How to Report a Drug Shortage to the FDA: The Email That Actually Gets Read

How to report a drug shortage to the FDA? Email drugshortages@fda.hhs.gov or call (240) 402-7770. Anyone can do it: patients, pharmacists, doctors. But before you write, check the Drug Shortages Database, because the first thing FDA staff will do is check whether they already know.

Most of the time, a drug that is not in stock is a local problem. The pharmacy's wholesaler is behind, the shipment is a day late, more product is on the way. But sometimes a local stockout is the first sign of a national shortage, and the FDA's drug shortages staff wants to hear about those early, which is what makes your report the early warning system.

Step zero: check the database

Search the FDA Drug Shortages Database by the drug's generic name, not the brand. If it is already listed, the FDA is already working on it, and your next move is talking to your doctor or pharmacist about alternatives, not filing a report. If it is not listed, your report is new information, and that is exactly what the reporting channel exists for.

What to put in the report

Keep it factual and short. Include the drug's generic name, the manufacturer if you know it, and the NDC number from the label if you have it. The NDC is the 11-digit code that identifies the exact product and package size, and it lets staff match your report to the right listing without guessing. Say where you ran into the gap: the pharmacy name and city is enough. Add your contact information so they can follow up; it is optional but useful.

One email to drugshortages@fda.hhs.gov with those five facts is a complete report. The phone line, (240) 402-7770, reaches the same team.

How to report a drug shortage to the FDA for biologics, devices, or animal drugs

Different FDA centers handle different products. For biological products like blood, vaccines, and tissues, email CBERshortage@fda.hhs.gov or call (240) 402-8380. For medical devices, contact the Center for Devices and Radiological Health at DeviceShortages@fda.hhs.gov. For animal drugs, the Center for Veterinary Medicine takes reports at ASKCVM@fda.hhs.gov. Sending a drug report to the device team just adds a forwarding delay, so route it right the first time.

What your report actually triggers

When the shortages team gets a credible report, they contact the manufacturer to confirm whether available supply will meet national demand. That early check is the whole value of reporting: if a drug is at risk, advance notice gives the FDA time to act before the shortage goes national, which can prevent it or shorten it.

What it cannot do matters just as much. The FDA cannot require a company to make a drug, make more of a drug, or change how it distributes what it makes. Your report is a signal, not an order. It puts the shortage on the agency's radar and starts the confirmation process. It does not conjure supply.

Clinicians should also file with the American Society of Health-System Pharmacists, which runs its own shortage reporting and works directly with the FDA. Hospital pharmacists tend to report there first, which is why ASHP's list sometimes shows a shortage before the FDA's does.

If your medication is hard to find right now, check whether it is listed as in shortage, report it if it is not, and set up shortage alerts so you hear about the next one before your refill runs out.

Frequently asked questions

Can patients report a drug shortage, or only doctors?

Anyone can report: patients, health care professionals, and organizations. The FDA explicitly invites reports from all three.

Do I need the NDC number to file a report?

It is not required, but it helps a lot. The NDC identifies the exact product and package size, so staff can match your report without guessing which version you mean.

What happens after I report?

The shortages team contacts the manufacturer to confirm whether supply will meet national demand. If the drug is at risk, early notice helps the FDA act to prevent or shorten the shortage.

Can the FDA force a company to make more of a drug?

No. The FDA cannot require a manufacturer to make a drug, increase production, or change distribution. Reporting puts the problem on the agency's radar; it does not create supply.

Should I report to ASHP as well as the FDA?

If you are a clinician, yes. The American Society of Health-System Pharmacists runs a parallel reporting system and shares data with the FDA, and hospital pharmacists often report there first.