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They are compounders which are licensed by the national medicines regulator (the TGA) to manufacture extemporaneously compounded sterile medicines in accordance with global GMP standards.

There are currently three TGA licensed compounders, namely Baxter Healthcare, Slade Health, and Wesley Pharmacy. All are members of the Licensed Sterile Compounders of Australia (LSCA).

As TGA licensed compounders, the LSCA members primarily compound infusions used in the treatment of cancer patients. These medicines are remunerated under the Efficient Funding of Chemotherapy (EFC) program which is part of the PBS.

The LSCA members have purpose built facilities that must comply with the TGA audited PIC/S Guide to GMP for Medicinal Products PE-009 requirements, along with their end-to-end systems and processes. The LSCA members have facilities in most capital cities, from which they distribute to hospitals and clinics nationally.

Yes, cancer medicines are also compounded by non-licensed compounders, which have their own facilities including in public and private hospitals. The TGA licensed and non-licensed compounders have complementary roles, and together they ensure that cancer patients has timely access to high quality cancer medicines treatment.