SA Pharmacies Face New Rules on Custom Medicine Compounding

South Africa is set to implement revised regulations governing the custom preparation of medicines. These updates specifically address sought-after GLP-1 treatments, commonly used for diabetes and weight loss. The South African Pharmacy Council and the South African Health Products Regulatory Authority (SAHPRA) are collaborating on new minimum standards and guidelines for compounding.

Pharmacies are being cautioned by regulators not to function as small-scale manufacturers, preparing medicines in anticipation of demand rather than for individual patient prescriptions. This practice, especially prevalent with weight-loss drugs, raises concerns about potential openings for counterfeit medicines. The revised standards and SAHPRA guidelines are slated for publication in March, aiming to bring clarity to the industry and address existing disputes and interpretations of current rules.