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When packaging and labeling help fight drug counterfeits

In the Food and Drug Administration’s ongoing battle against counterfeit drug products, the latest FDA guidance is aimed directly at packaging techniques.

In a July guidance document to industry, FDA set forth some suggestions for incorporating so called “physical-chemical identifiers” into solid oral dosage form drug products and paid particular attention to those that might migrate from packaging or container labeling.

FDA defines a PCID as a product with some unique physical and or chemical characteristic that is added to the dosage form of a drug product and which “makes it possible to detect and authenticate legitimate dosage forms and identify counterfeits.”

These so called PCIDs can include inks, pigments, flavors, or molecular taggants, says FDA. And FDA expects that many of them would be made of already existing substances used in food additives, colorants, or drug products excipients. The FDA’s guidance document, entitled “Incorporation of Physical-Chemical Identifiers Into Solid Oral Dosage Form Drug Products For Anticounterfeiting,” is primarily concerned with helping drug makers and applicants for new drug approvals incorporate relevant information about their PCIDs into new drug applications, supplemental applications, and annual reports submitted to FDA.

The guidance does not attempt to address radio frequency identification (RFID).

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