The need to establish item level serialization presents the opportunity to develop an information architecture that not only meets DSCSA compliance regulations but also provides business intelligence on supply integrity.
FDA has delayed enforcement of Drug Supply Chain Security Act (DSCSA) to minimize possible disruptions of the prescription medicine supply.
FDA intends to delay product tracing information requirements for 5 months.
HDMA urges FDA to Exercise DSCSA Enforcement Discretion.
The Healthcare Distribution Management Association (HDMA) recently wrote the FDA and expressed their concern about the pharmaceutical supply chain’s ability to meet DSCSA Phase I compliance on or before January 1, 2015. HDMA expressed concern that the complexity and disruptive nature of the DSCSA law could exacerbate supply shortages.