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To ask the Secretary of State for Health, what steps he is taking to encourage NHS England and the Medicines and Healthcare Products Regulatory Agency to collaborate to ensure aseptic capacity is managed to a commonly high standard, is reimbursed at a sustainable level and supports further investment to meet growing demand in the NHS.
NHS England Specialist Pharmacy Services have to date not undertaken a comprehensive assessment of aseptic capacity to meet the future demands for chemotherapy provision in England. They are currently working closely with colleagues at the Department and NHS Improvement to support a number of regionally based reviews of aseptic capacity and to help trusts develop local and regional Hospital Pharmacy Transformation plans, as recommended by Lord Carter in February 2016.
The Medicines and Healthcare products Regulatory Agency (MHRA) is an executive agency of the Department and is responsible for regulating unlicensed medicines under a Manufacturer's 'Specials' Licence. The General Pharmaceutical Council (GPhC) and Care Quality Commission (CQC) are responsible for regulating medicine prepared extemporaneously in a register pharmacy or hospital pharmacy respectively under the professional exemption.
MHRA will collaborate with the NHS, GPhC and CQC though inspections of MHRA licensed aseptic facilities or joint investigations of aseptic facilities in hospitals where there are patient safety concerns.