Extemporaneous compounding is the pharmaceutical science of formulating, preparing and dispensing medicines ordered by prescription from a medical professional. In Australia, cannabis medicines are able to be legally prepared and dispensed by approved and licensed compounding pharmacies. Distinct from the TGA’s Special Access Scheme, extemporaneous compounding is another pathway available to medical professionals to access medical cannabis as a potential treatment for their patients.
Medicinal cannabis is any pharmaceutical-grade medicine derived from the Cannabis Sativa plant used to treat or relieve a symptom, ailment or condition. Pharmaceutical-grade medicines must contain raw materials sourced from licensed manufacturers compliant to Therapeutic Goods Order No. 93 (Standard for Medicinal Cannabis/TGO 93). TGO93 is a therapeutic goods standard developed by the TGA that specifies minimum quality requirements for medicinal cannabis products, and ensure sources are rigorously tested for contaminants like bacteria, fungi, pesticides and heavy metals, and standardised for active constituents.
Phytocannabinoids and other active constituents in medicinal cannabis
Whilst there are more than 100 different phytocannabinoids found in cannabis plants, the principle and most widely studied for their potential benefits in humans are delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD). In spite of structural variances between the phytocannabinoids and the endogenous cannabinoids, similar interactions have been observed within the endocannabinoid system owing to their medicinal properties. Cannabis contains over 400 different chemical constituents including a class of volatile compounds known as terpenes. Classically attributed to providing the characteristic flavor and fragrance of cannabis, the primary terpenes in cannabis are also reported to influence either the pharmacodynamics or pharmacokinetics of CBD and THC producing what is known as the “entourage effect”. It is reported that their inclusion in medicinal cannabis preparations may enhance the overall benefits of the primary phytocannabinoids.
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There are numerous pathways under the Therapeutic Goods Regulation 1990 that allow unregistered therapeutic goods (exempt from being registered) to be supplied in Australia. Cannabinoids are now (2016) listed as therapeutic goods in the Poisons Standard (either schedule 4 or schedule 8). Cannabinoids are now treated like any other drug.