The Pharmacy Board of Australia’s new compounding guidelines came into force this week. Mills Oakley partner and Australian Medicinal Cannabis Association chair Dr Teresa Nicoletti unpacks what they mean for the industry.
In April 2022, an amendment was introduced to the Therapeutics Goods Regulations 1990 prohibiting the extemporaneous compounding of medicinal cannabis products under the exemption in sub-section 18(1) of the Therapeutic Goods Act 1989 and Item 6 of Schedule 5 to the Regulations.
These provisions previously allowed a pharmacist to compound medicinal cannabis products and such products were exempt from the requirements of registration in the Australian Register of Therapeutic Goods (ARTG).
However, as a result of the amendments, Item 6 of Schedule 5 was amended to prescribe that the following medicines were exempt.
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