Search Results for: HIBCC

standards

Can HIBCC Withstand The GS1 Tide In Medical Device Identification?

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I was recently asked to help a small medical device manufacturer switch all of their medical device-related product codes from Health Industry Business Communications Council (HIBCC) Universal Product Numbers (UPN) to GS1 Global Trade Item Numbers (GTIN).  Historically, the pharmaceutical supply chain has used GS1 GTINs but the medical device supply chain has predominantly used … Continue reading Can HIBCC Withstand The GS1 Tide In Medical Device Identification? →

GS1

Product Identification And National Registration Codes

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There is a long-running tug-of-war going on between GS1 and national governments around the world over how exactly to identify medical products, whether devices or pharmaceuticals.  National governments regulate those products to maximize the health of their citizens and so they take a natural interest in how they are identified.  They want to eliminate all … Continue reading Product Identification And National Registration Codes →

GTIN, NDC

Is A GS1 GTIN Really Usable As An NDC For DSCSA Compliance? Part 2

Part 1 of this essay provided a wealth of hyperlinks into the Code of Federal Regulations (CFR) and FDA guidance documents with content related to placing the National Drug Code in human- and machine-readable form onto drug packages prior to November 27, 2017 (see “Is A GS1 GTIN Really Usable As An NDC For DSCSA … Continue reading Is A GS1 GTIN Really Usable As An NDC For DSCSA Compliance? Part 2 →

GTIN, NDC

Is A GS1 GTIN Really Usable As An NDC For DSCSA Compliance? Part 1

After November 27, 2017 the U.S. Drug Supply Chain Security Act (DSCSA) requires drug manufacturers (2018 for repackagers) to affix a DSCSA “product identifier” to all drug packages entering the supply chain (see “The DSCSA Product Identifier On Drug Packages”).  According to the DSCSA, that product identifier must be present in both human-readable and 2D … Continue reading Is A GS1 GTIN Really Usable As An NDC For DSCSA Compliance? Part 1 →