DRUG SUPPLY CHAIN SECURITY ACT: FDA & INDUSTRY EFFORTS FOR A MORE SECURE DRUG SUPPLY CHAIN

The FDA has initiated efforts toward implementation of the Drug Supply Chain Security Act (“DSCSA”), also known as Title II of the Drug Quality and Security Act, which aims to mitigate risks in the pharmaceutical distribution supply chain by building an electronic, interoperable system able to trace prescription drug packages on a national level and other controls. FDA began the complex task of implementing specific requirements earlier this year by seeking comments from industry and supply chain members on standards for establishing an interoperable drug tracing system. Additional controls with fast-approaching deadlines include updated licensing requirements for drug manufacturers, distributors, and service providers; and heightened expectations with respect to questionable products. This program will address:

• Application of DSCSA and exemptions
• Understanding primary timelines for key stakeholders
• New investigation and reporting requirements for “suspect” and “illegitimate” products
• Methods for meeting January 1, 2015 deadlines
• Resources for further information

Speakers:
Chris Markus
Partner
King & Spalding

Elaine H. Tseng
Partner
King & Spalding

Caitlyn Ozier
Associate
King & Spalding

Contact:

Brooke Akins | Division Director, Life Science Programs
312.224.1693 | webinars@q1productions.com