cGMPs

FDA Publishes Updated Barcode Label Q&A

Source: PharmaManufacturing.com

Sep 13, 2011

rx-360.org

FDA published a revised Guidance for industry:  Bar Code Label Requirements---Questions and Answers, on August 11, 2011.  This revision amends the response to Question 12 of the October 2006 guidance and allows vaccine manufacturers to use “alternative coding technologies” to linear bar code technology.

FDA feels this is necessary based on the mandatory recordkeeping requirements associated with administration of childhood vaccines.  Administration generally occurs in a physician office or clinical that may have limited administrative support to record the necessary data for each administration and use of alternative coding technologies may facilitate collection and recording of this information.

To view or download the FDA's Q&A, click here

To view or download the FDA's Update Q&A, click here