FDA: Incorporation of Physical- Chemical Identifiers into Solid Oral Dosage Form Drug Products for Anticounterfeiting

This document is intended to provide guidance to pharmaceutical manufacturers who want to use physical-chemical identifiers (PCIDs) in solid oral dosage forms (SODFs). 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.