Inside the Box With Dr Andy Gray | How Should the Compounding of Medicines Be Regulated?

The South African Health Products Regulatory Authority (SAHPRA) and the South African Pharmacy Council (SAPC) have intensified enforcement action against compounding pharmacies engaged in the unlawful manufacturing and distribution of unregistered medicines. This crackdown, highlighted by a recent inspection at Sentra Pharmacy concerning GLP-1/GIP weight-loss medicines, underscores critical regulatory non-compliance and the blurring lines between legitimate patient-specific compounding and large-scale manufacturing. The Medicines and Related Substances Act 101 of 1965 strictly defines compounding, yet ambiguities persist, leading to a regulatory vacuum that compromises patient safety and the integrity of the pharmaceutical supply chain. This development necessitates a re-evaluation of current practices and a clearer regulatory framework for compounded medicines in South Africa.

This event has brought to the forefront long-standing debates about the appropriate regulation of compounded medicines, a practice traditionally intended for individual patient needs but increasingly exploited for commercial-scale production. As Dr Andy Gray, a prominent pharmaceutical sciences expert, observes, key elements of this regulatory environment remain contested, highlighting the urgent need for clarity and robust oversight. The core issue revolves around distinguishing between legitimate, patient-specific compounding and activities that effectively bypass the stringent registration requirements designed to ensure the safety, quality, and efficacy of medicines available to the public.

Crucially, a compounded medicine must not contain a prohibited substance, must not contain a component for which registration has been rejected, must not be advertised, and must use an active pharmaceutical ingredient (API) that is already included in a SAHPRA-registered medicine. The South African Pharmacy Council (SAPC) oversees the professional conduct of pharmacists, while SAHPRA is responsible for regulating health products. Historically, compounding was the norm, but with the rise of the pharmaceutical industry, it became a niche practice for specific patient needs, such as customised dosages or alternative formulations not commercially available. However, the lack of a clear distinction between extemporaneous compounding and large-scale preparation has created a regulatory 'grey zone', leading to the current enforcement challenges.

Furthermore, the *Medicines Act* stipulates that compounded medicines must use active ingredients found in SAHPRA-registered medicines, and they cannot be advertised. The recent crackdown revealed deficiencies such as the illegal importation of active pharmaceutical ingredients, lack of analytical testing, inadequate sterile manufacturing conditions, and absence of pharmacovigilance systems, all of which pose serious public health risks. The SAPC has also indicated that disciplinary action, including possible removal from the professional register, will be taken against pharmacists involved in such unlawful practices.

Practitioners must urgently review their clients' sourcing, dispensing, advertising, and distribution practices to ensure strict compliance with the law. The ongoing efforts to redraft regulations and issue guidelines, as mandated by the *ACPSA v Minister of Health and Others* judgment, are critical developments to watch. Until a clearer, updated regulatory framework is in place, the onus remains on pharmacies and healthcare professionals to operate within the spirit and letter of the existing law, prioritising patient safety and the integrity of the regulated medicines supply chain. The intention to declare certain compounded biological medicines, like GLP-1/GIP agonists, undesirable further underscores the need for vigilance and adherence to SAHPRA's evolving stance.