This year there was a significant jump in the percentage of drug products containing the 2D barcode mandated by the Drug Supply Chain Security Act (DSCSA). The problem is, for the last three years they have published their data four to five months after they collected the data (see also “Wholesalers Find Troubling Results In DSCSA Barcode Assessment“). What everyone really wants to know is, what percentage of drugs would have been marked with the 2D barcode in November of 2018 and today, not back in June of those years. And with three years’ worth of data, you can make a reasonable extrapolation of the data for the November dates, if you just apply a little spreadsheet and graphics skills. Let’s try it.
In late August, the China National Medical Products Administration (NMPA) issued three new drug and vaccine traceability guidance documents. Then in mid-September, they issued five draft documents for comment related to the data exchange protocol for drug traceability. Based on those publications, it appears that China really is accelerating their move toward traceability of drugs (see “China Commits To The Digital Future In Healthcare, Including Pharma Traceability”).
What is a counterfeiter to do today? Governments around the world are moving
toward standardized serialization and track & trace requirements aimed
directly at their bottom line. It’s
getting harder to fake your way past supply chain workers who are increasingly educated
on what to look for and how to raise their suspicions to the authorities. Or is it?
Let’s take a closer look.
I’m not talking about the mixed signals from Russia in your daily political newsfeed, I’m talking about the mixed signals we see between the Russian Federation decrees for their pharma serialization and traceability mandate, and the announcements of the government’s designated technology contractor to develop that system: CRPT, LLC. Considering how short the deadlines are, these mixed signals are counterproductive because they cause companies to pause while they figure out what they should do. Let me explain.
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 Sponsored: Newly Updated Global Serialization Regulation Map→
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→
A couple of days before President Obama signed the DQSA legislation back in 2013 I published an RxTrace essay that looked at what was going to be necessary in the next year from the FDA and the industry (see “DQSA: The U.S. Pharma Supply Chain Must Organize, Or Risk Failure“). The initial standards necessary at that time were for data exchange, and the FDA had one year to come up with them. My essay was about the need for the industry to work with the FDA to come up with the standards that would work. The FDA didn’t have the expertise or the knowledge of how the supply chain operated and so I felt it was imperative for the industry to help them out.
…a comprehensive exploration of the intersection between healthcare supply chains, track and trace technology, standards and global regulatory compliance
DISCLAIMER: RxTrace contains some of the personal thoughts, ideas and opinions of Dirk Rodgers. The material contained in RxTrace is not legal advice. Dirk Rodgers is not a lawyer. The reader must make their own decisions about the accuracy of the opinions expressed in RxTrace. Readers are encouraged to consult their own legal counsel and trading partners before taking any actions based on information found in RxTrace. RxTrace is not a vehicle for communicating the positions of any company, organization or individual other than Dirk Rodgers.