This Draft Guidance is related to the Drug Supply Chain Security Act (DSCSA), and is intended to aid trading partners in identifying a suspect product, to provide information on how to notify trading partners and FDA about illegitimate product, and to delineate the process to subsequently terminate those notifications. Due to the critical nature of supply chain security as well as the high impact of DSCSA and this Draft Guidance on industry, it is essential that the Final Guidance be clear, practical, and represent best practice based on regulator and industry experience.
The intent of DSCSA is to minimize the risk of illegitimate product reaching patients. While no measures can completely prevent introduction of counterfeit product into the supply chain, it is crucial that both industry and regulators take all appropriate measures to protect the supply chain and assure patient safety. The Draft Guidance provides insight into potentially problematic situations and product characteristics to aid industry in identifying suspect product and scenarios where heightened surveillance may be appropriate. To be effective, this Guidance must offer viable measures to identify suspect product without unintended impact on the ability of legitimate entities to carry out their business.