FUBINACA, which caused at least 1000 hospitalizations and 40 deaths in Russia as consequence of intoxication.

<span class="mw-page-title-main">NBOMe-mescaline</span> Chemical compound

NBOMe-mescaline or mescaline-NBOMe is a synthetic substituted phenethylamine. It is a partial agonist of serotonin receptors with a 5-HT2A pKi originally reported as 7.3, though more modern techniques assayed it as 140nM at 5-HT2A and 640nM at 5-HT2C, making it one of the least potent compounds among the N-benzyl phenethylamines.

<i>N</i>-Ethylhexedrone Chemical compound

N-Ethylhexedrone (also known as α-ethylaminocaprophenone, N-ethylnorhexedrone, hexen, and NEH) is a stimulant of the cathinone class that acts as a norepinephrine–dopamine reuptake inhibitor (NDRI) with IC50 values of 0.0978 and 0.0467 μM, respectively. N-Ethylhexedrone was first mentioned in a series of patents by Boehringer Ingelheim in the 1960s which led to the development of the better-known drug methylenedioxypyrovalerone (MDPV). Since the mid-2010s, N-ethylhexedrone has been sold online as a designer drug. In 2018, N-ethylhexedrone was the second most common drug of the cathinone class to be identified in Drug Enforcement Administration seizures.

This is an overview of the legality of ibogaine by country. Ibogaine is not included on the UN International Narcotics Control Board's Green List, or List of Psychoactive Substances under International Control. However, since 1989, it has been on the list of doping substances banned by the International Olympic Committee and the International Union of Cyclists because of its stimulant properties.

References

  1. "Controlled Substance Act". Archived from the original on 2021-06-30. Retrieved 2012-11-07.
  2. answers.com
  3. "Scitegrity | Controlled Substances Squared". www.scitegrity.com. Retrieved 2019-01-14.
  4. "Scitegrity | Research use of Controlled Substances". www.scitegrity.com. Retrieved 2019-01-14.
  5. "SR 812.121.1 Verordnung vom 25. Mai 2011 über die Betäubungsmittelkontrolle (Betäubungsmittelkontrollverordnung, BetmKV)". www.admin.ch. Retrieved 2019-01-14.
  6. "The Misuse of Drugs Regulations 2001". www.legislation.gov.uk. Retrieved 2019-01-14.
  7. "Controlled drugs: licences, fees and returns". GOV.UK. Retrieved 2019-02-27.