Frequently Asked Questions about Drug Shortages
General Questions
The Federal Food, Drug, and Cosmetic Act defines a drug shortage as a period of time when the demand or projected demand for the drug within the United States exceeds the supply of the drug. FDA tracks shortages at the national level and receives information from manufacturers about their ability to supply the market. We consider a drug to be in shortage when, on a nationwide level, supply is not meeting current demand, or if supply is not forecasted to meet projected demand.
Manufacturing quality issues are the most common reason for drug shortages. However, there have been other reasons such as production delays at the manufacturer and delays companies have experienced receiving raw materials and components from suppliers. Other shortages may be caused by sudden or unexpected increases in demand, or because of discontinuations. FDA can't require a firm to keep making a drug it wants to discontinue, and sometimes older drugs are discontinued by companies in favor of newer, more profitable drugs.
As an example, with fewer firms making older sterile injectable drugs, there are a limited number of production lines that can make these drugs. The raw material suppliers the firms use are also limited in the amount they can make due to capacity issues at their facilities. This small number of manufacturers and limited production capacity for older sterile injectables, combined with the long lead times and complexity of the manufacturing process for injectable drugs, results in these drugs being vulnerable to shortage. When one company has a problem or discontinues its production, it can be difficult for the remaining firms to increase production quickly, which can result in a shortage.
Questions for Consumers
Occasionally, we receive reports from hospitals, pharmacies, patients, health care professionals, and others about local supply issues. These are usually temporary and often involve distribution issues, which resolve when the pharmacy is able to reorder from their distributor. When the FDA receives these types of reports, the Agency checks with the manufacturers to determine whether supplies are adequate to meet demand at the national level.
If you can’t find your medication at your local pharmacy or store, it may be due to a temporary, localized supply issue. Check multiple stores or pharmacies, or ask your health care provider or pharmacist if there is an alternative to the medicine you’re looking for.
Yes. Health care professionals, patients/individuals, and professional organizations may submit drug shortage reports regarding potential new shortages through the online public portal.
Manufacturers and applicants can report shortages, supply interruptions, recalls, and an increase in product demand through the CDER Direct NextGen Portal. This portal is intended ONLY for drug manufacturers/applicants.
In addition, 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.
Pricing issues are not within the purview of FDA.
If you have concerns regarding the price of your medications, you may wish to contact the Federal Trade Commission (FTC). The FTC enforces a variety of federal antitrust and consumer protection laws. The FTC seeks to ensure that the nation’s markets function competitively, and are vigorous, efficient, and free of undue restrictions. Contact information for the FTC is as follows:
Federal Trade Commission
Bureau of Competition
Office of Policy and Evaluation
Room 394
Washington, D.C. 20580
Phone: (202) 326-3300
Website Address
When shortages occur, there are often faxed and e-mailed advertisements received by pharmacies from unknown distributors that offer these drugs at higher prices than the pharmacy normally pays. Concerns should be reported to FDA via the Office of Criminal Investigations.
Questions for Industry
Since the enactment of the Food and Drug Administration Safety and Innovation Act (FDASIA) in 2012, manufacturers have been required to notify FDA of certain changes in the production of certain finished drugs and biological products. These notifications may, in turn, help the Agency in its efforts to prevent and mitigate shortages.
In 2020, the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) enhanced FDA’s ability to identify, prevent, and mitigate possible shortages of human drugs by, among other things, expanding the notification requirement.
Currently, applicants and manufacturers of certain finished prescription drugs and biological products must notify FDA of:
- A permanent discontinuance in the manufacture of such products
- An interruption in the manufacture of such products that is likely to lead to a meaningful disruption in supply of those products in the United States
- A permanent discontinuance in the manufacture of active pharmaceutical ingredient (API) for such products
- An interruption in the manufacture of API for such products that is likely to lead to a meaningful disruption in the supply of the API for those products
Notifications must include disclosure of reasons for the discontinuation or interruption.
