Draft Guidance for Industry on “Incorporation of Physical-Chemical Identifiers into Solid Oral Dosage Form Drug Products for Anticounterfeiting,” Availability

摘要

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Incorporation of Physical-Chemical Identifiers into Solid Oral Dosage Form Drug Products for Anticounterfeiting." This draft guidance provides recommendations to pharmaceutical manufacturers on design considerations for incorporating physical-chemical identifiers (PCIDs) into solid oral dosage forms (SODFs), 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, supporting documentation to be submitted in postapproval submissions to report or request approval to incorporate PCIDs into SODFs, and procedures for reporting or requesting approval to incorporate PCIDs into SODFs as a postapproval change. This draft guidance also provides our recommendations regarding evaluation of toxicological and other concerns for PCIDs that are incorporated into packaging and labeling and procedures for reporting or requesting approval to add PCIDs to packaging and containers as a postapproval change.