South Africa’s health regulators are revising the rules that govern compounded medicines, including copies of popular GLP-1 treatments for diabetes and weight loss, and have warned pharmacies against operating as small-scale manufacturers.
Vincent Tlala, registrar and chief executive of the South African Pharmacy Council (SAPC), told a multi-stakeholder roundtable on counterfeit medicines that the council was working with the South African Health Products Regulatory Authority (Sahpra) on updated minimum standards and guidelines for compounding. The council expects to review the revised standards in February, with publication targeted for March, and Sahpra is expected to issue its updated guidelines at the same time.
Compounding allows a pharmacist to prepare a customised version of a registered medicine for a specific patient who needs a variation, such as a different dose or formulation. Tlala said the council’s concern was pharmacies producing stock in anticipation of demand rather than against individual prescriptions, which in effect turns them into manufacturers.
How the Compounded GLP-1 Dispute Unfolded in 2026
| Date | Development |
|---|---|
| March | Novo Nordisk’s semaglutide patent expires in South Africa |
| May | Sahpra and SAPC inspect iDexis; semaglutide and tirzepatide products recalled |
| 23 June | Pretoria High Court grants Novo Nordisk interim interdict against iDexis |
| July | iDexis seeks leave to appeal |
| September | Court dismisses iDexis’s application for leave to appeal |
| October | SAPC and Sahpra announce revised compounding rules for early 2027 |
Demand for GLP-1 drugs, including Novo Nordisk’s Ozempic and Wegovy and Eli Lilly’s Mounjaro and Zepbound, has driven rapid growth in compounded versions worldwide and drawn scrutiny from regulators in several markets. In South Africa, the issue came to a head this year in litigation between Novo Nordisk and local compounding pharmacy group iDexis.
On 23 June, the Pretoria High Court granted Novo Nordisk an interim interdict ordering iDexis to stop making, supplying and marketing products containing unregistered semaglutide, the active ingredient in Ozempic and Wegovy. The court found that only registered active ingredients may be used in compounding, and only against a prescription. It heard that iDexis was producing about 84,500 doses of semaglutide a month, more than Novo Nordisk’s combined South African sales of Ozempic and Wegovy. Novo Nordisk’s patent on semaglutide in South Africa expired in March.
The ruling followed a joint inspection by Sahpra and the SAPC in May, after which iDexis was directed to recall its semaglutide and tirzepatide products over safety concerns. In September, Judge Petrus van Niekerk dismissed iDexis’s bid for leave to appeal. iDexis has disputed the
regulators’ findings, said Sahpra had known of its compounding since November 2023, and argued that it was being singled out while other pharmacies made similar products.
Regulators also fear that large-scale compounding creates openings for counterfeit products in high-demand categories. Daphney Fafudi, Sahpra’s senior manager for market control, told Reuters there was a surge of compounded products in the weight-loss market, and said the new guidelines and standards were meant to clarify what is and is not permitted.
Existing regulations already contain provisions on compounding, but differing interpretations have led to industry disputes. The revised framework is intended to remove that ambiguity before more patients turn to cheaper alternatives to branded injections.