How are you? I’m sure your summer has been busy, just like mine. Hope you were able to get at least some time away. I’ve taken most Saturdays off, but the other days of the week have been very full with consulting, and then writing RxTrace essays every Sunday. You know, the wife is not very happy about that!
The European Commission published a discussion draft of the European Union Delegated Act (EUDA) about two weeks ago (See “Breaking News: The EC Has Published The Delegated Act“). The EUDA was called for in the Falsified Medicines Directive (FMD) back in 2011 and is primarily intended to define the “safety features” that must appear on most drugs three years after it is finalized. Assuming it gets finalized around the end of 2015, that means that manufacturers and repackagers targeting the European pharmaceutical market will need to begin placing the specified safety features on their drug packages near the end of 2018. EU Member States who already have an operational drug tracing law, like Italy and a few others, get an additional six years for companies to switch to the FMD and EUDA on drugs distributed there.
While listening to a monthly Drug Supply Chain Security Act (DSCSA) call hosted by one of the Big-3 wholesale distributors I heard a comment that snapped me out of my conference call-induced stupor. Unfortunately I was in a location where I could not take notes so I don’t remember the exact comments that were made, but I remember what it was that brought me back to full consciousness.
The comment made me realize in a jolt why the Big-3—or at least the one running this monthly call—may be unwilling to give up on their claims that they will need aggregation data to accompany shipments of prescription drugs from manufacturers as early as November 2019. It may have to do with a mis-interpretation of their handling of saleable returned product within the DSCSA. Let me explain. Continue reading Wholesaler Confusion Over DSCSA Aggregation Explained→
We are making progress stopping cancer through research. We hear about new drugs and therapies on a regular basis, but we have a long way to go. Lung, prostate and colon-rectal cancers are the most dangerous in men, and lung, breast and colon-rectal cancers are the most dangerous for women, according to the American Cancer Society.
It’s August and that means it is time to check in on the progress toward full serialization of drugs in the U.S. supply chain. This is an annual look I’ve been doing for five years now. For my previous essays, see:
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.