During 1997 EL(97)52 was issued which required external audit at an interval of 12 to 18 months of all hospital pharmacy departments preparing injections under Section 10 exemption. Audits were to be carried out by Regional Quality Assurance Specialists with reports made to Hospital Chief Executives and to those commissioning health services. They were also to involve the Regional Offices (for Regional Pharmaceutical Advisors and performance managers).

Reorganisation of the NHS has led to a new reporting process issued in 2013 by NHS England. This is now outlined in Appendix 1.

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