Section 10 exemption – extemporaneous dispensing
The Medicines Act 1968, now superseded by the Human Medicines Regulations 2012, provides a legal basis for the extemporaneous preparation of a medicinal product when carried out under the supervision of a pharmacist. Known as the 'Section 10' exemption it allows a Special to be prepared on registered pharmacy premises without the need for an MS licence and its inherent inspection and quality controls.
It is the absence of regulated Quality Control procedures coupled with fears over litigation that has led to the virtual abandonment of this exemption by the majority of community pharmacists. The exemption continues to be utilised by Specials manufacturers - under the supervision of a pharmacist and usually for bespoke 'one-off' preparations as opposed to batch productions. Products manufactured under the Section 10 exemption will not specify the manufacturer's licence number on the label but must state their name and address.
While the concerns over the quality of extemporaneous dispensing in community pharmacy are valid, there are also some clear benefits. Compounding a drug in the pharmacy, for example crushing tablets and forming a suspension, must be preferable to the patient crushing and administering a medicine without supervision. The strength of the product will be accurate with no loss of drug, and palatability issues could be overcome with a syrup or flavourings. The practical issues, discussed above, that are associated with tablet crushing by the patient or carer can be completely avoided. In addition the cost to the NHS would be considerably reduced.
GPhC has produced a guidance document for extemporaneous dispensing. The GPhC guidance is for pharmacy owners, superintendents and pharmacists and details the processes required to ensure that extemporaneously dispensed products meet the required standard. The specified processes include risk assessment, audit and review, record keeping, staff training, patient information, equipment and maintenance. The guidance is available to read on the GPhC website.6