Off-label Use of Medicines

Guidelines and Publications Regarding Off-label Use of Medicines

The following documents are provided to inform off–label use of medicines. They discuss clinical, safety, legal and ethical issues surrounding off–label use as well as those specific to the paediatric population.

  • Checklist for Written Consent: Unregistered Use of Medicine

    August 2021

  • Rituximab

    May 2019

    Click here for Supporting documents for off-label Rituximab use, resources that were developed to assist clinicians and Drug and Therapeutics Committees regarding off-label use of Rituximab. They seek to assist the complex medical, ethical and regulatory management issues that arise when using Rituximab in an off-label manner.

  • CATAG: Rethinking medicines decision-making in Australian Hospitals; Guiding Principles for the quality use of off–label medicines, November 2013


  • Gazarian M. Off-label use of medicines in the paediatric population: recommendations for assessing appropriateness. Discussion paper for consultation, 7 May 2007 [WHO Expert Consultation on Essential Medicines for Children, 9-13 July 2007, Geneva].


  • Gazarian M, Kelly M, McPhee JR, et al. Off–label use of medicines: consensus recommendations for evaluating appropriateness. Med J Aust 2006; 185(10): 544-548


  • NSW Health Policy Directive PD2016_033


    Approval Process of Medicines for Use in NSW Public Hospitals (Replaces PD2008_037: Evaluation of Medicines for Use in Public Hospitals) Available here

  • NSW TAG Discussion Paper: Off–Label Use of Registered Medicines and Use of Medicines under the Personal Importation Scheme in NSW Public Hospitals

    September 2003

Page last updated 12 August 2021