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Testing of medicinal cannabis products being supplied via SAS in Australia

TGA Laboratories testing report

7 October 2020

Background

Medicinal cannabis products are products intended for therapeutic use that contain or are derived from any part of the Cannabis plant. They generally contain the components cannabidiol (CBD) and/or tetrahydrocannabinol (THC) or their corresponding acids.

Medicinal cannabis products are permitted to be supplied into Australia under the Special Access Scheme (SAS), Authorised Prescriber scheme, and clinical trial schemes. Products supplied under these schemes are required to comply with Therapeutic Goods Order No. 93 (Standard for Medicinal Cannabis) (TGO93). In particular, Section 12(2) specifies the following assay limits:

  • in relation to a medicinal cannabis product in herbal final form - the average content of each active ingredient, together with any corresponding acid, in a representative sample of the product must be not less than 80.0 per cent and not more than 120.0 per cent of the stated content of that active ingredient
  • in relation to a medicinal cannabis product in tablet or capsule form, where that product is not included on the Australian Register of Therapeutic Goods (ARTG) - the average content of each active ingredient, together with any corresponding acid, in a pooled sample of not fewer than 20 tablets or capsules must be not less than 90.0 per cent and not more than 110.0 per cent of the stated content of that active ingredient
  • in relation to a medicinal cannabis product in any other dosage form - the average content of each active ingredient, together with any corresponding acid, in a representative sample of the product must be not less than 90.0 per cent and not more than 110.0 per cent of the stated content of that active ingredient.

The survey described in this report was conducted to assess compliance with TGO93 for medicinal products being supplied via SAS in Australia.

A total of 22 medicinal cannabis products were tested by the TGA. The samples were targeted based on the top 25 supplied medicinal cannabis products by volume.

Testing

Content of cannabinoids by Ultra High Performance Liquid Chromatography (UHPLC)

Each of the samples received were tested for compliance against TGO93, specifically, the stated content of each active ingredient.

An active ingredient for the purposes of TGO93 (whether or not specified) is defined as:

  • any THC (together with any corresponding acid) present in the product greater than or equal to 1.0% w/w or w/v
  • any other CBD present (together with any corresponding acid) in the product greater than or equal to 2.0% w/w or w/v.

All samples were labelled as containing either THC (together with any corresponding acid), CBD (together with any corresponding acid), or a combination of both.

The samples were tested for content of total CBD and/or total THC and were reported as a percentage of the stated content. Where samples contained any corresponding THC and CBD acids, the content of the acid was converted to the equivalent base (either THC or CBD) and included in the calculation of total THC and CBD contents.

Details of the results obtained are included in Appendix A.

Samples for three of the 25 requested products were not provided upon request. In all cases this was due to the product no longer being available.

An assessment of all samples was made for the presence of any other cannabinoids present in a concentration greater or equal to 2% w/w or w/v. This would classify them as active ingredients and would require declaration. In no cases were any additional cannabinoids identified above this limit, beyond those declared on the label and in the TGO93 declaration.

Of the 22 samples that were received for testing, five samples failed to meet the TGO93 requirements for content of the active ingredient. Three samples failed to meet the lower limit requirement, while two samples were marginally above the higher limit when compared with the declaration made to the TGA regarding content.

The sample of Bedrocan Dried Cannabis Flos for Inhalation imported by Novachem Pty Ltd returned a low result of 74.9% of the stated content for total THC. The requirements for content, for plant material finished products, are 80.0 - 120.0% of the stated content.

The sample of Spectrum Blue Cannabis Oil imported by Anspec Pty Ltd returned a moderately low result of 87.3% of the stated content for total THC. Analysis of the sample by an accredited third party laboratory returned a result of 90.7% of the stated content. The requirements for content, for oil finished products, are 90.0 – 110.0% of the stated content.

The sample of LGP Classic 20:5 Cannabis Oil (Tetrahydrocannabinol (THC) 20 mg/mL and cannabidiol (CBD) 5 mg/mL) supplied by Little Green Pharma returned a moderately low result of 88.3% of the stated content for total CBD. Analysis of the sample by an accredited third party laboratory returned a result of 89.1% of the stated content.

