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  • Submitted: May 04 2006 10:46 AM
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Download The FDA Bar Code Rule Decoded

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This document is a summary of the requirements contained in the FDA "Bar Code Label Requirements for Human Drug Products and Biological Products." It is designed to answer the most common questions about the Rule but is not intended to provide definitive answers to all possible questions. If there is any doubt about the applicability of the rule to a specific product or class of products, companies should contact the FDA for a clarification.

The discussion in this document focuses on prescription and over-the-counter (OTC) drugs and, except where specifically noted, does not apply to blood and blood products.

The FDA Rule was established to reduce the likelihood of errors dispensing medication. The use of bar codes is designed to ensure that the right medication in the right dosage is administered through the right route. The healthcare professional must ensure that it is administered to the right patient at the right time.

April 2006 FDA Q&A Guidance on "Bar Code Rule"

The FDA has issued an updated "Guidance for Industry Bar Code Label Requirements - Questions and Answers," including clarification of the effective date.

HTML: http://www.fda.gov/c...nce/7156fnl.htm

PDF: http://www.fda.gov/c...nce/7156fnl.pdf

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