TGA plots Schedule 3 (pharmacist-only medicine) entry for cannabidiol.
The Therapeutic Goods Administration has made an interim decision to amend the current Poisons Standard to down-schedule cannabidiol (CBD) to allow greater access through a new Schedule 3 entry, Pharmacy Daily can exclusively reveal.
The measure, with a proposed implementation date of 01 February 2021, will mean medicinal cannabis can be provided by a pharmacist, in accordance with additional supply requirements specified in Appendix M of the Standard.
Currently cannabidiol in preparations for therapeutic use is under S4 or S8 in various jurisdictions, with most products only available through the Special Access Scheme.
The proposed new entry in Schedule 3 specifies “cannabidiol in oral, oral mucosal and sublingual formulations for therapeutic use” when either plant derived, or if synthetic contains only the CBD enantiomer.
The maximum recommended daily dose is 60mg or less, and the cannabidiol is to be supplied in blister or strip packaging or in a container fitted with a child-resistant closure, for adults aged 18 years or over and in packs containing not more than 30 day’s supply.
An Appendix F listing would include a requirement for specific warning statements on the labelling of CBD-containing Schedule 3 products available to the public, and medicines containing CBD would be excluded from Appendix H meaning they could not be advertised directly to consumers. The proposed Appendix M listing would limit supply to medicines including CBD which are entered on the Australian Register of Therapeutic Goods.
The move is likely to be seen as a key endorsement of the role of pharmacists in managing medicinal cannabis patients, with the decision summary finding that the risks of cannabidiol use “cannot be managed with packaging and labelling in the absence of pharmacist advice”.
See tomorrow’s edition of Pharmacy Daily for more.
