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.Continue reading DSCSA Uniqueness: SNI vs SGTIN…Again
In case you didn’t see my note at the end of my essay a few weeks ago, I am publishing new, free-to-everyone, RxTrace essays, one per month, on the Center For Supply Chain Studies (C4SCS) community website under the “Tune In | Monthly Slice of RxTrace” heading. In fact, there are now two new essays there. I’m finding that they are getting little notice there, so I have decided to post short intro essays, like this one, here on RxTrace.com whenever I post a new essay on the C4SCS website. That way everyone here will get notified and can easily find them with a single click.
October’s essay is quite good. It discusses the differences between the SGTIN that drug manufacturers put on their packages and the SNI that the DSCSA requires them to put there, and the implications of those differences. It’s a very timely topic, I think you’ll agree. Continue reading DSCSA Uniqueness: SNI vs SGTIN
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
Until the Drug Supply Chain Security Act (DSCSA) was passed as part of the Drug Quality and Security Act (DQSA) last year (see “It’s Official, President Obama Signs H.R. 3204, DQSA, Into Law”), companies could use whatever code they wanted to refer to the prescription drug products in supply chain operations and for their own inventory management. Some probably chose the 10-digit National Drug Code (NDC), some probably chose the 11-digit reimbursement code that is based on the 10-digit NDC, and some probably chose to use a 12- or 14-digit GS1 Global Trade Item Number (GTIN) as a reference code for their inventory data. But now that the DSCSA mandates the use of the 10-digit NDC when exchanging transaction data on January 1, companies using the other codes that are based on the NDC might need to Continue reading The DSCSA, the NDC, Inventory Management, GS1 GTINs…and Turkeys
Back in 2007 the U.S. Congress passed the Food and Drug Administration Amendments Act (FDAAA) and it was signed into law by President Bush. One of the provisions of that law was an instruction to the FDA to “…develop standards and identify and validate effective technologies for the purpose of securing the drug supply chain against counterfeit, diverted, subpotent, substandard, adulterated, misbranded, or expired drugs”, and “…develop standards for the identification, validation, authentication, and tracking and tracing of prescription drugs.”
The FDA fulfilled these instructions for one of the specific standards that the law identified when the agency published their Standardized Numerical Identifier (SNI) standard back in 2010. That standard was fairly high level and for the vast majority of drugs, use of GS1’s Serialized Global Trade Item Number (SGTIN) (or “GTIN plus serial number”) for drug package identification would comply with it. The text of the FDA’s standard says as much.
By defining the SNI in this way did the FDA surrender the development of the real SNI standard to GS1 (at least the sNDC portion of it)? I don’t think so. In my essay about the SNI standard I described it as the FDA “aligning” with GS1’s SGTIN (see my essay “FDA Aligns with GS1 SGTIN For SNDC”). Alignment shouldn’t be confused with surrender. The choice of alignment with SGTIN was good for the FDA, good for patients and good for the industry.
WHAT WE GOT WHEN THE FDA ALIGNED THEIR SNI STANDARD WITH GS1’S SGTIN TECHNICAL STANDARD
In the case of the SNI aligning with GS1’s SGTIN we got the following things: Continue reading Should FDA Cede All Standards Development To GS1?
That’s right. And it comes from an economic reality that was evident even six years ago. That was when a small group of people with various pharmaceutical supply chain backgrounds had an informal discussion of the relative costs and impacts that each of the three primary business segments in the supply chain would face in a full deployment of Radio Frequency IDentification (RFID). As I recall, this conversation may not have even been part of the official proceedings of the project we were assembled to work on at the time. It may have actually occurred during one of the social hours after a day of meetings, but it stuck with me. Ever since that time I kept meaning to get around to creating the graphs that we envisioned at that time but have never gotten around to it, until now. Continue reading RFID is DEAD…at Unit-Level in Pharma
Last Friday, the FDA published the long awaited guidance on their Standardized Numeric Identifier (SNI) for prescription drug packages. This was right on time since the FDA Amendments Act of 2007 gave the agency 30 months to develop a standard for SNI and they published, almost to the day, 30 months later. Well done.
The published guidance is not radically different from the draft guidance that the agency published under the same name in January of 2009. In fact, in my view, the only really important difference is how the Continue reading FDA Aligns with GS1 SGTIN For SNDC