In general, manufacturers must notify FDA at least 6 months in advance of permanent discontinuance or interruption. However, if 6 months’ advance notice is not possible, the notification must be submitted as soon as practicable thereafter. A notification concerning a permanent discontinuance or interruption in manufacturing of a finished drug or biological product must be submitted no later than 5 business days after the discontinuance or interruption in manufacturing occurs.
FDA will issue a non-compliance letter to applicants and manufacturers who fail to comply with the drug shortage notification requirements and will make the letter and the company’s response to the letter available to the public.
In addition to reporting requirements, 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 or mitigating drug shortages. FDA appreciates information that manufacturers provide to help mitigate or prevent a shortage.
Related Information
- Drug Shortages: Non-Compliance With Notification Requirement
- Full information on the FDASIA
- Coronavirus Aid, Relief, and Economic Security Act (CARES Act) Drug Shortage Mitigation Efforts
FDA is responsible for ensuring that safe, effective drugs are available for U.S. patients. When there are severe quality issues identified that could result in harm to patients, there may not be a way to avoid a shortage. However, FDA does everything possible to work with firms to address any potential risks to keep medically necessary products available while also ensuring there is not going to be harm to patients associated with the quality issues. FDA ensures timely and effective internal coordination and alignment among field investigators and the staff of CDER’s Office of Compliance and the Drug Shortage Program.
FDA and ASHP websites provide drug shortage information, however, there are some differences.
Information about ASHP’s website is available at Contrasting the FDA (CDER) and ASHP Drug Shortage Websites: What are the differences?
FDA’s Role with Drug Shortages
FDA can help prevent or mitigate drug shortages by taking actions to address their underlying causes and to enhance product availability. FDA determines how best to address each shortage situation based on its cause and the public health risk associated with the shortage. Some of the steps FDA can take include:
For manufacturing/quality problems, FDA works with the firm to address the issues. Risks posed by manufacturing/quality problems can vary; regulatory discretion may be employed to address shortages to mitigate any significant risk to patients.
FDA can also help meet patient demand by working with other firms to help them ramp up production if they are willing to do so. Often, alternative manufacturers may need new production lines approved or need new raw material sources approved to help increase supply. FDA can and does expedite review of these to help resolve shortages of medically necessary drugs. FDA can't require firms to increase production.
When a shortage occurs and a firm has inventory that is close to expiry or already expired, if the company has data to support extension of the expiration dating for that inventory, FDA is able to review this and where appropriate, determine that an extended expiration date is supportable to help increase supplies until new production is available.
When U.S. manufacturers are not able to resolve a shortage immediately and the shortage involves a medically necessary drug, FDA may look for an FDA-registered foreign manufacturer that is willing and able to redirect foreign-approved product into the U.S. market to help address the shortage. FDA requests and evaluates relevant information from the manufacturer to determine whether the non-U.S. approved source is suitable to help address the shortage – such as information about the formulation and other attributes of the drug, as well as the quality of the manufacturing site where the drug is made. FDA’s Drug Shortages Staff (DSS) also monitors the shortage situation and determines when product from the non-U.S. approved source is no longer needed.
In rare circumstances, such as a declared public health emergency, natural disaster, or other unforeseen events, multiple firms that manufacture or distribute non-U.S. approved products may reach out to FDA seeking to help address a shortage. In those instances, FDA generally considers those inquiries as they come in, based on DSS’ assessment of the current shortage situation and needs at the time of the inquiry. FDA generally seeks the same type of relevant information from manufacturers (e.g., product formulation, manufacturing capabilities) as in those situations in which DSS initiates a search for potential suppliers, to ensure that any non-U.S. approved source FDA identifies is suitable to help address the shortage.
FDA works to find ways to mitigate drug shortages; however, there are a number of factors that can cause or contribute to drug shortages that are outside of the control of FDA.
