I have been outspoken on the question of whether or not the Drug Supply Chain Security Act (DSCSA) requires companies in the supply chain to provide their customers with serial number-based aggregation data prior to 2023. In my view, it does not, but others disagree, saying that there are requirements in the law that lead to the need for aggregation data during that time. I do not agree with that either. If you would like to review those arguments and find out exactly what “aggregation data” is, here is a list of RxTrace essays you should read:
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.
…a comprehensive exploration of the intersection between healthcare supply chains, track and trace technology, standards and global regulatory compliance
DISCLAIMER: RxTrace contains some of the personal thoughts, ideas and opinions of RxTrace. The material contained in RxTrace is not legal advice. The writers of RxTrace are not lawyers. 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 RxTrace.