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7 Things to Know About Drug Shortage Management

We know it can be frustrating when you can’t get a medicine you need. That’s why FDA works closely with the pharmaceutical industry and other stakeholders to prevent drug shortages and to lessen the impact on patients any time there is a delay in the availability of the medicines you need. Ensuring access to safe, effective, high-quality medicines is one of our top priorities.

7 things to Know About Drug Shortage Management

Under certain circumstances, there may not be a way to avoid a shortage. For example, drug manufacturers may have unexpected issues affecting their production. Other times, shortages may be caused by product quality issues, a drug company discontinuing a product, or unexpected surges in demand. When these situations occur, FDA works with pharmaceutical companies and other stakeholders to manage any resulting shortage until companies can meet demand, allowing consumers to get the medicines they need.

Here are 7 things to know about how the Center for Drug Evaluation and Research (CDER) manages drug shortages:

  1. The Drug Shortage Staff (DSS) serves as CDER’s focal point for the evaluation and management of drug shortages. DSS establishes and maintains a network of designated contacts within CDER to address drug availability issues comprehensively and proactively and serves as subject matter expert for any drug shortage-related issues within CDER. DSS monitors drug supply and demand to help ensure availability for emergency situations. Relatedly, DSS also serves as a liaison to private industry, other FDA centers, and other government organizations, including but not limited to the Centers for Disease Control and Prevention (CDC) and the Department of Defense (DoD).

  2. For many drugs, drug companies must notify FDA about permanent discontinuances in manufacturing and manufacturing interruptions that are likely to lead to a meaningful disruption in the supply of that drug. Many drug manufacturers also must develop and maintain a risk management plan evaluating risks to the supply of their product. CDER works closely with industry to prevent or reduce the impact of shortages. Early notification from manufacturers of any issue that could lead to a potential disruption in product supply has been, and will continue to be, critical to preventing and mitigating drug shortages. Industry can report discontinuances, manufacturing interruptions, recalls, and an increase in product demand through the CDER Direct NextGen Portal.

    FDA issued a draft guidance, Notifying FDA of a Discontinuance or Interruption in Manufacturing of Finished Products or Active Pharmaceutical Ingredients Under Section 506C of the FD&C Act. When finalized, this guidance is intended to assist applicants and manufacturers in providing FDA timely, informative notifications about changes in the production of certain finished drugs and biological products as well as certain active pharmaceutical ingredients (API) that may, in turn, help the agency in its efforts to prevent or mitigate shortages. The draft guidance also explains how FDA intends to communicate information about products in shortage to the public.

    In addition, FDA issued a draft guidance, Risk Management Plans to Mitigate the Potential for Drug Shortages, which, when finalized, is intended to help stakeholders develop, maintain, and implement risk management plans (RMPs) to proactively assist in the prevention of human drug product and biological product shortages. RMPs can provide stakeholders with a framework to proactively identify, prioritize, and implement strategies to mitigate hazards that can cause a supply disruption. Such a supply disruption may lead to a drug shortage.

  3. DSS will consider that a product is in shortage when the national supply available for product within the U.S. is not adequate. This occurs when, on a nationwide level, supply is not meeting current demand or supply is not forecasted to meet projected demand.

  4. CDER posts drugs on the Drug Shortage Database once they are determined to be in shortage. When a shortage is listed as current on the Drug Shortage Database, FDA is aware of the supply situation and is working with the manufacturers on efforts to mitigate the shortage. The CDER Drug Shortage Database is updated daily and reflects the most recent information from the drugs’ manufacturers. FDA also works with manufacturers on shortage prevention efforts for drugs not yet listed on the Drug Shortage Database.

    CDER does not post all drugs for which notifications have been received regarding discontinuance and interruption in manufacturing. This is to avoid hoarding of drugs and exacerbating supply concerns. All information on product availability and estimated duration is verified with manufacturers.

  5. DSS is responsible for coordinating all activities related to the prevention and mitigation of drug shortages. DSS facilitates prevention and resolution of shortages by working with key stakeholders from the FDA, other government agencies, industry, and the public.

    To help manage a shortage, CDER can:

    • Prioritize and expedite reviews of new drug applications and supplements for new production lines or material sources to help increase production quickly,
    • Prioritize and expedite an inspection or reinspection of manufacturing facilities that could help mitigate or prevent such drug shortage.

    CDER cannot require a pharmaceutical company to:

    • Make a drug,
    • Make more of a drug,
    • Change how much and to whom the drug is distributed (among lawful purchasers).
  6. Patients, health care professionals, and organizations can report new shortages through a public notification portal. 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 nationwide drug shortage. When FDA receives reports of new local supply disruptions, DSS contacts 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, this advanced notice helps FDA take early action to prevent or shorten the duration of a shortage. Anyone can submit reports on supply issues to drugshortages@fda.hhs.gov or 240-402-7770.
  7. DSS will consider that a “current” shortage is “resolved” when FDA determines that nationwide supply is no longer exceeded by demand or projected demand. Please note all of the presentation information posted under the individual product shortages are provided by the manufacturer and can change daily. When a status is noted as “available,” that reflects the most current information from the manufacturer but is not an FDA determination that the shortage has been resolved.  
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