FDA's Drug Supply Chain Security Act - What You Need to Know
Faculty:
Chris Chandler, PharmD
Vice President of Healthcare at USDM Life Sciences
Schedule:
6:00 pm - 7:00 pm
Registration:If you wish to register please email Chris Shoemaker at
cjshoema@uic.edu.
There is no fee to attend this program. A light dinner will be provided. Unable to attend? Presentation slides will be available after the event. Let us know in your RSVP if you're interested in the materials.
Location:
TWO UNIVERSITY OF ILLINOIS COLLEGE OF PHARMACY LOCATIONS
LIVE PROGRAM
Chicago campus - 833 S. Wood St., Rm. 134-2, Chicago
LIVE BROADCAST
Rockford campus - 1601 Parkview Ave., Rm. E226, Rockford
Learning Objectives:
At the conclusion of this knowledge-based continuing pharmacy education activity, participants should be able to:
- Identify systems and processes that comply with the FDA Drug Supply Chain -Security Act (DSCSA) authorization and verification requirements after January 1, 2015.
- Cite the transaction documentation required for accepting product after July 1, 2015.
- Describe future implementation requirements for product serialization and traceability in the next decade.
- Recognize how recent FDA guidance documents affect implementation.
Accreditation:
The University of Illinois at Chicago College of Pharmacy is accredited by the Accreditation Council for Pharmacy Education (ACPE) as a provider of pharmacy continuing education. This program has been assigned ACPE Universal Activity Number 0016-0000-15-074-L03-P, for 1 contact hour (0.1 CEU). Attendance at the entire knowledge based program, completion of the self-assessment questions on the evaluation form, and submission of NABP eProfile ID and MMDD are prerequisites for receiving continuing pharmacy education credit. All ACPE credit awarded to participants must be uploaded to CPE Monitor ™ within 30 days of the program date, so pharmacists and pharmacy technicians are required to provide their e-Profile ID and date of birth (MMDD) at the time of the program. Please contact
pharmce@uic.edu if you do not see program information listed within 30 days. For more information and to set up your e-Profile visit:
www.MyCPEmonitor.net.
Target Audience: Pharmacists, Physicians, Scientists, Post-docs, Pharmacy/Medical Students, Residents/Fellows, and Graduate Students.
The Drug Quality and Security Act (DQSA), was signed into law by President Obama on November 27, 2013. Title II of DQSA, the Drug Supply Chain Security Act or DSCSA develops a new electronic system for prescription drug traceability throughout the United States (U.S.) supply chain. Members of the healthcare community have worked with the Food and Drug Administration (FDA) for years on a federal system to detect counterfeit, stolen or otherwise harmful product distribution. This new law finally removes the variance in pedigree laws and licensing by the States providing FDA the authority for a national system to protect all patients in the U.S.
The DSCSA system will be phased in over 10 years utilizing new technologies to scan, transact and store product attributes in the event of suspect or illegitimate product verification, improving the recall process for patient safety.
The first deadlines for the FDA Drug Supply Chain Security Act (DSCSA) began in January 2015, with additional requirements in July 2015 followed by product marking and electronic interoperability requirements from 2017 through 2023. The goal of this session is to provide a summary of the DSCSA law, recent guidance documents and assist working with your trading partners for implementation.
