For some time there has been speculation that the FDA would announce the exercise of enforcement discretion for certain DSCSA requirements affecting dispensers and due to go into effect on November 27, 2020. On October 23, the FDA announced final guidance titled “Wholesale Distributor Verification Requirement for Saleable Returned Drug Product and Dispenser Verification Requirements When Investigating a Suspect or Illegitimate Product-- Compliance Policies.” This announcement addressed only the dispenser requirement related to suspect products and granted enforcement discretion for three years.
We have heard that some industry participants interpreted this FDA guidance to have granted enforcement discretion also for the requirement to only transact in serialized product, but the guidance did not address this latter requirement. Some of our customers have asked TraceLink to clarify our position on the matter. Any ambiguity over the requirement to only transact in serialized product was eliminated last week at the HDA Traceability Online Seminar, during which an FDA representative stated that the requirement would go into effect starting November 27, 2020. This has been reported by the American Pharmacists Association (Pharmacies Must Comply with Certain Track-and-Trace Requirements by November 27, FDA Says) and trade press (FDA Denies DSCSA Delay Sought by Dispensers).
Dispensers should have systems in place to ensure that they are meeting this requirement or they could face penalties from the FDA for failure to comply. If a dispenser does not have systems in place by the deadline, demonstrating that they are working in good faith to deploy a system is typically viewed favorably by the FDA. Note that TraceLink does not provide legal or regulatory counsel. We strongly recommend that dispensers’ legal and/or compliance organizations review the DSCSA dispenser requirements and the final guidance to understand their regulatory obligations.
We look forward to continuing to work with dispensers to help them conform with FDA requirements, ensure the integrity of the nation’s drug supply and the safety of patients, and put in place the foundation for a more efficient and effective supply chain.
General Manager, Track and Trace / Compliance