HDA, NACDS call on FDA to grant DSCSA reprieve for distributors and dispensers

The Healthcare Distribution Alliance (HDA) and the National Association of Chain Drug Stores (NACDS) are calling for the US Food and Drug Administration (FDA) to delay enforcement of Drug Supply Chain Security Act (DSCSA) requirements for trading partners. Instead, the groups are calling for a step-wise approach to implementation, with manufacturers having to comply with the 27 November deadline, followed by distributors and wholesalers, then by dispensers.

These requests were made in recent letters to FDA. Both groups told the agency that trading partners will still not have their systems up and running by the time the law takes effect this November 2024, despite a one-year stabilization period announced in August 2023 to give companies more time to prepare their systems. (RELATED: FDA gives firms one-year reprieve from DSCSA track and trace requirements, Regulatory Focus 25 August 2023)

NACDS told FDA in a 29 July letter that only 25% to 50% of manufacturers are sending accurate and complete Electronic Product Code Information Services (EPCIS) data, or serialized data, to distributors and expressed concern that many products will not be serialized in time to meet the 27 November deadline.

HDA expressed similar concerns in a 19 August letter, which was meant to support and “amplify” the concerns expressed by NACDS. Its members “are concerned that incomplete implementation of the EDDS [enhanced drug distribution security] requirements could lead to supply chain disruptions, which could aggravate existing drug shortages and delay patient care.”

The group urged FDA to provide more time and establish “narrow guardrails” that would provide a phased approach to allow more time for the supply chain to initiate data exchange between trading partners.

NACDS called for FDA to adopt a phased, stepwise approach to compliance, with manufacturers having to comply by 27 November, followed by wholesalers having to comply six to eight months later, and pharmacies having to comply by 27 February 2026.

Both groups also urged FDA to take quick action in approving any waiver, exemption or exception (WEE) that is submitted. NACDS sounded alarm bells over a potential backlog of WEE requests that may not be approved by the 27 November deadline.

“We fear that merely relying on a waiver and exemption process will cause catastrophic failures in the supply chain, higher prescription drug prices for patients, and exacerbation of existing prescription drug shortages, all leading to significant gaps in patient access to their medications,” wrote NACDS.

HDA also urged FDA to engage in more frequent communication with stakeholders to mitigate against potential supply chain disruptions come this November. The group said, “it would be prudent for FDA to establish a weekly call cadence with representatives from authorized trading partners leading up to the November compliance date and continue into the immediate future.”

Yet it remains uncertain whether FDA will consider any additional enforcement discretion. The agency has already granted enforcement discretion multiple times over the course of DSCSA implementation, and officials have said it will not be granting any more reprieves. (RELATED: Cavazzoni: No more ‘kicking the can’ down the road for DSCSA compliance, Regulatory Focus 16 May 2024)

HDA letter; NACDS letter

HDA, NACDS call on FDA to grant DSCSA reprieve for distributors and dispensers

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