Pharmacy Organizations Request Delay, Stepwise Implementation of DSCSA Provisions
NCPA, NACDS, and APhA have joined the Healthcare Distribution Alliance in calling for a delay in the implementation of DSCSA.
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.”
Hoey, Anderson, and Houge also called out their concerns around the readieness of some trading partners, as the ability of pharmacists and pharmacies to purchase medications from manufacturers and wholesalers is “completely reliant on their ability to comply with DSCSA requirements.”
“The inability to be ready by November 27 would cause significant risk to patients’ access to their lifesaving medications,” they wrote. “If upstream trading partners cannot accurately exchange interoperable package-level data to subsequently provide to dispensers, then the DSCSA is structured to prohibit dispensers from purchasing such product to meet their patients’ needs. This could potentially cause significant harm and drug shortages for patients who rely on these medications.”
Therefore, the NCPA, NACDS, and APhA are jointly recommending that the FDA immediately act to implement a phased approach across the supply chain as it relates to EDDS requirements. “Specifically, we request FDA use its authority under the law for dispensers to comply with the EDDS requirements no earlier than February 27, 2026,” enabling the supply chain to achieve full compliance.
Drug Topics will continue to provide updates on this story as they become available.
References
Hoey BD, Anderson, SC, Houge MD. Re: Request for phased implementation of the upcoming DSCSA requirements. Letter to FDA. Sent July 14, 2023. Accessed July 18, 2023. https://ncpa.org/sites/default/files/2023-07/phased-approach-dscsa-letter-fda.pdf
Kelly P. Letter from HAD to FDA. Sent June 2, 2023. Accessed July 18, 2023. https://ncpa.org/sites/default/files/2023-07/hda-phased-approach-cl.pdf
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