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FDA drug shortage list

Reading the FDA Drug Shortage List: The Injectables to Plan Around in Q4 2026

The FDA drug shortage list is the document most buyers check last, after the pharmacy has already called about a backorder. Read it the other way around. The list, the ASHP list that sits next to it, and the manufacturer availability reports behind both tell you which vials will be short next quarter, and Q4 2026 has two that touch nearly every procedure room: 0.9% sodium chloride vials and lidocaine with epinephrine. This is a purchasing guide, not clinical guidance. Substitutions and alternatives are decisions for your clinical lead and pharmacy.

How the FDA drug shortage list and the ASHP list differ

They are two lists with two jobs, and buyers who treat them as one miss shortages.

The FDA list is built on the statutory definition. FDA's own FAQ quotes the Federal Food, Drug, and Cosmetic Act: a shortage is "a period of time when the demand or projected demand for the drug within the United States exceeds the supply of the drug." The CDER Drug Shortage Staff weighs manufacturer, provider and patient input, then "evaluates the supply and demand (including projected demand) of the drug on a nationwide level." The database covers "current and resolved drug shortages and discontinuations" and "is updated daily with new and resolved shortages." The key word is nationwide. If one manufacturer is out and another can cover the country, the FDA list may show nothing.

The ASHP list, maintained with the University of Utah Drug Information Service, is written for practitioners. It tracks shortages by manufacturer, presentation and fill volume, which is why a 10 mL vial can appear there while the drug as a whole does not appear on the FDA list. FDA's FAQ acknowledges "there are some differences" between the two sites and points readers to ASHP for the explanation.

FDA list ASHP list
Question it answers Is national supply short of national demand? Can a pharmacy get this product, in this presentation, from this maker?
Granularity Drug level Manufacturer, strength, fill volume
Resolved means FDA determines supply no longer exceeded by demand or projected demand Product-level availability restored
Best use for a buyer Policy, allocation decisions, extended-use dates Ordering and par-level decisions

Use ASHP to decide what to order. Use FDA to understand why your distributor is on allocation and whether an extended-use date exists for lots you already own.

What "currently in shortage" and "resolved" mean

On the FDA list, "currently in shortage" means FDA is aware of the supply situation and is working with manufacturers to mitigate it. "Resolved" means exactly what the FAQ says: "A shortage is considered resolved when FDA determines that supply is no longer exceeded by demand or projected demand." Resolved is a national statement, not a promise that your wholesaler has stock.

The saline bags are the proof. FDA announced an end to the national shortage of 0.9% sodium chloride IV bags on August 8, 2025. Fourteen months later, the IV bag is resolved and the 10 mL vial of the same drug is depleted at Pfizer.

The Pfizer injectables depleted right now

Pfizer publishes a daily injectables availability report with the NDC, status and estimated recovery quarter for every presentation. The October 15, 2026 report shows:

Product Status Estimated recovery
0.9% Sodium Chloride Injection 10 mL LifeShield vial (00409-4888-12) Depleted, no current shipments 4Q 2026
0.9% Sodium Chloride Injection 10 mL plastic fliptop vial (00409-4888-10) Supply available n/a
0.9% Sodium Chloride Injection 20 mL plastic fliptop vial (00409-4888-20) Supply available n/a
0.9% Sodium Chloride Injection 50 mL vial (00409-4888-50) Limited supply 4Q 2026
Lidocaine 1.5% and Epinephrine ampul Depleted 1Q 2027
Lidocaine 0.5% and Epinephrine 50 mL vial Depleted 4Q 2026
Lidocaine 1% and Epinephrine vials (three presentations) One limited, two depleted 4Q 2026 to 2Q 2027
Lidocaine 2% and Epinephrine vials (four presentations) One depleted, three limited 1Q 2027 to 4Q 2028

Two things to take from that table. First, the 10 mL fliptop and 20 mL fliptop saline vials are available while the 10 mL LifeShield is not. A facility standardized on the LifeShield presentation has an alternate from the same manufacturer, if pharmacy approves the change. Second, the lidocaine with epinephrine recovery dates run from this quarter to 4Q 2028. That is not a backorder to wait out. It is a two-year planning problem that belongs in your continuity plan today.

Neither item is on the FDA list as a drug-level shortage as of this writing, which is the whole point. The signal is in the manufacturer report and the ASHP presentation-level entries, not the headline list.

A buyer's monthly check routine

Thirty minutes on the first business day of the month, documented in one spreadsheet:

  1. Pull the FDA list and filter out resolved and discontinued entries. Note anything new that your facility buys.
  2. Check ASHP for every injectable on your top 50 by volume. Record status and estimated resupply by manufacturer.
  3. Open the manufacturer availability reports for your primary makers. Pfizer's is a daily PDF with an "As of" stamp on every page. Record depleted and limited items.
  4. Compare against par. For anything depleted with recovery more than one quarter out, calculate weeks on hand at current usage.
  5. Check extended-use dates. FDA maintains a separate list of lots with extended expiration dates for shortage drugs. Confirm whether lots on your shelf qualify before you dispose of them.
  6. Send your distributor the gap list with catalog numbers and monthly usage, and ask for alternates with pharmacy sign-off still pending.
  7. Log it. Date, source, status.

Keystone's supply disruption monitor tracks these signals in one place, with Pfizer, Baxter and BD status pulled from the manufacturer reports and FDA recall classifications.

Rx items are quote-only for licensed facilities

Sodium chloride vials, lidocaine with epinephrine and every other prescription injectable in Keystone's catalog are quote-only and sold to licensed facilities only. Send the catalog number, the presentation and your monthly usage with your license on file, and Keystone will confirm availability and quote the same day during business hours. IV fluids follow the same rule.

The consumables around the vial are not restricted. Syringes, needles, IV administration sets, prep pads and sharps containers ship from Edina on Net 30 for approved accounts. If your plan calls for a presentation change, the delivery supplies change with it, and that part Keystone can fill today.

Request a quote on Rx injectables, browse IV and infusion supplies, or send your gap list and Keystone will work it line by line.

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