DSCSA Guidance: Definitions of Suspect and Illegitimate Product for Verification Obligations

As I mentioned last week, the FDA published two new draft DSCSA guidance documents on the day of the recent FDA DSCSA Public Meeting (see “FDA DSCSA Public Meeting #3: A Difference?”).  Let’s take a closer look at what’s in them and their significance to companies facing the Drug Supply Chain Security Act (DSCSA).  I’ll cover one of the two in this essay and cover the other document in the next essay.

First, draft FDA guidance is “not for implementation”, and, under normal situations, only “contains nonbinding recommendations”.  In theory, you have to wait until the draft guidance is “finalized” before it “…will represent the current thinking of the [FDA] on this topic”.  But some guidance documents from the FDA are never “finalized”, and they still seem to clearly represent their “current thinking” on the respective topic.  An example of this is last summer’s guidance containing the FDA’s compliance policy that announced their intention not to enforce the manufacturer’s DSCSA unique identifier and verification requirements for one year.  That guidance was issued in draft form, and it will likely never be “finalized” by the FDA, yet they are following the enforcement discretion it contained.

The most important aspect of a “draft” guidance is that the FDA always asks the public—particularly stakeholders—for comments on anything and everything contained within the draft.  They are apparently required to respond the every significant comment received before they can “finalize” that guidance.  If a given draft guidance is so bad that they get lots of really solid negative comments, that could be one reason they never “finalize” that particular guidance.  It would be too hard to fix it in response.  In other cases, when they do publish final guidance, the comments submitted almost always make the final version much better than the original draft version.

While I predict the enforcement discretion guidance from last summer will never actually be “finalized”, the two guidance documents that were published officially on March 2, 2018 will probably be finalized at some point.  So your thoughtful comments are very important to ensure they reflect clarity and logic relative to the DSCSA.  It’s on you and me to respond whenever we find problems in the draft.

Well, it’s on you anyway.  I post my comments here in RxTrace, and if they have merit, then I expect someone within the supply chain to take them up in their comment submission to the FDA docket.  There are a few readers of RxTrace who work for the FDA but, surprisingly, they don’t work in the departments that deal with the DSCSA.  If you figure that one out, let me know.

At this point, I will pause and make sure everyone knows that anyone with a “.gov” or “.edu” email address can get full access to RxTrace at no charge.  Just register here with that email address:  https://www.rxtrace.com/corporategroup-subscription/


This is the shorter of the two guidance documents.  It contains FDA’s own definitions of certain key words that were used within the original text of the DSCSA but were not defined there.  The new definitions contained in the guidance were used within the definitions of the terms “Suspect Product”, and “Illegitimate Product” and some in a few other places.  By providing a firm definition of these additional terms within the draft guidance, FDA is attempting to remove some ambiguity from the original terms and the original sections where they are used.

The new key terms defined within this guidance document include:

  • Counterfeit
  • Diverted
  • Fraudulent Transaction
  • Unfit for Distribution

The guidance says:

“While this guidance does not create an exhaustive list of the circumstances that may result in a counterfeit drug, a diverted drug, a fraudulent transaction, or a drug that is unfit for distribution, it describes the most common scenarios that FDA believes trading partners will encounter.”

This is an important disclaimer that can certainly also be applied to all of the definitions of terms inside of the original DSCSA.  These definitions are very specific to the interpretation and enforcement of the DSCSA.  Don’t make the assumption that you already know the definition of these terms.  The FDA definitions can be narrower or wider than what you probably already think they mean and therefore the interpretation and enforcement of the DSCSA are different than you would expect too.

Last week at the Healthcare Distribution Alliance (HDA) DMC conference I heard at least one person express concern over the definition of “Unfit for Distribution”.  I think I see the problem.  The FDA’s proposed definition of this term includes:

“…including drugs rendered nonsaleable because conditions (such as return, recall, damage, or expiry) cast doubt on the drug’s safety, identity, strength, quality, or purity…”

This may seem logical, but because drugs that are found to be “Unfit for Distribution” must be treated as “Illegitimate Product”, which means they are subject to the notification requirements.  This is too extreme for a drug package that gets damaged inadvertently in a warehouse somewhere—damaged so that it “cast[s] doubt on the drug’s safety”.  Sure, that makes it unfit for distribution, but it shouldn’t be considered “Illegitimate Product” and shouldn’t require notification of the FDA and trading partners.  Otherwise the FDA will be flooded with notifications of very minor and routine damaged product.  This happens all the time and it’s nothing to get excited about.

On the other hand, the definition of “Illegitimate Product” in the DSCSA only includes products that are “unfit for distribution” when those products “…would be reasonably likely to result in serious adverse health consequences or death to humans.”  Most damaged product shouldn’t raise to this level of concern, so maybe we shouldn’t be concerned about this language after all.

To submit comments to the FDA about this draft guidance document before April 2, 2018, follow the instructions here.

I will discuss the second guidance document in my next essay.