South Africa revises rules around customisation of weight-loss drugs
XLV•South African regulators are revising rules for compounding medicines, including GLP-1 treatments used for diabetes and weight loss. Updated standards are expected to go before the pharmacy council in February, with revised guidelines targeted for release in March.
1. New standards planned
The South African Pharmacy Council and the South African Health Products Regulatory Authority are working on updated standards and guidelines for compounding medicines. Council Registrar and CEO Vincent Tlala said the standards are expected to go before the council in February, with publication targeted for March; SAHPRA’s updated guidelines are expected at the same time.
2. Concerns over compounding
Tlala said the council was concerned pharmacies were compounding medicines in anticipation of demand rather than for specific patients, warning against pharmacies becoming “small-scale manufacturers.” Regulators are concerned large-scale compounding could create openings for counterfeit medicines, particularly among high-demand weight-loss drugs. Existing rules have been interpreted differently, contributing to industry disputes, including litigation involving iDexis and Novo Nordisk.
