Well over a year ago, my good friend Kevan MacKenzie, Director, Serialization Technology with McKesson, pointed out a really interesting discrepancy contained in the Drug Supply Chain Security Act (DSCSA) regarding the sale of non-serialized drugs. I’ve been meaning to write about it since then. The topic finally bubbled up to the top on my list.
What Kevan pointed out is that there are two sections of the DSCSA that contain slightly conflicting requirements. This leaves companies a little confused about exactly what Congress meant. In a normal world, this would lead the FDA to provide guidance to address the issue and explain what companies should do. I don’t have much faith in that happening anytime soon. Do you? (See “Who Is Being Harmed By Four Overdue FDA DSCSA Guidances?“, “FDA Forfeits Opportunity To Guide Industry” and “Is The FDA Intentionally Delaying Publication Of The Overdue DSCSA Guidance?“.)
We know that non-serialized drugs will exist in the supply chain after November 27th of this year because they can be sold legally by manufacturers prior to that date, and because the DSCSA (apparently) allows manufacturers to continue selling those that fall under the DSCSA grandfathering provision after that date (see “Will Manufacturers Be Able To Grandfather Products In Their DC And 3PL?“).
THE TWO SECTIONS OF THE DSCSA
Two DSCSA sections affect the sale and purchase of non-serialized products between November 27, 2019 and November 27, 2020. For wholesale distributors, DSCSA Section 582(c)(2) says (see “The Drug Supply Chain Security Act Explained“):
‘‘(2) PRODUCT IDENTIFIER.—Beginning [on November 27, 2019], a wholesale distributor may engage in transactions involving a product only if such product is encoded with a product identifier…”
For dispensers, DSCSA Section 582(d)(2) says:
‘‘(2) PRODUCT IDENTIFIER.—Beginning not later than [November 27, 2020], a dispenser may engage in transactions involving a product only if such product is encoded with a product identifier…”
What this appears to mean is that between November 27th of 2019 and 2020, dispensers can still buy drugs that are not serialized, but for that same one year period, wholesale distributors cannot sell them. In that case, as Kevan asks, who exactly is going to sell non-serialized drugs to those dispensers during that time? Why aren’t these dates the same?
WHAT DOES THIS MEAN?
I think he has a good point. In fact, the effect of these different dates could tempt pharmacies to consider acting as wholesale distributors of non-serialized drugs during that one year window. I don’t think that’s what Congress intended, and I think the FDA and State Boards of Pharmacy will frown on that kind of activity.
Keep in mind that the DSCSA accommodates the transfer of drugs between dispensers in DSCSA transactions [see DSCSA Sections 582(d)(1)(A) (ii) and (iii)]. So during this one year period, dispensers cannot buy non-serialized drugs from wholesale distributors, but they can still buy, sell and exchange them with other dispensers. I think this provision exists to enable the kind of trading of stock between pharmacies that has been used by hospitals historically to address spot-shortages within a local area. I’m pretty sure it was not intended to open the door to pharmacies doing business as a wholesale distributor–selling non-serialized drugs to anyone placing an order. What do you think?