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Unlicensed medicines

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Risk Associated with the Outsourcing of the Aseptic Compounding of Parenteral Nutrition (Yellow Cover)

16 December 2016The purpose of this document is to give guidance to those outsourcing PN compounding on the risks in the outsourcing and supply process and to…

Off-label or unlicensed product use under HMR 2012 exemptions

8 January 2020A legal position summary regarding the sale, supply or administration of off-label/unlicensed products under Schedule 17 of the Human Medicines Regulations 2012

Evaluating the quality of imported Specials

24 June 2024Information from suppliers enables purchasers to assess the quality of imported unlicensed medicines

Labelling and packaging of unlicensed medicines (Specials): best practice guidance for the NHS

1 March 2022National guidance from NHSE/I to reduce LASA errors and improve patient safety when considering requirements for unlicensed specials medicines

Unlicensed medicines

All our advice relating to making, purchasing and using unlicensed medicines.

Governance principles for unlicensed medicines

30 November 2023Factors to consider when unlicensed medicines are used, ensuring good governance.

Purchasing Specials

30 November 2023Factors to consider when purchasing Specials and imported unlicensed medicines from commercial manufacturers
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Summary of biopharmaceutical stability data reviewed and available extended shelf-life data

4 June 2021The stability of several aseptically compounded ready to administer presentations of monoclonal antibody products and other biopharmaceuticals is presented.

Guidance on Managing The Sourcing and Supply of Ready-to-Administer Chemotheraphy Doses for the NHS (Yellow Cover)

5 December 2016This document is aimed at staff in UK NHS hospitals considering or already sourcing their supply of chemotherapy as ready-to-administer doses.
Registration required

Cabazitaxel: Cytotoxic Drug Stability Monograph

12 March 2021Stability information is essential for the safe aseptic preparation of cabazitaxel