FDA Considers Changes to 2004 Bar Code Rule for Drugs, Biological Products
The Food and Drug Administration is announcing a review and comment request on its 2004 “Bar Code Final Rule,” which requires certain human drug products and biological products to have a bar code. The review is part of FDA's regulatory…
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review process established by Executive Order 13563, "Improving Regulation and Regulatory Review.” Information submitted can help FDA 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, including alternative identification technologies for drugs and biological products. 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. Comments are due by approximately Jan. 9, 2011. Reply comments are due by approximately Feb. 23, 2011.