Is compounded semaglutide legal? South Africa revises its compounding rules

What regulators announced

South Africa is reworking the rules that govern how pharmacies prepare customised medicines, according to Reuters. The changes cover GLP-1 treatments used for diabetes and weight loss.

Vincent Tlala, Registrar and CEO of the South African Pharmacy Council, made the announcement at a roundtable on counterfeit medicines on 14 October 2026. He said the council and the South African Health Products Regulatory Authority (SAHPRA) are drafting updated minimum standards and guidelines for compounding.

According to Tlala, the council is expected to consider the revised standards in February, and publication is targeted for March. He said SAHPRA's updated guidelines should be released at the same time. Semafor reported on 16 October 2026 that the new guidelines are expected around March next year.

Is compounded semaglutide legal now?

Under current law, compounding is allowed within strict limits. The SAHPRA semaglutide FAQ says semaglutide may be compounded because it is an ingredient of a registered medicine. The compounded product must meet the conditions in the Medicines and Related Substances Act and its regulations.

The Act defines compounding as the preparation, mixing, combining, packaging and labelling of a medicine by a pharmacist or another authorised person working within their scope of practice. According to SAHPRA, a compounded medicine:

• may not contain any component whose sale the Act prohibits;
• may not contain any component for which registration has been rejected;
• may not be advertised;
• must use active ingredients that are included in a registered medicine.

SAHPRA draws a firm line on salt forms. Its FAQ says that compounded products made with semaglutide sodium, semaglutide acetate or any form other than the semaglutide in the registered product are illegal under Section 14(4) of the Act. The regulator adds that it does not verify the safety or efficacy of compounded medicines, and that it has not reviewed the salt forms for safety or effectiveness.

Why regulators are concerned

Tlala said the council's concern is that some pharmacies are compounding medicines in advance of expected demand instead of for individual patients. "What we are seeing in the market, and which we are against, is when pharmacies become small-scale manufacturers," he told the roundtable.

Authorities are also worried that large-scale compounding could open the door to counterfeit medicines, especially in popular categories such as weight-loss drugs. Daphney Fafudi, SAHPRA's senior manager for market control, told Reuters there is "a scourge of compounded products, especially in the area of weight-loss". She said the new SAHPRA guidelines and the council's revised standards are meant to clarify what compounding may and may not include.

According to Reuters, the existing rules already address compounding, but disagreements over how to interpret them have led to disputes. These include litigation between the local compounding company iDexis and Novo Nordisk. Semafor reported that the policy discussion follows a court victory for Novo Nordisk in June against local compounding pharmacies making unauthorised copies.

Demand is a key factor behind the review. Semafor reported that GLP-1 medicines are in high demand in South Africa, but that the cost of the branded products puts them beyond the reach of most people.

What this means for patients and pharmacies

The semaglutide medicines currently registered with SAHPRA are Ozempic, Extensior (an authorised copy of Ozempic), Wegovy and Semagard (a generic of Ozempic), all injection pens, and Rybelsus tablets. Price details for registered pens are listed on the Ozempic and Wegovy prices page.

SAHPRA's guidance is that semaglutide should be obtained only with a prescription from a licensed medical practitioner and only from licensed pharmacies or dispensers. The regulator notes that South African online pharmacy websites are linked to physical pharmacies, and that it is worth checking a website belongs to a licensed physical pharmacy. It warns that products bought outside the legal supply chain may contain no active ingredient, dangerous amounts of it, a different ingredient such as insulin, or contaminants.

Anyone with questions about their own treatment should speak to a doctor or pharmacist. A comparison of registered pharmacies is available in the semaglutide pharmacy rating.