Tag Archives: Pharma Supply Chain

An Open Letter To The FDA, RE: Please Fix The National Drug Code Soon

Dear FriendDear FDA,

Thanks for inviting me to your DSCSA Pilot Party this week.  I look forward to visiting you at your Silver Spring home so we can catch up on what’s been happing in our lives recently.  I’m glad you are thinking more about the Drug Supply Chain Security Act (DSCSA) lately.  I am too.

In fact, I’ve been thinking about how nice it would be if you would fix the broken National Drug Code (NDC) as part of the implementation of the DSCSA.  It’s really not very hard to do.  You already laid out and tested the path that needs to be followed when you implemented the Unique Device Identification (UDI) numbering system for medical devices a few years ago.

Remember how happy that made me?  Remember, I called it “revolutionary” (see “FDA Proposed UDI: A Revolution In Number Assignment”), and it was!  But before I get to how you could do it for pharmaceuticals, let me explain why you should do it as clearly as I can. Continue reading An Open Letter To The FDA, RE: Please Fix The National Drug Code Soon

RxTrace Preview of 2016

It’s time to think about what is likely to happen in 2016 with regard to pharma serialization and traceability.  As part of that, let me remind you right off the top to fill out the 2016 RxTrace U.S. Pharma Traceability Survey, sponsored by Frequentz.  You don’t have to be a subscriber  to respond and the results will also be open to everyone in the coming months.

So what about 2016?  I think Continue reading RxTrace Preview of 2016

What The DNC Data Breach Means To The Future Of Traceability Data Repositories

iStock_000008540261SmallerThose of you who are paying close attention to the presidential election campaigns in the United States late last week were treated to a news story that may be a preview of stories that will be written at some point after 2023.  The story is about the potential game-changing impact of technology on business when competitors are forced to share a data repository.  That is, when private data that would be considered strategically valuable, in some way, if a competitor were to gain access to it, is held by an independent third-party.

In this case, Continue reading What The DNC Data Breach Means To The Future Of Traceability Data Repositories

Lack Of Preparedness By CMO’s Imperils Pharma Manufacturers

Somethings Gotta GiveEverywhere I traveled this fall I had conversations with people from drug manufacturers who told me their top concern right now is that their contract manufacturers (CMOs) or contract packagers (CPOs) are not taking the actions necessary to be prepared to meet the approaching serialization mandates in the U.S., the E.U. and elsewhere on time.  This threatens the manufacturer’s ability to be ready for those deadlines and they are grasping for something they can do now to fix the situation before it gets too late…if it isn’t too late already. Continue reading Lack Of Preparedness By CMO’s Imperils Pharma Manufacturers