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.
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.
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.
Since the law doesn’t specify a carrier technology, and because the manufacturers will foot the bill for whatever technology is used, naturally, they get to lead the supply chain in that choice. If you don’t like what they are choosing, then please, step up and pay them to put your preferred carrier technology on their packages. I’m sure the manufacturer’s would put whatever you want to pay for on their packages as long as it would comply with the law.
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.