Lots of people across the U.S. pharma supply chain are spending their spare time these days trying to read and understand the U.S. Federal Drug Quality and Security Act (DQSA) that was enacted in November and begins to take effect in a significant way next January (see “It’s Official, President Obama Signs H.R. 3204, DQSA, Into Law”). I am one of those people.
I have carried a printout of Title II (the Drug Supply Chain Security Act, or DSCSA) of the DQSA around with me ever since it was passed and it is now so dog-eared and marked up that I am about ready to print out another copy. Only trouble is, I would need most of those markings in the new copy too, so I just keep using the same printout.
My understanding of the law and its implications rises every time I study it. Sometimes I read it straight through and other times I skip around in an attempt to follow a particular topic or thread. One of the things I figured out early on was, you must read and fully understand the Definitions section—Section 581—or you will never properly understand the rest of the law. I repeat, you cannot skip that section if you expect to fully understand the law.
Section 581, Definitions, is a special glossary of terms whose definitions only apply within the text of the law. So if you read the other sections and you assume the dictionary or the everyday definition of certain terms, you will miss the full meaning of those sections. All you have to do to understand the importance of this is to skim through the text of the law and see how often terms like “Product”, “Manufacturer”, and “Transaction” are used throughout. Almost every sentence has at least one term that has a special meaning. Some have multiple.
What the authors have done is to define certain everyday terms in a special, DSCSA-specific way that made their job a lot easier when they wrote the other sections of the law. If you were to take each of the terms that are defined and replace every one of their occurrences in the rest of the text with their full definitions, the length of the law would explode into hundreds, if not thousands of pages. But because the definitions of these everyday terms are specific to the DSCSA you must not apply the everyday definition when you read the full text or you will misunderstand a lot.
For example, do you think you know what a transaction is? You might, except within the text of the DSCSA unless you have read the full page definition of “Transaction” in the Definitions section of that law. If you haven’t read and understood the DSCSA-specific definition of that word, then you will misunderstand those other sections. Fortunately the bulk of the definition of “Transaction” is taken up by what is NOT considered a transaction within the DSCSA, and that will be very important to companies who fit into one of those exemptions.
Here is a full list of the terms that have special, DSCSA-specific definitions in the law:
- Distribute or Distribution
- Exclusive Distributor
- Homogeneous Case
- Illegitimate Product
- Prescription Drug
- Product Identifier
- Returns Processor or Reverse Logistics Provider
- Specific Patient Need
- Standardized Numerical Identifier
- Suspect Product
- Third-Party Logistics Provider
- Trading Partner
- Transaction History
- Transaction Information
- Transaction Statement
- Verification or Verify
- Wholesale Distributor
The definitions of all of these terms are important in various ways, especially those that are used frequently in the text, but I found the definitions of some terms, like “Disposition” and “Verification or Verify”, to be extra important because their definitions are so different from their everyday dictionary definitions. They become terms with hidden meaning that sway unsuspecting readers to make incorrect assumptions about the impact of the clauses that use those terms. So before you study the other sections of the DSCSA, study the definitions section. And whenever you read a clause that contains one or more of these terms, think back to their full DSCSA-specific definition.