FDA provided on its website in early August a Q&A giving additional guidance on human drug recalls – their purpose, FDA’s authority to mandate them, over-the-counter (OTC) drug versus prescription drug recalls, and related investigations.
The Q&A was posted in the context of the recent debate and proposed legislation around FDA’s recall authority (IPQ In the News July 20 and August 11), and the issues raised by what was referred to in the Congressional inquiry as the “phantom recall” by J&J (IPQ In the News June 2). Links are provided in the Q&A to the specific guidance documents relevant to the issues addressed.
The Q&A document addresses the following six questions: ● What is a recall? ● Can FDA mandate a recall of human drugs? ● Are OTC drugs subject to the same recall provisions as prescription drugs? ● Do manufacturers of OTC products have to report quality defects? ● Does FDA expect firms to investigate both released and rejected lots for potential recalls? ● What happens if a firm does not voluntarily recall a defective product?
[More on FDA’s recall Q&A and a link are provided for subscribers here.]