FDA Invites Public Comments on Drug Compounding

The United States Food and Drug Administration (“FDA”) has been working towards implementing the Drug Quality and Security Act (“the act”) since the laws inception in 2013. They have issued multiple notices for input on a multitude of specific issues under the act, however, they have not invited general comment on the act.

On March 6, 2015, the FDA issued a general invitation to the public for comment on implementation of the act. The invitation for comment is related to regulations on human drug product compounding under section 503A and 503B of the act. However, it is designed to accept comments, recommendations, and information about the entire act, especially for issues that have not been addressed in other public dockets.

The comment period is being held open indefinitely. The invitation in the Federal Register may be found at the following link: https://s3.amazonaws.com/public-inspection.federalregister.gov/2015-05376.pdf

© 2015 Houghton Vandenack Williams

For more information, Contact Us