Overview
South Africa does not have a peptide-specific statute; instead, peptides are caught by the general medicines framework under the Medicines and Related Substances Act 101 of 1965, administered by SAHPRA. Any peptide product intended to treat, prevent or alter bodily function is a 'medicine' that must be registered before it may lawfully be sold, and therapeutic peptides such as semaglutide are prescription-only. Research or compounded peptides sold online, in gyms or as powders are generally unregistered and therefore unlawful to sell, and SAHPRA has moved to active enforcement in 2025-2026. Personal importation of unregistered medicines from abroad is prohibited without prior SAHPRA authorisation.
Key Points
- Under the Medicines and Related Substances Act 101 of 1965, any product intended to treat, prevent or alter bodily functions must be registered with SAHPRA before it can be sold in South Africa, which captures peptide products marketed for therapeutic effect. [1]
- SAHPRA has published dedicated public guidance on peptide products warning consumers to avoid unregistered peptides bought from social media, online vendors, gyms or informal suppliers, and stating that powder forms are not registered. [1]
- Scheduling of substances in South Africa is done by the Minister of Health under sections 22A(2) and 37A of the Medicines Act on SAHPRA's recommendation, with the consolidated schedules most recently republished on 1 August 2025. [2]
- Semaglutide is prescription-only in South Africa, with Ozempic the only registered semaglutide product, no registered generics, and no registration for weight-loss use. [3]
- SAHPRA's position is that compounded medicines may only contain an active ingredient present in a SAHPRA-registered product, and that salt forms such as semaglutide sodium and semaglutide acetate are not permissible under the Medicines Act. [4]
- On 23 May 2026 SAHPRA and the South African Pharmacy Council announced intensified enforcement action against the unlawful manufacture and distribution of unregistered GLP-1 and GIP medicines containing semaglutide, tirzepatide or a combination, promoted for weight loss. [5]
- Only a South African registered company licensed by SAHPRA may import medicines, and SAHPRA's importation guideline states that no person may order medicine from abroad for personal use unless SAHPRA has granted authorisation. [6]
- No SAHPRA scheduling entry or enforcement notice naming BPC-157 or TB-500 individually was located in this research; their restricted status above is inferred from the general rule that unregistered products with therapeutic claims may not be sold, not from a peptide-specific source. (No reliable source found for this point -- flagged as unverified rather than stated as fact.)