What time frame must manufacturers and distributors notify the FDA of an illegitimate product?

Manufacturers and distributors are required to notify the FDA within 24 hours of discovering or receiving information that a product is illegitimate. This regulation is part of the Drug Supply Chain Security Act (DSCSA), which aims to enhance the security of the drug supply chain and protect patients from unsafe medications. The 24-hour timeframe is important because it allows the FDA to promptly investigate and take necessary actions to address the issue, thereby minimizing the risk of the illegitimate product being distributed and consumed by patients. The timely notification helps ensure that the integrity of the drug supply chain is maintained, supporting patient safety and public health.