What is Section 10 exemption?

· London and South East Quality Assurance

The Medicines Act 1968 introduced a licensing system to regulate the manufacture, distribution and importation of medicinal products. Section 10 of the Act exempts pharmacists from the licensing requirements (ML, PL) in the following circumstances:

a) The medicinal product is prepared or dispensed in a hospital or health centre by or under the supervision of a pharmacist and in accordance with a doctor’s prescription. b) Assembling a medicinal product in a hospital or health centre by or under the supervision of a pharmacist c) Preparing a stock of medicinal products in a hospital or health centre by or under the supervision of a pharmacist with a view to dispensing them

The Farwell Report (section 3.2, p5) lists five criteria from “Guidance to the NHS on the Licensing Requirements of the Medicines Act 1968”, (Medicines Control Agency; 1992). These criteria must be met by unlicensed aseptic preparation units when preparing stock in anticipation of a prescription for parenteral administration under section 10 exemption:

i) The preparation is done by or under the supervision of a pharmacist ii) The preparation uses closed systems iii) Licensed sterile medicinal products are used as ingredients or the sterile ingredients are manufactured in licensed facilities iv) Products will have an expiry date of no longer than one week. The shelf life should be supported by stability data v) All activities should be in accordance with defined NHS guidelines

Farwell states “The same criteria should also be considered appropriate for preparation for dispensing directly to named patients”.

References: Farwell J. Aseptic Dispensing for NHS Patients. (The Farwell Report). London: Department of Health;1995 Guidance to the NHS on the Licensing Requirements of the Medicines Act 1968. Medicines Control Agency; 1992 The Medicines Act 1968

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