Public Workshop: Proposed Pilot Project(s) under the Drug Supply Chain Security Act

The FDA held a public workshop on April 5 and 6, 2016, entitled “Proposed Pilot Project(s) under the Drug Supply Chain Security Act (DSCSA).” This public workshop provided a forum for discussing proposed design objectives of pilot projects that will explore and evaluate methods to enhance the safety and security of the pharmaceutical distribution supply chain.

The information gathered from the workshop and the public comments submitted to the docket further informed FDA’s development of its pilot project program.

Federal Register Notice

• Proposed Pilot Project(s) under the Drug Supply Chain Security Act; Public Workshop; Request for Comments

Contact Information

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 Discussion Topics

• Agenda (PDF)
• Discussion Topics (PDF)
• Slides from Day 1: 4/5/2016 (PDF)
• Slides from Day 2: 4/6/2016 (PDF)
• Workshop Summary (PDF)

Comments

To access the electronic comments regarding the topics of the workshop please visit http://www.regulations.gov, and search the Docket No. FDA-2016-N-0407.

Other Resources

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

 

ResourcesForYou

• Public Meetings at the FDA White Oak Campus
• Title II of the Drug Quality and Security Act
• Drug Supply Chain Security Act (DSCSA)