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Zdrowie i gospodarka · 26.10.2011

Bar Code Technologies for Drugs and Biological Products; Retrospective Review Under Executive Order 13563; Request for Comments

The Food and Drug Administration (FDA) is announcing a review of the "Bar Code Final Rule," under Executive Order 13563, "Improving Regulation and Regulatory Review." The Bar Code Final Rule, which was published in 2004, requires certain human drug products and biological products to have a bar code. 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. FDA is establishing a public docket to receive information relevant to reassessing the Bar Code Rule. This is an opportunity for interested persons to share information, research, and ideas on the need, maturity, and acceptability of alternative identification technologies for the identification, including the unique identification, of 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.

Source: Federal Register — Health and Human ServicesOpen original release →