GUIDANCE ON REPACKAGING AND OVER-LABELLING SMALL BATCHES OF MEDICINES IN PHARMACY DEPARTMENTS

Kathryn DaviesSource NHSPQA CommitteePublished Last updated See all updates

Guidance on how repacking and overlabelling operations can be carried out in accordance with the principles of GMP in hospital pharmacies with no MS Licence

Scope

There is an increasing demand for small packs of licensed medicines to be provided to clinics, day case units and Emergency/Urgent Care Departments with labels already attached, to allow issue against a prescription or under a Patient Group Direction without further pharmacy involvement.

Purpose

The labels give patients instructions for use that have been specified by the prescriber for a specific patient group in accordance with local clinical governance policy. The labels have a space for the patient’s name and date of issue to be added by the clinic staff. These medicines improve both efficiency and safety by allowing patients to be supplied with medicines that have been appropriately labelled when an on-site pharmacy service is not available.

Good governance

The safest and most appropriate method for the repackaging and overlabelling of medicines is under GMP in an MHRA- licensed Pharmacy Specials manufacturing unit. However, there are a limited number of Specials units licensed to perform repackaging and overlabelling operations and therefore there is sometimes a need for small scale batches to be assembled in dispensaries.

This document provides guidance on how repacking and overlabelling operations can be carried out in accordance with the principles of GMP in hospital pharmacies that do not hold a Specials Manufacturing licence from the MHRA. Such activities can be carried out under the professional exemption from licensing provided they are undertaken by or under the supervision of a pharmacist. Specific guidance for sites that hold a Specials licence is available from the MHRA and batch manufacture under a licence is outside of the scope of this document.

Attachments

Change history

  1. Updated to include the MHRA Q&As for Specials Manufacturers 2015 and the Falsified Medicines Directive. Title changed to reflect change in scope to Section 10 activity only. Addition of template worksheets.
  1. Published