Why is this mandatory in Australia?
There have been a few incidents over the years that have raised concerns with pharmacy regulators and Insurers, which have led to the adoption of a global standard for sterile compounding, USP(797).
Guild Insurance – Australia’s largest insurer of pharmacies – reports that millions of dollars have been paid out to claimants from compounding pharmacy cases in recent times. In fact, nearly every single payout in the last 2 years has involved self-assessed sterile compounders.
And that, right there, is the problem.
Too many compounders are engaging in poor sterile practices that have an implicit level of danger attached. Without proper training or independent evaluation of their practice, patients could be hurt or worse.
The relevant pharmacy councils recognise this, and have decided to increase the standards under which compounding pharmacies operate. As USP is recognised in the Australian Pharmaceutical Formulary as the analytical standard, it makes sense to adopt the relevant chapters for Australian compounding pharmacies.
There have been terrible cases overseas where self-assessed compounding pharmacies have produced poorly-made, compromised products that have led to disability and even death. It is so important that we employ this standard – independently audited – to ensure maximum patient safety and outcomes.