On Thursday, December 11, the law firm Arnold and Porter will be hosting a webinar: “Drug Supply Chain Security Act (DSCSA): How To Get Ready (Fast) for Track & Trace.” The presentation is part of a three-part series entitled “Pharmaceutical Brand Protection, Product Counterfeiting, and Diversion.”
In November 2014, the Food and Drug Administration is expected to release guidance on important elements of the new drug track and trace law, the Drug Supply Chain Security Act, which must be implemented in part by January 1, 2015. Companies must act now to ensure compliance. The statute will ultimately mandate use of an electronic, interoperable system to identify and allow the tracking and tracing of prescription drugs as they are distributed in US commerce. The system developed under the DSCSA will require the exchange of information at the individual package level about where a drug has been in the supply chain, enhance detection of illegitimate products, and facilitate more efficient recalls.
This webinar will focus on:
- Expectations for prescription drug manufacturers now and in the future
- Roles and responsibilities of wholesalers and third-party logistics providers
- Detection of and response to suspect products
- Notification requirements
View FDA's 10-year timeline for compliance with the DSCSA and further guidance here.
Dan Kracov, Partner, Arnold & Porter LLP, Washington, DC
Abe Gitterman, Associate, Arnold & Porter LLP, Washington, DC
Thursday, December 11, 2014; 12:00 p.m. ET, 5:00 p.m. GMT, 6:00 p.m. CET (60 Minute Webinar)
Part 2 of the series, “Use of Investigative Resources and Assertion of Victim Rights To Support Brand Protection,” will follow in January.