Category Archives: Interoperability

DSCSA: Interoperable Data Exchange In 2023

Lots of people have been talking lately about what interoperable data exchange in the US pharma supply chain will look like after the Enhance Drug Distribution Security (EDDS) phase of the Drug Supply Chain Security Act (DSCSA) takes effect in November 2023 (see “Does Interoperability Change In 2023?”, “5 Myths About The DSCSA In 2023” and “Interoperability And The DSCSA”). 

Increasingly, I’ve heard the opinion expressed that there will surely be multiple approaches adopted for exchanging data, and so it will be necessary for all of those approaches to be made interoperable with each other.  Proponents of this idea claim it is unrealistic to expect a single approach to be accepted by all companies in the supply chain and therefore, having to deal with multiple approaches is inevitable.  This kind of talk makes me nervous.  Here’s why.

Continue reading DSCSA: Interoperable Data Exchange In 2023

Interoperability And The DSCSA

Divi-Divi tree Aruba.  Click image to enlarge.
Divi-Divi tree in Aruba. Click image to enlarge.

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