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Enforcement actions are postponed to May 1 under new guidance
We all knew it was coming; now FDA makes it official: FDA’s Office of Compliance, generally the central point for enforcement of the Drug Quality and Security Act (DSCSA), has issued “immediate implementation” guidance that the looming Jan. 1 deadline for having a functioning system for transmitting transaction information from manufacturers to trading partners is being postponed to May 1.
The relatively brief (six-page) guidance reads, in part: “FDA recognizes that some manufacturers, wholesale distributors, and repackagers may need additional time beyond January 1, 2015, to work with trading partners to ensure that all of the product tracing information required under section 582 of the FD&C Act is provided to and captured by the recipient trading partner. To minimize possible disruptions in the distribution of prescription drugs in the United States, FDA does not intend to take action against trading partners who do not, prior to May 1, 2015, provide or capture the product tracing information.”
Informal assessments had indicated that roughly three-quarters of the pharma supply chain would be ready by Jan. 1 for the DSCSA deadline; that indicated that pallets of undocumented product could start stacking up at distributors’ loading docks and, as one major wholesaler put it, “We will not be building new warehouses to handle quarantined [undocumented] product.” The Healthcare Distribution Management Assn., for one, had sent letters to FDA cautioning that full industry readiness had not yet been achieved. The next deadline in the 10-year process of full DSCSA compliance is to be a July 1 date for retail and other pharmacies to have the transaction information available to FDA inspectors; allowing two months between complete manufacturer-distributor data exchange, and subsequent data exchange with retailers, seems problematic at this point, but FDA wants to keep the pressure on to keep DSCSA compliance moving forward.
UPDATE: On Dec. 29, HDMA issued a statement that "applauds FDA's decision to apply enforcement discretion [to implement DSCSA] with minimal supply chain disruption."