Monday, May 4, 2015

The DSCSA Product Identifier On Drug Packages - Dirk Rodgers

According 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])
In an earlier essay, “DSCSA ‘Serial Numbers’” Dirk focused on the serial number portion of the product identifier, and in his last essay “Identification Of Pharma Cases In The U.S.” he focused on how the product identifiers would be placed onto cases.  In this essay Dirk takes a look at issues surrounding the application of the product identifier on drug packages.

Section 582(a)(9) of the DSCSA, “PRODUCT IDENTIFIERS”, in part says:
“…the applicable data—
“(i) shall be included in a 2-dimensional data matrix barcode when affixed to, or imprinted upon, a package; …”
To read Dirk's full essay please continue on RxTrace.com