FAQs – Semaglutide

Semaglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist. Semaglutide mimics the GLP-1 hormone that is released in the gastrointestinal tract in response to eating. Semaglutide reduces blood glucose by causing the body to produce more insulin which causes a reduction in blood sugar (glucose). It also reduces appetite and causes an increased feeling of fullness.

SAHPRA has registered one product which contains semaglutide called Ozempic. There are two (2) registered presentations of the pre-filled injectable pen for Ozempic available in South Africa namely, Ozempic 0,25 mg and 0,5 mg/dose pen and Ozempic 1 mg/dose pen.

Ozempic (each 1,0 ml solution contains Semaglutide 1,34 mg) is registered in South Africa for the treatment of adults with Type 2 Diabetes to reduce blood sugar levels for the treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise. It is also registered for use in reduction of risk of cardiovascular events such as heart attack, stroke, or death in adults with Type 2 Diabetes with known heart disease.

• Ozempic is not registered in South Africa for use in weight-loss.
• Ozempic is only available on prescription and there are no generic versions of Ozempic registered in South Africa.

The Medicines and Related Substances Act, Act 101 of 1965, as amended and its regulations herein referred to as the Medicines Act defines compounding as the preparation, mixing, combining, packaging and labelling of a medicine by a pharmacist, veterinarian, or a person licensed in terms of section 22C(1)(a) of the Medicines Act to dispense and compound, and practicing within their scope of practice.

The Medicines Act provides conditions for compounding, namely that the compounded medicine may:

• • not contain any component the sale of which is prohibited by the Medicines Act;
  • not contain any component of which an application for registration has been rejected and
  • not be or has not been advertised.
  • In addition, the Act stipulates that the active component/s of a compounded medicine must be included in another medicine which has been registered under the Medicines Act.

Compounded medicines are not required to be reviewed by SAHPRA for registration (the physician prescribes medicines for a specific patient use and should only be specified for a short period) and it must be noted that SAHPRA does not verify the safety or efficacy of compounded medicines.

Yes, as semaglutide is included in a medicine that has been registered by SAHPRA. The compounded medicines containing semaglutide must be in accordance with the conditions and requirements contained in the Medicines Act and its regulations.

Compounded medicine using semaglutide cannot be in different forms to the registered product, i.e., it cannot contain salts, for e.g., semaglutide acetate, semaglutide sodium or any other form of semaglutide other than the semaglutide in the registered product; that will be illegal and is not permissible in terms of Section 14(4) of the Medicines Act. The use of the salt forms of semaglutide have not been evaluated for safety or effectiveness by SAHPRA.

SAHPRA has received reports of compounded medicines claiming to contain semaglutide. Patients are urged to use a SAHPRA approved product if available. Patients, pharmacists, doctors, and other health care professionals should be aware that compounded medicines claiming to contain semaglutide have not been reviewed by SAHPRA for safety, quality, and efficacy.

For update of a licence the RC005 form must be completed. Please allow 30 days for administration of this process.  You will receive an updated licence via email, when the changes have been effected to your licence.

SAHPRA is informed that compounders may be using salt forms of semaglutide, such as semaglutide sodium and semaglutide acetate. The public, including pharmacists, medical doctors and other healthcare professionals should be aware that the salt forms of semaglutide have different active ingredients than the semaglutide used in the registered product. As compounded medicines may only contain the active ingredient that is registered, any compounded medicine using semaglutide acetate, semaglutide sodium or any other form other than semaglutide in the registered product is illegal and not permissible in terms of Section 14(4) of the Medicines Act. The use of the salt forms of semaglutide have not been shown to be safe or effective and has not been reviewed by SAHPRA.

Patients should be aware that products claiming to contain semaglutide may not contain the same active ingredient, semaglutide, as the SAHPRA registered product. Compounded products or products obtained outside of the legitimate sources, i.e., the legal supply chain may contain the salt forms of semaglutide described earlier and those have not been reviewed by SAHPRA for safety or efficacy.

Patients should only obtain medicines containing semaglutide with a prescription from a licensed medical practitioner, and only obtain medicines from licensed pharmacies/dispensers. Purchasing medicines from unregulated and unlicensed sources can lead to use of substandard or falsified medicines which have not been evaluated by SAHPRA and the use of which can cause harm to patient health. In South Africa, online pharmacy webpages are linked to physical pharmacies, so it is important to check that a website is owned by a physical licenced pharmacy.

Patients should be aware that any medicines that are bought outside of the legal supply chain:

• • May not contain any active ingredient.
  • May contain dangerous levels of the active ingredient.
  • May contain another active ingredient such as insulin instead of semaglutide.
  • May contain harmful inactive ingredients.
  • May be nonsterile and contaminated with microbes, therefore not suitable for injection.

Pharmacists, medical doctors, and other healthcare professionals who are considering the use of compounded medicine providers should be aware that the medicines may contain the salt forms of semaglutide. The use of salt forms of semaglutide is not permissible as per the Medicines Act. These products containing the salts, such as semaglutide sodium and semaglutide acetate, have not been reviewed by SAHPRA for quality, safety or efficacy.

SAHPRA is monitoring the supply chain and internet for substandard, falsified and unauthorised/unregistered products containing or claiming to contain semaglutide and is investigating any contraventions relating to the Medicines Act committed by the public and healthcare professionals.

• SAHPRA encourages patients, pharmacists, and other health care professionals to report any contraventions or quality problems to SAHPRA’s 24-hour hotline (0800 204 307) or via our web reporting facility: https://bit.ly/3nrku5t.
• Healthcare professionals are urged to report any adverse events occurring with the use of products containing semaglutide to adr@sahpra.org.za ; or the Med Safety App.