Drug Shortages
Drug Shortages can occur for many reasons, including manufacturing and quality problems, delays, and discontinuations. Manufacturers provide FDA most drug shortage information, and the agency works closely with them to prevent or reduce the impact of shortages. When a shortage is listed as current on the Drug Shortage Database, the FDA is aware of the supply situation and is working with the manufactures on efforts to mitigate the supply disruption. FDA also continue to work with manufacturers on shortage prevention efforts for drugs not yet listed on the Drug Shortage Database.
Drug Shortage Notifications
For Industry
Industry can notify FDA Drug Shortage Staff of drug and supply shortages via the CDER Direct NextGen Portal.
This portal is intended ONLY for drug manufacturers/applicants. Industry can notify the FDA Drug Shortage Staff of new discontinuances, GMP issues, increase in product demand, recalls, supply interruptions, or other events. If you have any questions, please contact: drugshortages@fda.hhs.gov.
Drug Shortage Status Information
Patients, healthcare providers, organizations, and other interested parties may submit information to FDA regarding the status of an existing shortage by emailing drugshortages@fda.hhs.gov.
Public portal for patients, healthcare providers, and organizations to report NEW shortages
When a medication is not available, it can be helpful to make FDA's Drug Shortages staff aware. Usually when a drug is not in stock, it's a temporary, localized issue and more product is on the way. Occasionally local supply issues can be a signal of a future drug shortage.
When FDA receives reports of new local shortages, we contact the manufacturers to confirm if their available supply will meet the national demand for the drug. If a drug is at risk of going into shortage, sometimes this advanced notice helps FDA take early action to prevent or shorten the duration of a shortage.
To use the public portal:
- First check the Drug Shortages Database for current shortages to see if FDA is already aware of this shortage. Search by your product's generic name or active ingredient.
- If the drug is already in the Drug Shortages Database, talk with your health care provider or pharmacist for other treatment options during the shortage. FDA is actively working on resolving that shortage.
- If the drug is NOT in the Drug Shortages database, send a report to FDA through our new public portal.
Spotlight
2023 Drug Shortages Report
Annual report to Congress summarizing the major actions taken by FDA in 2023 to prevent or mitigate drug shortages in the United States.
Guidance for Industry: Notify FDA
Guidance to assist applicants and manufacturers in notifying FDA about finished drugs and biological products production changes.