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Pharmaceutical Manufacturing and Packing Sourcer

Assessing the Implications of the New Drug Labelling Legislation

The issues surrounding the labelling of pharmaceutical products have generated considerable coverage in the press over the last few months. This upsurge in interest has been sparked by two imminent changes in labelling legislation. The first comes from the FDA and relates to licensed products, while the second change is driven by the European Union and focuses on investigational products. This article will consider the implications these changes will have on the assembly and packaging of pharmaceutical products.

FDA Final Ruling

On 25th February this year, the FDA issued its final ruling on the requirement to include bar codes on the packaging of human drug products and biological products. The motive behind the ruling is the desire to reduce the number of adverse events and transfusion errors that occur - the FDA estimates that this new ruling will prevent over 500,000 such errors over a period of 20 years, with an associated cost saving of billion in the same period.

In some hospitals that are already using bar coding systems, medication error rates have been reduced by as much as 85 per cent and one hospital in the US has administered 5.7 million doses of medication to date without a single error. On the downside, according to the FDA's own figures, the financial impact of this ruling on the pharmaceutical industry is expected to be million in the first two years. Despite this, there has been widespread support for this approach to improving patient safety from health care professionals, hospitals and trade and professional associations alike.

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By Dr Sue Miles, Head of Clinical Trials Services at Brecon Pharmaceuticals Ltd

Dr Sue Miles is Head of Clinical Trials Services at Brecon Pharmaceuticals Ltd. She has an MA from Cambridge and a PhD from Edinburgh and has gained valuable industry experience working in preclinical research in the pharmaceutical sector. Before joining Brecon, Sue was CEO at Quantum Research Ltd for six years.
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Dr Sue Miles
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