Every medicinal cannabis product lawfully supplied in Australia, including prescribed CBD oil, must comply with a legal quality standard called TGO 93.1 The standard sets rules for what is in the product and how it is made. It does not mean the Therapeutic Goods Administration (TGA) has assessed the product for safety or effectiveness.2
What is TGO 93?
Its full name is the Therapeutic Goods (Standard for Medicinal Cannabis) (TGO 93) Order 2017. According to the TGA, it covers:1
- how much the cannabinoid content may vary from what is stated
- pesticides
- microbial contamination (bacteria and fungi)
- mycotoxins (poisons made by moulds)
- adulteration (added substances that should not be there)
- plant identification.
The standard applies to registered medicines and unapproved products alike. It does not cover devices such as vaporisers.1
How has the standard changed?
| Year | Change |
|---|---|
| 2017 | TGO 93 made |
| March 2022 | Amended to add manufacturing, packaging and labelling requirements |
| 2023 | Good Manufacturing Practice made mandatory for both domestic and overseas manufacturers |
These dates are from the TGA’s 2025 consultation paper.1
What is Good Manufacturing Practice?
Good Manufacturing Practice (GMP) is a set of rules for how medicines are made. It covers things such as clean facilities, trained staff, documented processes and batch records, so that each batch matches the last.
Since 2023, GMP has been mandatory for both Australian and overseas manufacturers.1 The TGA accepts GMP evidence from the United Kingdom, European Union member states, Israel, South Africa, New Zealand and Canada. Manufacturers in other countries need a TGA inspection.3
This matters because much of the supply is imported. In 2024, 77.4 tonnes of medicinal cannabis were imported, compared with 42.4 tonnes produced in Australia, and Canada supplied 80% of the imports. These figures come from a Penington Institute report citing Office of Drug Control data, and they cover all medicinal cannabis, not only CBD.4
Does meeting the standard mean the product is approved?
No. This is the most common point of confusion.
| Quality standard (TGO 93) | TGA registration | |
|---|---|---|
| What it checks | Contents, contaminants, manufacturing | Safety, quality and effectiveness for a stated use |
| Who it applies to | All medicinal cannabis supplied in Australia | Only medicines on the national register |
| How many cannabis products | More than 1,000 unapproved products have been supplied | Two |
The TGA says most medicinal cannabis products “have not been assessed by us for safety, quality or effectiveness”.2 It also says over 1,000 unapproved products have been supplied, and that only two cannabis medicines are registered.15 See the registered cannabis medicines.
Because of this, it is unlawful for an advertisement to imply that a product is “TGA approved”.6 Prescribers must tell patients that the product they are being prescribed is unapproved.7
Who checks that products meet the standard?
The company that supplies the product, called the sponsor, is responsible for making sure it complies. The TGA does not test every product. It uses risk-based surveillance testing, which means it selects products to sample.1
Other controls sit around the standard:
- Sponsors must hold unregistered medicinal cannabis under their “direct control” until it is supplied to a patient through an approved pathway. Wholesaling unregistered finished products is prohibited.3
- Prescribers must report adverse events (harmful reactions) to the TGA within 15 calendar days.7
- Medicinal cannabis is a named TGA compliance priority for 1 January 2026 to 31 December 2027.8
The TGA reported 1,101 adverse event cases linked to medicinal cannabis from 2016 to 31 July 2025, with 24% classed as serious. That covers all medicinal cannabis, not CBD alone.1 In March 2026 it said: “To date a safety signal has not been flagged for any unapproved medicinal cannabis product”.5
What would apply to an over-the-counter CBD product?
A pharmacist-only (Schedule 3) product would need full registration, so it would be assessed by the TGA, not just held to TGO 93. The Poisons Standard adds packaging conditions. The product must be “packed in blister or strip packaging or in a container fitted with a child-resistant closure” and in packs of “not more than 30 days’ supply”.9 It must carry warnings against use in pregnancy and breastfeeding.5 No such product exists as of November 2026. See over-the-counter CBD.
What about products bought outside the prescription system?
None of the above applies to them. A product ordered from an overseas website or sold without a prescription has not been supplied through the system that TGO 93 and the GMP rules govern, so there is no assurance about what is in it.
One risk is THC. Sport Integrity Australia cites a study in which 21% of CBD products contained THC, and says there are “currently no batch-tested CBD products available in Australia” that meet its threshold to be considered low risk for athletes.1011 See is what is on the label in the bottle? and buying CBD online.
Hemp seed oil is a food and comes under food law, not TGO 93. See hemp foods.
How can a patient check a prescribed product?
A certificate of analysis is a laboratory report for a batch of product. The prescriber and the dispensing pharmacist are the people to ask about a specific product. See how to read a certificate of analysis and how to read a CBD label.
