The Food and Drug Administration (FDA) is seeking comments on its plan to reassess bar code technologies for drugs and biological products. FDA requests comments by January 9, 2012, with reply comments by February 23.
According to FDA, the “Bar Code Final Rule” of 2004 requires a bar code on certain human drug products and biological products. The agency plans to reassess the costs and benefits of the rule and to identify any relevant changes in technology that have occurred since it took effect. “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,” states the agency. “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.”
FDA specifically invites small businesses to address such topics as (i) any successes or challenges in adopting linear bar code technologies, (ii) product coding changes since 2004, and (iii) unplanned expenses if an alternative to the linear bar code were implemented. See Federal Register, October 26, 2011.