What is exempt from misbranding when returned medications are commingled?

Returned medical devices that have been properly sanitized are exempt from misbranding when commingling occurs because they are not intended for human consumption in the same way pharmaceuticals are. Medical devices can often be cleaned and restored to a state that allows them to be reused safely, provided they are properly sanitized to eliminate any risk of contamination or infection. This regulatory understanding emphasizes the importance of the sanitation process, which ensures that the returned items do not pose a health hazard to future users.

In contrast, returned solid dosage forms and repackaged bulk medications do not receive the same exemptions due to the inherent risks of contamination or degradation that can occur when they are mixed with other products. Unopened drugs with original labels may still be considered for reuse; however, their status is more closely associated with proper storage and handling protocols rather than the commingling of returned medications. Thus, the unique nature of properly sanitized medical devices allows them to be treated differently under misbranding regulations.