Recent CSCS Updates
The Pistoia Alliance Controlled Substance Compliance Services Project Successfully Passes the First Phase of Industry Testing
The Controlled Substance Challenge
Legislation exists at local, national and international levels to restrict the production, import/export, supply, use and possession of certain substances.
Compliance is increasingly resource intensive due to a number of factors:
- The legislation is complex, differs from country to country and changes rapidly to keep pace with the criminals
- Companies are externalizing more of their operations and so move substances around the world more often
- Some of the legislation is ambiguous and difficult to translate into chemical structures
- There are high stakes for non-compliance
This collaborative project facilitated the creation of two vendor created systems that allow the user to look up the controlled status of a chemical structure across multiple countries. They provide alerts for new legislation and regular updates to ensure the information is current. These systems are now available on the open market.
Controlled Substances Squared
Scitegrity’s Controlled Substances Squared (CS2) system was built specifically to Pistoia CSCS requirements and is now in daily use by the pharmaceutical industry, forensic companies and regulators.
Compliance Checker is a software system combined with a content package. With ChemAxon's robust chemical knowledge in the background, it provides invaluable help in improving your controlled substance compliance according to Pistoia requirements. Developed by Patcore and ChemAxon.
The CSCS project members found real benefit from collaborating and discussing areas of difficulty in their day-to-day work. The Controlled Substance Compliance Expert Community was created to:
Improve the understanding and interpretation of controlled substance legislation around the world.
The community works jointly on areas of uncertainty drawing on expertise from across the industry to reach consensus. Recent discussions have included how to identify the latest regulations in China, how best to import into South America and the community is building links with regulators.
Currently the following companies are involved in the community: