The TGA has announced its interim decision on the down scheduling of CBD with a new schedule 3 entry it claims will allow greater access for patients.

However, the change comes with several provisos which appear to confirm industry fears it will make little difference.

The interim decision would mean 98% pure CBD products could be made available for sale behind the counter at pharmacies, as long as:

  • they contain no more than 1800mg of CBD total in a pack (30 doses of the maximum daily dose of 60mg)
  • they are oral ingestibles only (no vapes)
  • they are packed in blister or strip packets, or in a child-proof container
  • they are only sold to people 18 years or older

Any product being sold must first have been registered on the ARTG meaning companies must prove their product is safe and effective at 60mg/day in treating a specific indication/symptom.

That will likely require large and expensive clinical trials.

The TGA has also proposed restricting pharmacists from compounding schedule 3 CBD which would have bypassed the difficulties around proving efficacy.

Products that do get registered on the ARTG will not be allowed to be advertised to the public.

Another round of public consultations will take place before the final decision is published in November.

To find out how the industry has reacted to the TGA’s interim decision on down scheduling CBD, click here.

Rhys Cohen

As well as being editor-at-large at Cannabiz, Rhys is the director of Cannabis Consulting Australia, which provides commercial consulting services to various domestic and international cannabis companies....