According to the guidance, "There are various available means for presentation and detection of PCIDs (e.g., photolithography,
holography, optical microscopy, laser scanning devices, excitation/fluorescence detection). Some identifying characteristics,
such as pigments or flavors, could be easily observed by patients, healthcare practitioners, and pharmacists. Others could
require the use of a detection instrument (e.g., a scanner, photometric detector, mass spectrometry)." What is the expectation
in terms of who has responsibility—for example, healthcare providers or pharmacists—for determining and authenticating the
presence of a PCID before patient distribution?
There is no intention by FDA to place a burden of responsibility on healthcare providers to authenticate drugs by determining
the presence of a PCID before patient distribution.
Are there plans to extend the guidance beyond solid dosage forms?
There are no plans at this time to extend the guidance on PCIDs beyond solid oral dosage forms.
What other anticounterfeiting measures does FDA recommend for oral solid dosage forms in addition to PCIDs?
FDA encourages manufacturers to continue exploring promising technologies for use as anticounterfeiting measures. These may
include radiofrequency identification (RFID), nanotechnology, encryption and other track-and-trace technologies.
Manufacturers can submit information about their intent to use a PCID in a solid oral dosage product in an NDA or ANDA or
as a postappoval change. Some industry members have raised convern over confidentiality. Can you confirm that PCID information
submitted in these documents is confidential and therefore protected from would-be counterfeiters?
FDA confirms that information on PCIDs submitted by applicants or master file holders is considered confidential.
1. FDA, Guidance for Industry: Incorporation of Physical- Chemical Identifiers (PCIDs) into Solid Oral Dosage Form Drug Products for Anticounterfeiting (Rockville, MD, October 2011).
2. FDA, Counterfeit Drug Task Force Report: "Combating Counterfeit Drugs" (Rockville, MD, February 2004).