SLAS 2019 European Sample Management Symposium

Pharmaceutical companies routinely work with controlled substances, narcotics and psychotropic drugs, and must have controls in place to meet the legislative requirements. Today these organisations hold and dispense tens of millions of samples in highly automated processes making manual compliance activities impractical.

In 2016 the UK government amended the 1971 Misuse of Drugs Act and added a section designed to control the newer synthetic cannabinoids in increasing supply on the black market. Unfortunately, the definition was drawn extremely broadly.

The impact of this amendment is that typical Pharmaceutical libraries have seen their controlled compounds rise into the tens of thousands, with the clear majority having no indication of CB1 activity. This has prevented early discovery activities and limited collaborative research due to the inability to ship these compounds outside the UK. Many existing products like Atorvastatin (Lipitor – Pfizer, statin) and Lostartan (Cozaar – Merck & Co, Angiotensin) are also affected. Not only are these proven medicines, and so do not fall into Schedule 1, which is specifically for substances considered by the government to have no medicinal value, but they also do not exhibit any cannabinoid-like activity

This talk covers the needs for software packages to identify controlled substances and how the Controlled Substance Compliance Expert Community (Pistoia Alliance) is working with the UK’s Advisory Council for the Misuse of Drugs by providing expertise to narrow the scope of the definition and suggest other measures such as de-minimis limits and research exemptions.