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.
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.
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→
If you’re like me, you are doing at least some work this week. I usually do some work work during this quiet time when I am not interrupted. It’s usually things I need to do to wrap up the year, but also includes planning for the new year. In case you are working this week but you need a little diversion, here is something to think about for 2018.
It has become increasingly clear that what the US pharma supply chain needs is for some organization to step up and take responsibility for the decisions and actions that are needed to ensure successful development and operation of the Enhanced Drug Distribution Security phase of the Drug Supply Chain Security Act (DSCSA). There are less than six years before that phase is supposed to begin. But with no one clearly specified as the organization responsible, odds are, it isn’t going to happen. This was the topic I covered two months ago when I originally published “A US Medicines Verification Organization (USMVO)?”. With the end of the year and the holidays coming up, I’ve been too busy to write a new essay this week, so take another look at this idea. Continue reading A US Medicines Verification Organization (USMVO)? Again→
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.