FDA Announces Review of Bar Code Final Rule

This post was written by Erin Janssen.

The Food and Drug Administration (FDA) has published a notice announcing that it will conduct a review of its 2004 ‘‘Bar Code Final Rule,” which requires certain human drug products and biological products to have a bar code. The rule was intended to help reduce the number of medication errors that occur in hospitals and other health care settings FDA now wishes to reassess the costs and benefits of the rule and to identify any relevant changes in technology that have occurred since it went into effect. FDA will use the information received to assess whether the Bar Code Final Rule is achieving its intended benefits as effectively as possible or should be modified. Initial comments must be received by January 9, 2012 and reply comments by February 23, 2012. 

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