FDA drafts guidance for the use of physical-chemical identifiers in pharmaceuticals to make it tougher for counterfeiters

July 14, 2009 § Leave a comment

Inks and Pigments and Flavors, oh my! A bit of a softball opening, sure, but the implications of the FDA’s recently circulated draft guidance on the use of these identifiers to help staunch the flow of bogus drugs into the marketplace are anything but. This set of recommendations has the potential to throttle the counterfeiters who sell damaging knockoffs. By including security measures that help determine whether a given drug is authentic or not, pharmaceutical companies can provide an additional layer of protection for their customers.

The industry term for these deterrents is physical-chemical identifiers (PCID). In addition to those mentioned above, the FDA’s guidance suggests that certain PCIDs may be used as “molecular tags” to identify a drug as legitimate. The equipment to test for the presence of this type of PCIDs would be given exclusively to the drug wholesalers and pharmacists. The FDA feels that the chance any complicating factors could result from adding these trace elements to the drugs is reduced as the potential components for the PCIDs are already used in other products and have established safety profiles.

This is an exciting development.

Still, whatever the ‘flavor’ used in these PCIDs, that the sham artists may be undone by a few proposed additives when they infamously add all sorts of chemicals and heavy metals to make their fake pills is an irony that we find most sweet.

Read the entire story.

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