Specials Medicines

The term 'Specials' may include:

  • Batch manufactured products – made by a 'Specials' manufacturer
  • Bespoke 'Specials' – made by a 'Specials' manufacturer as a single pack for a named patient

The manufacturer or assembler of 'specials' must hold a Manufacturer's 'Specials' Licence granted by the Licensing Authority. The manufacturing/assembly site and its operations are inspected for compliance with Good Manufacturing Practice (GMP) which requires that manufacture or assembly is carried out under the supervision of appropriately qualified staff, including a named quality controller and production manager who are acceptable to the Regulatory Authority.

A holder of a Manufacturer's "Specials" Licence may also be a registered pharmacy supplying unlicensed medicinal products prepared under the exemption provided by section 10 of the Medicines Act. The exemptions from licensing which apply to pharmacists are contained in Section 10 of the Medicines Act 1968 and cover the preparation or dispensing of a medicinal product in accordance with a prescription given by a practitioner.

Certificate of analysis vs. certificate of conformity

A certificate of analysis should be available for any batch manufactured 'Special' and is evidence that critical parameters have been confirmed by retrospective physical, chemical or microbiological assay of a sample of the final product. This differs considerably from a certificate of conformity which is a signed statement by the manufacturer that they believe the product complies with the purchaser's specification.

To ensure the quality of the medicine, the RPSGB (Royal Pharmaceutical Society of Great Britain) advises that a certificate of analysis or a certificate of conformity should be requested by pharmacists with every product.