The TGA recently held a webinar to discuss the recent reforms to medicinal cannabis legislation and it included:
- GMP requirements for imported products to level the playing field for local manufacturers
- Updated labelling and packaging details in TGO 93.
- Updates to medicinal cannabis compounding permissions.
I have discussed how to ensure GMP compliance for imported medicinal cannabis products in a previous blog. The updates to TGO 93 are also fairly straight forward – i.e. expectations from other TGOs have been included, such as the requirement for child resistant packaging (unless the product is plant material only), labelling to align with expectations in TGO 91, and the inclusion of microbiological testing requirements. There was also a clarification that no synthetic cannabinoids were permitted.
With those points in mind, this blog will primarily seek to address the reforms that impact compounding medicinal cannabis, as the information covered in the webinar left me with more questions than answers.
What are the changes for compounding medicinal cannabis?
In the TGA webinar they stated that domestically cultivated or manufactured cannabis could now be supplied to pharmacies for extemporaneous compounding (as long as the pharmacist has the SAS or AP prescriptions for the doses they are producing).
While it definitely seemed like an improvement, two thoughts immediately sprang to mind:
- This update suggests that GACP materials (i.e. bulk-packed dried flower) can be provided to pharmacies for compounding.
- There may be no upper limit on the quantity compounded by pharmacies so long as the corresponding number of prescriptions are held.
If both assumptions are correct, it could be a huge game changer for the industry. GMP licencing is an expensive process on top of already onerous ODC fees – why would cultivators even bother supplying to GMP-licenced third parties for further manufacture, or bother going through the process of obtaining GMP licences to manufacture finished products after this?
However, before I jump to conclusions, some due diligence is needed. The next section of this blog will dive a bit deeper into the regulations to answer a burning question: Where is is the line drawn between compounding and GMP manufacturing?
How is the compounding medicinal cannabis different to GMP manufacture?
The TGA defines compounding as: “The preparation, mixing, assembling, altering, packaging, and labelling of a medicines, medicine-delivery device, or device, in accordance with a doctor’s prescription, or initiative based on the doctor/patient/pharmacist/compounder relationship in the course of professional practice”.
Sounds a lot like GMP manufacturing right? Well, not quite; while the Therapeutic Goods Act 1989 sets out the legal requirements for the import, export, manufacture and supply of therapeutic goods in Australia, the Therapeutic Goods Regulations 1990 actually exempts pharmacists from having to get a GMP licence when compounding medicines (also known as extemporaneous preparation).
Unlike registered medicines, compounded preparations have not generally been assessed for safety and efficacy – their use is off label and is based on extrapolation from the component ingredients.
Compounding of medicine is overseen by the Pharmacy Board of Australia (PBA) – specifically, their Guidelines on compounding of medicines. In the PBA’s Background in to the regulation of compounding by pharmacists and their FAQ document, they explain that a GMP licence from the TGA is not required if you are a compounding pharmacist working in a community pharmacy or public hospital pharmacy department, provided you:
- have a prescription or order for individually named patients for each of the units of issue to be compounded
- document the preparation of compounded medicines in accordance with local guidelines, and the information published in the APF (this applies regardless of if the product being compounded is for a single product, or a batch of products for a group of named patients).
In the scope of medicinal cannabis, pharmacists may compound and supply:
- S4 medicine (CBD), when a prescription has been received for a particular person
- S8 medicine (THC), when a prescription has been received for a particular person,
- S3 medicine (low-dose CBD), when a particular person requests such a medicine (which means S3 CBD may finally become relevant!)
If employed in a public hospital or public institution, pharmacists are also allowed to manufacture therapeutic goods for supply to other public hospitals or public institutions in the same state or territory.
NOTE: A TGA licence is normally required if supplying compounded medicines by wholesale, however this is moot given that supply by wholesale is not permitted for cannabis medicines.
4 golden rules for compounding
Given that the upper limit for compounding isn’t well defined, there still seems to be a bit of a loophole! However, before we start getting carried away, there are 4 main compounding rules to be wary of:
- Compounding medicinal cannabis is only allowed if there is a prescription (i.e. SASB or AP)
- Although there are GMP-exemptions for pharmacies, the regulations do state that this should not result in large scale compounding as there are inherent risks involved outside the strict framework of processes and procedures in GMP-licensed facilities.
- You are not allowed to manufacture in advance, and not allowed to store excess quantities of compounded medicines in anticipation of additional prescriptions subsequently presented by patients. Only premises that hold a manufacturing licence from the TGA are permitted to compound medicines in advance of receiving prescriptions or orders.
- While compounding pharmacies may be exempt from requiring a GMP licence, the compounded and medicines themselves are not exempt from meeting the quality standards expected for medicinal products (i.e. you still have to comply with expected packaging and labelling requirements).
The PBA guidance specifically states that:
“Supply via compounding must not be considered as an opportunity to avoid the stringent requirements applicable in manufacturing by a GMP-licensed premises.”
It is also important to bear in mind that compounding pharmacies will come under scrutiny: the state/territory pharmacy premises regulatory authority does conduct audits/inspections of approved and/or registered premises and their associated facilities to ensure compliance with Guidelines on compounding of medicines.
Compounding reform changes come into effect on the 28 April 2022, so make sure you are prepared!
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