Bar Code Label Requirements for Human Drug Products and Biological Products

This ICR collects information regarding waiver requests or exemptions from bar code requirement regulations. A request that FDA waive the bar code requirement for a particular drug product must include the following information: (1) Compliance with the bar code requirement would adversely affect the safety, effectiveness, purity, or potency of the drug or not be technologically feasible, and the concerns underlying the request could not reasonably be addressed by measures such as package redesign or use of overwraps; or (2) an alternative regulatory program or method of product use renders the bar code unnecessary for patient safety.

The latest form for Bar Code Label Requirements for Human Drug Products and Biological Products expires 2022-08-31 and can be found here.