PharmTech:
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?
FDA:
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.
PharmTech:
Are there plans to extend the guidance beyond solid dosage forms?
FDA:
There are no plans at this time to extend the guidance on PCIDs beyond solid oral dosage forms.
PharmTech:
What other anticounterfeiting measures does FDA recommend for oral solid dosage forms in addition to PCIDs?
FDA:
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.
PharmTech:
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:
FDA confirms that information on PCIDs submitted by applicants or master file holders is considered confidential.
Reference
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).
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