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Bar Codes: FDA Issues Drug Serialization Guidelines

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Bar Codes: FDA Issues Drug Serialization Guidelines

Bert Moore

Protection of the pharmaceutical supply chain takes a (small) step forward

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 above.

Publication date: April 2010

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