The Drug Supply Chain Security Act – DSCSA (Title II, Drug Quality and Security Act, 2013) has been signed into law, with full implementation phased in over the next 10 years. The next milestone for manufacturers is November 27, 2017; the date by which Pharmaceutical manufacturers are required to print a unique product identification code on all Rx units of sale and homogeneous cases distributed domestically.
Starting November 27, 2017, prescription drug products can no longer be shipped without a DSCSA-required unique serial identification code. Although manufacturers already print lot and date codes on each unit of sale, either by a static or variable barcode, the reality of these new regulations goes far beyond printing a few more added attributes and modifications to your existing labels. The core concept behind DSCSA is to develop and maintain a tracking system from the manufacturing floor through the point-of-sale capable with 100% accuracy.
Manufacturers are required to comply with the following by November, 2017:
- Serialize units of sale and sealed homogeneous cases with a unique product identifier.
- Provide transaction data to trading partners in electronic format only. The Transaction Data (TD) set includes Transaction Information (TI), Transaction History (TH) and Transaction Statement (TS).
- Verify the unique product identifier of suspect products at the unit of sale level.
- Verify the unique product identifier of returned products intended for resale.
The FDA statement:
“This system will enhance the US Food and Drug Administration’s ability to help protect consumers from exposure to drugs that may be counterfeit, stolen, contaminated or otherwise harmful. The system will improve detection and removal of potentially dangerous drugs from the drug supply chain to protect US consumers. Failure to comply with the requirements of the law can result in penalties.
The development of the system will be phased in with new requirements over a 10-year period. These requirements will include providing product and transaction information at each sale with lot level information, in paper or electronic format, and placing unique product identifiers on individual drug packages.”
If you have further questions or would like assistance in meeting these deadlines please contact the Pragmatyxs team.