CPSA — Compounding Pharmacy of South Africa
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Pharmaceutical compounding is the preparation of a medicine for an individual patient when a commercially available product does not fully meet that patient’s specific needs.

A pharmacist may adjust factors such as strength, dosage form or selected inactive ingredients when clinically appropriate and permitted by South African law.

How does compounding differ from commercial medicines?

Commercial medicines are manufactured in standard strengths and dosage forms for broad patient populations.

A compounded medicine is prepared for an individual patient or specific clinical need. As a result, its labelling, Beyond-Use Date and regulatory pathway may differ from mass-manufactured products.

When might compounding be considered?

Compounding may be appropriate when a patient:

  • Needs a strength or dosage form that is not commercially available
  • Has a relevant sensitivity to an inactive ingredient
  • Has difficulty using a standard dosage form
  • Has another patient-specific clinical need

Regulatory status

Compounded medicines are not registered in the same way as mass-manufactured medicines. They must still be prepared and supplied in accordance with South African medicines and pharmacy legislation and under appropriate professional oversight.