How FDA tracks drug shortages

On Oct. 30, 2026, FDA's drug shortage database listed 69 drugs in current shortage. Forty-nine of them were injectables, and four, including atropine sulfate injection and lidocaine hydrochloride injection, carried first-posted dates in 2012. GxRadar pulled the figures from the openFDA drug shortages feed¹, which republishes the FDA Drug Shortages Database described on the agency's drug shortages page⁵ and updates daily.

New shortages have slowed sharply. FDA counted 251 new drug shortages in 2011 and four in 2025, according to its annual report to Congress for calendar year 2025². The long-running ones have not cleared at the same pace: the median current entry on Oct. 30 had been posted for about 1,700 days, or 4.7 years, a pattern our analysis of how long shortages last looks at drug by drug.

Both numbers come out of one system: a legal definition of shortage, a reporting duty placed on manufacturers, and a Drug Shortage Staff inside FDA's Center for Drug Evaluation and Research that checks each report against national supply. How those pieces fit together explains what lands on the list, what stays off it, and why other shortage counts often look different.

The legal definition of a shortage

The Food, Drug, and Cosmetic Act, in the provision codified at 21 U.S.C. 356c³, defines a drug shortage as "a period of time when the demand or projected demand for the drug within the United States exceeds the supply of the drug." FDA applies that nationally. Its shortage FAQ⁴ says a drug is in shortage when nationwide supply is not meeting current demand, or is not forecast to meet projected demand.

That national test screens out a lot. FDA says most reports of a drug being out of stock at one pharmacy or hospital turn out to be temporary, local distribution problems that clear when the pharmacy reorders. When such a report arrives, the shortage staff checks with manufacturers to see whether total supply covers national demand.

Most shortage information comes from manufacturers, which report through FDA's CDER NextGen portal. FDA also runs a public portal where patients, clinicians and organizations can report a possible new shortage, after first checking whether the drug is already listed, as described on its drug shortages page⁵.

How the 506C early-warning rule came about

Section 506C of the act holds the core reporting duty. Executive Order 13588⁶, signed Oct. 31, 2011, near the peak of the shortage wave, directed FDA to take steps that included broader reporting of discontinuances that could lead to shortages. Congress then widened the requirement in the Food and Drug Administration Safety and Innovation Act⁷ (FDASIA), signed July 9, 2012.

Under FDASIA, manufacturers of most prescription drugs that are life-supporting, life-sustaining, or used to prevent or treat a debilitating disease or condition must tell FDA about a permanent discontinuance or an interruption in manufacturing likely to cause a meaningful disruption in US supply. The statute sets the timing: notice is due "at least 6 months prior to the date of the discontinuance or interruption," or as soon as practicable if six months is not possible. For finished drugs and biologics, FDA's shortage FAQ⁴ adds, notice must arrive no later than five business days after the discontinuance or interruption occurs. The agency has also issued draft guidance on 506C notifications⁸ that covers what a notice should contain, including the reasons.

A company that fails to notify gets a non-compliance letter, which FDA posts with the response. The agency has issued 11 such letters since 2014 and none in 2024 or 2025, its CY 2025 report says. Reporting has grown regardless. In 2025, FDA received 1,424 notifications of potential shortage situations from 167 different manufacturers.

What the CARES Act added in 2020

The Coronavirus Aid, Relief, and Economic Security Act, Public Law 116-136⁹, was signed March 27, 2020, as FDA's CARES Act shortage page¹⁰ notes. Its drug shortage amendments took effect Sept. 23, 2020, according to the agency's CY 2025 report².

Later laws added to the toolkit. The FDA Reauthorization Act of 2017 required FDA to prioritize generic applications for drugs on the shortage list, and the Food and Drug Omnibus Reform Act of 2022 formalized coordination between field investigators, CDER's Office of Compliance and the shortage staff. In 2025, according to the same report², FDA expedited 224 submissions and prioritized 10 inspections to address shortages. Inspection outcomes themselves are covered in our piece on Form 483s and warning letters.

What the database showed on Oct. 30, 2026

Each database entry gives the drug name and National Drug Codes, the applicant, the reason as determined by FDA and the estimated duration. Entries carry a status of current, resolved or to be discontinued, the last being a manufacturer's notice that it will stop making a product (GxRadar has a separate piece on those to-be-discontinued entries). The openFDA version covers 2012 onward, and new postings also appear on GxRadar's radar feed.

GxRadar's Oct. 30 pull showed 69 current shortages and 161 entries marked to be discontinued. Of the 69 current entries, 19 were first posted before 2020. The live list, with charts by form and therapeutic category, is on our shortage tracker, and a separate article explains why injectables dominate it.

Those labels come from a fixed list in the statute, which also includes shortage of an inactive ingredient. They are broad, and the most common is Other. FDA's 2019 root-cause report¹¹, which drew on more detailed follow-up from manufacturers, found that quality problems were behind 62 percent of drugs that went into shortage from 2013 to 2017. Our explainer on why drug shortages happen goes further into the economics.

Why shortage counts differ

Different sources give different numbers for the same month, and FDA itself publishes more than one count.

• New versus ongoing. FDA's annual reports count new shortages per year (four in 2025) separately from ongoing ones (93 at the end of 2025, per the CY 2025 report²).
• Which FDA center. The year-end figure of 93 includes shortages tracked by both CDER and the Center for Biologics Evaluation and Research. The CDER database, which openFDA republishes, does not include CBER's separate list.
• The unit being counted. One database entry can cover many strengths, package sizes and manufacturers. In its 2019 analysis, FDA treated each combination of active ingredient, route and dosage form as a drug, so 163 drugs corresponded to 130 shortages.
• The definition. FDA counts only national shortfalls, assessed mainly with information from manufacturers. Its FAQ⁴ notes that the American Society of Health-System Pharmacists keeps its own list with some differences from FDA's.

For one specific medicine, FDA suggests searching its database by generic name or active ingredient. If the drug is listed, a prescriber or pharmacist can talk through options; the 2023 cancer drug shortage showed how much those conversations can matter. If a drug is not listed and seems hard to get, FDA's public portal is the channel for telling the agency, and because section 506C-1 requires a report to Congress for each calendar year, FDA's official tally for 2026 will come in its next annual report.