Tag Archives: HRI

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I’ve Changed My Mind, Follow GS1’s HRI Specification

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HRI zoomThat’s right, I now recommend that you follow GS1’s Human Readable Interpretation (HRI) specification for drug labeling, even when under a serialization regulation.  Previously I recommended against it (see “The DSCSA Product Identifier On Drug Packages”, and “The ANVISA Unique Medicine Identifier (IUM) on Drug Packages”).  Why have I changed my mind?  GS1 modified their specification to accommodate most of the objections I had over it.  Let me explain.

The new specification for HRI is in the latest version of Continue reading I’ve Changed My Mind, Follow GS1’s HRI Specification →

DSCSA Product Identifier

The DSCSA Product Identifier On Drug Packages

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DSCSA Product IdentifierAccording to the Drug Supply Chain Security Act (DSCSA), manufacturers must apply a new “Product Identifier” on all of their prescription drug products by November 27, 2017 (Repackagers by that date in 2018).  The DSCSA Product Identifier is defined this way:

“PRODUCT IDENTIFIER.—

The term ‘product identifier’ means a standardized graphic that includes, in both human-readable form and on a machine-readable data carrier that conforms to the standards developed by a widely recognized international standards development organization, the standardized numerical identifier, lot number, and expiration date of the product.”  (Section 581[14])

Continue reading The DSCSA Product Identifier On Drug Packages →