Last week the US Department of Health and Human Services (HHS) Office of Inspector General (OIG) published their second report on the experience of selected members of the pharma supply chain with the exchange of drug product tracing information as required by the DSCSA. This one was aimed at dispensers. The one published last fall was aimed at wholesale distributors. As you know, starting in January 1, 2015 (delayed until May 1, 2015), pharmaceutical wholesale distributors have been required to pass to their customers for non-exempt prescription drug shipments, and retain for six years, transaction documents (TI, TH and TS). Since July 1, 2015 (delayed until March 1, 2016), dispensers have been required to receive and store these Continue reading DSCSA: OIG Report Exposes Likely Enforcement Approach
Tag Archives: Pharma Supply Chain
The 2 Most Helpful Requirements In The DSCSA
There are lots of impactful requirements in the Drug Supply Chain Security Act (DSCSA), but there are two whose impact will likely increase the safety of patients far more than all of the others. That is, they are the most helpful requirements. Do they include serialization? Verification? Transaction documentation? Wholesaler and 3PL licensing? Not even close.
The two requirements that I believe will have the biggest impact on the safety of drugs in the US supply chain are the requirement to only engage in transactions with authorized trading partners, and the lot number being included in the 2D barcode. Let me explain. Continue reading The 2 Most Helpful Requirements In The DSCSA
Newly Updated Global Serialization Regulation Map
I just helped IQPC update their printable global pharma serialization regulation map. Get a copy here. Things change around the world pretty often so it’s important to update resources like this frequently. The information for most of the existing countries was updated and I added a few new countries. It’s a great resource to print and pin up on your office wall, or the company bulletin board to keep everyone focused on the approaching deadlines around the world. And it looks great too! Continue reading Newly Updated Global Serialization Regulation Map
Sponsored: Interview With Four Pharma Supply Chain Thought Leaders
The IQPC PharmaTrace Summit will be held on June 4-6 in Princeton, NJ. In preparation for the event, IQPC asked four industry veterans to respond to a set of forward-looking questions to get a glimpse of the future of serialization and track & trace in the US pharma supply chain. The four include: Continue reading Sponsored: Interview With Four Pharma Supply Chain Thought Leaders
The Most Head-Scratching Section Of The FMD
Just after I posted my last FMD essay on RxTrace (see “FMD, One Year Out”) I found out that the European Commission had published version 9 of their “Safety Features for Medicinal Products for Human Use, Questions and Answers”. This is must reading for anyone with questions about how to interpret the most confusing provisions of the Falsified Medicines Directive (FMD) (also known as EU Directive 2011/62 and which amends Directive 2001/83) and the Delegated Regulation (EUDR) (also known as EU Regulation No 2016/161) (see “The E.C. Officially Published The Pharma Safety Feature Delegated Act This Morning“).
With each major revision this Q&A document grows. This time it grew substantially with the addition of 21 new questions and answers and updates to four previously posted answers.
But there is one provision of the FMD that defies explanation, even though the Q&A document burns two Q&As to attempt it. That provision in the FMD is Section 1 of Article 45a, which basically says, in part, that you cannot put an anti-tamper device on non-prescription drugs unless the EC or a Member State specifically says you can. What’s going on here? Continue reading The Most Head-Scratching Section Of The FMD
Wholesalers Find Troubling Results In DSCSA Barcode Assessment
Last month GS1 US published the results of an assessment of the implementation progress by drug manufacturers of the Drug Supply Chain Security Act (DSCSA) serialization requirements. It contains troubling indications of the next problem the industry will face in its quest for DSCSA compliance: too many unusable barcodes.
Big deal, you say? That kind of complacency could come back to haunt you later this year. Now is the time to look at your own packages and address any deficiencies. Here is a look at what GS1 US found in their assessment. Continue reading Wholesalers Find Troubling Results In DSCSA Barcode Assessment
Blockchain Will Not Be Used For DSCSA Data Exchange
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
3 DSCSA Requirements You Can Totally Ignore
The Drug Quality and Security Act (DQSA) was constructed back in 2013 by Congressional staff, with input from the FDA, members of the industry and who knows who else. There was one bill in the House of Representatives and a different bill in the Senate. Once these bills passed their respective houses, they formed a conference committee who merged the two bills into the final text that we know today as the DQSA (see “It’s Official, President Obama Signs H.R. 3204, DQSA, Into Law”). Chapter 2 of that act is the Drug Supply Chain Security Act (DSCSA). Most readers of RxTrace haven’t forgotten that history but it is important to look back at that history to explain why most companies can ignore certain requirements in the law. That’s right. There are requirements in the law that you can ignore because they will not be enforced by anyone. They are the result of the disjoint way the DQSA was written. Let me explain. Continue reading 3 DSCSA Requirements You Can Totally Ignore
