Who Will Enforce The DSCSA 2017 Serialization Mandate?

Last week I listened in on a Drug Supply Chain Security Act (DSCSA) call hosted by one of the Big-3 U.S. wholesale distributors.  It was a well-run call that included several presentations and a Q&A session.  Several times the question was discussed about whether or not the wholesale distributor would accept non-serialized product in the time between November 27, 2017 and November 27, 2019.

These two dates represent the date on which the DSCSA requires drug manufacturers to begin applying DSCSA product identifiers (including serial numbers) on their drug packages and homogeneous cases, and the date on which wholesale distributors must begin engaging in transactions that only include drug packages that contain those DSCSA product identifiers.  The core question is, will wholesale distributors enforce the DSCSA requirement for drug manufacturers to apply the DSCSA product identifier, or will they not enforce that requirement, at least until their own requirement to not accept those products?

This is an interesting question.  If the wholesale distributors do not enforce the manufacturer’s DSCSA requirement during that timeframe, then it will be up to the FDA to enforce those regulations—which will be pretty hard/costly for them to do.  And in that case, it is possible that no one will enforce that requirement during that timeframe.  So manufacturers have a keen interest in the enforcement plans of the wholesale distributors.

It turns out, this particular wholesale distributor does not intend to refuse non-serialized drug products prior to their requirement on November 27, 2019.  They simply plan to trust that manufacturers at that time are following whatever grandfathering allowances the FDA offers in their future guidance.  The DSCSA requires the FDA to publish guidance on grandfathering for manufacturers before November 27 of last year and that guidance has still not been published (see “Will Manufacturers Be Able To Grandfather Products In Their DC And 3PL?” and “Who Is Being Harmed By Four Overdue FDA DSCSA Guidances?”).  Maybe we will see it before this November.  Maybe not.

This approach by the wholesale distributor makes perfect sense to me, given the way the DSCSA is written.  Each entity in the supply chain is required to do certain things at certain times, but it is not a requirement for any one entity to enforce the requirements of another.  That is, no one is required to play “cop” to any other.  I suspect that the other two major wholesale distributors will take the same approach, although it is a good idea to ask them explicitly.

Will this apparent lack of meaningful enforcement by anyone lead to widespread missing of the November 27, 2017 serialization deadline?  If that happens, is it a bad thing, considering that the wholesale distributor’s deadline in 2019 will finally be the wedge that forces all trade through wholesale distributors to be serialized?  Remember, there really isn’t any mandated use of those serial numbers during those interim two years.

Is it a valid business strategy to actually plan to miss the 2017 serialization deadline?  No.

Can the 2-years between the manufacturer serialization deadline and the wholesale distributor deadline be used as a buffer to finish up any late serialization line conversion projects without negatively impacting the availability of drugs in the U.S. supply?  I think so (but see my earlier thoughts on the manufacturer’s deadline “An Open Letter To The FDA, EMA and ANVISA, RE: Who Are You Going To Punish?“ and ” How Will The DSCSA Serialization Mandate Be Enforced After 2017?”).  What do you think?