Standards for Standardized Numerical Identifier, Validation, Track and Trace, and Authentication for Prescription Drugs; Request for Comments

Zusammenfassung

The Food and Drug Administration (FDA) is seeking information and comments on issues related to standards for identification, validation, tracking and tracing, and authentication for prescription drug products. Particularly, we are requesting information and comments from drug manufacturers, distributors, pharmacies, other supply chain stakeholders, foreign regulators, standards organizations, and other Federal agencies and interested parties. This request is related to FDA's implementation of the Food and Drug Administration Amendments Act of 2007 (FDAAA). Elsewhere in this issue of the Federal Register, FDA is publishing a related document entitled "Technologies for Prescription Drug Identification, Validation, Track and Trace, or Authentication; Request for Information."