Establishing Supply Network Visibility

Posted on May 27th, by Gary Lerner in Integrity Matters, Medical Devices, Pharmaceuticals.

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 Announces DSCSA Enforcement Delay

Posted on January 6th, by Gary Lerner in News, Pharmaceuticals, Regulations.

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 seeks enforcement leniency for DSCSA non-compliance

Posted on December 2nd, by Gary Lerner in News, Pharmaceuticals, Regulations.

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.