Public Meeting: Progress Toward Implementing the Product Identification Requirements of the Drug Supply Chain Security Act

The FDA held a public meeting on October 14, 2016, entitled “Progress Toward Implementing the Product Identification Requirements of the Drug Supply Chain Security Act.”

This public meeting provided members of the pharmaceutical distribution supply chain and other interested stakeholders an opportunity to share information with FDA about the efforts under way to implement the DSCSA’s product identification requirements.

Federal Register Notice

• Progress Toward Implementing the Product Identification Requirements of the Drug Supply Chain Security Act; Public Meeting; Request for Comments

Contact Information
Daniel Bellingham, Office of Compliance, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, 301-796-3130, FAX: 301-847-8722, email: CDERODSIRpublicmeetings@fda.hhs.gov

Agenda and Meeting Information

• October 14th Public Meeting Agenda (PDF - 32KB)
• FDA Slides  (PDF - 313KB)
• Mike Rose, (Johnson & Johnson Supply Chain) (PDF - 973KB)
• Heather Zenk, (AmerisourceBergen Contribution to the Product Identification Requirements of the Drug Supply Chain Security Act; Public Meeting. (PDF - 958KB)
• Eric Marshall, Progress Toward Implementing the Product Identification Requirements of the Drug Supply Chain Security Act (PDF - 365KB)
• JP Allard, Optel Vision, (PDF - 39.5MB)
• Riya Cao, LSPediA FDA DSCSA Implementation (PDF - 865KB)
• Susanne Somerville, (The LinkLab) (PDF - 1.1MB)

Comments
To access electronic comments regarding the topics of the public meeting, please visit http://www.regulations.gov and search the Docket No. FDA-2016-N-2673.

Other Resources

• FDA’s Drug Supply Chain Security Act
• Title II of the Drug Quality and Security Act; The Drug Supply Chain Security Act