| Standard not met | Reason | Action being taken by the Pharmacy | By when | Notification By Pharmacy Improvements Made |
|---|---|---|---|---|
| 3.3 | The areas used to store ingredients and manufacture the pharmacy’s unlicensed cough mixture are not maintained to an appropriate standard of cleanliness. There is dust, aged fittings and poor storage conditions, and the pharmacy does not maintain cleaning records for these areas. The condition of the environment means the pharmacy cannot demonstrate that the product is prepared and stored under suitably hygienic conditions, increasing the risk of product contamination. |
Production of BM has ceased. |
21/10/2026 | 01/10/2026 |
| 4.3 | The pharmacy does not consistently manage medicines and medicinal products safely. It does not have an effective date-checking process, some medicines are not stored appropriately. This means the pharmacy cannot demonstrate that all medicines and medicinal products it supplies are consistently safe and suitable for people to use. |
Electronic CD register software has been installed to help maintain accurate records of CDs and date checking. All pre popped meds to speed up blister packing have been responsibly disposed of. |
21/10/2026 | 01/10/2026 |
| 1.1 | The pharmacy does not adequately identify and manage the risks associated with the manufacture and sale of an unlicensed cough mixture. Risk assessments have not been completed and the pharmacy cannot demonstrate it has adequately considered the safety, suitability or ongoing review of the formulation it uses. Procedures focus largely on the ingredients and do not sufficiently cover the wider risks associated with sourcing ingredients, producing the product, storage, cleaning, quality assurance and supply. This means the pharmacy cannot demonstrate that the risks associated with this activity are appropriately managed to protect people receiving the product and make sure that it is safe to use. |
BM production has ceased. |
21/10/2026 | 01/10/2026 |
| 1.6 | The pharmacy keeps some records relating to the manufacture of its unlicensed cough mixture. However, it does not maintain records of who the product is supplied to. This means the pharmacy cannot effectively trace recipients or respond appropriately if concerns arise regarding the quality, safety or suitability of the product. Also, some responsible pharmacist entries and sign-out records had been missed, emergency supplies are not routinely recorded, and prescriber details are absent from a small number of unlicensed medicines records. This means the pharmacy cannot always demonstrate a complete and accurate audit trail for all pharmacy services provided in line with requirements. |
Production of BM has ceased. The RP log will always be completed. All pharmacists working for the group have been informed; the instruction will be incorporated into SOP Emergency supply records will be kept routinely When dispensing unlicensed medicines/specials, an additional prescription token will be printed and kept with the stored paperwork. |
21/10/2026 | 01/10/2026 |