Advice on Storage Conditions of Medicines

All medicines must be stored in accordance with pharmacy and medicines legislation and PSI Guidelines. The maintenance of appropriate storage conditions is imperative to assure the quality, safety and efficacy of medicines and to assure traceability. 

Medicines storage areas are reviewed in the course of pharmacy inspections and the inspectors would ask you to make sure that:

  • Medicinal products are retained in the manufacturer’s original packaging during storage. In exceptional circumstances, if a medicinal product is removed from its original packaging it should be labelled with its name, strength, marketing authorisation number, batch number, expiry date, the name of the supplier (wholesaler or manufacturer), and packaged with a copy of the patient information leaflet, prior to returning it to storage. When medicinal products are removed from their original packaging the stability implications for the medicinal product must also be considered.
  • Medicines requiring storage between 2 and 8oC must be stored in a pharmaceutical grade refrigerator. A separate pharmaceutical grade refrigerator is required for the storage of cold chain veterinary medicines. These fridges must not be used for the storage of non-medicinal food or drink products, should be routinely cleaned and should be serviced regularly. The refrigerator should be of adequate capacity to allow for organised, well-spaced storage of all medicinal products on the shelves of the unit.
  • Maximum/minimum temperature monitoring and recording is in place in all areas of the pharmacy where medicines are stored, including pharmaceutical grade fridges, the dispensary and any additional medicines storage areas. 
  • Medicines are stored in a designated area of the pharmacy which is adequately equipped for the storage of medicines. The area should be structurally sound and free of damp and mould. Surfaces should be impervious and non-shedding and walls and floors should be intact. The area must be clean and well maintained. It is not appropriate for medicines to be stored on the floor or other areas of the pharmacy such as in cloakrooms, toilets etc.

The PSI Inspectors have compiled these key reminders to help you review storage conditions in your pharmacy, and as an aid to the requirements contained in these PSI Guidelines on the Storage of Medicinal Products.

(This was included in the PSI Newsletter in February 2014)