Drug shortages in the United States have remained a serious and persistent challenge, with over 270 medications in active shortage as of March 2025. The number of shortages has been steady since a record-setting peak of 323 active shortages in the first quarter of 2024, the highest level reported since tracking began in 2001.

These shortages have affected a wide variety of medications, including sterile injectables, antibiotics, stimulants, and chemotherapeutics. Many shortages have persisted for months or years, presenting significant public health concerns. When they occur, drug shortages can disrupt care, lower adherence, and increase burdens on both patients and health care providers.

Drug shortages are not new, but the chronic nature of the problem has driven action from federal agencies, state and federal lawmakers, boards of pharmacy, and other stakeholders. In 2023, the US Senate Committee on Homeland Security and Governmental Affairs held a hearing to discuss the national security implications of drug shortages.

Regardless of these initiatives, the complex set of factors contributing to drug shortages has made it so there is no clear “silver bullet” solution.

What Causes Drug Shortages?

There are a variety of factors that contribute to drug shortages. These factors include:

  • Supply Chain Disruptions

    The early months of the COVID-19 pandemic affected nearly every industry, including pharmaceuticals. In the years since, several interconnected factors have contributed to continued shortages.

  • Quality Control

    Many essential medications are produced in only a few facilities. When one manufacturer halts production for any reason, including contamination or noncompliance, there may be few or no alternative sources.

  • Natural Disasters

    Damage to suppliers’ facilities due to natural disasters can cause shortages. For example, in 2023, a Pfizer, Inc, facility responsible for producing nearly 8% of the nation’s sterile injectables was damaged by a tornado, affecting at least a dozen products of concern and contributing to several drug shortages. Similarly, in 2024, Hurricane Helene damaged a Baxter International, Inc, manufacturing plant that supplied approximately 60% of intravenous (IV) fluids to US hospitals.

  • Reliance on Foreign Suppliers

    Heavy reliance on foreign suppliers for many active pharmaceutical ingredients (APIs) can cause drug shortages. About 60% of APIs for US prescription medications come from India, China, and the European Union. This makes the overall supply chain vulnerable to geopolitical events and various production issues. If a single overseas supplier is unable to meet demand, entire segments of the international drug supply can be impacted.

  • Economic Issues

    Manufacturers may respond to narrow profit margins or lower demand by ceasing or limiting production, causing shortages. When only 1 or 2 manufacturers exist for a particular medication, even one disruption to a single facility has the potential to create a nationwide shortage. This happened in 2023, when a shortage of albuterol inhalation solution was caused by the closure of Akorn Pharmaceuticals.

  • Regulatory Concerns

    Certain policies and regulations may have inadvertently contributed to or prolonged shortages. For example, Drug Enforcement Administration’s (DEA’s) annual production quotas for controlled substances have complicated the response to ADHD medication shortages, as manufacturers are unable to increase output even when demand rises.

Federal Efforts to Address Drug Shortages Continue

In Congress, several bipartisan bills have been introduced in an effort to address various contributing factors related to drug shortages. Some noteworthy proposals include the following:

  • Drug Shortage Prevention Act: Expands reporting requirements, obligating manufacturers to notify US Food and Drug Administration (FDA) of disruptions to production, surges in demand, export restrictions, and other changes that may trigger a drug shortage.
  • End Drug Shortages Act: Improves early warning systems, requiring definitions for demand surges. The act would also allow FDA to incorporate stakeholder reporting into shortage designations.
  • Finance Committee Proposal: A draft proposal from the Senate Finance Committee outlines Medicare incentives for purchasers to enter multiyear contracts for shortage-prone generics, encouraging reliable supply through pricing stability.

Currently, FDA can take various actions when drugs are in shortage, including expediting application review and facility inspection. FDA has also issued temporary compounding guidance in response to the 2024 IV fluid shortage, permitting outsourcing facilities and hospitals to compound essential solutions beyond standard limitations.

Meanwhile, DEA has allowed limited quota transfers and production adjustments in response to stimulant shortages. These efforts have provided short-term relief but highlight the potential need for structural reform.

State Strategies to Address Drug Shortages

Several states have taken action in recent years to mitigate drug shortages. There are a variety of approaches being taken, but they broadly include strategic stockpiling of critical medicines, expanding pharmacists’ authority for substitutions, improving transparency in drug supply, and reforming procurement policies.

Strategic stockpiling involves creating or expanding state-managed reserves of essential medications to ensure availability during shortages, emergencies, or other circumstances that may limit access. These stockpiles may only involve specific drugs or allow for broader reserves. For example, pending legislation in New Jersey would authorize pharmacists to dispense emergency insulin supplies to diabetics who need it, while California, Massachusetts, New York, and Washington are among states currently stockpiling medical abortion drugs as a precaution to prepare for potential shortages that may be caused by future federal-level restrictions.

In addition to stockpiles, some states are also taking steps to improve tracking of inventories and to alert the public or providers when shortages occur. A proposed New York bill would maintain an online searchable database listing all drugs currently in shortage and identifying which pharmacies in the state have those drugs in stock. In 2025, Hawaii’s Medicaid program adopted a plan that permits foreign-approved drugs to be used as alternatives if a drug is in shortage. Tools like this may be able to help patients maintain access to medications during a shortage.

NABP’s Efforts to Support Shortage Mitigation

NABP continues to collaborate with industry, federal agencies, pharmacy associations, and other stakeholders to develop additional strategies and technological tools to help address drug shortages.

Along with this collaboration, we are developing and implementing Pulse by NABP™, a secure digital platform designed to enhance the integrity and transparency of the drug supply chain. Pulse facilitates compliance with the Drug Supply Chain Security Act (DSCSA) by enabling authorized trading partners and regulators to conduct product verification requests. Beyond product verification, NABP is leveraging Pulse to pilot initiatives aimed at other supply chain-related issues, including mitigating drug shortages by increasing visibility and transparency within the supply chain. By facilitating secure communication channels between regulators and trading partners, Pulse aims to proactively identify and address potential disruptions to medication availability.

NABP will continue to provide updates on these initiatives as well as medication shortages.

This blog was adapted from an article that originally appeared in the July/August 2025 issue of Innovations.