The FDA published a new draft guidance yesterday with explanations intended to dispel various kinds of confusion over the five kinds of trading partners defined in the Drug Supply Chain Security Act (DSCSA) text. They are clearly on a roll, with the combination of the recent draft compliance policy, pilot and public meeting announcements, and now this draft guidance exceeding all of the DSCSA-specific communications they produced last year. We’ll know for sure that the logjam has been cleared when we finally see one of the four mandated guidance documents that were originally due on November 27, 2015 (see “Who Is Being Harmed By Four Overdue FDA DSCSA Guidances?“). But what about this new one?
You can find the new guidance document here.
The one word that came to my mind when I read through the guidance was “minutia”. That is, the FDA takes a hard look at each of the five supply chain participants defined in the DSCSA and provides us with the way they “split hairs” between entities like “Jobbers”, and “Brokers”, “Returns Processors and Reverse Logistics Providers”, and a number of others. Are these wholesale distributors? Are they Third Party Logistics Providers (3PL)? Is a “solution provider” a 3PL? This document has the answer (no, they are not).
Of course, these distinctions are incredibly important, to Jobbers, Brokers, Returns Processors and Reverse Logistics Providers and Solution Providers, and others discussed in this draft guidance, but to most people, it’s just minutia. Minutia, but it has to be done, and the FDA does a fine job of it.
The document does also discuss, at length, the definitions of manufacturers, wholesale distributors, repackagers, dispensers and 3PL’s by quoting the relevant portions of the law. And they dispel a number of confusing issues that were raised by the specific wording of some of those definitions in the DSCSA. And there is a very handy table at the end of the document that summarizes the five types of DSCSA authorized trading partners.
Remember, FDA guidance is non-binding. It simply reflects the FDA’s current thinking on the topic, and technically it isn’t even that until it is final. If you disagree with their current thinking, or if you think they should have commented on some other type of entity. As with other draft guidance documents the FDA releases, there is a docket open to receive your comments.
I hope to see you all at the FDA DSCSA Public Meeting tomorrow!