FDA issued this document to provide guidance to pharmaceutical manufacturers who want to use physical-chemical identifiers (PCIDs) in their solid oral dosage forms to prevent/ reduce the potential for counterfeiting. The use of PCIDs is to unequivocally identify and authenticate a drug product or a dosage form (SOFD). Although the proclaimed statistics related to counterfeit drugs by WHO appear to be unsubstantiated, it appears that the industry is experiencing an increase in the number of counterfeit drugs that are entering into our supply chain. Therefore, ensuring the integrity of the supply chain is paramount to ensuring that patients get the proper drug in the proper dosage form, tested to conformance with stringent specifications.
This guidance provides recommendations to pharmaceutical manufacturers on (1) design considerations for incorporating PCIDS into SODFs, (2) 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, (3) supporting documentation to be submitted in post-approval submissions to report or request approval to incorporate PCIDs into SODFs, and (4) procedures for reporting or requesting approval to incorporate PCIDs into SODFs as a post-approval change.