A few weeks ago, GS1 Healthcare US published version 1.1 of their guidance for using the GS1 Electronic Product Code Information Services (EPCIS) standard to meet the U.S. Drug Supply Chain Security Act (DSCSA). See “GS1 Healthcare US Publishes Updated Guidance For DSCSA”. I was too busy at that time to review the document properly, but it is an important addition to the spectrum of information that companies can use to help them understand how to best meet the requirements of the DSCSA so I wanted to get back to it when I had time. That time is now.
As long term readers of RxTrace know, I did not believe EPCIS would ever be usable to meet the now obsolete California Pedigree law (see “The California Pedigree Law Is Now Officially Inoperative”), or any other State pedigree laws, and I do not believe it will be widely used to meet the Federal DSCSA before maybe 2021 or 2022, but I do believe it will take center-stage for meeting the long-term requirements of the DSCSA.
In 2023 the DSCSA transitions into Continue reading The GS1 Healthcare US Guidance For DSCSA, Vsn 1.1
GS1 just updated their website with the newly updated versions of their Electronic Product Code Information Services (EPCIS) and Core Business Vocabulary (CBV) which were ratified by the GS1 Board on Monday. Both carry the new version number “1.1”. The two standards are separate but intertwined because the core business vocabulary is used within the various EPCIS events, so the two standards are likely to always be updated at the same time, as in this case.
This update marks the culmination of several years worth of hard work by the team, co-chaired by Michele Southall of GS1 US and Andrew Kennedy of FoodLogiQ, facilitated by the great Gena Morgan of GS1 US and with Ken Traub serving as the Editor for both standards documents, under the GS1 Global Standards Management Process (GSMP).
WHY THIS IS SIGNIFICANT FOR THE PHARMA SUPPLY CHAIN
This is a significant event for pharma supply chains around the world, but particularly for Continue reading GS1 Ratifies Updated Versions of EPCIS and CBV
This is the second in a series of essays about data exchange components required by the Drug Supply Chain Security Act (DSCSA) beginning next January. Last week’s essay was about DSCSA Transaction Information (TI). On the surface, Transaction History (TH) looks simple. The DSCSA, which is Title II of the Drug Quality and Security Act (DQSA), defines TH this way:
“(25) TRANSACTION HISTORY.—
The term ‘transaction history’ means a statement in paper or electronic form, including the transaction information for each prior transaction going back to the manufacturer of the product.”
According to this simple definition, Continue reading DSCSA: Transaction History
The U.S. FDA just published a docket asking for public input into standards for the interoperable exchange of information for tracing of human, finished, prescription drugs in paper or electronic format. Ironically, they will accept responses to the docket in either paper or electronic format. Comments should be submitted to the FDA within 60 days. If my calculation is correct, you have until April 21st to submit your comments.
This docket was expected because the Drug Supply Chain Security Act (DSCSA), enacted last November, gives the FDA one year to publish a draft guidance document that establishes standards for the interoperable exchange of that type of information, and they are required to consult with the industry and other interested parties [see Section 582(a)(2)]. I have written about this requirement and the short time after the guidance is published before the members of the supply chain must make use of those standards (see “The Flaw That Must Be Addressed in H.R. 3204, The Drug Quality and Security Act” and “DQSA: Getting To Electronic Transaction Data Exchange“). This docket fulfills the first of many mandates that the FDA is facing in
Continue reading DQSA: How Should Transaction Data Be Exchanged?
The supply chain provisions contained within the Drug Quality and Security Act (DQSA)—themselves known as the Drug Supply Chain Security Act (DSCSA)—mark a significant achievement by Congress and the industry to protect the U.S. pharmaceutical supply chain from criminals. It is the first completed attempt since 1987 when the Prescription Drug Marketing Act (PDMA) was enacted by Congress and signed by President Ronald Reagan. In comparison, the provisions of the DSCSA are much more detailed and extensive than the PDMA and they read as if they were heavily influenced by people who solidly understand the scale and complexity of the legitimate supply chain. Which, they were, based on the contribution of the Pharmaceutical Distribution Security Alliance (PDSA)—made up of key stakeholders in the supply chain—in their development. That should ensure that the industry will be able to adopt the technology and process modifications necessary to meet the new law on time.
But will all this also lead to true protection of the supply chain from criminal activities? Will the DSCSA portion of the DQSA end up presenting new and insurmountable barriers against criminals who game the supply chain to their advantage and thereby putting patients at risk? These are the true measures of the success of this type of legislation. How can we know if the DSCSA will have these positive affects? Continue reading How the DQSA Will–And Won’t–Protect The Supply Chain, Part 1
If there is one overriding lesson exposed by my essays last week it is that the companies in the U.S. pharmaceutical supply chain must quickly organize to work out technology and process issues that stand in the way of an efficient implementation of phase 1 of Title II of the Drug Quality and Security Act of 2013 (see “DQSA: Getting To Electronic Transaction Data Exchange” and “DQSA: Will U.S. Pharma Distributors Mandate Aggregation Data In Phase 1?”). Title II of the DQSA is the Drug Supply Chain Security Act (DSCSA).
The law gives the FDA one year to publish guidance containing standards for use by companies in the supply chain for the exchange of Continue reading DQSA: The U.S. Pharma Supply Chain Must Organize, Or Risk Failure
While we wait for President Obama to sign the Drug Quality and Security Act of 2013 (DQSA, a.k.a. H.R. 3204) we can be confident it will become law in the next week or so. This President has been presented with over 740 bills so far in his Presidency and he has signed all but two. He has 10 days to sign the bill or it becomes law anyway but there might be some delay in the process between passage by the Senate and when the President is presented with the bill.
My interest in the DQSA of 2013 is only the Drug Supply Chain Security Act (DSCS) which is Title II within the overall bill. I’m going to keep referring to it as the DQSA of 2013 but be aware that I probably won’t ever write about the compounding part, Title I. If that is what brought you here, sorry, look elsewhere.
It is not law yet, but we can now be 100% sure it will be very soon. Even before the bill was Continue reading DQSA: Getting To Electronic Transaction Data Exchange
Rumors abound that the Drug Quality and Security Act (DQSA), H.R. 3204 will be debated and voted on in the Senate any day now (see “Waiting For The Senate To Act On A Track & Trace Bill, Again”). It already passed the House of Representatives back in September and the text is a compromise between the bill managers in both the House and the Senate, so everyone expects it to pass and be signed into law by President Obama. No one (except maybe some folks who don’t like the compounding part) wants to see its progress slowed, but there is a problem with the track and trace part that must be addressed before it is adopted or its implementation will quickly run into difficulties. Continue reading The Flaw That Must Be Addressed in H.R. 3204, The Drug Quality and Security Act