South African regulators review compounding rules amid rising demand for cheaper Ozempic alternatives

At a multi-stakeholder roundtable on counterfeit medicines, South African Pharmacy Council registrar and CEO Vincent Tlala said the council was working with the South African Health Products Regulatory Authority (Sahpra) on updated minimum standards and guidelines for compounding medicines.

The council expects to review the revised standards in February, with publication targeted for March. Tlala said Sahpra is expected to release the updated guidelines at the same time.

Regulatory scrunity

The popularity of GLP-1 medicines, including Novo Nordisk’s Ozempic and Wegovy and Eli Lilly’s Mounjaro and Zepbound, has fuelled growth in compounded versions, prompting global regulatory scrutiny.

Compounding refers to pharmacists preparing customised medicines for patients who need a variation of a commercially available product. Tlala said the council was concerned pharmacies were compounding medicines in anticipation of demand rather than for specific patients.

“What we are seeing in the market, and which we are against, is when pharmacies become small-scale manufacturers,” he said.

Compounding counterfeit woes

Authorities are concerned that large-scale compounding may create openings for counterfeit medicines, particularly in high-demand categories such as weight-loss drugs.

“There is a scourge of compounded products, especially in the area of weight-loss,” Daphney Fafudi, Sahpra’s senior manager for market control, told Reuters on the sidelines.

Fafudi said the updated guidelines from Sahpra and revised minimum standards from the pharmacy council were intended to clarify what is and isn’t permissible when compounding medicines.

While existing regulations already include provisions governing compounding, differing interpretations have led to industry disputes, including litigation involving local pharmaceutical compounding company iDexis and Novo Nordisk.