Drug Supply Chain Security Act: Update

Saturday, October 10, 2015, 8:00 a.m. - 9:00 a.m.
Gaylord National Resort and Convention Center
Continuing Education Credits: 0.1 (1.0 Contact Hours)
ACPE #: 207-000-15-101-L04-P and ACPE #: 207-000-15-101-L04-T

The Drug Supply Chain Security Act (DSCSA) was signed into law in late 2013. In a nutshell, this legislation establishes a national system for tracing pharmaceutical products through the supply chain and sets national licensing standards for wholesale distributors and third party logistics providers (3PLs). Implementation of the first phase of this new law began for wholesalers in May and will be begin for dispensers on November 1, 2015. This new law will require dispensers to pass, capture and maintain certain types of information with respect to each transaction (or change in ownership) effective November 1, 2015. This session will provide dispensers with the latest "need to know" information from the FDA about this important new law including:

Pharmacist and Pharmacy Technician Learning Objectives:

  1. Outline the responsibilities of the pharmacy to pass, capture and maintain certain transaction information

  2. Discuss the responsibilities of the pharmacy with regard to "suspect" or "illegitimate" drug products

  3. Discuss ways in which the law allows pharmacy to collaborate with a third party (e.g., wholesaler) to meet certain requirements of the law, how the law deals with returns

  4. Explain Waivers and Exemptions possible under the law

  5. Discuss Phase II requirements

Speaker: Connie Jung, RPh., Ph.D, FDA Office of Drug Security, Integrity and Recalls, Washington, DC

Activity Type: Application-based
Audience: Pharmacists and Pharmacy Technicians