Facing Industry Disruptions, FDA Grants Temporary Exemption From DSCSA Requirements For Trading Partners

The FDA has issued an exemption from the enhanced drug distribution security requirements of section 582 of the Food, Drug, and Cosmetics Act (FDCA) mandated by the Drug Supply Chain Security Act (DSCSA) for eligible connected trading partners, according to a news release and letter from the agency.^1,2

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Eligible trading partners, according to the FDA, are those who have to this point finished or made documented efforts to finalize data connections with their immediate trading partners but have still faced obstacles in exchanging data.¹

Exemption durations vary depending on the trading partner. For manufacturers and re-packagers, the exemption ends May 27, 2025. Wholesale distributors have until August 27, 2025 to ensure compliance, while dispensers with 26 or more full-time employees have until November 27, 2025 to comply.¹

The announcement followed the June determination from the FDA that small dispensers would be granted an exemption from compliance until November 27, 2026, with small dispensers being considered so if the company that owns them has 25 or fewer full-time employees licensed as pharmacists.³

“While much progress has been made, including establishing electronic system data connections, this exemption is intended to support continued implementation of DSCSA without disrupting patient access to their medications,” the FDA said in the news release.¹

These exemptions were granted to ensure that partners can successfully implement the new requirements while preventing potential disruptions to the supply chain and medication access. FDA had faced pressure from outside groups in recent weeks, including Congressional leaders and the National Association of Chain Drug Stores (NACDS), as the end of the 1-year stabilization period instituted by the agency in August 2023 was set to expire in November.^4,5

Twenty-one members of Congress signed a letter sent to Robert Califf, MD, commissioner of the FDA, on October 7 asking for clarity on the volume of Waivers, Exceptions, and Exemptions (WEE) requests that have been submitted by trading partners struggling to comply with the requirements set forth by the DSCSA by November 27, 2024, the end of the FDA’s stabilization period. Furthermore, they explained the possibility of major industry-wide impacts due to the present gaps in compliance.⁴

“Absent government intervention, there will likely be disruptions that could lead to drug shortages and patients being unable to access critical medications,” the Congressional members wrote. Though they were encouraged by the FDA’s exemption granted to small dispensers, “given the varying degrees of readiness among trading partners across the supply chain, we believe that the FDA needs to take additional steps beyond that exemption to prevent shortages or access constraints.”⁴

NACDS sent a letter of their own to the FDA and the Department of Health and Human Services, urging the agency to take action “to prevent risks to patients’ access to essential medications, worsening of drug shortages, health risks due to disruption of patients’ medication regimens, inflated drug prices due to supply and demand factors, and long lines and bottlenecks at pharmacies.”⁵

Upon the FDA’s announcement, the NACDS praised the FDA for “a sound public policy decision” that both prevents risks to medication access and supply chain disruptions but continues to prioritize implementation of the DSCSA. Steven Anderson, president and CEO of NACDS, said that implementation of the law was key, but by issuing this new exemption, the FDA avoids “the dreaded law of unintended consequences.”⁶

Josh Bolin, associate executive director of government affairs and innovation at NABP, commended the FDA for taking this action, saying in a statement that it “provides critical relief to those who have demonstrated their commitment to DSCSA compliance by actively working to establish interoperable connections.” At the same time, Bolin cautioned dispensers to “remain vigilant” towards vendors who may promote technologies that aren’t statutorily required.⁷

Bolin had previously spoke to the need for key stakeholders to stay DSCSA compliant—and if not, file a WEE request with the FDA. Importantly, Bolin explained how an exemption does not mean the DSCSA is moot during that period—dispensers, both large and small, must continue to monitor their products for suspect or illegitimate medications.⁸

“Those are all things that pharmacy should be doing,” Bolin said, discussing how the exemption is focused on the use of specific technologies, not from the law at all. “I think that’s, unfortunately, a common misconception, that they’re just exempt from everything for 2 years, because that’s not the case.”⁸

REFERENCES

1. FDA. Waivers and exemptions beyond the stabilization period: FDA grants exemption to connected trading partners. Updated on October 9, 2024. Accessed October 10, 2024. https://www.fda.gov/drugs/drug-supply-chain-security-act-dscsa/waivers-and-exemptions-beyond-stabilization-period?utm_medium=email&utm_source=govdelivery

2. FDA Letter. DSCSA exemptions from section 582(g)(1) and other requirements of the FD&C act for certain trading partners. Issued October 9, 2024. Accessed October 10, 2024. https://www.fda.gov/media/182584/download?attachment

3. Bolin J. FDA’s small dispenser exemption: What does FDA’s small dispenser exemption really mean? National Association of Boards of Pharmacy. Published July 19, 2024. Accessed October 10, 2024. https://nabp.pharmacy/news/blog/fdas-small-dispenser-dscsa-exemption/

4. Letter to Commissioner Robert M. Califf from the Congress of the United States. Washington, DC. Issued October 7, 2024. Accessed October 10, 2024.

5. National Association of Chain Drug Stores. NACDS urges FDA, HHS to preserve medication access as supply chain pursues DSCSA compliance. News Release. Released September 27, 2024. Accessed October 10, 2024. https://www.nacds.org/news/nacds-urges-fda-hhs-to-preserve-medication-access-as-supply-chain-pursues-dscsa-compliance/

6. National Association of Chain Drug Stores. NACDS praises FDA move to preserve medication access as supply chain pursues DSCSA compliance. News Release. Released October 9, 2024. Accessed October 10, 2024. https://www.nacds.org/news/nacds-praises-fda-move-to-preserve-medication-access-as-supply-chain-pursues-dscsa-compliance/

7. National Association of Boards of Pharmacy. Statement on FDA exemptions from Josh Bolin. Provided to Pharmacy Times on October 10, 2024. Accessed October 10, 2024.

8. Halpern L. NABP emphasizes education as end of DSCSA stabilization period approaches. Pharmacy Times. Published September 25, 2024. Accessed October 10, 2024. https://www.pharmacytimes.com/view/nabp-emphasizing-education-for-dispensers-as-end-of-dscsa-stabilization-period-approaches