Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, what discussions he has had NHS England on the future (a) oversight and (b) regulation of (i) specialist pharmacies and (ii) aseptic services within hospitals.

The Department has asked NHS England to continue to progress work on the Infusions and Special Medicines Programme, which is tasked with the implementation of Lord Carter’ 2020 report, Transforming Pharmacy Aseptic Services in England. The work included publication of guidance for the quality assurance of aseptic production in National Health Service hospitals and improved audits in unlicensed aseptic medicines preparation units, using digital tools to improve the transparency of the work. These hospital aseptic medicines preparation units make unlicensed ‘special’ medicines, which include ready to administer chemotherapy injections and intravenous nutrition products. The majority of these units are regulated by the Care Quality Commission.

A minority of aseptic medicines preparation services in hospitals are licensed units with a Medicines and Healthcare products Regulatory Agency (MHRA) Specials Authorisation. These units are regulated by the MHRA.