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Track-and-Trace Technology |
“Track and trace” is the ability to locate an item (package) in the supply chain (track) and the ability to tell where an item (package) has been – its path (trace). There are efforts within the industry and government to develop a standardized product identifier – a serial number that can uniquely identify prescription drugs at the unit level, which sets the stage for implementation of electronic systems that are interoperable across the supply chain.
HDMA supports FDA’s efforts to develop system attributes to facilitate the tracking and tracing of prescription drugs.
- HDMA Comments on the Determination of System Attributes for the Tracking and Tracing of Prescription Drugs Notice - April 12, 2011
- HDMA Comments on the Unique Device Identifier—September 18, 2009
- HDMA's Comments on Standards for Standardized Numerical Identifier, Validation, Track and Trace, and Authentication for Prescription Drugs; Request for Comments; 73 Fed. Reg. 14988 (March 20, 2008) [Docket No. FDA–2008–N–0120]—May 19, 2008
- HDMA's comments on Technologies for Prescription Drug Identification, Validation, Track and Trace, or Authentication; Request for Comments; 73 Fed. Reg. 14991 (March 20, 2008) [Docket No. FDA–2008–N–0121]—May 19, 2008
- Section 913. Assuring Pharmaceutical Safety. This is the section of the statute that calls for FDA to evaluate standards and technologies including the Standardized Numerical Identifier (SNI).
- US Food & Drug Administration – Guidance for Industry: Standards for Securing the Drug Supply Chain – Standardized Numerical Identification for Prescription Drug Packages (Final Guidance), March 2010.
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Techinical/Standards
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Issue Contact: Anita Ducca (Federal Regulatory Affairs), John Howells (Industry Relations) |
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