Compounded medicines

I have just read the excellent article regarding extemporaneously compounded medicines.¹ I found it very informative and useful but there were several points that were not fully explained or were omitted.

To meet the Therapeutic Goods Administration (TGA) exemption, compounding must be for an individual patient (only stated in the conclusion) and cannot be in ‘bulk’.

Compounded medicines cannot be supplied by wholesale, for example from one pharmacy to another.

In NSW, an authority is required by a prescriber from the NSW Ministry of Health for compounded Schedule 8 drugs. This authority number must be written on the prescription form.

Several TGA-licensed companies prepare compounded medicines in bulk and hold a wholesale licence to provide those medicines to, for example, hospitals under contract.

The Pharmacy Board of Australia guidelines and the TGA specify that compounding should not occur if a product on the Australian Register of Therapeutic Goods is available. This includes, for example, the addition of ingredients to products and the variation of the strength of a product, where such changes have no significance with regard to the indications or efficacy of the final product. Some compounding pharmacists seem to be able to convince prescribers that this practice is legitimate.

Alex Gavrilovic
Pharmacist
North Sydney, NSW