THE TGA has released details of revised Poisons Standard entries for medicinal cannabis, with a proposed implementation date of 01 Oct this year.
The interim ruling is in line with recommendations from the Advisory Committee on Medicines Scheduling, and amends the Schedule 4 entry for cannabidiol, and the Schedule 8 and Appendix K entries for tetrayhydrocannabidiols and cannabis to make them clearer.
The proposed Schedule 4 entry covers cannabidiol in preparations for therapeutic use where:
a. cannabidiol comprises 98% or more of the total cannabinoid content of the preparation; and
b. any cannabinoids, other than cannabidiol, must be only those naturally found in cannabis and total 2% or less of the cannabinoid content of the preparation.
Cannabis, including seeds, extracts, resins and the plant, is also included in Schedule 8 when cultivated or produced in accordance with the Narcotic Drugs Act 1967.
There is also a proposed S8 entry for tetrahyrdrocannabidiols when extracted from cannabis for human therapeutic use.
The update confirms that the "consideration is about clarification only and does not seek to change the original scheduling decisions".
In particular, "clarification of these entries is necessary to prevent their inadvertent or deliberate misinterpretation resulting in harm through Schedule 8 products being treated as Schedule 4 medicines, including not obtaining State authority to prescribe and increased potential for diversion/misuse because of less restrictive storage and recording requirements," the update notes.
See tga.gov.au.
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