Opportunities for Drug Serialization to Make U.S. Drug Supply Chain Safer, More Secure
The Drug Supply Chain Security Act (DSCSA), signed into law in 2013, requires drug manufacturers and repackagers to identify each individual package of a prescription drug with a unique serial number. This significant requirement provides a way for stakeholders in the pharmaceutical supply chain to verify the drug’s authenticity and track its ownership as it moves from the manufacturer to the wholesale distributor to the pharmacy.
The law establishes baseline obligations for checking serial numbers, but as repackagers, shippers, and businesses at every link in the supply chain work with regulators to implement the law, they have the opportunity to also use serial numbers to provide even stronger protections against counterfeit, tainted, or stolen drugs.
DSCSA minimum requirements for drug serialization and authentication
Drug serialization is the foundation for the fully electronic, interoperable drug tracing system that must be established by 2023. Most drug packages have a linear bar code with a 10-digit national drug code (NDC). Starting in November 2017, manufacturers must add a two-dimensional bar code that includes the NDC, the lot number, the expiration date of the drug, and a serial number unique to each package. Repackagers will start serializing pharmaceutical products in November 2018.
By late 2020, companies in the supply chain must start using the serial numbers to check the authenticity of drugs they suspect to be illegitimate. Companies must also verify serial numbers when reselling returned products.
The law requires a fully electronic traceability system by late 2023 that includes exchanging information about the purchase and sale of each serialized package in an interoperable, electronic manner between supply chain trading partners. These baseline requirements will aid in preventing potentially dangerous or compromised products from reaching patients.