How FDA works to prevent drug shortages, and where its powers stop

In 2025, FDA says, it helped head off 330 drug shortages. Over the same 12 months it identified four new ones. Both figures come from the agency's annual shortage report to Congress¹, which also notes that new shortages peaked at 251 in 2011.

In FDA's telling, prevention mostly means acting fast on information. Manufacturers warn the agency about trouble, and FDA responds with faster reviews, longer expiration dates, temporary imports and case-by-case tolerance for products with known defects. Each of those tools is limited by law, and the report is candid that some shortages last for years anyway.

This piece walks through each tool, with FDA's own counts of how often it used them from 2022 through 2025, and then the things FDA has no power to do. How the agency decides a shortage exists in the first place is covered in How FDA tracks drug shortages.

The early-warning requirement

Everything starts with notice. Section 506C of the Food, Drug, and Cosmetic Act, codified at 21 U.S.C. 356c⁶, requires makers of prescription drugs that are life-supporting, life-sustaining or used for a debilitating condition to tell FDA about a permanent discontinuance, or an interruption likely to cause a "meaningful disruption" in US supply, at least six months ahead or "as soon as practicable." FDA's shortage FAQ⁵ adds that a notice must arrive no later than five business days after production stops. The CARES Act of 2020 extended the duty to active pharmaceutical ingredients.

Volume has grown. Manufacturers filed 1,293 such notices in 2022, according to FDA's report for that year⁴, and 1,424 from 167 companies in 2025. A company that fails to notify gets a public letter. FDA has sent 11 since 2014, and none in 2024 or 2025, according to its 2025 report; the letters and company replies are posted on its non-compliance page¹¹.

Faster reviews and inspections

When a shortage looms, the statute says FDA "shall, as appropriate, prioritize and expedite" review of applications and supplements that could help, along with inspections of the plants involved. That wording dates to the CARES Act; before 2020 the law said FDA "may" expedite. In 2025 the agency expedited 224 submissions, 164 of them generic drug applications or supplements, and prioritized 10 inspections.

According to the FAQ, makers trying to fill a gap often need FDA to approve new production lines or new raw-material sources first, and those are the submissions it moves to the front. FDA's FAQ puts it plainly that it "can't require firms to increase production." Speed is the lever it controls.

Sources: FDA reports to Congress on drug shortages for 2022⁴, 2023³, 2024² and 2025¹. Figures combine FDA's drug and biologics centers.

Both the prevented and new-shortage columns are FDA's own tallies. The agency's 2025 report¹ credits the notice rules for part of the decline since 2011, saying it "believes that the requirements related to the early notification of permanent discontinuances and interruptions in manufacturing are helping to reduce the threat and impact of drug shortages, as are FDA's own actions."

Stretching expiration dates

Some of the fastest relief comes from stock already on shelves. The FAQ says that when a firm has inventory near or past expiry and "has data to support extension of the expiration dating," FDA can review it and decide a later date is supportable. Approved extensions go on a public list of extended use dates⁷, by lot number.

On the version updated Oct. 20, 2026, the list held 35 lot entries for four products. Twenty-one were penicillin G benzathine injection, the long-acting antibiotic used for syphilis. Six were spinal bupivacaine, six were 25% dextrose syringes and two were flumazenil, a sedation-reversal drug. The extensions ran from five months to a full year beyond the printed date. FDA says it is not requiring or recommending that those lots be relabeled, and expects them to be replaced once new supply arrives. Why printed dates are conservative in the first place is covered in How drug expiration dates are set.

Temporary imports and regulatory flexibility

When US makers can't close a gap, the FAQ says FDA "may look for an FDA-registered foreign manufacturer that is willing and able to redirect foreign-approved product into the U.S. market," after reviewing its formulation and the quality of the plant. A December 2024 FDA presentation¹⁰ called importation a "last resort," pursued with regulators that have strong standards (it named the EU, UK, Canada and Australia as examples) and only after confirming the import "will not cause shortage in other countries."

Penicillin G benzathine shows how that works. FDA dates the shortage to April 26, 2023, driven by demand from rising syphilis rates, with one FDA-approved product on the market. In November 2023 FDA posted a letter to clinicians⁸ announcing the temporary import of a version marketed in France and made in Italy, and in June 2024 a second letter⁹ covering a product made in Portugal. Neither was FDA-approved. GxRadar's shortage tracker still lists the injection as current, with limited availability, on Oct. 30, 2026. Importation for shortages runs on FDA discretion and is separate from the state programs described in Drug importation under section 804.

The broader category, which FDA calls regulatory flexibility and discretion, covered 78 instances affecting 67 products in 2025. FDA's 2025 report¹ lists examples: shipping filters with a product to remove particulate matter, extra quality testing before release, third-party oversight of a troubled plant, and special instructions to health professionals and patients. The report frames these as trade-offs between quality concerns and the risk to patients "if treatment options are not available for critical conditions."

Controlled substances need a second agency. FDA's shortage staff contacted the Drug Enforcement Administration 30 times in 2025, and the report describes a July 2024 FDA request that led DEA to raise the lisdexamfetamine production quota that September.

What FDA cannot do

The limits are written into the same documents. FDA's FAQ says the agency "can't require a firm to keep making a drug it wants to discontinue" and that "Pricing issues are not within the purview of FDA." The 2024 presentation listed what FDA cannot require: that a company report a demand increase that might lead to shortage, make a drug, or make more of it, and it cannot require a distributor to report how much it ships and which buyers get priority. FDA's shortage staff is small; the FAQ describes 17 scientific and regulatory experts, with about 25 full-time equivalents across the drug center supporting them.

Those limits show up in how long shortages last. The 2025 report says shortages "often persist due to market conditions," including a "lack of incentives for firms to manufacture older, less profitable products." In GxRadar's analysis of openFDA shortage data¹², the 69 drugs listed as current on Oct. 30, 2026, had been on the list for a median of about 1,700 days, roughly four years and eight months. Most are hospital injectables, for reasons laid out in Why drug shortages happen and Why sterile injectables dominate shortage lists.

Newer efforts aim at supply itself. The 2025 report describes FDA's PreCheck program, launched Feb. 1, 2026, which offers early technical advice and streamlined review to companies building new US plants; the policy backdrop is in The federal push to make more medicine in the US. FDA's next shortage report to Congress, covering 2026, is due by March 31, 2027.