Drug Shortage

Key facts

Legal definition

FD&C Act Section 506C

Manufacturer notice

At least 6 months before discontinuance or interruption, or as soon as practicable

Notification law expanded by

FDASIA (2012) and the CARES Act (2020)

Official list

FDA Drug Shortages Database

Separate list

ASHP, with the University of Utah Drug Information Service

What is a drug shortage?

A drug shortage exists when the national supply of a drug cannot meet current or projected demand. Many shortages involve older, low-priced generic sterile injectables, such as chemotherapy drugs, anesthetics and emergency medicines, but any product can be affected.

Manufacturers of certain drugs must notify the Food and Drug Administration (FDA) of a permanent discontinuance or an interruption in manufacturing that is likely to lead to a meaningful disruption in U.S. supply. The requirement covers drugs that are life-supporting, life-sustaining or intended to prevent or treat a debilitating disease, including those used in emergency care or surgery.

FDA responds by working with other manufacturers to increase production, expediting review of new sources, and using temporary regulatory flexibility, such as allowing importation of a comparable product.

How drug shortages are tracked

Two main public lists exist, and they often disagree:

The immediate trigger is often a manufacturing or quality problem. A 2019 FDA report on root causes pointed to weak economic incentives to make low-priced generics, a market that does not reward manufacturing quality, and logistical and regulatory hurdles that slow recovery after a disruption.

• FDA Drug Shortages Database: products FDA has confirmed are in national shortage, with statuses such as currently in shortage, resolved and to be discontinued, plus availability and reasons by presentation.
• ASHP list: run by the American Society of Health-System Pharmacists with the University of Utah Drug Information Service, using a broader definition based on effects on pharmacy operations and patient care, so it usually lists more shortages than FDA.

Why drug shortages matter

Shortage status has commercial and legal consequences:

• Hospital pharmacy and supply chain teams plan substitutions and allocation when a presentation goes short.
• Generic manufacturers and investors look for shortage-prone molecules with few suppliers as entry opportunities.
• Federal compounding rules allow more copying of a drug while it is on the FDA shortage list, which is why FDA declaring the tirzepatide and semaglutide shortages resolved in late 2024 and early 2025 mattered to compounders.
• Prices of scarce generics, including NADAC benchmarks, can move sharply during and after a shortage.

Common misconceptions about drug shortages

A product listed as "to be discontinued" is not itself in shortage. That status records a manufacturer notice that it will stop making the product, and other suppliers may still meet demand, so counting those entries as shortages inflates totals.

A shortage also rarely means no supply at all. It is often limited to certain strengths, package sizes or manufacturers, and local backorders can happen without a national shortage.