The Drug Enforcement Administration (DEA) has recently published a final rule to amend its regulations related to “cannabimimetic agents”.
About the author
Joe Bradley is a Biochemist with decades of experience in controlled drug regulations, drug discovery and cheminformatics. He has spent the last 12 years working to improve controlled drug and regulatory compliance within the chemicals and pharmaceuticals industry, through the development of software solutions which allows the rapid and accurate identification of controlled and regulated chemicals.
He founded Scitegrity in 2011 and the tools he helped create are now used by many of the worlds top chemical and pharmaceutical companies, specialist controlled drug suppliers and regulators.
He has consulted for regulators globally, helping to refine and assess the impact of proposed controlled drug regulations before final enactment.
When not absorbed in chemical regulations you'll find him on is skateboard, trials bike or with snooker cue in hand.
They have ‘included’ within the act several generic definitions relating to Cannabinoids. Rather than controlling individual substances, these define chemically which chemicals are considered cannabinoidsand controlled, e.g. it defines the chemicals family and chemical space. The animation below outlines how generic statements work and our more detailed article on generic statements is here.
These definitions are not new, they have technically been included in the Controlled substances Act (CSA) since 2012 by the FDA Synthetic Drug Abuse Prevention Act. However this final ruling enact them as DEA regulations and also lists 18 new separate substancesas specifically named – even if they previously fell within the generic definitions.
The DEA numbers of some cannabinoids have also changed, and some, such as JWH-018 and AM2201, are moved to the “hallucinogens” paragraph of the schedule to facilitate quota and international reporting requirements
If you are struggling to understand how these changes impactyour organisation, you can contact Scitegrity about our Controlled Substances Squared platform which will allow you to easily and quickly upload your chemical structures, for an instant determination if they are controlled, including against the Controlled Substances Act and its “cannabimimetic agents” definition. You can then ask the system to automatically check all your chemicalseach week and alert you if any become controlled due to legislation updates.
The full wording of these “cannabimimetic agents” definitionare below
…cannabimimetic agent means any substance that is acannabinoid receptor type 1 (CB1 receptor) agonist as demonstrated by bindingstudies and functional assays within any of the following structural classes:
(A) 2-(3-hydroxycyclohexyl)phenol with substitution at the5-position of the phenolic ring by alkyl or alkenyl, whether or not substitutedon the cyclohexyl ring to any extent.
(B) 3-(1-naphthoyl)indole or 3-(1-naphthylmethane)indole bysubstitution at the nitrogen atom of the indole ring, whether or not furthersubstituted on the indole ring to any extent, whether or not substituted on thenaphthoyl or naphthyl ring to any extent.
(C) 3-(1-naphthoyl)pyrrole by substitution at the nitrogenatom of the pyrrole ring, whether or not further substituted in the pyrrolering to any extent, whether or not substituted on the naphthoyl ring to anyextent.
(D) 1-(1-naphthylmethylene)indene by substitution of the3-position of the indene ring, whether or not further substituted in the indenering to any extent, whether or not substituted on the naphthyl ring to anyextent.
(E) 3-phenylacetylindole or 3-benzoylindole by substitutionat the nitrogen atom of the indole ring, whether or not further substituted inthe indole ring to any extent, whether or not substituted on the phenyl ring toany extent.
Do you want to be able to easily and automatically check if your chemicals are controlled and regulated around the world - even for novel and propriatory chemicals - then you need Controlled Substances Squared.
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