Pharmacy Organizations Request Delay, Stepwise Implementation of DSCSA Provisions

Three pharmacy organizations—the National Community Pharmacists Association (NCPA), the National Association of Chain Drug Stores (NACDS), and the American Pharmacists Association (APhA)—have submitted a joint letter1 to the FDA requesting that the agency delay implementation of the Drug Supply Chain Security Act (DSCSA), which is currently slated to go into effect on November 27, 2023. This request follows an earlier letter sent to the FDA by the Healthcare Distribution Alliance (HDA), similarly requesting a delay in implementation.

Together, the organizations are requesting that the FDA “adopt a phased, stepwise approach to the implementation of the enhanced drug distribution security (EDDS) requirements” within the DSCSA. The letter, signed by NCPA CEO B. Douglas Hoey, RPh, MBA; NACDS President and CEO Steven C. Anderson, FASAE, CAE, IOM; and APhA Executive Vice President and CEO Michael D. Hogue, PharmD, FAPhA, FNAP, FFIP, emphasizes the organizations’ support of the original request made by the HDA. “We…strongly believe a phased approach would best achieve DSCSA’s prescription drug product traceability and security goals while also minimizing the potential for supply disruptions and ensuring there are no interruptions to patient care.”
In their letter to the FDA, sent on June 2, 2023, the HDA outlined the problems and challenges associated with the current DSCSA rollout.2 HDA represents primary pharmaceutical distributors, giving the organization clear insight into the current state of the pharmaceutical supply chain and stakeholders’ DSCSA readiness.

“HDA and its wholesale distributor members have long supported the DSCSA,” wrote Patrick Kelly, Executive Vice President, Government Affairs, at HDA.2 Although stakeholders have been aware of DSCSA requirements since the legislation passed in 2013, “given the complexity of developing necessary systems, many, if not most, manufacturers will not be ready by November 27 to send package-level data to their customers. Or, if they are ready, much of the data will not be accurate.”

In their letter, Hoey, Anderson, and Hogue emphasized the support of their respective organization’s members for a “phased, stepwise approach” to DSCSA implementation “to ensure that all sectors of the pharmaceutical supply chain have adequate time to stabilize the complex systems and processes necessary for efficient transactions across the supply chain.”

Crucially, they noted, their support for this stepwise approach “is not to delay all implementation activity,” they wrote. “We believe during the phased period it is important for our trading partners to continue on the path toward package-level tracing and enhanced supply chain security Congress envisioned when it enacted the DSCSA 10 years ago.”

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