Revised guidance to replace EL(97)52 in England published 17th March 2023
10 March 2026
The revised guidance will support the NHS in England to continue providing critical medicines for patients through safe and effective services, using modern practices, working across the new integrated health and care structures.
The guidance strengthens accountability and responsibility for the preparation of ready-to-administer injectable medicines in unlicensed pharmacy aseptic units in the NHS in England, as recommended in Transforming NHS pharmacy aseptic services in England - A national report for the Department of Health and Social Care by Lord Carter of Coles. These units produce life-saving specialist medicines, such as chemotherapy and parenteral nutrition, and prepare other injectable medicines, including antibiotics, in syringes or infusion bags for direct administration to patients. This benefits patients through increasing the time available for nursing teams who do not need to prepare the medicines before use and allowing patients to receive safe treatment outside hospital settings.
The guidance defines the roles and responsibilities for:
- NHS organisations performing aseptic preparation activities, in meeting quality standards, responding to audits and inspections, and reporting quality indicators.
- The NHS Specialist Pharmacy Service Quality Assurance service, in providing regulatory oversight and inspection of aseptic preparation activity, and auditing services against quality standards.
- NHS England, in commissioning the overarching governance and assurance process, providing oversight, and ensuring the delivery of enforcement where necessary.
- Chief pharmacists at NHS trust, Integrated Care Board and regional level.
It also describes the relationships with the regulatory bodies, primarily the Medicines and Healthcare Products Regulatory Authority, Care Quality Commission and General Pharmaceutical Council, and introduces a new digital, good manufacturing practice based audit and compliance management system: the Interactive Quality Assurance of Aseptic Preparation Services (iQAAPS).