Defining DSCSA Trading Partners

Posted on August 21st, by Gary Lerner in News, Pharmaceuticals, Regulations.

August 21, 2017: FDA issues draft compliance guidance on how to identify the 5 key types of DSCSA Trading Partners. This document clarifies the DSCSA participants and their role in facilitating compliance.

Unmarked Product to Become Risky

Posted on July 7th, by Gary Lerner in Integrity Matters, News, Pharmaceuticals.

Some manufacturers might be lulled into thinking a one-year enforcement delay is a good opportunity to relax serialization efforts. However, a more thorough understanding of the revised product identifier requirements suggests that time is of the essence.

FDA Proposes 1 Year Enforcement Delay

Posted on June 30th, by Gary Lerner in News, Pharmaceuticals, Regulations.

This new guidance informs manufacturers and other supply chain stakeholders that although manufacturers are to begin including a product identifier on prescription drug packages and cases on November 27, 2017, the FDA is delaying enforcement of those requirements until November 2018 to provide manufacturers additional time and avoid supply disruptions. While manufacturers work to meet product identifier requirements, they must comply with other DSCSA requirements.