What Does it Mean?
On Monday, July 3rd, 2017 the U.S. FDA published a new draft compliance policy for comment, regarding the requirement for drug manufacturers to apply or affix a unique identifier on their prescription drug products and homogeneous cases by November 27, 2017, under the Drug Supply Chain Security Act (DSCSA). The reason FDA is pursuing this delay in enforcement is out of concern for the readiness of manufacturers for implementation of the product identifier requirements. FDA wishes to minimize possible disruptions in the distribution of prescription drugs in the United States. That’s a noble cause.
If finalized, this compliance policy would establish the FDA’s intention to not enforce that requirement on manufacturers between November 27, 2017 and November 26, 2018—a delay of one year. Further, the FDA would also not enforce the manufacturer’s requirement to verify those specific drugs at the serial number level. They would continue to require verification at the lot level. Odds are very high that the FDA will finalize this policy soon after the 60 day public comment phase.
This enforcement delay would result in cascading enforcement delays down the supply chain because it would allow non-serialized drugs to enter the supply chain after the original DSCSA deadline. Once that happens, the FDA would be forced to allow repackagers, wholesale distributors and dispensers to engage in transactions involving drugs that were not serialized beyond their respective deadlines. That is also part of this draft guidance.
It’s a delay, so it’s all good, right? That depends on how you interpret the draft guidance, where your serialization program is at, and how you react to it.
Before you finalize your compliance plans in light of this new draft, make sure you listen to Systech’s Regulatory Strategist, Dirk Rodgers explain exactly what the FDA says they will do—and won’t do—and what it means to manufacturers, repackagers, wholesale distributors and dispensers.