Pharmaceutical Product Serialization and DQSA

Serialization, the process of assigning and marketing each individual pharmaceutical product or component with unique markers provides a comprehensive history of the product’s chain of custody from manufacturing through to drug dispensation. Using serialization enables improved collection, traceability and security of pharmaceutical products throughout the supply chain. Currently over 50% of the pharmaceutical industry uses serialization with coding and marking technology implemented during the manufacturing process but is less commonly used by co-packers and smaller pharmaceutical companies. Using product serialization for pharmaceuticals is beneficial in a variety of ways. Serialization helps to control costs, improve shipping accuracy, facilitate better control of inventory, and minimize product chargebacks associated with packaging errors. Serialization of pharmaceutical products helps ensure compliance with federal regulations. In addition, pharmaceutical product serialization helps to protect against counterfeiting to ensure consumer product safety and help to safeguard brand reputation. Serialization is a key component of the new Drug Quality and Security Act (DQSA). The Drug Quality and Security Act ensures that one consistent regulation is applied across all states. The new law will help to eliminate threats to patient safety and security and will aid in improving the effectiveness of product recalls. By the end of 2017, full serialization on a package level for pharmaceutical products is required. Pharmaceutical manufacturers must place a unique serial number on individual packages of prescription drugs to facilitate product tracing and authentication from the point of manufacturing through to dispensation. Over the next ten years, the Drug Quality and Security Act mandates the following key provisions for implementation: third party logistics provider licensing; product identification, product tracing; product verification; wholesale licensing; notification; detection and response.