Health regulators have issued a warning to pharmacies not to operate as small-scale manufacturers as the country’s regulations regarding the customisation of medications, including popular GLP-1 therapies for diabetes and weight loss, are being updated.
This week the South African Pharmacy Council Registrar and CEO Vincent Tlala stated that the council was collaborating with the South African Health Products Regulatory Authority (SAHPRA) on revised minimum standards and guidelines for compounding medications during a multi-stakeholder roundtable on counterfeit medicines.
The revised standards are expected to go before the council in February, with publication targeted for March. Updated SAHPRA guidelines are expected to be released at the same time, Tlala said.
The popularity of GLP-1 medicines such as Novo Nordisk’s Ozempic and Wegovy and Eli Lilly’s Mounjaro and Zepbound has fuelled growth in compounded versions, drawing scrutiny from regulators globally.
Compounding refers to the preparation of customised medicines by pharmacists for patients needing a variation to 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.
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,” said Daphney Fafudi, SAHPRA’s senior manager for market control.
Fafudi said the updated guidelines from SAHPRA and revised minimum standards from the pharmacy council were intended to provide greater clarity on what is and is not permissible when compounding medicines.
While existing regulations already contain provisions governing compounding, differing interpretations of those rules have led to disputes in the industry, including litigation involving Pretoria compounding company iDexis to get it to stop manufacturing Novo Nordisk’s GLP-1. – Reuters
- The South African Pharmacy Council and SAHPRA are updating regulations on the customisation of medications, including GLP-1 therapies.
- Revised minimum standards and guidelines for compounding medications are expected to be approved by the council in February and published in March.
- Authorities warn against pharmacies operating as small-scale manufacturers by compounding medicines in anticipation of demand rather than for specific patients.
- There is concern that large-scale compounding of high-demand medicines, particularly weight-loss drugs, may facilitate counterfeit products.
- The updated guidelines aim to clarify permissible practices in compounding to reduce disputes and prevent misuse in the industry.
