USP: Drug shortages declined in 2025 but are lasting longer
A recent report from the US Pharmacopeia (USP) reveals that drug shortages decreased by 23% in 2025; however, the duration of shortages is on the rise. Over 64% of the drugs that are currently in shortage have been unavailable for more than three years, and 39% have been in shortage for over five years.
The 2025 USP Annual Drug Shortage Report examines the drug shortages reported by the US Food and Drug Administration (FDA) as of 31 December 2025. Notably, this report integrates data from the USP Medicines Supply Chain Map (MSP) for the first time, highlighting the sources of key starting materials (KSMs).
In 2025, the total number of year-end drug shortages decreased by 23%, falling from 98 at the end of 2024 to 75. Of the drugs in shortage at the end of last year, 71% were sterile injectable drugs, 16% were oral solid drugs, and 13% were in other dosage forms. The duration of current drug shortages increased to 5.3 years on average in 2025, up from 4.3 years in 2024, and approximately two years in 2019.
USP attributed the shortages to low prices, manufacturing complexity, geographic concentration, and quality concerns. “Together, these factors create overlapping vulnerabilities that increase the risk of supply chain disruption,” USP said.
Reliance on foreign manufacturers, especially for KSMs and Active Pharmaceutical Ingredients (APIs), can heighten the vulnerability of the US drug supply to potential disruptions, said the report.
Among the 75 drugs currently in shortage, 33 depend on at least one KSM that is produced exclusively in a single country. An analysis of APIs reveals a similar trend: 15 of the 75 drugs in shortage have the European Union as their primary API supplier, with over 50% of their API volume sourced from the EU. Additionally, India serves as the primary API supplier for seven of the drugs that are in shortage.
The report highlights the case of cefotaxime injection, a third-generation cephalosporin antibiotic used to treat serious bacterial infections, which has been in short supply for over a decade. According to USP’s analysis, there is significant geographic concentration in the production of cefotaxime at both the API and KSM levels. The cefotaxime API supplied to the US is produced entirely in India, while nearly all of its KSMs are manufactured in China.
A variety of therapeutic categories are affected by shortages, with pediatric drugs the most affected with 16 drugs in shortages, followed by gastroenterology with 11 drugs in shortages, anesthesia with ten, endocrinology/metabolism with ten, and oncology with six.
Six of the pediatric drugs in shortage are intravenous (IV) fluids and additives, such as dextrose for injection.
According to the report, the shortage of IV fluids poses significant challenges because they serve as both medications and diluents for other drugs. When these fluids are in short supply, clinicians are forced to ration them. For example, a child experiencing a hypoglycemic crisis will take priority over patients with less urgent needs. The risk to pediatric patients is greater due to their smaller body mass, narrower therapeutic windows, and immature renal and hepatic clearance systems, which leave less room for error. Consequently, a child who is stable on dextrose can deteriorate rapidly if supply issues force a substitution.
When asked if there were any surprises in the report, Matthew Christian, director of supply chain insights at USP, told Focus that “ninety-five percent of the drug shortages from 2024 made it to 2025… The spike in discontinuations was surprising, it was a 60% increase from the prior year, and one of the things that stands out to me was that 65% of the discontinued drugs had a price point below $1 per unit, so a lot of these older low cost generic drugs, they don’t have enough incentive to invest in resilience, so [manufacturers] have to make the tough decision on product portfolios and this includes product discontinuations.”
Christian also discussed potential solutions for policymakers to address drug shortages.
“I think first of all, any program that provides visibility is an essential starting point, you can’t fix what you can’t see,” he said. “So something like key starting materials [data] we are able to publicize and talk about … this allows policy makers to make medicine specific decisions as opposed to a generic onshoring program. The next biggest policy change is a lot of the contract or procurement mechanisms have this race to the bottom pricing concept so if you really want to make a difference there needs to be procurement incentives that value resilience, and this is not something we have today, so there are no incentives to invest in resilience.”
