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Unlicensed medicines

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Unlicensed medicines and use of PGDs

16 November 2021This page explains why PGD are not legal mechanism for the administration or supply of unlicensed medicines.

A Guide to Quality Control Chemical Testing of Aseptically Prepared Products

2 July 2021This document covers laboratory chemical analysis of aseptically prepared products. The reasons for analysis are outlined in Section 2 of this document

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.

Cabazitaxel: Cytotoxic Drug Stability Monograph

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

Vincristine: Cytotoxic Drug Stability Monograph

15 December 2020Stability information is essential for the safe aseptic preparation of vincristine

About SPS Cytotoxic Drug and Biopharmaceutical Stability monographs and advice

24 August 2020Validated stability data ensures products compounded by cytotoxic reconstitution processes within aseptic units are safe for patients

Off-label or unlicensed products and Schedule 17 of the Human Medicines Regulations 2012 exemptions

8 January 2020The below summary details the legal position regarding the sale, supply or administration of off-label/ unlicenced products under Schedule 17 of the HMR 2012

Using Standardised Strengths of Unlicensed Liquid Medicines in Children

10 October 2019A joint statement from the Neonatal and Paediatric Pharmacists' Group (NPPG) and the Royal College of Paediatrics and Child Health (RCPCH)

Emergency Preparation of Eye Drops In Unlicensed Aseptic Units 1st Edition

18 September 2019This document aims to provide guidance to NHS Chief Pharmacists and Accountable Pharmacists working under the Section 10 exemption to the Medicines Act 1968 on…

Guidance to the NHS on the licensing provisions of the Medicines Act 1968. (Medicines Control Agency, 1992)

2 April 2019This document provides guidance and advice which is still relevant to the NHS today, on the application of the licensing provisions of the Medicines Act…