Tuesday Nov 21, 2023
DSCSA “Set”
The Drug Supply Chain Security Act was designed to ensure the safety and integrity of our nation’s drug supply and prevent counterfeit medications from entering the market. In this second of a four-part series, Carolyn Liptak, Eric Marshall, and Josh Bolin share their insights on FDA final DSCSA guidance with host Gretchen Brummel and how member providers can be ready.
Guest speakers:
Carolyn Liptak, MBA, BSPharm
Pharmacy Executive Director
Vizient Center for Pharmacy Practice Excellence
Eric Marshall
Principal at Leavitt Partners
Executive Director of the Partnership for DSCSA Governance
Josh Bolin
Associate Executive Director, Government Affairs and Innovation
National Association of Boards of Pharmacy
Host:
Gretchen Brummel, PharmD, BCPS
Pharmacy Executive Director
Vizient Center for Pharmacy Practice Excellence
Show Notes:
[00:55-02:27] Josh and Eric’s backgrounds
[02:28-03:36] What we need to know for DSCSA implementation on November 27th
[03:37-05:10] NABP view of FDA DSCSA guidance
[05:11-07:27] PDG view of FDA DSCSA guidance
[07:28-08:23] Next steps for DSCSA compliance that our members should be focusing on
[08:24-11:11] Why it is important to have documented policies and procedures to ensure compliance
[11:12-12:28] Where organizations that need help with creating those policies and procedures go
[12:29-15:24] How the 24-hour time frame is defined since medications are not traced within a hospital
[15:25-18:17] DSCSA regulatory responsibilities are shared between the FDA and state boards of pharmacy
[18:18-21:26] How we account for traceability across state lines and what should we expect in the future
[21:27-23:49] Some complexities here especially around 340B medications
[23:50-24:54] Where verification has to occur: data flowing from the manufacturer to the covered entity, but the product is flowing to the actual contracted pharmacy
[24:55-26:30] Last thoughts on how our members can be set for DSCSA
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