A new analysis from US Pharmacopeia (USP) suggests that vulnerabilities in the pharmaceutical supply chain could put dozens of widely used medicines at risk of shortage, even when current supplies appear stable.
In its 2025 Vulnerable Medicine List (VML), USP identified 100 clinically important medicines that are most at risk of disruption based on upstream structural weaknesses such as limited supplier diversity, manufacturing complexity, and single-country sourcing. “Supply chain vulnerabilities are particularly acute when production of key inputs is geographically concentrated or limited to a small number of suppliers,” notes the report.
Addressing these vulnerabilities is an urgent matter, the report states. “Strengthening America’s medicine supply chain is a national and economic security imperative and critical to ensuring millions of Americans have reliable access to the medications they need.”
Vulnerabilities affect broad range of drugs
Of the 100 drugs on the list, 50 are used in acute care and 50 for chronic conditions. To create the list, USP focused on medicines most susceptible to disruption, regardless of whether the drug is currently available. In total, “70% of the VML listed drugs are not in shortage but are structurally vulnerable,” the authors note. Rather, those drugs are included on the list because of vulnerabilities in their supply chains.
Strengthening America’s medicine supply chain is a national and economic security imperative .
Injectable drugs account for 63% of the vulnerable medicines on the list, reflecting their greater manufacturing complexity and fragility. These include clinically important drugs such as anesthetics, antibiotics, intravenous fluids, pain medications, and chemotherapy agents. Drugs taken orally in the form of tablets and capsules compose the second-largest category, at 22%.
The findings suggest that no one class of drugs would be disproportionately affected by supply-chain disruptions, highlighting the broad effect shortages could have on patients.
Nearly half of drugs rely on single-nation source materials
A main goal of the report was to identify disruptions that could happen early in the supply chain. Specifically, the report looked at manufacturing data on key starting materials (KSMs), or the chemical building blocks used to produce drugs.
The findings show that nearly half (48%) of the drugs on the list rely on at least one KSM manufactured exclusively in one country, creating a potential single point of failure.
“A medicine may have multiple finished-dosage or API [active pharmaceutical ingredient] manufacturers, but if they all rely on the same sole-source KSM supplier, the perceived redundancy is an illusion” notes the report. “In fact, more than one-quarter of medicines on the updated VML appear stable at the finished-dosage level yet share a single upstream potential point of failure—risks that might remain completely invisible without KSM-level insight.”
Aiming to guide policy, strengthen supply chain
Reliance on relatively few global suppliers leaves the United States vulnerable to supply-chain disruptions from geopolitical tensions, pandemics, natural disasters, export restrictions, and regulatory actions, according to the report authors.
By identifying supply-chain vulnerabilities before shortages emerge, USP officials say they hope the report will help shape policies that protect supply chain resilience, influence drug purchasing decisions, address manufacturing challenges, foster drug shortage mitigation strategies, and support targeted investments in the supply chain.
