Thursday, November 6, 2014

FDA blows off GS1 Healthcare for facility identification schema

Read the full article: FDA blows off GS1 Healthcare for facility identification schema - Pharmaceutical Commerce:

"What’s left unsaid in the document is how establishment location data necessary for tracking drug shipments (as opposed to filing paperwork with FDA) will be reconciled with DUNS. GS1’s interlocking numbering systems—GTIN for product identification, GLN for physical locations, and the EPCIS system for communicating transaction information (among others)—is looked on as the likely choice for structuring drug traceability under the Drug Supply Chain Security Act (DSCSA); additionally, many of the leading group purchasing organizations (GPOs) have been pushing suppliers (including pharma companies) to use GS1’s GLN and GTIN format for recording shipments to member organizations. GLN has the advantage over DUNS (which originated as a way to track the financial records of companies) of providing a high degree of precision on location—the specific loading dock at a hospital pharmacy, for example."

'via Blog this'

Read the document:
FDA Guidance - Specification of the Unique Facility Identifier (UFI) System for Drug Establishment Registration (PDF)

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