I first learned about the significance of the annual document about 18 months ago when an FDA official explained it in a conference presentation. In response to a question from the audience about when she thought the FDA would publish the Track & Trace (T&T) standard for pharmaceuticals, she recommended that people watch for a notice of it in the “Guidance Agenda…” each year. She said Continue reading InBrief: FDA To Publish Track & Trace Standard By Year End→
One of the biggest challenges for companies in the U.S. pharmaceutical supply chain when the California pedigree law becomes operational after December 31, 2014 will be the need to maximize the efficiency of dealing with serial numbers on each drug package. One way to do that is to maximize the use of “inference” where the case serial number is read and the unit package-level serial numbers are “inferred” from the unit-to-case aggregation information supplied by the upstream trading partner (See my essays “Inference in the Pharmaceutical Supply Chain” and “Will The Pharma Supply Chain Be Able To Use Inference? Maybe Not!”).
But the problem with the use of inference is that you need to be able to rely on the accuracy of the aggregation information that your supplier provides to you. There is an element of trust in that—not just that you trust your supplier to be truthful with you but that you trust that your supplier’s case packing processes and systems will always accurately capture and document the unit-to-case hierarchy—or “aggregation”. You must be able to trust that the aggregation information your supplier provides to you will be 100% accurate. That’s a lot of trust. Continue reading Pharma Aggregation: How Companies Are Achieving Perfection Today→
During the California Board of Pharmacy, Enforcement Subcommittee meeting on Wednesday the members voted unanimously to recommend to the full board the approval of a regulation that would require the use of the Food and Drug Administration’s (FDA) Standardized Numerical Identifier (SNI) as the unique identifier that is required on all drugs packages as part of their pedigree law. That law currently requires pharmaceutical manufacturers to apply unique identifiers to 50% of all their prescription drug packages by January 1, 2015 and the remainder by January 1, 2016.
I also saw a presentation by one of the members of the PDSA last week that touched on the RxTEC proposal. It was characterized as a “stepping-stone” to full traceability in the U.S. supply chain someday down the road. In other words, the PDSA apparently means that their RxTEC proposal isn’t the final destination but it is only the first step toward that ideal. At least, that’s how I interpreted that “stepping-stone” comment.
I’ve been tracking the number of pageviews of RxTrace for the last two years and I can report to you that I have recently observed a fairly abrupt rise of those numbers that I describe as a “surge” when compared with the previous trend. The surge I am seeing started in November (discounting December when the holidays interfere with readership stats) and continues to this day. I have seen a comparable surge of the number of new subscription requests for RxTrace.
What is the cause of this development? I have a theory which I will share with you. With this essay I am also announcing that I have formalized an RxTrace advertising program to enable companies to advertise their events, products and services unobtrusively in the margins. More about that in a minute, but first, here is a graph of the relative number of pageviews each month for the last two years. Continue reading The Abrupt Surge of Interest in Serialization and ePedigree Topics→
The California pedigree law will have a surprising influence on how the pharmaceutical supply chain operates in another state. I’ll get to that in a minute, but first, the law will change some things about the way the supply chain operates in all states. Prescription drug manufacturers who want to continue offering their products to patients within California after 2015-2016 must add unique serial numbers to each drug package and start an electronic drug pedigree.
California is the only state that requires both of those things but most manufacturers are forced to treat the California state law as if it applies nationwide. That’s because most drug manufacturers sell through distributors in the United States and so they have no way of knowing which drug package will end up being shipped into California and which ones will not. Voila! Pharma manufacturers end up having to serialize and create a pedigree for every single package that enters the U.S. supply chain.
This almost certain outcome will likely affect the full nationwide supply chain in a couple of interesting ways.
AFTER 2015: ALL DRUGS IN THE U.S. SUPPLY CHAIN ARE SERIALIZED AND PEDIGREED BY THE MANUFACTURER
…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.