The National Security Need to Optimize the Drug Supply Chain Security Act (DSCSA)

The author contends that the Drug Supply Chain Security Act (DSCSA), while a step forward, is too reactive because it only mandates tracking when a product is suspected of being counterfeit. To close this loophole, the paper recommends implementing 'end-of-commerce' scanning—proactive verification and decommissioning of serial numbers at the point of dispense. This is framed as a national security priority, particularly for the Department of Defense and HHS stockpiles, given that over 58% of US-procured pharmaceuticals originate overseas. The document suggests an Executive Order to mandate these practices across federal health systems by 2027 and calls for international collaboration and the re-shoring of pharmaceutical manufacturing to mitigate risks from adversarial nations.

• The Drug Supply Chain Security Act (DSCSA) contains a significant vulnerability because it is primarily reactive, requiring tracking and tracing only when a party 'suspects' a medicine is counterfeit, fake, or illegally diverted.
• A critical loophole exists because the DSCSA does not require the decommissioning of serial numbers at the point of dispensing, meaning a counterfeit drug with a legitimate serial number could be scanned as authentic if the original product was never verified or decommissioned.
• A 2024 pilot by the National Association of Boards of Pharmacy (NABP) demonstrated that the technology and frameworks for proactive verification and decommissioning at the point of dispense already exist and could be implemented via market-driven incentives.
• The US pharmaceutical supply chain is a national security risk because over 58% of procured pharmaceuticals come from overseas, often from high-risk adversarial nations, impacting the readiness of the US Armed Forces.
• The FDA has implemented phased-in compliance and stabilization periods from November 27, 2024, through various dates in 2025 for certain trading partners to avoid contributing to drug shortages.
• Certain industry stakeholders, including high-volume distributors and pharmacy management firms, may resist increased DSCSA transparency because they monetize the proprietary logistical and sales data that proactive scanning would make transparent.

APA

The Council on Strategic Risks (2024). The National Security Need to Optimize the Drug Supply Chain Security Act (DSCSA). https://councilonstrategicrisks.org/2024/11/22/the-national-security-need-to-optimize-the-drug-supply-chain-security-act-dscsa/

Chicago

The Council on Strategic Risks. The National Security Need to Optimize the Drug Supply Chain Security Act (DSCSA). 2024. https://councilonstrategicrisks.org/2024/11/22/the-national-security-need-to-optimize-the-drug-supply-chain-security-act-dscsa/.

Wikipedia

{{cite report |author=The Council on Strategic Risks |title=The National Security Need to Optimize the Drug Supply Chain Security Act (DSCSA) |date=22 November 2024 |url=https://councilonstrategicrisks.org/2024/11/22/the-national-security-need-to-optimize-the-drug-supply-chain-security-act-dscsa/ |access-date=23 October 2026 |via=Climate Insights Directory}}

BibTeX

@techreport{thecouncilonstrategicrisks2024national, author = {{The Council on Strategic Risks}}, title = {{The National Security Need to Optimize the Drug Supply Chain Security Act (DSCSA)}}, institution = {The Council on Strategic Risks}, year = {2024}, month = nov, url = {https://councilonstrategicrisks.org/2024/11/22/the-national-security-need-to-optimize-the-drug-supply-chain-security-act-dscsa/}, urldate = {2026-10-23}, note = {Indexed by Climate Insights Directory} }