When must dispensers notify the FDA and trading partners upon identification of an illegitimate product?

Dispensers must notify the FDA and their trading partners immediately upon the identification of an illegitimate product as part of the Drug Supply Chain Security Act (DSCSA). This urgency is critical because it helps ensure patient safety and maintains the integrity of the drug supply chain by allowing swift action to mitigate risks associated with illegitimate products.

The requirement for immediate notification emphasizes the potential dangers posed by such products, which can include counterfeit drugs, contaminated medications, or products that may have been tampered with. By establishing an immediate timeframe, regulatory authorities aim to prevent adverse events and protect public health effectively. Therefore, recognizing and acting on these illegitimate products without delay is a key responsibility of dispensers in maintaining compliance with federal regulations.