Last week, the Pharmaceutical Distribution Security Alliance (PDSA) published two papers aimed at kickstarting the creation of a new non-profit organization that would accept the responsibility for setting up and executing governance over Drug Supply Chain Security Act (DSCSA) phase II interoperability (see “A Serious DSCSA Governance Organizational Proposal Emerges From PDSA”). PDSA defines “DSCSA phase II” to be the same as what the DSCSA text calls the “Enhanced Drug Distribution Security” (EDDS) phase (see “EDDS: The New Data Exchange Requirements”). The EDDS phase (err, Phase II of the DSCSA) starts on November 27, 2023. In most informal conversations this phase is usually just referred to as “2023”.Continue reading PDSA’s Proposal for Governance of DSCSA Phase II Interoperability
Two days before the Drug Supply Chain Security Act (DSCSA) was signed by then President Obama, I published “DQSA: The U.S. Pharma Supply Chain Must Organize, Or Risk Failure”. Under the heading “Who should organize and start the effort [to organize the industry around solutions to the DSCSA]?”, I wrote:Continue reading A Serious DSCSA Governance Organizational Proposal Emerges From PDSA
Lots of people have been talking lately about what interoperable data exchange in the US pharma supply chain will look like after the Enhance Drug Distribution Security (EDDS) phase of the Drug Supply Chain Security Act (DSCSA) takes effect in November 2023 (see “Does Interoperability Change In 2023?”, “5 Myths About The DSCSA In 2023” and “Interoperability And The DSCSA”).
Increasingly, I’ve heard the opinion expressed that there will surely be multiple approaches adopted for exchanging data, and so it will be necessary for all of those approaches to be made interoperable with each other. Proponents of this idea claim it is unrealistic to expect a single approach to be accepted by all companies in the supply chain and therefore, having to deal with multiple approaches is inevitable. This kind of talk makes me nervous. Here’s why.Continue reading DSCSA: Interoperable Data Exchange In 2023
There are a lot of discussions going on in the industry right now, over which approach and which technologies the US pharma supply chain should select to meet the 2023 requirements of the Drug Supply Chain Security Act (DSCSA). People are understandably confused over these discussions. Why should we guess what the FDA will accept in 2023? Blockchain? EPCIS? Aren’t these debates and discussions just a waste of our time? Why doesn’t the FDA just tell us which technology they will accept for the DSCSA in 2023? In fact, these questions have become so common lately that I think it is time to examine what is going on. There are definitive answers to these questions, and they are contained within the DSCSA itself. Continue reading DSCSA: Why FDA Will Not Mandate Blockchain, EPCIS Or Any Other Specific Technology
Dear Blockchain Vendors,
It was good to see all of you at last week’s Drug Supply Chain Security Act (DSCSA) and Blockchain proof of concepts pilots review held by the Center For Supply Chain Studies (C4SCS) in Rockville, MD. I hope your travel home was uneventful. Let me say right at the top, I was in the audience representing Systech International. My co-worker, Joe Lipari partnered with Dwight deVere of RxTransparent as the Green Team. RxTrace is independent of Systech International. That said, as the author of RxTrace, I have some helpful advice for you. Continue reading An Open Letter To Blockchain Vendors: Please Pay More Attention
That’s right. I have now concluded that Blockchain will never be used in the US supply chain to fulfill the DSCSA requirement for sellers to provide buyers with Transaction Information (TI) and Transaction Statements (TS) (see also “Could Blockchain Technology Be Used For DSCSA Compliance?”). So if you are currently planning to do a pilot to test a proposed architecture to do that, I recommend that you adjust it to test something else (see also “What Should FDA Pilot?”).
In fact, the thing to test is whether or not it can be used to facilitate gathering the TIs for a given Standardized Numerical Identifier (SNI) going back to the original manufacturer, as needed after November 27, 2023 during a suspect product investigation or recall. Those are rare events compared with the number of drug sales and shipments where the TI and TS will need to be exchanged.
How and why did I come to this conclusion? Let me explain. Continue reading Blockchain Will Not Be Used For DSCSA Data Exchange
Once again, the Healthcare Distribution Alliance (HDA) has submitted written comments to the FDA as a follow-up to the FDA’s most recent DSCSA Public Meeting held on December 5-6 (see “HDA Schools FDA On DSCSA”, and “FDA DSCSA Public Meeting #2, Still A Gulf”). The comments cover seven “issues” HDA wanted to provide further comments on, beyond those already expressed in the public meeting itself and earlier written comments. The seven issues include:
- “HDA urges greater appreciation for and recognition of the ‘distributed model’…”
- “HDA recommends topics to address at the February 28 public meeting”
- “We expand upon certain data standard and exchange issues from the December public meeting”
- “…we offer suggestions for where ‘guardrails’ may be useful [to the industry]”
- “We summarize our understanding of the aggregation and inference discussion at the public meeting…”
- “HDA urges FDA to begin undertaking the small business assessment mandated by the DSCSA”
- “…various other issues raised during the public meeting…”
Happy New Year, 2018 is here! Last year, the FDA announced a series of three Drug Supply Chain Security Act (DSCSA) Public Meetings (see “FDA Announces New DSCSA Pilot Program and Public Meeting Series”). So far they have held two (see “FDA DSCSA Public Meeting #1 Exposes Gulf In Goals” and “FDA DSCSA Public Meeting #2, Still A Gulf”). One more is left in that series, to be held on February 28, 2018. Continue reading 2018: The Year of FDA DSCSA Public Meetings