Archive for the ‘Industry News’ Category

What Direction is the FDA Heading with Track-and-Trace?

The drug industry was in a track-and-trace coma until the FDA’s publication of the final guidance on a Standard Numerical Identifier (SNI) for pharmaceutical packages in March 2010 woke them up. Manufacturers no longer have to wait until the January 1, 2015 deadline set by California to see what the accepted practice will be.

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Serialization Survey – The Results are in!

It is well known that the counterfeiting of pharmaceutical drugs and medical devices is a real and constant threat to patient safety.  This is a global issue that doesn’t recognize borders of trade agreement and its supply chain is fast to react to new opportunities.

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National Audit Office puts its weight behind GS1 standards in NHS*

The National Audit Office (NAO) has made an explicit recommendation that the Department of Health (DoH) should call for the adoption of universal bar coding standards in the NHS.

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Barcodes required for all Indian pharmaceutical exports

Counterfeit pharmaceuticals are an ongoing problem worldwide.  And the labelling industry has been heavily regulated as a result.  Different geographies can sometimes be at a higher risk than others, and in recent weeks, India has been cited as a source of counterfeits. (more…)

There’s More to Labels than Meets the Eye: the GHS Standards for Durability

When you think about labels for pharmaceuticals, chemicals and medical devices, you think about the contents of the label for identification and tracking purposes and the regulations surrounding them.  But there’s more to labels than the words and symbols that appear on them.   (more…)

Why are Some Pharmaceutical Labels Still Putting Patient Safety at Risk?

When the FDA introduced SPL (structured product labeling), the idea was to help inform consumers and improve patient safety. This regulation requires manufacturers to submit prescribing and product information (i.e., the package insert or label) using standardized medical terminology in a readable, accessible format. (more…)