Could you have controlled drugs and chemicals in your collection and how to monitor and manage this is chemical compliance software
After "is R&D exempt from controlled drug laws" probably the next most asked question we get at Scitegrity is 'do we need to check if all our chemicals are regulated' or 'why would we have any controlled chemicals – we are not selling or supplying them or working on CNS programs.
So today I've taken some time to sit down and write a blog post specifically about this.
Are you at risk of inadvertently having controlled or regulated chemicals?
In our experience working with chemical suppliers and pharma companies, a compound collection of 1M compounds will likely have several thousand regulated or controlled substances from…
Library compounds from previous programs that are now controlled (e.g CB1, Opioid, many pain targets, sleep disorders programs, anti-depressants). Remember in most cases, it’s not just the named chemicals like 'Fentanyl' that is controlled by all chemicals with a similar chemical structure (read our blog on this).
“Collateral damage” e.g the chemical is not addictive, not even a CNS target, but caught by a generic description so must be treated as controlled as it very similar to a controlled substance. We have assisted several Pharma in this respect – it can and does happen. De risk early! It being in a clinical trial will not exempt it, get your licence sorted early and work with legislators for an exemption early on
Some common building blocks can chemicals also be regulated as they are easily convertible into Controlled Substances or can be used for military applications (EU Military dual use lists, US Commerce Control Lists and International Traffic in Arms Regulations etc). although often not 'controlled drugs these still require special record keeping, especially when importing / exporting or selling or storing in bulk, like in a stockroom.
Chemicals bought from suppliers (standards or reference compounds) or obtained through mergers
Ok, so you might be thinking that maybe my company - but this can’t apply for a few mg’s for Research Purposes can it?
This is a common held belief that's almost always wrong. In general there are no exemptions based on research use or small amounts, even milligrams. Where such exemptions exist you will still require some form of licence and cannot supply the chemicals to anyone else who does not have the licence. This especially applies when shipping chemicals to customers or collaborators on different sites. We've been working with our industry partners and organisations for several years to push for better and more workable research exemptions (you can read about them here), and read about a few research exemption we are aware of, however it's a slow process with limited progress to date.
Part of the difficulty for regulators is who defines what legitimate research is and avoiding loop holes, which could be exploited by criminals or less reputable companies to sell novel and potentially dangerous psychoactive substances 'legally' for 'research purposes’. Unfortunately already there are a large number of illegitimate overseas websites that will freely supply dangerous NPS's to anyone and try and hide behind the "research purposes only" disclaimer thinking it has legal weight. It doesn't, but it shows the difficulty legislators face when considering wider ranging "research exemptions' with legal weight. At the start of the indoor smoking ban in the UK, some pubs and bars tried to claim they were running clinical trials and 'research' on smoking with the consent of the customers to get around the ban - and its naive to think similar things would not be tried in the NPS space if not carefully thought through.
This is obviously generalised, with some differences between countries, but as a rule, in general there are no widely encompassing research exemptions in the USA, UK and most European countries. We have a page with more information on known research exemptions globally.
Can I just check against my home counties law and assume it’s the same everywhere?
Unfortunately what is considered controlled varies greatly. Each european country has its own laws (these are not harmonised at the EU level) and the USA and many Europe countries in general take very different approaches in defining what chemicals and chemical space is controlled. So if you ship or store internationally or even just within Europe you need to check both the send and destination countries laws. The table below shows the number of controlled chemicals by country listed in ACD (Available Compounds Directory) as of January 2017 & legislation as of February 2020. There were 11.7M distinct chemicals in total.
Suppliers – what are you selling? Purchasers – what are you buying?
Will regulators will turn a blind eye?
You are expected to self police and the impact can be severe if you do not put appropriate controls in place. The Opioid and Cannabinoid crisis combined with the ease of internet ordering means increased interest by regulators and law enforcement on chemical suppliers with pressure to get results and be seen to take action. Below are just some of the examples we are aware of:-
2017 - Pharma A had to apply for emergency licencing to continue a cancer clinical trial after finding the lead molecule fell under a newly enacted piece of UK Controlled Drug legislation. The fact it was a potential cancer treatment did not exempt it. Unfortunately in this case the UK parliament makes the rules and the regulators enforce them.
2018 - Chemical supplier X which supplies research companies and universities in the USA was raided and ordered to shut for several weeks after the DEA found it was able to order milligram amounts of US scheduled substances.
2019 - AAE Chemie Trading, a wholesaler, Anex Customs and Danmar Logistics between €75,000 and €500,000 for shipping isopropanol to Syria*. 2 managers were jailed
“a lawyer representing AAE Chemie Trading, said his client did not know about the rules requesting exporters to obtain a special license for the export of isopropanol. Not once, he said, did customs authorities make any objections to the shipments, leading his client to believe he was doing nothing wrong.”
2014 - “…according to the report, German chemical wholesaler Brenntag AG sold the chemicals isopropanol and diethylamine to Syria in 2014 using a subsidiary in Switzerland. The recipient was a Syrian pharmaceutical company”