FDA just issued another DSCSA compliance extension. This time it was offered to wholesale distributors who were facing a November 27th deadline for verifying saleable returns. They now have an extra year to establish compliance with this provision of the law. I find it interesting, however, that FDA waited virtually until the last moment to issue this pass when it must have been clear to the agency all along that wholesale distributors were never going to meet this milestone. Was the 4th quarter nature of this reprieve really necessary? Perhaps FDA could have stated its intentions much earlier in the process to allow these trading partners an opportunity to catch their breath a bit and more realistically plan for a 2020 compliance deadline.
The other concern I have with this guidance is that it fails to reference the verification requirement for saleable returns found in the product tracing section of the law. FDA focused its attention solely on section 582 (c)(4)(D), but appears to have missed the parallel requirement found below in section 582 (c)(1)(B)(i)(II). This is quite an oversight, especially since the law is six years old.
Beginning 6 years after the date of enactment of the Drug Supply Chain Security Act (except as provided pursuant to subsection (a)(5)), a wholesale distributor may accept returned product from a dispenser or repackager only if the wholesale distributor can associate returned product with the transaction information and transaction statement associated with that product. For all transactions after such date, the transaction history, as applicable, of such product shall begin with the wholesale distributor that accepted and verified (emphasis added) the returned product.
Lastly, as much as I would like to agree with FDA, I don’t believe there is any basis in the law’s verification requirements for determining whether a returned product is a suspect product. FDA will likely get pushback from stakeholders for claiming its guidance “does not affect the requirement that a wholesale distributor must have verification systems in place to determine whether a returned product is a suspect product (emphasis added).”
Unfortunately, the DSCSA’s verification requirements are triggered only “Upon” a determination being made that a product in the possession or control of a wholesale distributor is a suspect product. While trading partners are certainly required to respond to suspect product incidents, there does not appear to be any overt requirement in the law for identifying suspect products in the first place. To me, this conundrum represents the ultimate DSCSA paradox.