HDA Urges FDA To Adopt Alternatives to Broad DSCSA Enforcement Discretion
Association Calls for Narrow Exemptions As November Final Compliance Deadline NearsFebruary 07, 2023
The Healthcare Distribution Alliance (HDA) urged the Food and Drug Administration (FDA) to avoid delaying certain requirements for manufacturers and repackagers to comply with the November 27, 2023, Drug Supply Chain Security Act (DSCSA) deadline, in public comments submitted to the agency. The comments were prepared in response to FDA’s December 7–8, 2022, public meeting on “Drug Supply Chain Security Act Implementation and Readiness Efforts for 2023.”
“This is a highly integrated process — and the distributor community is dependent on receiving complete and accurate serialized data from manufacturers to facilitate compliance with the federal traceability law. With the deadline now nine months away, it is important for supply chain partners to stay the course on implementation plans, and, specifically, to communicate with distributors their plans for sending DSCSA-required data,” said Elizabeth A. Gallenagh, General Counsel and Senior Vice President, Supply Chain Integrity, HDA. “Accordingly, FDA should pursue narrow exemptions, which would be far less disruptive to supply chain operations — and ultimately, support the safe and efficient flow of critical medicines to pharmacies/providers and their patients come November 28.”
While progress has been made in the nine years since the DSCSA was enacted, there are varying states of readiness for supply chain partners to meet the law’s requirements. According to a benchmarking study completed by the HDA Research Foundation last fall, while many healthcare distributors reported the ability to receive serialized product today, they also noted that many manufacturer suppliers were not yet providing data for total product lines as the supply chain closes in on the compliance deadline.
Beyond HDA’s recommendation to FDA on enforcement discretion, the organization’s comments:
- Call for a period of flexibility following the November 2023 deadline for trading partners to manage data and file-related errors and exceptions;
- Raise awareness of certain challenges related to unreadable barcodes; and,
- Reiterate the need for FDA to finalize its 2022 interoperable data exchange draft guidance and national licensure standards for wholesale distributors and 3PLs (as well as underscore HDA’s support for federal preemption of state licensure rules), among other issues.
The Healthcare Distribution Alliance (HDA) represents primary pharmaceutical distributors — the vital link between the nation’s pharmaceutical manufacturers and pharmacies, hospitals, long-term care facilities, clinics and others nationwide. Since 1876, HDA has helped members navigate regulations and innovations to get the right medicines to the right patients at the right time, safely and efficiently. The HDA Research Foundation, HDA’s nonprofit charitable foundation, serves the healthcare industry by providing research and education focused on priority healthcare supply chain issues.