Extemporaneous compounding of MDMA and psilocybin products

Pharmacists should consider the guidelines on compounding of medicines. See the Pharmacy Board of Australia codes, guidelines and policies- external site. 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 psilocybin products are controlled drugs under the Commonwealth Criminal Code. This means MDMA and psilocybin 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 psilocybin 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 psilocybin containing products.

Prescribers and pharmacists should also consider individual legal and professional responsibilities when a compounded medicine is prescribed and subsequently compounded and dispensed.

It is expected that pharmacists will use Natural Pharmaceutical Grade Psychedelics ingredients that comply with quality standards.

Quality standards

There are currently no pharmacopeial monographs for MDMA or psilocybin. The TGA will develop quality standards based on the active ingredients and finished products currently being supplied to clinical trials. 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.

GMP licensed pharmacy 

TGA GMP licensed compounders will need a new authorisation on their licence to compound MDMA or psilocybin. 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 psilocybin medicines and have conditions to report on the quantity of goods held and supplied.