The samples of Althea Jasper Cannabis Oil (labelled as 5.39mg/mL THC, THCA; 10.26mg/mL CBD, CBDA) and Althea Capilano Cannabis Oil (labelled as 10.72mg/mL THC, THCA; 12.79mg/mL CBD, CBDA) supplied by Althea Pty Ltd returned high results of 111.2% and 110.1% of the stated content for total CBD. It was noted that these two products had a declared stated content that was lower than the amount included on the product label. The testing results found the amount of CBD present was within 110% of the label claim, but marginally exceeded the 110% upper limit for the stated content. The inconsistencies in the label claim and declared stated content were highlighted as a concern with the supplier.

It is well known that the content of active ingredients of medicinal cannabis declines with time, as such the reported results represent the content measured at the time of analysis. Medicinal cannabis products supplied through the SAS are required to meet the requirements of TGO93 for the duration of the shelf life.

All suppliers of the products failing to meet the requirements were notified of the testing results, reminded of the requirements of TGO93 and the provisions of penalties if they supply a good that does not conform to the standard.

Responses from the suppliers included evidence to demonstrate that the products had met the requirements at the time of manufacture, and for products with unacceptably low levels of active ingredient, an assurance that any remaining stock would not be supplied under the current TGO93 declaration until the matter had been resolved to the satisfaction of TGA. TGA has subsequently written to advise that supply of any remaining stock under the current TGO93 declaration would constitute an offence under the Act.

The remaining 17 products tested met the requirements for the content of active ingredients.

Packaging - Child resistant closures

Products not included on the ARTG (such as products supplied under the SAS or Authorised Prescriber scheme) and not declaring child-resistant packaging are not required to adhere to the packaging requirements of Therapeutic Goods Order No. 95 - Child resistant packaging requirements for medicines 2017 (TGO95).

Despite not being required, the majority of samples received were enclosed in child resistant packaging. Three samples were observed to not be packaged using child-resistant closures (CRC). These products were Nanabis Cannabis Oil Extract, Bedrocan Dried Cannabis Flos for Inhalation and CDA CBD-240 Oil.

The TGA has written to the suppliers of these products regarding the lack of child-resistant packaging. Information was provided to the suppliers outlining the risks of not utilising CRCs, and a recommendation was made to incorporate a CRC into their products packaging.

To date as a result, one of the suppliers has indicated that they are in the process of implementing a child-resistant closure.

Appendix A: Details and results of samples analysed

P1339

Product Name Batch Number Expiry Date Supplier Stated content (label claim where different) TGA Assay Result (total THC &/or CBD as % of stated content)

Satipharm CBD 50 Gelpell Cannabidiol 50 mg Capsules

0980011

11.2020

Health House International

50 mg CBD/cap

CBD: 95.8%

Nanabis Cannabis Oil Extract 8.33mg/mL of THC & 8.33mg/mL of CBD

PPP.19.1542

05/Dec/2021

Medlab Clinical Ltd (VIC)

CBD 8.33 mg/mL
THC 8.33 mg/mL

CBD: 107.9%
THC: 103.5%

MXP 100 CBD 100mg/mL Oral, drops, solution

4072/1119

08.06.2020

Health House International

100 mg/mL CBD

CBD: 100.6%

Medicabilis 5% CBD 50mg CBD & <2mg THC per mL Oral Solution

74719004-A

07/2021

Bod Australia Ltd

50 mg/mL CBD,
<2 mg/mL THC

CBD: 93.5%
THC: < 2 mg/mL

T15 Flower for Vaporisation 10g 15.0% THC, <1.0% CBD

5089(3)

30 August 2020

Cannatrek Medical Pty Ltd

15% THC, <1.0 % CBD

THC: 92.5%

Tilray 100 CBD Oral Solution (100mg/mL CBD)

N0000007946

06/2020

Pharmaceutical Packaging Professionals Pty Ltd

100 mg/mL CBD

CBD: 102.1%

Tilray 10 THC 10 CBD Oral Solution (10mg/mL THC, 10mg/mL CBD)

N0000008421

12/2020

Pharmaceutical Packaging Professionals Pty Ltd

10 mg/mL CBD;
10 mg/mL THC

CBD: 97.6%
THC: 90.8%

Tilray 25 THC 25 CBD Oral Solution (25mg/mL THC, 25mg/mL CBD)

