The FDA issued a draft guidance “Draft Guidance for Industry: Incorporation of Physical-Chemical Identifiers (PCID) into Solid Oral Dosage Form Drug Products for Anticounterfeiting” on July 13, 2009. This PCID guidance focuses on the use of inks, pigments, flavors and other physical-chemical identifiers that can be used by manufacturers of solid oral dosage forms (SODF) to provide a drug product that is more difficult for counterfeiters to duplicate. One clear message from this guidance is that many of the ingredients that would be reasonable to incorporate into SODF as PCIDs will be those already used as food additives, colorants, or excipients in the Inactive Ingredient Guide with established safety profiles. What is the safety data in humans available on the PCID that is being incorporated into the SODF? The amount of the PICD must also be considered when evaluating this safety profile.
In addition to the overall safety of the PCID added to the SODF, the FDA is concerned that there is no interference with the bioavailability of the active ingredient. Therefore the earlier in the development process of the SODF that the PCID is incorporated the more information will be available at the time of filing.