Healthcare professionals have been warned not to prescribe, dispense or administer recalled compounded semaglutide and tirzepatide products, with South Africa’s three health regulators saying failure to comply could result in disciplinary action.

In a joint statement released on Wednesday (July 8), the South African Health Products Regulatory Authority (Sahpra), the South African Pharmacy Council (SAPC) and the Health Professions Council of South Africa (HPCSA) reiterated that all compounded semaglutide and tirzepatide products subject to a Class I Type A recall must be removed from circulation immediately.

The regulators said practitioners who continue to prescribe, dispense, administer or retain stock of the recalled products could face regulatory action.

The legitimate versions of Ozempic, Wegovy and Mounjaro are still available, only the compounded products have been recalled.

A list of the recalled products can be viewed here: 

Compounding dispute under spotlight

The latest warning follows an earlier announcement by Sahpra and the SAPC after an inspection at iDEXIS Compounding and Sentra Pharmacy in Pretoria.

The regulators said the inspection uncovered what they described as the unlawful manufacture of unregistered GLP-1 medicines containing semaglutide and tirzepatide.

According to Sahpra, the products were manufactured using imported active pharmaceutical ingredients and were being supplied without registration under the Medicines and Related Substances Act 101 of 1965.

At the time, Sahpra announced a Class I Type A recall, its highest level of recall, citing what it described as a severe risk to public health.

Understanding pharmaceutical compounding

Compounding has long formed part of pharmacy practice, with pharmacists preparing customised medicines to meet the specific needs of individual patients when commercially manufactured medicines are not suitable, available or affordable.

According to information published by iDEXIS, dedicated compounding pharmacies prepare customised medicines on behalf of pharmacies and healthcare providers that may not have the capacity to do so themselves. The company, in a Facebook post, said its role is to facilitate access to compounded formulations while meeting appropriate pharmaceutical standards.

The dispute centres on whether the compounded semaglutide and tirzepatide products supplied by iDEXIS constitute lawful pharmaceutical compounding or the unlawful manufacture of unregistered medicines.

iDEXIS challenges official findings

Following Sahpra’s initial announcement in May, iDEXIS issued a statement to healthcare practitioners saying it would challenge the regulator’s findings through the statutory processes provided for in the Medicines Act and the Promotion of Administrative Justice Act 3 of 2002.

The company said its compounding processes comply with the Medicines Act, Sahpra’s Good Compounding Practice guidelines and Good Pharmacy Practice guidelines. It further stated that the active pharmaceutical ingredients used in its semaglutide and tirzepatide products are sourced from ‘reputable, internationally approved pharmaceutical manufacturers’ and are independently tested for sterility and quality.

iDEXIS also said it had dispensed compounded semaglutide and tirzepatide products to 214 406 patients on prescription through clinicians or retail pharmacies and had received no reports of adverse reactions, adding that it intended challenging what it described as Sahpra’s ‘impugned findings’.

Ozempic manufacturer wins interim interdict

In a Facebook post published on June 10, the company said: “Today marks the beginning of a landmark court case for Compounding Pharmacy in South Africa. iDexis stands alone at the forefront – firm, unwavering and carrying the responsibility on behalf of all medical practitioners and the patients they serve. This is bigger than iDexis. It is a fight for the future of personalised medicine, clinical choice and access to quality compound care in South Africa.”

The post referred to the case brought against the company by pharmaceutical manufacturer Novo Nordisk, which distributes the registered semaglutide medicines Ozempic and Wegovy.

On June 22, the Gauteng High Court granted an interim interdict preventing iDEXIS Compounding Specialists and its director from manufacturing, marketing or selling compounded medicines containing semaglutide until regulatory processes are complete.

According to court documents published on the Southern African Legal Information Institute, the court found that iDEXIS could not rely on the Medicines Act exemption that allows pharmacists to compound medicines because the semaglutide active pharmaceutical ingredient it used had not been registered by Sahpra and was therefore not the registered ingredient contemplated by the Medicines Act exemption.

The judge ruled that the law must be interpreted strictly to protect public safety, rejecting the argument by iDEXIS that a ‘similar’ active ingredient was sufficient. The court also noted Sahpra’s investigation, which uncovered numerous alleged regulatory breaches.

Call for immediate compliance

In their latest statement, Sahpra, the SAPC and the HPCSA urged all healthcare professionals to comply fully with the recall.

They advised practitioners to stop prescribing, dispensing or administering the recalled products immediately, quarantine any remaining stock and follow Sahpra’s recall procedures.

Patients currently using compounded semaglutide or tirzepatide products have been advised to consult their healthcare providers regarding appropriate treatment options.

• iDEXIS could not immediately be reached by telephone for comment on the latest joint statement, but an email has been sent to them. This article will be updated should the company respond.
• Phone calls to Sentra Pharmacy directed Caxton Network News to a man only identified as ‘Mr Ntlhoro’.

*The article has been amended after it was first published.

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