IUPAC Name
N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-(4-fluorobenzyl)-1H-indazole-3-carboxamide
Current Scheduling Status
None
Year(s) and type of review / ECDD meetings
Drug Class
Recommendation (from TRS)
Summary
At its fortieth meeting the ECDD considered a critical review of cannabidiol and recommended that preparations considered to be pure cannabidiol should not be scheduled within the international drug control conventions. Cannabidiol is found in cannabis and cannabis resin, but does not have psychoactive properties and has no potential for abuse and no potential to produce dependence. It does not have significant ill-effects. Cannabidiol has been shown to be effective in the management of certain treatment-resistant, childhood-onset epilepsy disorders. It was approved for this use in the United States in 2018 and is currently under consideration for approval by the European Union.
■■ Cannabidiol can be chemically synthesized or it can be prepared from the cannabis plant. The approved medication (Epidiolex®) is a preparation of the cannabis plant. The Committee noted that medicines without psychoactive effects that are produced as preparations of the cannabis plant will contain trace amounts of Δ9- THC (dronabinol). The cannabidiol preparation approved for the treatment of childhood-onset epilepsy, Epidiolex®, contains not more than 0.15% Δ9-THC by weight and has no effects indicative of potential for abuse or dependence. In keeping with the recommendation of the fortieth ECDD that preparations considered pure cannabidiol not be controlled, the Committee recognized that trace levels of Δ9- THC may be found in such preparations, such as the concentration of 0.15% in Epidiolex®. The Committee acknowledged that chemical analysis of Δ9-THC to an accuracy of 0.15% may be difficult for some Member States, and considered existing national capacities to accurately detect trace amounts of Δ9-THC up to 0.2%.
Recommendation
The Committee recommended that a footnote be added to Schedule I of the 1961 Single Convention on Narcotic Drugs to read: "Preparations containing predominantly cannabidiol and not more than 0.2 per cent of delta-9-tetrahydrocannabinol are not under international control."
The Committee noted precedence in the use of footnotes in the Schedules relating to levomethorphan and levorphanol, whose stereoisomers, dextromethorphan and dextrorphan, would normally be subject to the same level of control under Schedule I of the 1961 Convention. Because these substances are not liable to abuse or to produce dependence and are used medically, a footnote was used to indicate that dextromethorphan and dextrorphan are not under international control.
At its fortieth meeting the ECDD considered a critical review of cannabidiol and recommended that preparations considered to be pure cannabidiol should not be scheduled within the international drug control conventions. Cannabidiol is found in cannabis and cannabis resin, but does not have psychoactive properties and has no potential for abuse and no potential to produce dependence. It does not have significant ill-effects. Cannabidiol has been shown to be effective in the management of certain treatment-resistant, childhood-onset epilepsy disorders. It was approved for this use in the United States in 2018 and is currently under consideration for approval by the European Union.
■■ Cannabidiol can be chemically synthesized or it can be prepared from the cannabis plant. The approved medication (Epidiolex®) is a preparation of the cannabis plant. The Committee noted that medicines without psychoactive effects that are produced as preparations of the cannabis plant will contain trace amounts of Δ9- THC (dronabinol). The cannabidiol preparation approved for the treatment of childhood-onset epilepsy, Epidiolex®, contains not more than 0.15% Δ9-THC by weight and has no effects indicative of potential for abuse or dependence. In keeping with the recommendation of the fortieth ECDD that preparations considered pure cannabidiol not be controlled, the Committee recognized that trace levels of Δ9- THC may be found in such preparations, such as the concentration of 0.15% in Epidiolex®. The Committee acknowledged that chemical analysis of Δ9-THC to an accuracy of 0.15% may be difficult for some Member States, and considered existing national capacities to accurately detect trace amounts of Δ9-THC up to 0.2%.
Recommendation
The Committee recommended that a footnote be added to Schedule I of the 1961 Single Convention on Narcotic Drugs to read: "Preparations containing predominantly cannabidiol and not more than 0.2 per cent of delta-9-tetrahydrocannabinol are not under international control."
The Committee noted precedence in the use of footnotes in the Schedules relating to levomethorphan and levorphanol, whose stereoisomers, dextromethorphan and dextrorphan, would normally be subject to the same level of control under Schedule I of the 1961 Convention. Because these substances are not liable to abuse or to produce dependence and are used medically, a footnote was used to indicate that dextromethorphan and dextrorphan are not under international control.
ECDD Recommendation
The Committee recommended that a footnote be Inclusion in Schedule I of the 1961 Convention on Narcotic Drugs to read: "Preparations containing predominantly cannabidiol and not more than 0.2 per cent of delta-9-tetrahydrocannabinol are not under international control."
Link to full TRS
9789241210270-eng.pdf453.93 KB
MS Questionnaire Report