Medicines licensing Over-the-counter (OTC) medicines Pharmacist and technician responsibilities Record-keeping requirements Safe dispensing practices

Pharmacy medicines (P)

Pharmacy medicines (P medicines) are medicinal products that may be sold or supplied only from registered pharmacy premises and only under the supervision of a pharmacist.

The legal classification, supply restrictions and supervision requirements for P medicines are set out in the Human Medicines Regulations 2012.

Under the Human Medicines Regulations 2012, a pharmacy medicine is a medicinal product that:

Pharmacist and technician responsibilities

Responsible Pharmacist Legislation in the UK: Current Law vs. Proposed Changes

Responsible Pharmacist Presence: Under UK law, any registered pharmacy (a premises carrying on a retail pharmacy business) must have a Responsible Pharmacist (RP) – a registered pharmacist in charge – whenever it is open for pharmacy services (legislation.gov.uk). In practice, this means a pharmacist must be signed in as RP to lawfully operate the pharmacy and oversee the safe and effective running of the business. Only one RP can be in charge of a pharmacy at a time, and a pharmacist cannot be the RP for more than one pharmacy simultaneously under current law.

Pharmacist Supervision of Dispensing: By law, certain activities – notably the dispensing, assembly, and sale/supply of prescription medicines – must be carried out by a pharmacist or under the supervision of a pharmacist in community pharmacies and most clinical settings (gov.uk). Regulation 220 of the Human Medicines Regulations 2012 and section 10 of the Medicines Act 1968 require a pharmacist’s oversight for preparing and dispensing Prescription-Only Medicines (POM) and Pharmacy (P) medicines (with limited exceptions) (gov.uk). In effect, no prescription medicine can be handed out to a patient at a pharmacy without a pharmacist supervising that transaction under current rules. The RP is accountable for all medicinal sale/supply transactions occurring in the pharmacy. If the RP must briefly leave, the pharmacy’s ability to supply medicines is restricted – e.g. checked prescription items generally cannot be handed to patients in the pharmacist’s absence (except via delivery services or automated collection lockers) because the law has been interpreted to require the pharmacist’s direct supervision for any in-person hand-out (gov.uk). This is why, currently, patients may experience delays if a pharmacist is on a meal break or otherwise temporarily away from the dispensary – staff cannot legally complete a sale of a POM/P medicine to a patient on-site without a pharmacist present to supervise (gov.uk). (Note: The RP can legally be absent for a limited period (up to 2 hours per day) under the 2008 RP Regulations, but strict conditions apply and certain activities must pause during the absence.)

RP Duties and Record-Keeping: The role and duties of the Responsible Pharmacist are defined by the Medicines Act 1968 (as amended by the Health Act 2006) and the Medicines (Pharmacies) (Responsible Pharmacist) Regulations 2008. These require the RP to display a notice naming themselves, maintain a pharmacy record (logging who is RP and any absences), and establish and uphold standard operating procedures (SOPs) for the safe running of the pharmacy (legislation.gov.uk). The pharmacy owner/superintendent is obliged to ensure these records and procedures are in place and kept up to date. In summary, under current law the RP has personal responsibility for the day-to-day safe pharmacy operations, and any dispensing of prescriptions or sale of pharmacy medicines must be pharmacist-led or closely supervised by them.