Even before the Drug Quality and Security Act (DQSA) was passed last November I began to study Title II, the Drug Supply Chain Security Act (DSCSA). But as soon as it was passed, I began to devote all of my spare time to that study. The DSCSA text is much more complicated than any previous U.S. drug pedigree law and so, to really understand it, I’ve read it through many times, concentrating on different parts at different times. I wanted to understand the law as well as I had come to understand the California pedigree law, the one that previously was the most complex.
It has taken this long, but I can now say that I have cracked it. And I have created a resource that will make the chore of understanding the DSCSA a lot easier than the path I took. Today I am announcing the availability of my new book, “The Drug Supply Chain Security Act Explained”. Click here to get a copy.
THE DRUG SUPPLY CHAIN SECURITY ACT EXPLAINED
If you need to implement the requirements of the new DSCSA law, then you need to understand it well. Don’t make assumptions. And don’t listen to those who have not studied the whole thing in depth. I’ve heard some pretty sloppy statements made by vendors recently that could lead people in the wrong direction. Make your own decisions about how to implement, and base it on a solid understanding of the actual text.
My document explains every section of the DSCSA, from the definition of Affiliate (the first section of the law) to the Savings Clause (the last section), and includes an explanation of the implications of key requirements—including those that are buried in some obscure places in the text.
I convert every abbreviated numeric reference to another section into the full number and title of that section, and a hyperlink to it, so you can immediately understand the significance of the reference and you can jump to it with a single click if you wish. I convert every relative date into an absolute date and I include timeline graphs and super-handy summary tables (with more hyperlinks!) for each segment of the supply chain, making it easy to focus on the requirements of a single segment at a time.
That brings me to the most important feature of the document: it is loaded with thousands of internal hyperlinks. Here is a sample section from the actual DSCSA:
“(2) PRODUCT IDENTIFIER.—Beginning not later than 7 years after the date of enactment of the Drug Supply Chain Security Act, a dispenser may engage in transactions involving a product only if such product is encoded with a product identifier (except as provided pursuant to subsection (a)(5)).
And here is the section from “The Drug Supply Chain Security Act Explained” that covers this “simple” section (click the image to enlarge it):
The section number in the left margin is a hyperlink that will take you to the original DSCSA text for this section. Each of the underlined words are also hyperlinks that will take you to my explanation of the DSCSA definitions of these terms. You can see the relative date has been converted to the absolute date, and the obscure reference to “subsection (a)(5)” has been explained, and a link provided so you can quickly check out the grandfathering provisions and then quickly return to this point in the text. These features are spread throughout the document, in every section.
The links to the DSCSA definitions of key words used in the law are extremely important, because many of these definitions differ from what we would normally think they are. To understand the real meaning of a given clause, you really need to review those definitions as they are used in that clause (see “Don’t Skip The DQSA Definition of Terms Section”). These hyperlinks make that easy.
The document also includes pages of external reference material in the form of endnote references, including hyperlinks so you can leap right to them.
If you need to understand the DSCSA and its implications, then you need “The Drug Supply Chain Security Act Explained”. It will make your study time much more efficient. What took me months of study time can be accomplished in a fraction of that time using this tool. Every piece of information you need is at your fingertips, and it includes my special explanation.