In mid-October, FDA released a final version of a 2009 draft guidance for industry intended to provide guidance to pharmaceutical manufacturers who want to use physical-chemical identifiers (PCIDs) in solid oral dosage forms (SODFs) to help prevent counterfeiting.
A PCID is a substance or combination of substances possessing a unique physical or chemical property that unequivocally identifies and authenticates a drug product or dosage form.
On-dose authentication technologies are receiving increasing attention as a means to address the threats stemming from pharmaceutical repackaging, where packaging ID features are not able to prevent genuine product from ending up in counterfeit packaging, and vice versa.
Soon after the 2009 draft guidance was published, CDER compliance official Richard Freidman spoke on the promising “new innovative approaches by which pharmacies and patients can authenticate products,” including PCID technology (IPQ “In the News” September 9, 2010).
The final guidance provides recommendations to pharmaceutical manufacturers on: ● design considerations for incorporating PCIDS into SODFs ● supporting documentation to be submitted in new drug applications (NDAs) and abbreviated new drug applications (ANDAs) to address the proposed incorporation of PCIDs in SODFs ● supporting documentation to be submitted in postapproval submissions to report or request approval to incorporate PCIDs into SODFs, and ● procedures for reporting or requesting approval to incorporate PCIDs into SODFs as a postapproval change.
The incorporation of components or features used in radiofrequency identification for drug products is outside the scope of the guidance. In addition, this guidance does not apply to manufacturing or formulation changes made in conjunction with the addition of a PCID that go beyond simply inserting the PCID into a blending or mixing operation (e.g., adding a PCID to a non-functional tablet film coating is covered by this guidance, but adding a non-functional film coating that contains a PCID to a previously uncoated tablet involves manufacturing changes that are not covered by this guidance). The incorporation of a PCID into the packaging or labeling is not covered in the guidance.