FDA Bar Coding Final Rule Sets Two-Year Implementation Timeline For Existing Products
This article was originally published in The Pink Sheet Daily
Executive Summary
New products approved after April 26 would have to include bar codes on packages within 60 days. The proposed rule would have created a blanket three-year implementation period.
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FDA's bar code final rule has a shorter implementation timeline than the proposed rule. Under the 1 final rule, "Bar Code Label Requirements For Human Drug Products and Biological Products," manufacturers have two years to apply the bar code requirements to products approved before April 26, the rule's effective date. For new drugs approved on or after April 26, the bar code must be added within 60 days of approval. The proposed rule would have created a three-year implementation period for all products. The rule requires bar codes on the packages of most prescription drugs and biologics, and over-the-counter drugs commonly used in hospitals. It is expected to be published in the Federal Register on Feb. 26. FDA estimates that once fully implemented, the bar code rule will save $93 bil. over 20 years and prevent almost 500,000 adverse events. At a Feb. 25 press conference in Washington, FDA Commissioner McClellan called these estimates "conservative," noting that in some bar coding studies, medication errors were reduced by up to 85%. - Elizabeth Walker |