PackTalk is a blog for the Healthcare Packaging Industry

FDA Pilots Programs to Enhance Traceability


Published on July 30, 2020

What is happening with FDA Title II Drug Supply Chain Security Act (DSCSA)?

In October 2014, the FDA issued draft guidance in response to Title II (a/k/a the DSCSA) of the Drug Quality and Security Act (DQSA) of 2013. The requirements and compliance deadlines of the Act include Section 5851, establishing pharmaceutical traceability, wholesale distributor and third-party logistics standards and regulations.

The FDA has continued to refine portions of the DCSCA draft guidance that has included publication of final guidance for certain portions. Specific to the traceability and supply chain processes and Section 585, the FDA announced the undertaking of a pilot project in 2017, with a call for comments and pilot participants from the pharmaceutical industry. The purpose of the pilot program is to test new technology in the pharmaceutical manufacturing setting, seeking best practice processes for traceability systems. The Act is currently set for full adoption by 2023.

As the industry watches the progress of this significant initiative, this article offers a summary of the activities and outcomes that have taken place so far. The most recent action published by the FDA relating to the supply chain pilot projects was the 2019 reopening of industry comment period and request for information regarding the pilot projects, extending the comment period to June 28, 2022. We are watching eagerly for anticipated pilot program reporting in the months ahead.

Read More

 

You might also like Full FDA DSCSA timeline

Source: (Uniform National Policy) of the Federal Food, Drug, and Cosmetic Act (FD&C Act),


Comments (0)

Related Articles

An Evolution of Vigilance

December 8, 2022

Since its inception, the pharmaceutical industry has been required to meet myriad, sometimes conflicting, priorities. And while patient safety has always been the cornerstone, early warnings still serve as sobering reminders for constant watch in an...

Learn More

A Shift to Data Driven Material Selection

December 8, 2022

Over the past couple of years, supply chain issues have been a common concern for everyone in the medical device and packaging industry. Companies have had to find ways to pivot or make do with the supply they have, and all of this has companies thinking....

Learn More

From the Operating Room to Medical Packaging

December 8, 2022

Jurgen Van Roosbroeck, Medical Segment Leader for the EMEA region at Oliver Healthcare Packaging, started his career in nursing, where he spent 10 years working in the emergency room, the intensive care unit, and the operating room. Years later, after working...

Learn More

Stay Informed

To stay up to date on innovative technology and products, as well as industry trends, subscribe to Oliver’s PackTalk blog below.