USP Reports Drug Discontinuations on the Rise

The US Pharmacopeia (USP) published its annual drug shortages report on June 9, 2026.^1,2 The report finds that drug shortages are lasting longer, up from 2 years in 2019 and 4.3 years in 2024 to 5 years in 2025. Product discontinuation is also at a high level, with a 60% increase from 2024 to 2025. However, the total number of shortages decreased by 23% in 2025.

According to USP, shortages are due to low prices, geographic concentration, and quality concerns that are complicated by manufacturing complexity, natural disasters, geopolitical pressures, and policy changes. A combination of factors can be at fault, such as the complexity of sterile injectable drugs, which make up 71% of shortages.

“Manufacturers of generic drugs and their ingredients operate on thin, sometimes unsustainable margins,” said Matthew Christian, director of Supply Chain Insights at USP, in the press release.¹ “This report shows a relationship between prices received by manufacturers and continued production. Product discontinuations add to supply fragility and risk of future shortages if supply cannot meet demand.”

How Did USP Arrive at the Numbers?

USP analyzed drug shortage data from the FDA that was current as of December 31, 2025. In addition, USP used data on key starting materials (KSMs), which have been added to USP’s Medicine Supply Map (MSM).³ The USP MSM Shortage Risk Model is used to predict shortages, with an accuracy of 96%. When the model flagged a drug as at risk, the prediction was correct 80% of the time and identified 82% of active shortages reported by the FDA and the American Society of Health-System Pharmacists. Predictive analysis was used to analyze the USP MSM data.

“Performance on entirely new injectable shortages, the dosage form where supply disruptions carry the greatest patient risk, is harder to assess given the small sample size. (There were only two new injectable shortages reported by FDA in 2025). The model correctly identified 50% of new injectable shortages as high risk (see Appendix A for USP’s risk scores.),” the report states.²

The KSM data indicates that geographic concentration may begin earlier in the supply chain, with 44% of drugs that are in short supply having at least 1 KSM that is manufactured in one single country.

Why Are Shortages Lasting Longer and Why Are Discontinuations Increasing?

According to the USP report, the duration of drug shortages increased to 5.3 years in 2025. This is a result of new shortages declining, and therefore, long-standing shortages become the bulk of the total number.

“More than half (64%) of the drugs in shortage have been in shortage for more than 3 years, with 29 (39%) drugs being in shortage for more than 5 years,” the report states.² “Increased durations of drug shortages are a critical public health risk that can lead to compromised patient care, treatment delays, and unfavorable outcomes. Without intervention, prolonged shortages will continue to directly burden patients and healthcare providers.”

The 2025 increase in drug discontinuations—a 60% year-over-year rise—is the largest since December 2019. USP states in the report that discontinuations of drugs happen for a variety of reasons, such as formulation changes and portfolio consolidation. The organization speculates that the price of discontinued products may indicate a fragility in the market. Two-thirds of discontinued oral solid dosage products were priced below $1 per unit, with the median price falling by 78% in one year. More than a third of discontinued injectable drugs (35%) were priced below $15 per unit. “These findings suggest that very low prices may be closely associated with a higher likelihood of discontinuation,” the report states.²

What Do These Numbers Mean for the Industry?

The data indicate that a variety of therapeutic categories are impacted by shortages. However, pediatric drugs appear to be impacted at a higher rate, with 16 shortages compared with the least impacted category, oncology, with 6 shortages.

Six of the pediatric drug shortages are intravenous (IV) fluids and additives, which are often used for other drugs. Shortages of these types of products create interrelated problems: IV fluids may be rationed by doctors; a shortage of a common diluent, such as dextrose, may increase shortages in other therapeutic classes; these shortages may also change dosing protocols and increase the use of substitutions that may continue after the shortage is over.

“These findings underscore a fundamental reality: today’s market does not reward resilience,” said Anthony Lakavage, executive vice president for Global External Affairs at USP, in the release.¹ “Policymakers and stakeholders must act to realign incentives—establishing clear benchmarks for supply reliability, creating sustainable payment mechanisms that value quality and continuity, and advancing reforms that strengthen the foundation of our medicines supply chain.”

Earlier this year, Lakavage spoke with PharmTech about USP’s efforts in securing the supply chain.^4,5 “For years, supply chain fragility has been tied to ongoing drug shortages, the system hasn't been able to absorb a wide range of disruptions,” Lakavage explained. “But now there's a growing concern that the medicine supply chain could essentially be weaponized through trade. The concentration of key starting materials in China in particular represents a real vulnerability, both for national security and patient care.”

References

1. USP Annual Drug Shortages Report finds rising discontinuations, hidden upstream risk. Press release. USP. June 9, 2026. https://www.usp.org/news/usp-2026-annual-drug-shortages-report-rising-discontinuations-supply-chain-risk
2. USP. 2025 USP Annual Drug Shortages Report. US Pharmacopeia. June 2026.
3. USP Medicine Medicine Supply Map. USP.org. Accessed June 9, 2026. https://www.usp.org/supply-chain/medicine-supply-map
4. Lakavage T, Haigney S, Zubulake Z. How USP Is Navigating Global Disruptions and Building a Better Future for the Industry. PharmTech.com. March 27, 2026. https://www.pharmtech.com/view/how-usp-is-navigating-global-disruptions-and-building-a-better-future-for-the-industry
5. Lakavage T, Haigney S, Zubulake Z. Inside USP’s Strategy to Fortify Medicine Supply Chains. PharmTech.com. March 23, 2026. https://www.pharmtech.com/view/inside-usp-s-strategy-to-fortify-medicine-supply-chains