N0000008633

07/2020

Pharmaceutical Packaging Professionals Pty Ltd

25 mg/mL CBD;
25 mg/mL THC

CBD: 107.4%
THC: 91.9%

Tilray Purified CBD 25 (Cannabidiol 25mg/mL)

N0000008894

03/2021

Pharmaceutical Packaging Professionals Pty Ltd

25 mg/mL CBD

CBD 102.1 %

Bedrocan Dried Cannabis Flos for Inhalation (22% THC, < 1% CBD)

19I30EY19K05

11/2020

Novachem Pty Ltd

22% THC;
<1% CBD

THC 74.9%

GD Cann C Purified Cannabidiol 100mg/mL

GDP161019A1

SEP-2020

GD Pharma Pty Ltd

CBD 100 mg/mL

CBD: 100.8%

Spectrum Therapeutics Yellow Cannabis Oil (CBD 20mg/mL, THC less than 1mg/mL)

1900005816

11/2020

Anspec Pty Ltd

20 mg/mL CBD;
<1 mg/mL THC

CBD: 95.3%
THC: < 1 mg/mL

Spectrum Blue Cannabis Oil (CBD 15 mg/mL, THC 10 mg/mL)

1900013049

05/03/2021

Anspec Pty Ltd

15 mg/mL CBD;
10 mg/mL THC

CBD: 98.8%
THC: 87.3%[1]

CDA Health Cannabidiol 240mg/mL Oil

0-605

08/2021

Burleigh Heads Cannabis

240mg/mL CBD

CBD: 95.5%

Althea Capilano Cannabis Oil (10.72mg/mL THC, THCA; 12.79 mg/mL CBD, CBDA)

6985-8649

2020-Aug-07

Althea Company Pty Ltd

12.5 (12.79) mg/mL CBD, CBDA;
10 (10.72) mg/mL THC, THCA

CBD: 110.1%
THC: 104.8%

Althea Rideau Cannabis Oil (CBD, CBDA 24.57 mg/mL, THC, THCA 0.98 mg/mL)

7264-8652

2020-Aug-08

Althea Company Pty Ltd

25 (24.57) mg/mL CBD, CBDA;
>2 (0.98) mg/mL THC, THCA

CBD: 107.2%;
THC: 0.96 mg/mL

Althea Henik Dried Cannabis for Vaporisation 10g (18.54% w/w THC, THCA; <0.07% w/w CBD, CBDA)

3101718719-8764

2021-Mar-03

Althea Company Pty Ltd

18 (18.54) %w/w THC, THCA;
<1 (<0.07) %w/w CBD, CBDA

87.3% total THC
CBD not detected

Althea Jasper Cannabis Oil (5.39mg/mL THC, THCA; 10.26mg/mL CBD, CBDA)

6988-8650

2020-AUG-07

Althea Company Pty Ltd

10 (10.26) mg/mL CBD, CBDA;
5 (5.39) mg/mL THC, TCHA

CBD: 111.2%
THC: 108.3%

Althea Champlain Cannabis Oil Champlain (20.19mg/mL THC, THCA; 0.00 mg/mL CBD, CBDA)

7632-8656

2020-AUG-12

Althea Company Pty Ltd

<1 (0.00) mg/mL CBD, CBDA;
20 (20.19) mg/mL THC, THCA

CBD not detected
THC: 101.8%

Althea CBD100 (Cannabidiol 100mg/ml, Tetrahydrocannabidiol less than 1mg/mL)

PPP.20.597

05/2021

Althea Company Pty Ltd

100 mg/mL CBD;
<1 mg/mL THC

CBD: 106.5%
THC: not detected

LGP Classic 10:10 (Tetrahydrocannabinol 10mg/mL:Cannabidiol 10mg/mL)

P1339

03/04/2021

Little Green Pharma Pty Ltd

10 mg/mL CBD;
10 mg/mL THC

CBD 94.2%
THC 96.7%

LGP Classic 20:5 (Tetrahydrocannabinol (THC) 20 mg/mL and cannabidiol (CBD) 5 mg/mL)

P1338

02/04/2021

Little Green Pharma Pty Ltd

5 mg/mL CBD;
20 mg/mL THC

CBD 88.3%[2]
THC 99.1%


Footnotes


Version history
Version Description of change Author Effective date

V1.0

Original publication

TGA Laboratories

September 2020

V1.1

Testing results updated

TGA Laboratories

October 2020