Understanding FDA-reported drug shortages in healthcare settings

Drug shortages continue to shape how care is delivered across the U.S. healthcare system. For many organizations, they influence pharmacy operations, clinical decisions and daily supply planning.

At the same time, not every disruption reflects a true shortage. The U.S. Food and Drug Administration (FDA) uses a structured, national process to identify and track FDA drug shortages based on verified supply and demand data.

Understanding how drug shortages are defined, monitored and communicated can help healthcare providers better interpret what they’re seeing and better understand reported shortage information. Organizations such as McKesson Medical-Surgical also work with healthcare providers to help support visibility into supply conditions and planning efforts.

In this article, we’ll walk through how FDA drug shortages are identified, where to find reliable drug shortage information, what drives an ongoing shortage and general operational considerations organizations may review from an operational standpoint.

FDA drug shortages: an overview

An FDA drug shortage occurs when the national supply of a medically necessary drug is not sufficient to meet demand. This designation reflects a verified imbalance between supply and demand, not just a temporary issue at a single location.

The FDA is responsible for monitoring the availability of regulated drug products and working with manufacturers regarding reported supply disruptions. This work supports broader public health efforts and helps maintain visibility into critical supply issues.

As part of the Department of Health and Human Services (HHS), the FDA continues to evolve how it tracks and responds to drug shortages. This includes using data-driven tools to understand supply chain conditions better and identify potential disruptions earlier, as well as encouraging manufacturers to strengthen quality systems, since production issues are a common factor in many shortages.¹

Because drug shortages are often influenced by multiple factors, responding to them typically involves coordination across manufacturers, regulators and the broader healthcare system.

It’s important to distinguish between a local supply issue and a true drug shortage, since they are not the same and may require different responses.

• Local stockouts: These typically affect a single facility, region or distributor and are often caused by ordering patterns, shipping delays or temporary inventory gaps. In many cases, the drug may still be available through other suppliers or nearby locations.
• National shortages: These occur when the overall supply of a drug is not enough to meet demand across a broader region or the entire country. This type of drug shortage is verified at the federal level and may reflect larger issues such as manufacturing delays, supply interruptions or increased demand.

Understanding this distinction can help healthcare providers assess whether they are dealing with a short-term disruption or a broader supply challenge that may require more coordinated planning.

When potential supply interruptions are reported, the FDA evaluates manufacturing data, demand trends and availability of active pharmaceutical ingredients to determine whether a local issue reflects a broader shortage.

Where to find current, resolved and discontinued drug shortages

The FDA Drug Shortages Database, available through the FDA website and FDA site resources, is the primary source for tracking current drug shortages and historical trends.

This database organizes drug shortages into three categories:

• Current shortages: Active supply issues affecting availability
• Resolved shortages: Shortages where supply has stabilized
• Discontinued products: Drugs that are no longer produced due to discontinuation or permanent discontinuance

Each entry provides structured drug shortage information, including:

• Drug name and drug product formulation
• Status (current, resolved or discontinued)
• Key dates related to the shortage
• Reported cause, when available
• Estimated resupply timelines
• Any additional information relevant to providers

For certain critical drugs or injectable drugs, the FDA may also provide guidance on extended use dates when supported by stability data. This may provide information related to the use of available inventory during periods of short supply.

Healthcare teams, including health system pharmacists and other pharmacy professionals, often rely on this database to stay informed about ongoing drug shortages and make timely decisions.

What causes drug shortages?

Most drug shortages are not caused by a single issue. Instead, they are typically driven by a combination of supply and demand factors.

Common causes include:

• Manufacturing quality issues that slow or pause production
• Disruptions affecting active pharmaceutical ingredient availability
• Sudden increases in demand, including spikes related to therapies such as hormone therapy or ADHD medication
• Production capacity limitations for certain drug products, including generic drugs
• Business decisions that lead to the discontinuation of lower-volume products

Broader structural challenges can also contribute to ongoing drug shortages. These include limited incentives to produce lower-margin medications, gaps in quality system maturity and logistical or regulatory complexities that can slow recovery after a disruption.²

Shortages involving essential drugs for EMS or critical drugs may have broader implications for care delivery, particularly when alternatives are limited.

Because these factors often overlap, shortages may evolve and require ongoing monitoring. Manufacturers are required under the FDC Act to report certain supply interruptions to the FDA, providing additional visibility into potential risks.

Operational impacts of drug shortages on healthcare organizations

An ongoing shortage can create a range of operational challenges for healthcare organizations. These impacts often extend beyond supply chain teams and into clinical workflows and patient care coordination.

Healthcare providers may experience:

• Challenges related to inventory management
• Unavailability of preferred drugs
• Changes to clinical workflows to support continuity of care

These impacts can also affect patients, particularly when substitutions or delays are involved. Drug shortages may lead to frequent switches between medication brands or formulations, which can make it more difficult for patients to stay consistent with their treatment plans.³

In some cases, considerations related to alternative therapies or adjusting treatment approaches based on availability may arise.

In situations involving ongoing drug shortages, maintaining visibility into current shortages and anticipated resupply timelines becomes especially important.

Organizations may also explore broader strategies, such as evaluating sourcing approaches or considering potential solutions that help support supply continuity over time.

How shortages are reported and monitored

The FDA relies on manufacturer reporting and regulatory oversight to monitor drug shortages and potential future shortages.

Manufacturers are required to notify the FDA when they anticipate supply interruptions involving medically necessary drugs. This includes disruptions related to production, quality or availability of key inputs.

Once a report is submitted, the FDA works with manufacturers to:

• Assess the scope of the shortage
• Evaluate potential impact on public health
• Identify options that may help support supply continuity
• Share updates through the FDA website and drug shortage database

This process is supported by ongoing collaboration across stakeholders, including efforts such as the FDA Drug Shortages Task Force, which focuses on identifying potential and enduring solutions to reduce the frequency and severity of shortages.

FAQ: FDA drug shortages

Preparing for ongoing supply variability in healthcare

While FDA drug shortages are tracked nationally, their impact is managed locally by each healthcare provider.

Organizations are often navigating real-time decisions about supply, substitutions and patient care. Having a clear approach to monitoring drug shortages, communicating across teams and planning for variability may support more consistent operations.

Many healthcare organizations are also evaluating how they work with supply chain partners, including McKesson, to help improve visibility into current shortages, anticipate potential disruptions and respond to changing conditions.

To learn more, explore McKesson EMS solutions or log in to the customer portal for additional resources.