FDA has issued a second compliance extension to dispensers, giving this group of trading partners even more time to meet the DSCSA’s product tracing requirements that were originally set to take effect on July 1, 2015. FDA’s initial compliance policy, issued on July 6, 2015, gave these trading partners until November 1, 2015 to meet these new DSCSA requirements. This latest compliance policy now extends that date to March 1, 2016, or eight months after the requirements were first mandated to take effect. Interestingly, manufacturers, wholesale distributors, and repackagers are not exempt from providing such information to dispensers. Product tracing requirements for these trading partners originally took effect on January 1, 2015, but FDA subsequently extended that date to May 1, 2015.
According to FDA’s most recent guidance, “some dispensers-primarily smaller, independent pharmacies and health systems-have expressed concern that they will be unable to comply with these requirements by November 1, 2015.” However, a possible unintended consequence of granting these delays may be to bolster the eventual onslaught of “undue economic hardship” claims from such dispensers attempting to qualify for waivers from any of the product tracing, product identifier, authorized trading partner, and verification requirements under the DSCSA. Other trading partners (excluding 3PLs) will be encouraged to make similar claims as they look to jump on the DSCSA waiver bandwagon. Unquestionably, many of these claims will be legitimate and entirely warranted, but many will also amount to clever subterfuge by corrupt trading partners seeking to exploit the DSCSA’s waiver provision so they can maintain the status quo and avoid any additional regulatory scrutiny or requirements that may come their way as a result of the DSCSA.
Pursuant to the DSCSA, FDA has until November 27th of this year to issue guidance establishing “a process by which an authorized manufacturer, repackager, wholesale distributor, or dispenser may request a waiver from any of the requirements set forth in [section 582], which the Secretary may grant if the Secretary determines that such requirements would result in an undue economic hardship [emphasis added] or for emergency medical reasons, including a public health emergency declaration pursuant to section 319 of the Public Health Service Act.” I suspect this guidance is likely to receive the same type of scrutiny and objections that FDA’s final pedigree regulations faced back in 2000 and 2006.
FDA also announced that its “compliance policy does not extend to other requirements of the FD&C Act, including those in section 582, such as verification related to suspect and illegitimate product (including quarantine, investigation, notification and recordkeeping) and requirements related to engaging in transactions only with authorized trading partners.”
The DSCSA’s verification requirements are potentially quite burdensome on smaller dispensers. Investigating suspect product incidents and validating transaction data when such determinations are made can be extremely time consuming and resource-intensive activities and they are also unfamiliar territory for many dispensers. The same can be said for the notification processes associated with illegitimate product determinations. Hopefully, the same group of dispensers that was the focus of FDA’s most recent compliance policy is equally committed to meeting all of the DSCSA’s mandates, not just those related to product tracing. Without the presence of robust verification systems, the exchange of product tracing information among manufacturers, wholesale distributors, dispensers, and repackagers becomes a mostly meaningless process that fails to advance the supply chain security objective of the DSCSA.