Every country has a published controlled substance list, but the named substances are only common examples. The list also covers analogs and defined chemical space around these substances, which complicates matters for chemical suppliers, manufacturers, and research chemists, who must determine whether a substance is controlled.
Many people mistakenly believe that small quantities or substances used for research are exempt from regulation or that only named substances are controlled. These beliefs are largely untrue.
If a chemical is covered by the regulations, even if it is not specifically named on the list, it is still considered controlled, and a license must be obtained for its storage, supply, or production.
Pharmaceutical companies and pharmacies are typically well-informed about the regulations that affect their operations. However, the same strict rules apply to smaller-scale medicinal chemistry labs, researchers, and chemical suppliers, who may not be as familiar with the overarching legislation.
For example, chemists may not realize that strict regulations apply to their reference standards or test compounds.
Legislation such as the Controlled Substances Act (CSA) presents a significant challenge for managing regional substance controls, as controlled substance lists vary widely from country to country, even within closely aligned regions like Europe and the European Union.
Each European country, for example, has its unique laws and regulations that differ from those in Canada, the US, the Asia-Pacific region, and other areas. The Misuse of Drugs Act 1971 in the UK and the CSA in the US, for instance, do not include all of the same substances or definitions of controlled chemical space.
As a result, a substance that is legal in the country of production may not be permitted in the destination country or the country to which the chemical is intended to be shipped. The approach to defining controlled substances in North America also differs significantly from that of most European countries.
Simply adhering to the rules of the CSA in the USA or the Controlled Drugs and Substances Act (CDSA) in Canada is insufficient to ensure compliance in other countries, which can create problems during shipping. Moreover, controlled substance lists are frequently updated.
How the Controlled Substances Act impacts chemical suppliers and manufacturers
Chemical companies bear the responsibility of ensuring that their substances comply with all relevant regulations.
Failure to do so can have significant consequences, including prosecutions, fines, enhanced inspections or external oversight or the revocation of site wide controlled drug licences. In one case a cancer clinical trial was disrupted due to the discovery that the active ingredient technically fell within the scope of controlled drug legislation in of a country.
Additionally, chemical suppliers have been prosecuted and fined for inadvertently supplying even small quantities of controlled substances to customers.
Therefore, it is crucial to determine whether the chemicals being supplied constitute a controlled substance, as structural analogs and derivatives may also be subject to restrictions under the CSA and related regulations.
The CSA can present challenges for businesses involved in the chemical supply, and it is important to carefully consider whether the chemicals being supplied fall within its regulatory scope.
Critical challenges include:
- Failing to identify and establish controls on the use of certain substances can lead to significant consequences, including fines, legal action, imprisonment, and damage to reputation.
- What is on a controlled substances list is not the same in every country, and the company needs to be aware of this before and during production, storage, and supply.
- Typically, there are no exceptions for small amounts of controlled substances used in research and development (R&D) applications, and a license is required for both their use and supply.
- Identifying what actually is controlled. Name matching to controlled substances lists is not dependable due to differences in naming conventions between countries. For example, some countries may use full chemical names (such as 3,4-methylenedioxy-methamphetamine), while others may use abbreviations (such as MDMA). Moreover, name matching does not account for analogs, derivatives, and other related compounds.
Image Credit: Scitegrity
How can we identify and manage our controlled substances?
Scitegrity has developed software that identifies whether a chemical is controlled against controlled drug regulations in more than 28 countries globally.
The Controlled Substances Squared (CS2) software has a widespread presence and is used by the worlds top pharma companies and chemical suppliers, as well as specialist suppliers such as Cayman Chemical and LGC Standards.
This software allows users to input the name of a substance, provide a chemical structure, or draw its chemical composition, after which the software takes care of the rest.
By utilizing this software, users can obtain valuable information such as whether a chemical is regulated, in which countries it is regulated, and the requirements surrounding it, including analogs, esters, ethers, salts, stereoisomers, and controlled chemical space. This information is accessible even if the chemical in question is proprietary.
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Scitegrity was founded in 2011 by ex-Pfizer, GSK and Roche chemists and data scientists with the goal of making compliance to chemical regulations are far more robust, accurate and automatic.
By automatically checking all the chemicals an organisation has at the structure level, it allows enterprise wide automatic compliance checks against hundreds of regulations globally, even for novel and proprietary chemical collection running into millions of chemicals.
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