Recent testing of a range of medicinal cannabis products being supplied via the SAS in Australia showed some inconsistencies. But there’s a twist.
Medical cannabis products can be accessed in Australia under the Special Access Scheme (SAS), Authorised Prescriber scheme, and clinical trial schemes.
Of 22 samples received for testing by Australia’s Therapeutic Goods Administration (TGA), five samples failed to meet requirements for the active ingredient. Three didn’t meet the lower limit requirement, while two samples were a little above the higher limit when compared with the declaration made to the TGA regarding content.
The samples involved:
- Bedrocan Dried Cannabis Flos for Inhalation – 74.9% of the stated content for total THC. Requirement: 80.0 – 120.0% of the stated content.
- Spectrum Blue Cannabis Oil – 87.1% of the stated content for total THC. Requirement: 90.0 – 110.0% of the stated content for oils.
- Little Green Pharma LGP Classic 20:5 Cannabis Oil (THC 20 mg/mL and CBD 5 mg/mL) – 88.3% of the stated content for total CBD.
- Althea Jasper Cannabis Oil and Althea Capilano Cannabis Oil – high results of 111.2% and 110.1% of the stated content for total CBD.
While the differences weren’t huge, there are some aspects that have left heads being scratched.
Little Green Pharma noted last week it engaged an Australian Government-owned, National Association of Testing Authorities (“NATA”) accredited and TGA-regulated and licensed Good Manufacturing Practices (“GMP”) laboratory to conduct testing of its medicines; so was disappointed with the divergence in test results produced by the TGA’s audit.
“The Company and its testing agency are working closely with the TGA to determine how the agency’s TGA-licensed testing methodology and the TGA’s own methodology have produced differing results. That work is ongoing,” said a statement from Little Green Pharma release early last week.
All samples submitted for testing were targeted based on the top 25 medicinal cannabis products supplied into Australia by volume. Three of the 25 requested products were not provided due to the items no longer being available.
The full TGA Laboratories testing report can be viewed here.
For further information on accessing medicinal cannabis in Australia and the TGA’s role, see this page.