There are a lot of discussions going on in the industry right now, over which approach and which technologies the US pharma supply chain should select to meet the 2023 requirements of the Drug Supply Chain Security Act (DSCSA). People are understandably confused over these discussions. Why should we guess what the FDA will accept in 2023? Blockchain? EPCIS? Aren’t these debates and discussions just a waste of our time? Why doesn’t the FDA just tell us which technology they will accept for the DSCSA in 2023? In fact, these questions have become so common lately that I think it is time to examine what is going on. There are definitive answers to these questions, and they are contained within the DSCSA itself. Continue reading DSCSA: Why FDA Will Not Mandate Blockchain, EPCIS Or Any Other Specific Technology
There are many terms specifically defined within the Drug Supply Chain Security Act (DSCSA) text (see “Don’t Skip The DQSA Definition of Terms Section”). One of the words you should expect to be defined there is “interoperability”, because it plays such a big role in the system(s) that must be used by everyone in the supply chain after November 27, 2023. That is, the “…interoperable, electronic tracing of product at the package level…” that is at the core of the Enhanced Drug Distribution Security (EDDS) phase that is defined in Section 582(g). But surprisingly, the term is not defined in the text.
In fact, it appears to be left up to Continue reading Does Interoperability Change In 2023?
Last week the FDA announced it will coordinate one or more pilot(s) to assist in the development of the electronic, interoperable system that will identify and trace drugs in the U.S. under the Drug Supply Chain Security Act (DSCSA) in its Enhanced Drug Distribution Security (EDDS) phase starting in 2023. Once they start work on pilot planning, they will call for proposals from stakeholders and others. But they can’t start until they get permission from the Office of Management and Budget (OMB), and they won’t even ask OMB for permission until they collect comments on the proposed collection of information associated with establishing the pilot program. Believe it or not, that was the Continue reading What Should FDA Pilot?
During the report out and follow-up discussion at last week’s FDA Drug Supply Chain Security Act (DSCSA) Pilots Workgroup (see “The 2016 FDA Pilots Workshop”) I heard an example of the industry throwing interoperability under the bus. That is, setting us all up for major complications down the road that could easily be avoided if the leaders would just address interoperability right today. One of the long-time leaders of the use of serialization and traceability in the U.S. pharma industry spoke up in front of the entire assembly and said that there existed a general “agreement” within the industry that “not everyone will use EPCIS”. That is, not everyone will use GS1’s Electronic Product Code Information Services (EPCIS) standard for meeting the DSCSA, and consequently, the FDA and the industry will need to allow other formats of the data in 2023. I just about fell out of my chair. Continue reading InBrief: Pharma Supply Chain Leaders, Stop Throwing Interoperability Under The Bus
I just arrived home from a vacation in Aruba so I missed out on the winter weather many of you experienced last week. Here are a few pictures to help warm you up!
While I was in Aruba I spent some time thinking about interoperability as it applies to the provisions of the U.S. Drug Supply Chain Security Act (DSCSA). The text of the law uses the term “interoperable” multiple times with regard to the exchange of data between trading partners, but interestingly, it does not define the term. That leaves the definition of the term up to the FDA.
Before we look at the FDA’s definition of “interoperable”, let’s Continue reading Interoperability And The DSCSA
As we near the end of 2014, several important pharma traceability deadlines around the world are approaching. Besides the U.S. Drug Supply Chain Security Act (DSCSA), these include deadlines in Brazil and South Korea. Of course, each regulation is different. Now that the initial implementation of the exchange of transaction data in the U.S. is widely being implemented in Electronic Data Exchange (EDI) Advance Ship Notices (ASNs), the next hurdle for drug manufacturers will be to deploy serialization technologies on their U.S. and Korea market packaging lines. The data exchange technology problem will shift to Brazil, and that’s where I see trouble. Continue reading Global Traceability Data Exchange: Troubled Waters Ahead
There is a new and valuable resource available for anyone who needs to make use of both GS1 RFID and GS1 barcodes–or even just one or the other–on any product or shipping container and in any supply chain. It is called “RFID Bar Code Interoperability, GS1 Guideline” and it is available as a free PDF download here on the GS1 website.
This is a guidance document, which means that it isn’t a standard itself but draws contents from GS1 standards documents to better explain the subject. In this particular case it draws primarily from the GS1 General Specifications and the Tag Data Standard. Both of those source documents are huge and so you will find this new guidance document a relative joy to read if you need this kind of information.
Even if you are already familiar with GS1’s RFID and barcode standards, intermingling them so that they are fully interoperable in a single application isn’t Continue reading InBrief: RFID and Barcode Interoperability
[This essay is one of two long lost essays that have now been restored on RxTrace. It was originally published on November 22, 2010. See “Return Of Two Classics” for an explanation.]
In my last essay, “Who Will Decide Which Pedigree Model You Will Invest In?” I pointed out how easy it is to get confused about pedigree technology because of varying claims made by certain companies who have interests that don’t align well with yours. So where can you get better information? I can provide you with a few good sources, and I will also tell you about a missing ingredient that I see in the current guidance landscape that will need to be addressed in the next couple of years. Continue reading Standards and Guidance For U.S. Pharma Supply Chain Technology