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

FDA Still Receives Requests For Exemptions From 2006 Barcode Rule

FDALogoThis morning the FDA is due to publish an announcement for an opportunity to comment on their proposed collection of certain information as part of ongoing requests for exemptions from the linear “barcode rule” that has been in effect since April 26, 2006.   The FDA is soliciting comments on the barcode label requirements for Continue reading FDA Still Receives Requests For Exemptions From 2006 Barcode Rule

HDMA Updates Q&A For DSCSA

HDMA LogoI was on the HDMA’s website last week doing some research for one of my clients, and I found that the HDMA has updated their highly regarded Q&A document that provides answers to questions related to the U.S. Drug Supply Chain Security Act (DSCSA).  I have reviewed this document before in its previous incarnation and view it as one of the best resources out there for all supply chain participants (see “InBrief: HDMA Updates DSCSA Q&A“).  Each time they update it they Continue reading HDMA Updates Q&A For DSCSA

Sponsored: Tell The FDA About Your Progress Toward The DSCSA Serialization Deadline, Anonymously

2015-12-09 20.36.00This is a “sponsored” essay, which simply means it is free to everyone and does not count against their one free essay per month for those who are not full subscribers.  The reason for that is to maximize the number of people who have the opportunity to tell the FDA how they are progressing toward the DSCSA serialization  deadline, and do so anonymously. Continue reading Sponsored: Tell The FDA About Your Progress Toward The DSCSA Serialization Deadline, Anonymously

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

FDA DSCSA Deadline Passes Quietly

Last Friday was the deadline for the FDA to publish four new guidance documents under the Drug Supply Chain Security Act (DSCSA) (see “Decoding The FDA’s DSCSA Timeline”).  The deadline was established by the U.S. Congress when they enacted the legislation and it was signed by President Obama on November 27, 2013 (see “It’s Official, President Obama Signs H.R. 3204, DQSA, Into Law”).  But time spent by the FDA to meet their obligations under the DSCSA is “unfunded”.  That is, Congress did not provide any specific additional money to pay for the FDA’s new obligations under the DSCSA.  It is an unfunded mandate.

Fortunately the FDA is Continue reading FDA DSCSA Deadline Passes Quietly

Insufficient Transitional Measures Doom The FMD-EUDA

EU Member States
EU Member States. Source

The pharmaceutical supply chain in most markets is complex, but in my view, the one in the European Union easily takes the prize for being the most complex of any other.  The addition of unit-level serialization and verification of authenticity to that supply chain over the next few years as required by the Falsified Medicines Directive (FMD) and the Delegated Act (EUDA) is going to be difficult (see “Breaking News: The EC Has Published The Delegated Act“).  It represents a huge change to the way drugs are packaged and how they are handled by each entity in the supply chain.  It is vital that the transition Continue reading Insufficient Transitional Measures Doom The FMD-EUDA