FDA's essential medicines list, and what happened to it

Heparin injection, a blood thinner, went onto FDA's shortage list on Nov. 14, 2017. Three years later FDA put it on a federal list of medicines "medically necessary to have available at all times." On Oct. 30, 2026, it was still listed as in shortage, according to GxRadar's analysis of the openFDA drug shortages data¹¹.

Heparin is not alone. GxRadar matched the 69 drugs FDA listed as current shortages that day against FDA's 2020 essential medicines list, by active ingredient and route. Twenty-three of them, a third, are on it.

FDA's list came out of a 2020 executive order meant to bring production of critical medicines back to the US and reduce shortages. It has since been narrowed by HHS to 86 drugs, tied to a Medicare payment for hospital stockpiles, and named in a 2025 order on stockpiling drug ingredients for the Strategic API Reserve. What it has not done is keep the listed drugs off the shortage list, as a comparison with our shortage tracker shows.

What the 2020 executive order asked for

Executive Order 13944², signed Aug. 6, 2020, set a policy of building "resilient domestic supply chains" for essential medicines, medical countermeasures and their ingredients. Section 3(c) gave FDA 90 days to identify, in consultation with the budget office, HHS's preparedness office and White House economic and trade staff, the products "that are medically necessary to have available at all times in an amount adequate to serve patient needs and in the appropriate dosage forms."

It also told agencies to favor domestic production when buying those products, told FDA to increase unannounced inspections of plants that make them, and allowed FDA to refuse imports from facilities that refuse or delay an inspection. The policy argument behind it is laid out in The federal push to make more medicine in the US.

How FDA built the list

FDA published the list on Oct. 30, 2020, together with a criteria document³. The essential medicines portion covers drugs "necessary to address immediately life-threatening medical conditions" seen in US acute care facilities and used to stabilize patients for discharge. Drugs "for longer-term chronic management" were left out on purpose. Where several drugs treat the same condition, FDA picked the one that covers the widest population. Rare conditions made the cut only if they are fatal within hours to days and preventable with a specific medicine.

Two other parts sit beside it. A medical countermeasures section covers stockpiled products for pandemics and chemical, biological, radiological and nuclear threats. A critical inputs section names every active pharmaceutical ingredient, plus source materials for biologics such as crude heparin and human plasma. FDA's page on the order¹ describes a separate device list covering test kits, protective equipment, ventilators and monitors, and a public docket that asked whether drugs should be added or removed and how often the list should be revisited.

FDA's drug and biologic list⁴ is a table arranged by drug category, with a dosage route for each entry. GxRadar counted the entries in some of the larger categories.

Source: GxRadar count of FDA's Oct. 30, 2020, essential medicines, medical countermeasures and critical inputs list (drug and biologic portion).

By GxRadar's count, roughly four in five entries in the essential medicines portion are listed in at least one injectable form. A few common outpatient generics made the list in oral form, among them amlodipine, furosemide, famotidine and hydrochlorothiazide.

From FDA's list to 86 medicines

Building on a 2021 federal supply chain review, HHS's preparedness office, then called the Office of the Assistant Secretary for Preparedness and Response (ASPR), commissioned an outside manufacturing institute to take a closer look. The resulting May 2022 assessment⁵ used workshops and surveys of clinicians to narrow FDA's list to the medicines "most critically needed for typical acute patient care" in intensive care, emergency departments and urgent surgery. The result was 86 medicines "identified as either critical for minimum patient care in acute settings or important for acute care, with no comparable alternative available." Blood and plasma products, vaccines and countermeasures were out of scope.

That shorter list now carries money. In its fiscal 2025 inpatient payment rule⁶, published Aug. 28, 2024, Medicare began paying small, independent hospitals for the extra cost of keeping a six-month buffer stock of one or more of the 86. CMS estimated that about 500 hospitals would qualify and that their combined cost would be roughly $2.8 million, with Medicare paying its share of about $0.3 million.

In January 2026 CMS went further with an advance notice of proposed rulemaking⁷ floating a "Secure American Medical Supplies" designation for hospitals that commit to buying domestically made protective equipment and essential medicines. Comments closed March 30, 2026. A footnote in that notice states that "there have been no subsequent revisions" to the 86-medicine list.

How the list lines up with today's shortages

Source: GxRadar analysis of openFDA drug shortage records and FDA's 2020 list, matched on active ingredient and route. Strengths can differ. We counted penicillin G benzathine, methylprednisolone acetate and desmopressin spray as non-matches because the list names other forms of those drugs. The Jan. 1, 2012, dates are round numbers that probably mean "on or before"; see The longest-running drug shortages.

Being on the list has not kept these drugs supplied. The 2022 assessment, using FDA data from December 2021, already showed heparin in shortage since November 2017. Twenty-two of the 23 matches are injections, consistent with the pattern described in Why sterile injectables dominate shortage lists. Several other listed drugs, among them vancomycin, ceftriaxone, cefepime, succinylcholine and ketamine injections, appeared on FDA's to-be-discontinued list over the past year. Those entries reflect individual manufacturers' notices, and GxRadar's tally of approved generic applications in FDA's Drugs@FDA data¹² still shows 36 for vancomycin hydrochloride and 14 for ceftriaxone sodium that are not in discontinued status.

The 2025 orders

Two executive orders in 2025 built on the 2020 one. Executive Order 14293⁹, signed May 5, 2025, told FDA to streamline review of new domestic plants; FDA's 2025 shortage report¹⁰ says its PreCheck program, launched Feb. 1, 2026, responds to it. Executive Order 14336⁸, signed Aug. 13, 2025, recounts that FDA's 2020 list was later reduced to 86 essential medicines and states that only about 10 percent of the active ingredients by volume for US finished drugs are made domestically.

That order gave ASPR 30 days to list about 26 drugs "especially critical to the health and security interests of the Nation" and to plan a six-month supply of their active ingredients for the Strategic Active Pharmaceutical Ingredients Reserve. It gave the office 90 days to update the 2022 list of 86, with a plan to stock six months of ingredients for those drugs too. Both deliverables go to White House staff and the budget office, and the order does not require them to be published. The 90-day deadline for the updated list fell in November 2025. Two months later, CMS's notice still described the 2022 list as unrevised.