South Africa Tightens Scrutiny of Weight-Loss Medicines as Regulators Target Unsafe Compounding

South African health authorities are preparing stricter guidelines for customised medicines as the growing popularity of injectable weight-loss treatments raises concerns about patient safety and unregulated pharmaceutical manufacturing. The South African Health Products Regulatory Authority (SAHPRA) and South African Pharmacy Council (SAPC) are reviewing standards governing medicine compounding, a process in which pharmacists prepare treatments for individual patients according to specific prescriptions. The review follows rising demand for medicines containing semaglutide and tirzepatide, active ingredients associated with popular diabetes and weight-management treatments such as Ozempic, Wegovy and Mounjaro. Regulators warn that some pharmacies may be producing compounded medicines in large quantities for commercial distribution rather than preparing them for individual patients, potentially exposing consumers to contamination, incorrect dosages and unverified ingredients. SAHPRA has previously taken enforcement action against facilities producing unauthorised GLP-1 medicines, highlighting weaknesses in manufacturing conditions and quality testing. Revised minimum standards are expected to be considered in February 2027, with publication targeted for March. Although legitimate medicine compounding remains permitted under specific legal conditions, authorities emphasise that compounded products have not necessarily undergone the same safety, quality and effectiveness assessments as registered medicines. The proposed changes aim to strengthen oversight, clarify the responsibilities of pharmacists and manufacturers, and protect patients seeking treatment for obesity and diabetes.