Compounded medicines are often considered unlicensed because they are prepared by compounding pharmacies on a case-by-case basis to meet the unique needs of individual patients. Unlike commercially available medications, compounded medicines are not pre-approved by regulatory agencies such as the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) or the General Pharmaceutical Council (GPhC), which regulates pharmacies and pharmacists in England, Scotland, and Wales.

Several factors contribute to why compounded medicines are typically unlicensed:

  • Customization: Compounded medicines are tailored to specific patient requirements, such as specific dosages, formulations, or ingredient combinations, which may not be available in commercially manufactured products.
  • Regulatory Oversight: While compounding pharmacies are subject to regulatory oversight by the GPhC, they operate under different regulations than pharmaceutical manufacturers. Compounding pharmacies must adhere to specific standards set forth by the GPhC, but these standards may vary and are generally less stringent than those for commercial drug manufacturers.
  • Limited Clinical Trials: Unlike mass-produced pharmaceuticals, compounded medications often lack extensive clinical trials to establish their safety and efficacy. Instead, their use is based on healthcare providers’ and pharmacists’ expertise and judgment.
  • Patient-Specific Needs: Compounded medicines are typically prescribed when commercially available products are not suitable or practical for a particular patient due to allergies, intolerances, or other medical reasons. They provide a valuable option for patients with unique medical needs but may not undergo the same rigorous testing and approval processes as commercial drugs.
  • Out-of-stock medicines: Compounded medicines can also be made when a certain dosage form of medicine is out of stock, and then an alternative dosage route can be employed.

Patients and healthcare providers must recognise that while compounded medicines may lack formal licensing from regulatory agencies like the MHRA and GPhC, they fulfil a critical role in healthcare by providing personalised treatment options for patients with specific medical requirements. However, patients and healthcare providers should work closely with compounding pharmacists to ensure the safety, quality, and appropriateness of compounded medications for individual patients.