Category Archives: DSCSA

Next Week’s HDA Traceability Seminar

Every year I look forward to the Healthcare Distribution Alliance (HDA) Traceability Seminar.  It’s the one event in the US that is attended by everyone connected with pharma serialization and traceability, including those from manufacturers, 3PLs, repackagers, wholesale distributors, dispensers and solution providers.  In that one time and place I can get answers to burning questions about what is going on in the industry and a sense for what people are thinking about a wide range of issues that appear here in RxTrace.  The sessions are helpful, but the real goldmine are the hallway conversations.  Of course, I’ve written about this before (see “2014 Fall Conference Season Preview” and “Terminology: Track and Trace, and Pedigree”).

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No Surprise: DSCSA Verification Delay

Dr. Ilisa Bernstein leaves FDA for APhA

It was fairly easy to predict the FDA would invoke enforcement discretion for the wholesale distributor’s saleable returns requirement of the Drug Supply Chain Security Act (DSCSA), as they announced last Tuesday (see “Is The FDA About To Delay Enforcement Of The Wholesaler’s 2019 Mandate?”).  The deadline for the mandate was originally this November 27, but with the announcement, will not be enforced until November 27, 2020.

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GS1 US Publishes New DSCSA VRS Implementation Guide

Last week GS1 US announced that they have published a new implementation guideline to help companies in the US pharma supply chain make use of the new GS1 lightweight messaging standard for verification of product identifiers to meet the saleable returned drug verification requirement of the Drug Supply Chain Security Act (DSCSA).  The messaging standard itself was ratified by GS1 in January and it can be used to implement a wide range of product verification schemes in any industry.  The new GS1 US guideline is a valuable resource for companies wanting to apply that standard to the problem of verifying drugs that fall under the DSCSA, so it contains a wealth of information needed to ensure interoperability of Verification Router Service (VRS) solutions.

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DSCSA Uniqueness: SNI vs SGTIN…Again

Ahh, summer.  Some years it seems like everyone is on vacation except me.  I usually only take a few days off here and there in the summer, preferring to do longer vacations in other parts of the year.  So next weekend I’m going to take an extra day off, and so there will be no RxTrace essay published next Monday (the Labor Day holiday here in the US), and I’m going to link to one of my favorite essays from the last year this week as the summer winds down.  This essay was posted on October 7, 2018 under the “A Monthly Slice of RxTrace” on the Center For Supply Chain Studies (C4SCS) website.  Unfortunately I haven’t been able to keep up with the “Monthly” part of that title due to time pressures, but there is some great content out there from the last 12 months (see “A Monthly Slice of RxTrace”).  Other than my diverted attention, nothing has changed so I may post more new content on the C4SCS site in the future if I can make some time.

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PDSA Releases Prospectus To Prospective Governance Group Members

Last week the Pharmaceutical Distribution Security Alliance (PDSA) released a prospectus for the, as yet, unnamed non-profit organization that they are trying to kickstart to help govern supply chain interoperability of the Drug Supply Chain Security Act (DSCSA) solutions targeting the Enhance Drug Distribution Security (EDDS) phase that will go into effect in November of 2023 (see “PDSA’s Proposal for Governance of DSCSA Phase II Interoperability” and “PDSA Brainstorms Vision For DSCSA Governance Organization With Stakeholders”).  You can download the prospectus here.

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Can Trump/Azar/Sharpless Eliminate Parts of the DSCSA to Enable Importation?

Can President Trump, HHS Secretary Azar and Acting FDA Commissioner Sharpless eliminate/adjust/reinterpret any part of the Drug Supply Chain Security Act (DSCSA) to allow Florida, Colorado, Vermont, Maine or any other US state or territory to import drugs from foreign markets?  Let’s take a closer look at what’s been going on recently with the idea of importing drugs from other markets in an attempt to help American citizens buy them at a lower cost. 

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DSCSA Schedule Assessment, July 2019

It’s time to assess the progress of the industry and the FDA in their quest toward the November 27, 2023 Drug Supply Chain Security Act (DSCSA) goal known as the Enhanced Drug Distribution (EDDS) phase…otherwise known as just ‘2023’ (see “EDDS: The New Data Exchange Requirements”).  Let’s step back and look at where we have come and where we need to go.

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Is The FDA About To Delay Enforcement Of The Wholesaler’s 2019 Mandate?

On November 27, 2019 the Drug Supply Chain Security Act (DSCSA) requires wholesale distributors to step up their supply chain security activities another notch.  They are required to:

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