This webinar addresses the increasing threat to our drug supply chain from counterfeiting, fraud, and theft, and how the new Drug Supply Chain Security Act is designed to combat all three. The speaker will provide background on what led to the creation of these new DSCSA regulations, and a thorough overview of the three basic requirements for all pharmaceutical dispensers. As we move toward the “new normal” of post-DSCSA regulations, a review of best practices for implementing the new law and executing its transition requirements into the workplace workflow will be provided. Participants will hear about some simple steps to becoming compliant with DSCSA requirements.
What is DSCSA?
The Drug Supply Chain Security Act (DSCSA) is a new law that is now being actively enforced by the FDA. It requires the implementation of specific steps designed to build an electronic, interoperable system to identify and trace certain prescription drugs as they are distributed in the United States. This is a complex law and brings significant change to the way most pharmacies must track and trace their products. As of March 1, 2016, initial traceability requirements are in place and being enforced. By 2026, the system will facilitate the exchange of information at the individual package level about where a drug has been in the supply chain. This impacts all dispensers of pharmaceutical products.
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After participating in the webinar, attendees will be able to:
- List recent counterfeiting, fraud, and theft issues related to the nation’s drug supply chain and explain how these activities prompted the need for greater government regulations.
- Understand how the implementation of Verification, Inspection and Reporting, and the Data Transaction should be completed and recorded.
- Describe the responsibilities of the healthcare professional to maintain the History, Information and Statements on all drug products both incoming and outgoing.
- Explain how to effectively implement this new law and execute its transition into the workplace/workflow.
- List the law’s future requirements and the implementation time frame.
Presenter: Denise Garcia
Denise Garcia is a health care attorney with over 20 years of experience and is now serving as Vice President of Legal and Chief Compliance Officer for InfiniTrak, a DSCSA compliant cloud-based software solution designed for dispensers. Prior to joining InfiniTrak, Denise served as crisis manager for Inova Health System, providing system-wide oversight of design, implementation and monitoring of a court-ordered Consent Decree regarding the American with Disabilities Act of 1990 (ADA) and Section 504 Equal Access compliance. Denise oversaw the design of a state-of-the-art electronic health record ADA screening module that helped ensure compliance. Denise has served as General Counsel for a Driscoll Children’s Health System in Corpus Christi, Texas. She continues to focus her practice in designing practical, user-friendly healthcare compliance solutions to complex regulatory requirements. Denise has a JD from Harvard Law School and a BA in Broadcast Journalism from C.W. Post College.
Free for MPhA members and $25 for nonmembers. Student pharmacists and residents are provided a complimentary registration.
Student pharmacists and residents are provided a complimentary registration, please use the promo code “WebinarComp16” when checking out.
This presentation is being submitted to the Minnesota Board of Pharmacy for Continuing Education credit approval (one hour).
To receive Board of Pharmacy credits for this program the following must be completed:
Board of Pharmacy credit processing takes place on the 15th of each month.
||The Minnesota Pharmacists Association is accredited by the Minnesota Board of Pharmacy as a provider of continuing pharmacy education.
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