Keep in mind that a lawful Schedule 4 CBD product may contain up to 2% other cannabinoids, which can include a small amount of THC.9 That is permitted by the schedule and is not a quality failure. It can matter for driving and drug tests.
Are the quality rules likely to change?
Possibly. The TGA’s 2025 review found stakeholders agreed the current framework is “not fit-for-purpose and not proportionate to the potential safety and quality risks”.12 Ideas raised include child-resistant closures for all products, plain packaging, limits on THC concentration and restrictions on gummies and pastilles. None has been adopted.5
The TGA’s stated medium-term step is to “consider current scheduling arrangements, reviewing quality requirements”.8 As of the latest documents we found (mid-2026), no change to TGO 93 had been decided.
Footnotes
-
Therapeutic Goods Administration. Consultation paper: reviewing the safety and regulatory oversight of unapproved medicinal cannabis products, August 2025. https://consultations.tga.gov.au/medicines-regulation-division/test-soms/user_uploads/final---consultation-paper---medicinal-cannabis-review---august-2025.pdf ↩ ↩2 ↩3 ↩4 ↩5 ↩6 ↩7 ↩8
-
Therapeutic Goods Administration. Medicinal cannabis access pathways. https://www.tga.gov.au/products/unapproved-therapeutic-goods/medicinal-cannabis/access-pathways ↩ ↩2
-
Therapeutic Goods Administration. Medicinal cannabis reforms: frequently asked questions. https://www.tga.gov.au/products/unapproved-therapeutic-goods/medicinal-cannabis/overview/medicinal-cannabis-manufacturing/medicinal-cannabis-reforms-frequently-asked-questions ↩ ↩2
-
Penington Institute. Cannabis in Australia, November 2025. https://www.penington.org.au/wp-content/uploads/2025/11/Penington_Institute_Cannabis-in-Australia_Nov_2025.pdf ↩
-
Therapeutic Goods Administration. Paper to the scheduling advisory committee, 18 March 2026, released as FOI 26-2886. https://www.tga.gov.au/sites/default/files/2026-06/FOI%2026-2886.PDF ↩ ↩2 ↩3 ↩4
-
Therapeutic Goods Administration. Advertising guidance for businesses involved with medicinal cannabis products, December 2023. https://www.tga.gov.au/sites/default/files/2023-12/advertising-guidance-businesses-medicinal-cannabis-products.docx ↩
-
Therapeutic Goods Administration. Do your patients know the risks of unapproved medicinal cannabis products? https://www.tga.gov.au/news/blog/do-your-patients-know-risks-unapproved-medicinal-cannabis-products ↩ ↩2
-
Therapeutic Goods Administration. Update to the sector on the medicinal cannabis review, July 2026. https://www.tga.gov.au/sites/default/files/2026-07/update-tga-sector.pdf ↩ ↩2
-
Australian Government. Therapeutic Goods (Poisons Standard, October 2026) Instrument 2026. https://www.legislation.gov.au/F2026L01327/asmade/2026-09-30/text/original/pdf ↩ ↩2
-
Sport Integrity Australia. CBD flyer. https://www.sportintegrity.gov.au/sites/default/files/SIA321-0624-CBD%20Flyer-A-3%20%5BDIGITAL%5D.pdf ↩
-
Sport Integrity Australia. Cannabis and CBD use in sport. https://www.sportintegrity.gov.au/node/737 ↩
-
Therapeutic Goods Administration. Consultation hub: reviewing the safety and regulatory oversight of unapproved medicinal cannabis products. https://consultations.tga.gov.au/medicines-regulation-division/test-soms/ ↩
Common questions
What is TGO 93?
It is the Therapeutic Goods (Standard for Medicinal Cannabis) (TGO 93) Order 2017, the legal quality standard for medicinal cannabis in Australia. It sets requirements for cannabinoid content, contaminants, and since 2022 manufacturing, packaging and labelling.
Does meeting TGO 93 mean a CBD product is TGA approved?
No. TGO 93 is about how a product is made and what is in it. Approval means the TGA has assessed a medicine for safety, quality and effectiveness for a stated use. Only two cannabis medicines have that.
Are prescribed CBD products tested by the TGA?
Some are. The TGA says it uses risk-based surveillance testing, not testing of every product or batch. The company supplying the product is responsible for meeting the standard.
Is Australian-made CBD better quality than imported CBD?
The same standard applies to both. Since 2023, overseas manufacturers must meet Good Manufacturing Practice just as Australian ones do. Country of origin alone does not tell you about quality.
This page is general information, not medical or legal advice. Laws and evidence change; we show the date we last checked the facts at the top of every page. Talk to your doctor or pharmacist before starting, stopping or changing any medicine.
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