The Therapeutic Goods Administration (TGA) announced on 15 December a final decision to down-schedule certain low dose cannabidiol (CBD) preparations from Schedule 4 (Prescription Medicine) to Schedule 3 (Pharmacist Only Medicine).
According to a statement released by the TGA this decision allows approved low-dose CBD-containing products (up to a maximum of 150mg/day) for use in adults, to be supplied OTC by a pharmacist, without prescription.
The caveat is that this decision limits OTC supply of CBD-containing products to only those that have been approved by the TGA and included on the Australian Register of Therapeutic Goods (ARTG).
According to the TGA, the final decision was made following an earlier TGA safety review of low dose CBD, which indicated that the known adverse events of CBD at low doses were not serious.
There are reportedly no TGA approved products on the ARTG that meet the Schedule 3 criteria at this time.
The TGA says that sponsoring companies can now lodge an application to the TGA for inclusion of Schedule 3 CBD preparations on the ARTG.
For more information on this can be found here.
A cautious welcome
Painaustralia has reportedly cautiously welcomed this decision by the TGA as changes that provide more accessible and affordable pain management options are necessary, according to CEO of Painaustralia, Carol Bennett.
“While the number of people living with pain in Australia rises, there will still be significant gaps in access to, and understanding of, best practice holistic pain management,” says Ms Bennett.
“With the recent restrictions applied to opioids in Australia making pharmacological pain treatments less accessible, the Schedule 3 listing of CBD and ready availability in pharmacies will add another drug to the list of available treatments.
“The missing piece of the puzzle remains access to multidisciplinary treatment.”
Painaustralia is reportedly advocating for a National Action Plan for pain management to ensure a national and holistic policy framework that supports consumers, health professionals and the wider community.
Information on the action plan can be found at: painaustralia.org.au/improving-policy/national-action-plan
For more information on medicinal CBD, visit: rpassistants.com.au/feature/medicinal-cannabis-the-role-of-assistants/
