Bar Codes: FDA Issues Drug Serialization Guidelines
Protection of the pharmaceutical supply chain takes a (small)
In a move that will please some and puzzle others,
the U.S. Food and Drug Administration (FDA) has issued "Standards for Securing the Drug Supply Chain -
Standardized Numerical Identification for Prescription Drug Packages --
Guidance for Industry" for package level serial number identification
(SNI) of prescription pharmaceuticals, blood products and biologicals.
It will please many because it is compatible with
existing GS1 and International Council for Commonality in Blood Banking
Automation (ICCBBA) ISBT 128 coding structures. It will puzzle others because
it is neither a regulation nor a mandate as the Food and Drug Administration
Amendments Act of 2007 (FDAAA) (Public Law 110-85) required.
So, is it bad news, good news or simply confusing?
In most respects, the new guidance is all of the
Publication date: April 2010