Why FDA and ASHP count drug shortages differently

In the first three months of 2024, the drug shortage list kept by pharmacists at the University of Utah reached 323 active shortages, the most since it began counting in 2001, according to data published that April¹ by the American Society of Health-System Pharmacists (ASHP) and the university's Drug Information Service. For the whole of 2024, FDA recorded 15 new shortages, the agency told Congress in its annual report¹².

Both figures were accurate. They answer different questions, using different definitions, different sources of reports and different rules for deciding when a shortage is over.

That gap has not closed. On Nov. 3, 2026, FDA's database listed 69 drugs in current shortage, according to GxRadar's tracker. The most recent ASHP figure, for the second quarter of 2026, was 227 active shortages, AJMC reported². This piece sets out how each count is built and why the official list carries legal weight that the larger one does not.

Two definitions of a shortage

FDA uses the definition written into federal law: a period "when the demand or projected demand for a drug within the United States exceeds the supply of the drug," as its report for 2025¹³ puts it. The agency applies that nationally. Its FAQ⁵ says reports of a drug missing from one pharmacy usually turn out to be local distribution problems.

ASHP and the Utah service use a definition built around the pharmacy. A shortage is "a supply issue that affects how the pharmacy prepares or dispenses a drug product or influences patient care when prescribers must use an alternative agent," as a 2025 study using the Utah data⁸ quotes it. Under that test a missing strength or package size can count, even if national supply of the drug in other forms looks adequate.

Federal agencies acknowledge the split. A 2024 HHS white paper on shortages noted that "alternative definitions exist" and said it would use FDA's, in a footnote to the report⁴.

Who reports, who checks, and what gets posted

Sources: FDA FAQ⁵ and "7 Things to Know"⁶; methods sections of a 2025 pediatric pharmacology study⁸ and a 2016 Health Affairs study⁹.

Intake differs at the most basic level. FDA's list starts with manufacturers, whose notifications are required by law for many prescription drugs. The Utah list starts with the people who run out. A report from the AMA's Council on Science and Public Health summed it up in its 2025 shortage update³: because FDA's database "has a more limited definition of a drug shortage and requires self-reporting from manufacturers, their drug shortage numbers and statistics tend to be smaller."

FDA also keeps some known problems off its public list on purpose. In a 2024 explainer, it said CDER does not post all drugs⁶ for which it gets a discontinuance or interruption notice, "to avoid hoarding of drugs and exacerbating supply concerns."

Utah's process, as described in the 2025 study⁸, is manual. Pharmacists find every potential manufacturer and every NDC for the product, then contact each maker to learn which packages are on backorder or allocation nationally. The same paper notes two limits: the service does not track regional shortages and "cannot reliably distinguish between limited availability of a drug versus complete absence."

The end rule does much of the work

Perhaps the sharpest difference is the exit. FDA's database says the market is covered "when supply is available from at least one manufacturer to cover total market demand," and adds that "some manufacturers may not have all presentations available," according to the notes on the database page⁷. A drug can leave FDA's list while particular strengths are still hard to find.

Utah's list waits longer. In the 2016 Health Affairs study⁹, a shortage counted as resolved "when all suppliers have all formulations and dosages available or have permanently discontinued their products, or when the FDA reports on its website that the shortage has been resolved." The last clause means an FDA resolution can close a Utah entry, but a Utah entry can stay open after FDA's version of the same shortage has closed.

A stricter exit and a looser entry both push the Utah count up. Its database had logged 3,086 shortage reports from 2001 through mid-2024, once discontinuations, business decisions and one-day blips were removed, and the median shortage lasted 298 days, a 2026 ophthalmology study¹⁰ found.

The numbers side by side

Sources: FDA reports to Congress for 2023¹¹, 2024¹² and 2025¹³; the 2024 HHS white paper⁴ for January 2024; the AMA council report³ for ASHP's new-shortage counts; KPCW¹ and AJMC² for ASHP's active counts; GxRadar analysis of openFDA shortage data¹⁶ for November 2026.

Even FDA's own figures measure different things. Its reports count new shortages in a year, shortages "prevented" with manufacturers' help (330 in 2025), and "ongoing" shortages carried over from earlier years, which stood at 98 at the end of 2023, 113 at the end of 2024 and 93 at the end of 2025. None of those is the same as the number of drugs on the database on a given day.

Both systems show manufacturers often declining to say why. AJMC reported that makers gave the cause of 59 percent of 2025 shortages as "unknown" or declined to answer, based on the Utah investigation. In openFDA's current records, 720 of 1,153 package entries have no shortage reason, as our guide to FDA's database explains.

Why the official list carries legal weight

The smaller list is the one federal law points to. Under 21 U.S.C. 826(h)¹⁴, DEA must review a manufacturer's request for more production quota within 30 days when the request concerns a Schedule II drug on FDA's shortage list, a process covered in our piece on DEA quotas. Under 21 U.S.C. 353b¹⁵, outsourcing facilities may compound copies of approved drugs, or use certain bulk ingredients, when the drug "appears on the drug shortage list in effect under section 356e," which is FDA's list. Our explainer on compounding during shortages goes further.

The larger list tracks the problems pharmacists see at the shelf. Its entries include affected and available products, reasons, estimated resupply dates and, where relevant, notes on alternatives, per the 2025 study's description⁸. Those notes are written for clinicians, and decisions about any one patient's medicine belong with a prescriber or pharmacist. Our piece on how hospitals manage shortages describes that work.

A third set of figures will arrive by March 31, 2027, the legal deadline for FDA's report to Congress on shortages in 2026. For context on the earlier peaks, see the 2011 shortage crisis and GxRadar's analysis of how long shortages last.