South Africa revises rules on compounding GLP-1 weight-loss drugs

South African health regulators are updating rules for medicine compounding to curb the unauthorized production of GLP-1 weight-loss treatments, including Ozempic and Mounjaro. On October 14, 2026, the South African Pharmacy Council and SAHPRA warned that pharmacies are improperly acting as small-scale manufacturers by compounding drugs ahead of demand, raising risks of counterfeit products and spurring litigation between iDexis and Novo Nordisk. Revised standards and guidelines are set for release in March.

Plans to revise compounding rules

• ▪The South African Pharmacy Council expects its revised compounding standards to go before the council in February, targeting publication in March.
• ▪The South African Pharmacy Council and SAHPRA announced the regulatory review during a multi-stakeholder roundtable on counterfeit medicines on October 14, 2026.
• ▪The South African Health Products Regulatory Authority plans to release updated medicine compounding guidelines alongside the South African Pharmacy Council's revised standards.
• ▪South African health regulators are revising rules governing the customisation of medicines, including GLP-1 treatments for diabetes and weight loss.

Clarifying compounding rules

• ▪South African health regulations define compounding as the preparation of customised medicines by pharmacists for specific individual patients needing variations of commercial products.
• ▪South African Health Products Regulatory Authority senior manager Daphney Fafudi reported that updated regulatory guidelines and standards aim to clarify what is permissible when compounding medicines.

Warnings over compounding and counterfeit risks

• ▪South African health authorities warned during an industry roundtable on October 14, 2026, that large-scale medicine compounding creates opportunities for counterfeit products to enter high-demand weight-loss drug categories.
• ▪South African Pharmacy Council CEO Vincent Tlala warned pharmacies against acting as small-scale manufacturers by compounding medicines in anticipation of demand.
• ▪South African Health Products Regulatory Authority senior manager Daphney Fafudi reported that compounded products have become a widespread issue in the weight-loss drug market.