Low Dose CBD Goes S3

Pharmacists will be able to provide cannabidiol (CBD) products containing a maximum daily dose of 150mg to patients over-the-counter from 01 Feb 2021, following a move to down-schedule it.

The announcement made yesterday morning sees the maximum dose more than double the 60mg/day flagged in the Therapeutic Goods Administration (TGA) interim decision.

The delegate of the Secretary of the Department of Health, said the decision to increase the maximum daily dose for S3 CBD was based on the view that the “proposed dose is potentially sub-therapeutic and may present a barrier for sponsors to register an S3 preparation on the Australian Register of Therapeutic Goods (ARTG)”.

The delegate noted that the original maximum dose had been based on a body mass of 60kg, significantly lighter than the average Australian adult female (72kg) or male (87kg).

“Many of the submissions provided references supporting a higher dose, while still maintaining a safety profile that aligns with an S3 medicine,” the delegate said.

“Accordingly, I have considered these submissions alongside a number of reviews detailed below and I have resolved that a maximum daily dose of 150mg is consistent with the expected safety profile of an S3 medicine.”

The delegate added that there was no need to delay the rescheduling until 01 Jun 2021, as originally planned.

Source: https://issues.pharmacydaily.com.au/2020/Dec20/pd151220.pdf , viewed 18 December 2020

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