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
The Drug Supply Chain Security Act (DSCSA) makes it clear that the FDA must work with industry stakeholders to figure out exactly how the US pharma supply chain should meet its requirements after November 27, 2023–see DSCSA Section 582(g). That section specifies “The transaction information and the transaction statements shall be exchanged in a secure, interoperable, electronic manner…”. There is no mention of the creation of an independent third-party to design or coordinate that exchange, and Continue reading A US Medicines Verification Organization (USMVO)?
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.
RxTrace, a comprehensive exploration of the intersection between healthcare supply chains, track and trace technology, standards and global regulatory compliance.
Contact Us | Privacy Statement
Copyright © 2009-2019 Dirk Rodgers Consulting, LLC. All Rights Reserved.
RxTrace is a registered trademark of Dirk Rodgers Consulting, LLC
L, A, S, C