The article discusses the critical importance of traceability and pharmacovigilance for compounded medicines, particularly in South Africa.It highlights how inadequate documentation and monitoring can compromise patient safety, as seen in the iDexis legal case.

While compounded medicines are essential for patients with unmet clinical needs, they require robust systems to track batch numbers, preparation dates, and adverse events.The piece emphasizes that pharmacovigilance principles must apply equally to both compounded and commercially manufactured drugs.

It calls for regulatory frameworks that balance access to treatments with rigorous safety standards, ensuring that unexpected harms are swiftly addressed.

The debate around compounding raises questions about the distinction between pharmacy practice and pharmaceutical manufacturing, underscoring the need for clear oversight by authorities like SAHPRA.Ultimately, the article argues that patient safety is paramount, regardless of how a medicine is produced.