Under the Authorised Prescriber scheme, MDMA and psilocybine can only be accessed by a psychiatrist for treating post-traumatic stress disorder and treatment-resistant depression, respectively.
For other indications MDMA and psilocybine will remain as prohibited substances and in Schedule 9 to the Poisons Standard, limiting their use to medical and scientific research, such as clinical trials.
Although the scheduling of MDMA and psilocybine in the Poisons Standard has changed, unlike many other substances included in Schedule 8 to the Poisons Standard, these substances are classified as controlled drugs under the Commonwealth Criminal Code.
Substances can be identified as controlled drugs under the Criminal Code regardless of their scheduling in the Poisons Standard. The import, manufacture, possession and supply of these goods are prohibited under the Commonwealth Criminal Code, unless authorised under a law of the Commonwealth or a state or territory.
This means that, in relation to goods containing MDMA or psilocybine, additional authorisation by law is required before engaging in any of these activities. Some of these activities are authorised under Commonwealth laws in certain circumstances (e.g manufacturing on a site covered by a GMP licence from the TGA). In other cases, unless the activity is authorised under the relevant state or territory law, it will be unlawful.
In addition to compliance with Commonwealth laws, those involved in manufacture, possession and supply of goods containing MDMA and psilocybine must also comply with state and territory legislation that applies to these goods.
Quality standards for MDMA and psilocybine
There are currently no pharmacopeial monographs for MDMA or psilocybine. In the absence of international quality requirements, we have developed Australian- specific quality for these goods. These standards (Therapeutic Goods Orders, TGO) will ensure consistent quality of the medicines supplied to Australian patients. The requirements will apply to both compounded and commercially manufactured medicines.
Therapeutic Goods (Standard for MDMA) (TGO 112) Order 2024 is the standard that specifies the minimum quality requirements for MDMA active pharmaceutical ingredient (API) and finished product.
Therapeutic Goods (Standard for psilocybine) (TGO 113) Order 2024 is the standard that specifies the minimum quality requirements for psilocybine API and finished product.
From 6 January 2025 all MDMA and psilocybine API and finished product supplied or manufactured in Australia must comply with TGO 112 and TGO 113 respectively.
Sponsors and manufacturers are reminded there may be other relevant standards their products must comply with prior to 6 January 2025. There are civil and criminal penalties under sections 14 and 14A of the Therapeutic Goods Act 1989 for the import, export and supply of medicines that do not comply with an applicable standard.
Possession and supply
Pharmacists must not hold or supply goods containing MDMA or psilocybine unless:
- The possession and supply is authorised under a law of the relevant state or territory (for example where pharmacy licensing arrangements under the relevant state or territory law authorise these activities in relation to Schedule 8 or Schedule 9 substances); and
- The goods are either:
- exempt from the requirement to be on the ARTG because they are starting materials that are ingredients to be used in compounding; or
- the subject of a clinical trial approval or exemption under the Therapeutic Goods Act 1989; or
- the subject of an Authorised Prescriber authority under the Therapeutic Goods Act 1989. The pharmacist must have an arrangement in place with an Authorised Prescriber who is authorised to supply the goods to a patient, under which the pharmacy will hold and/or supply the goods to the Authorised Prescriber. The Authorised Prescriber authority in relation to the goods must be in force at the time the goods are held and supplied by the pharmacy.
Dispensing MDMA and psilocybine products
Pharmacists can only dispense Schedule 8 MDMA or Schedule 8 psilocybine products directly to a psychiatrist who has the relevant authorisations from the TGA under the Authorised Prescriber scheme. The products cannot be supplied to the patient.
Pharmacists must comply with all legislation relevant to the practice of pharmacy in the jurisdiction where the practice occurs.
Pharmacists may wish to contact the relevant state and territory health departments. See the list of contacts for state/territory medicines & poisons regulation units.
SAS & AP validation tool
Pharmacists can register to access the SAS and Authorised Prescriber Online System and use the submission validation search to verify that the request to supply has been made by an approved Authorised Prescriber.
An AP approval granted by the TGA will generate a submission number. This number should be provided to pharmacists by the psychiatrist directly and can be validated through the SAS & AP validation search.
For instructions, refer to this demonstration video for using the SAS/AP submission validation tool to check real time information about SAS or AP submissions prior to dispensing to a patient.
Extemporaneous compounding of MDMA and psilocybine products
Pharmacists should consider the guidelines on compounding of medicines. See the Pharmacy Board of Australia codes, guidelines and policies. The guidelines include detailed guidance on when it is appropriate for a medicine to be compounded and the requirements to be complied with when compounding medicines.
Pharmacists should be aware:
- MDMA and psilocybine products are controlled drugs under the Commonwealth Criminal Code. This means MDMA and psilocybine cannot be possessed, manufactured or supplied unless authorised by law.
- The exemptions under the Therapeutic Goods Act 1989 that permit pharmacists to engage in extemporaneous compounding do not amount to an authorisation under the Criminal Code.
- Compounding by pharmacists may be unlawful in some states and territories. If the pharmacy licensing arrangements in the relevant state or territory do not authorise the compounding of MDMA and psilocybine products (e.g., if they do not authorise the compounding of Schedule 8 or Schedule 9 substances) and there is no separate authority that applies, the compounding of such goods will contravene the Commonwealth Criminal Code. Hence, pharmacists should seek advice from their state or territory health department prior to engaging in extemporaneous compounding of MDMA or psilocybine containing products.
Prescribers and pharmacists should also consider individual legal and professional responsibilities when a compounded medicine is prescribed and subsequently compounded and dispensed.
Things to know if you compound psilocybine or MDMA capsules
If you are compounding and are exempt from the requirement to hold a manufacturing licence from the TGA, there are specific testing requirements that apply to these medicines. The API used to compound an MDMA or psilocybine finished product must be:
- tested against, and show compliance with, the requirements of the TGO
- the testing must be conducted at a site that holds a manufacturing licence from the TGA.
This is required because extemporaneous compounding occurs on a per patient basis and insufficient number of capsules would be compounded to allow for destructive testing of the finished product.
GMP licensed pharmacy
TGA GMP licensed compounders will need a new authorisation on their licence to compound MDMA or psilocybine. These licences will be conditioned to require reporting on the quantities these goods manufactured and held at the premises, as required under Australia’s international obligations.
Any site applying for a new TGA GMP licence will similarly require the specific authorisations under that licence to manufacture MDMA or psilocybine medicines and have conditions to report on the quantity of goods held and supplied.