TGA News Issue 19 (June 2005) - From the Compliance Branch
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New recall coordinator for therapeutic goods
Mr Jeff Dutton has been appointed the Australian Coordinator for the Uniform Recall Procedure for Therapeutic Goods, following the retirement of Mr Ray Murray.
Even with the best manufacturing procedures, mistakes and other unpredictable events can result in mislabelled, defective or unsafe products being released for distribution, with the potential for such goods to cause harm to consumers. The objective of the Uniform Recall Procedure for Therapeutic Goods is to facilitate recall when a deficiency in a therapeutic good is established which warrants such action. The Procedure sets out step-by-step actions that are taken to ensure prompt recall. It is a practical procedure that aims to protect the consumer and provide guidance for the manufacturer.
Mr Dutton is also the secretary to the National Coordinating Committee on Therapeutic Goods which oversees the recall procedure. He has been with the Department for ten years, and was previously a senior hospital pharmacist.
Mr Roger Nixon has been appointed the Deputy Recall Coordinator and Mrs Allison Jansen is the administrative assistant.
Expiry dating: towards 2000
Over the last few months, the TGA Compliance Branch has received several enquiries from sponsors of drug products seeking advice on how they should express the year in the expiry date on labels, where the year of expiry is "2000".
This matter was raised with the industry bodies about a year ago and there was general agreement that it would be acceptable to express the year "2000" on labels as "00" preceded, as usual, by the month. For example, if the expiry date is "March 2000" then it could be expressed as "MAR 00" or "3/00". Some sponsors may wish to use "2000" in full for greater clarity and this will also be acceptable - the example would then be expressed as "MAR 2000" or "3/2000".
