Meaning
Pharmaceutical tracking requirements demand the application of unique identifiers to individual packages and homogenous cases. The dscsa serialization process involves printing a standardized data matrix that contains a product code, serial number, lot number, and expiration date. This system allows for the electronic tracing of a medicine from the factory to the pharmacy.
Identification Standard
Each unit of sale receives a distinct number that no other package of the same product shares. Under the rules for dscsa serialization, these identifiers must be readable by both humans and machines to ensure data can be captured at every point in the supply chain. The use of a standard format prevents confusion between different manufacturers and distributors.
Supply Integrity
The primary goal of these marking requirements is to prevent counterfeit or stolen medicines from entering the legitimate market. By checking the dscsa serialization data against a central database, a wholesaler can verify that the package in their warehouse is exactly what the manufacturer produced. This verification step must happen before the goods are sold to a hospital or retail pharmacy.
Reporting Compliance
Manufacturers and distributors must maintain electronic records of all transactions involving these serialized units for several years. Achieving dscsa serialization involves heavy investment in high speed printing and scanning technology that can handle thousands of units per hour. Failure to provide the required data during an audit results in heavy fines and the potential loss of a license to distribute controlled substances.
