The Therapeutic Goods Administration (TGA) has announced a significant change in its final decision to down-schedule low-dose CBD, with the maximum dose increased to 150mg/day, up from the 60mg/day it signalled in its interim decision in September.
The move follows further consideration of safety information, public submissions on the interim decision and the advice of the Joint Committee of the Advisory Committees for Medicines Scheduling and Chemicals Scheduling at its November 2020 meeting.
The industry had raised concerns about its ability to demonstrate efficacy at 60mg/day when the interim decision was announced.
The move will allow low-dose CBD-containing products, up to a maximum of 150 mg/day, for use in adults that have been approved by the TGA, to be supplied over-the-counter by a pharmacist, without a prescription.
The decision limits over-the-counter supply to products that are approved by the TGA and included on the Australian Register of Therapeutic Goods (ARTG). The decision also outlines additional limits on dosage form and packaging requirements, including pack size and child resistant closures.
There are currently no TGA approved products on the ARTG that meet the Schedule 3 criteria.
The move has been welcomed by industry leaders, although some warned of the challenges ahead.
FreshLeaf Analytics managing director Cassandra Hunt said: “History suggests that the first movers among product companies will be the winners, with the first movers in the medicinal cannabis industry in Australia still dominating today.