Tuesday Jan 16, 2024

DSCSA “Go”

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 third of a four-part series, Carolyn Liptak and Dwight deVera 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

Dwight deVera
VP of Healthcare Intelligence
Inmar

Host:
Gretchen Brummel, PharmD, BCPS
Pharmacy Executive Director
Vizient Center for Pharmacy Practice Excellence

Show Notes:

[00:44-01:14] Dwight’s background

[01:15-02:20] What Carolyn and Dwight are hearing in the market

[02:21-03:39] Carolyn and Dwight’s thoughts on taking that stabilization period as an opportunity to wait

[03:40-05:22] Meeting the deadline on GLN’s

[05:23-06:59] Issue with having duplicate GLNs for a single site

[07:00-07:43] How Dwight is advising clarity on a timeline with the quarantine process

[07:44-09:23] Other tools our members need to know about if they have a suspect product investigation

[09:24-10:30] Comments and advice from Dwight and Carolyn

Links | Resources:

Drug Supply Chain Security Act (DSCSA) portal

FDA Requests Feedback on Enhanced Drug Distribution Security Implementation Progress

Enhanced Drug Distribution Security at the Package Level Under the Drug Supply Chain Security Act (DSCSA)

Wholesale Distributor Verification Requirement for Saleable Returned Drug Product and Dispenser Verification Requirements When Investigating a Suspect or Illegitimate Product—Compliance Policies

DSCSA Standards for the Interoperable Exchange of Information for Tracing of Certain Human, Finished, Prescription Drugs Guidance for Industry

Enhanced Drug Distribution Security Requirements Under Section 582(g)(1) of the Federal Food, Drug, and Cosmetic Act – Compliance Policies

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