Skin prick testing is the primary mode of testing for immediate IgE-mediated allergy. This testing is widely practised, carries very low risk of side effects to patients and provides high quality information when performed optimally and interpreted correctly.
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Ferrer Pharma Pty Ltd
Due to supply issues since 2008, it is necessary for medical practitioners in Australia to use skin testing products that are not registered with the Therapeutic Goods Administration (TGA).
This requires either endorsement as a TGA Authorised Prescriber or a Special Access Scheme (SAS) C application, as detailed below.
B. Section 19(5): Obtain "Authorised Prescriber status" by endorsement by an ethics committee - ASCIA members who work in hospitals and/or universities with access to a human research ethics committee (HREC) can obtain endorsement from an HREC to enable access to unregistered skin testing products. For details go to www.tga.gov.au/form/authorised-prescribers
C. Special Access Scheme (SAS) Category C: This is a notification pathway which allows health practitioners to supply goods that are deemed to have an established history of use without first seeking prior approval. The goods deemed to have an established history of use are specified in a list along with their indications and the type of health practitioner authorised to supply these products for the respective indications. For details go to www.tga.gov.au/form/special-access-scheme
Patient consent should be obtained when using unregistered skin testing products. Completed forms are for your record only and do not need to be sent to the TGA.
Content updated July 2018