Australian pharmacists may be cleared for over-the-counter purchase of Cannabidiol (CBD) products under a proposed Therapeutic Goods Administration reclassification, opening up a potential AU$200 million market segment.
On 9 September, the Therapeutic Goods Administration (TGA) ruled in an interim decision that from 1 June next year medicinal cannabis products containing a maximum of 60mg of cannabidiol (CBD) may be sold to people aged 18 and over by pharmacists over the counter, without a doctor's prescription.
To be eligible, CBD must make up 98% of the total cannabinoid content of the product and the pack must not contain more than 30 days’ supply and must be child-proof. All medicinal cannabis products not meeting the criteria will remain prescription-only in Australia, as is currently the case with all medicinal cannabis products in New Zealand.
In Australia, CBD is currently a Schedule 4 substance, which makes it available only with a prescription. The TGA their interim decision is to amend the country’s Poisons Standard and down-schedule CBD to a Schedule 3 product in oral, oral mucosal and sublingual formulas for therapeutic use.
Commercially, this decision could open up a potential AU$200 million non-prescription wellness market for CBD products. According to a Business News Australia report, shares in several medicinal cannabis companies jumped following the announcement.
Under the interim decision, CBD products could be sold without a prescription if they adhere to all of the following criteria:
The cannabidiol is plant derived, or follows specific protocols if synthetic.
The maximum recommended daily dose is 60 milligrams or less of cannabidiol.
The product is sold in packs containing a 30 days’ supply or less.
CBD comprises 98% or more of the total cannabinoid content of the preparation.
Any cannabinoids other than CBD must be only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the preparation.
The product is for adults 18 years and over.
The product is packed in blister or strip packaging or in a container fitted with a child-resistant closure.
The proposed implementation date for the down-scheduling is June 1, 2021.
The interim decision includes a new appendix entry for CBD that would restrict the supply of CBD to products listed in the Australian Register of Therapeutic Goods (ARTG) to ensure that only those approved for Schedule 3 will be available without a prescription.
The delegate who issued the interim decision said additional advice would be requested from a November meeting on the following criteria:
The aforementioned appedix entry to limit supply to medicines entered in the Australian Register of Therapeutic Goods.
Comments on the interim decision can be submitted by October 13, and a final decision on down-scheduling has been scheduled for November 25.
It is anticipated that New Zealand regulations may follow suit in the future.