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

 

Links | Resources:

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

NABP Links:

https://nabp.pharmacy

https://nabp.pharmacy/pulse  

 

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