Also, FDA issued a long-term strategic plan to outline the agency’s priority actions, as well as actions drug manufacturers and others can take, to prevent drug shortages by promoting and sustaining quality manufacturing.
Related Information
- Strategic Plan for Preventing and Mitigating Drug Shortages (PDF - 381 KB)
FDA's Drug Shortage Staff (DSS) resides in the Center for Drug Evaluation & Research (CDER). It consists of a dedicated staff of 17 scientific and regulatory experts who are responsible for the coordination of all activities related to the prevention and mitigation of drug shortages.
The DSS coordinates with a host of other experts in CDER, which is estimated to utilize a total of about 25 full time employees, currently. Among other activities, these additional experienced and capable staff consider appropriate action on inspection reports and assess proposals of firms as they attempt to avoid supply disruption or increase production. They reside in many Offices across CDER, including the Office of Compliance, Office of Generic Drugs, Office of Pharmaceutical Quality and the Office of New Drugs.
We expect that reports of potential and actual drug shortages will continue to increase in the next months to years, requiring that FDA allocate more resources to mitigate drug shortages in a timely manner to protect public health. In doing so we will continue to focus on assuring a multifaceted approach, including close collaboration of all stakeholders within and outside of the Agency, including industry, regulators, payers, Congress, and others.
- Center for Biologics Evaluation and Research (CBER)
Biological products, including blood and vaccines
Website: CBER-Regulated Products: Shortages and Discontinuations
E-mail address for reporting shortages: CBERshortages@fda.hhs.gov.
Also, biological product manufacturers and health care personnel may report a real or suspected biological product shortage by calling 240-402-8380 - FDA Human Food Program (HFP)
Food, including medical foods and cosmetic products
Human Food Program Website – 1-888-SAFEFOOD - Center for Veterinary Medicine (CVM)
Food additives and drugs that will be given to animals
AskCVM@fda.hhs.gov - Center for Devices and Radiological Health (CDRH)
Medical devices and radiation-emitting products
dice@cdrh.fda.gov – 1-800-638-2041
Contacts for Medical Devices During the COVID-19 Pandemic
The Drug Shortages Staff in CDER maintains an up-to-date list of drugs that are determined by the Agency to be in shortage in the United States. FDA’s drug shortage list is publicly available on the Agency’s website. FDA’s drug shortage list includes the names and National Drug Code (NDC) numbers for such drugs; the name of each applicant for such drugs, the reason for the shortage as determined by FDA, and the estimated duration of the shortage. This list is updated daily with new and resolved shortages, as well as additional information we receive from product suppliers on their manufacturing capacity.
FDA is aware that there are drugs being marketed that have not received FDA approval but are medically necessary and have been marketed for many years. When shortages occur for these drugs, FDA addresses these shortages through our normal processes and works with the companies to help ensure patient needs are being met while also ensuring there is not any significant risk associated with the drug due to quality, safety, or efficacy that could result in harm to patients. FDA encourages the companies making these drugs to notify us of any changes in supply and also encourages the firms to seek FDA approval to help ensure ongoing quality and safety of these drugs for US patients.
FDA receives and reviews input regarding drug shortages from numerous stakeholders, including manufacturers, patients, healthcare providers, and others, including compounders. Most information is provided by manufacturers. The CDER Drug Shortage team utilizes this information to determine if a shortage exists. In determining whether a shortage exists, FDA evaluates the supply and demand (including projected demand) of the drug on a nationwide level, assessing whether demand or projected demand exceeds supply.
Questions about the drug shortages database
According to section 506E of the FD&C Act and FDA’s regulations, the following may be cited as a reason for a particular drug shortage:
(A) Requirements related to complying with good manufacturing practices.
(B) Regulatory delay.
(C) Shortage of an active ingredient.
(D) Shortage of an inactive ingredient component.
(E) Discontinuation of the manufacture of the drug.
(F) Delay in shipping of the drug.
(G) Demand increase for the drug.
Following are definitions for each status:
- Currently in Shortage - A drug is currently in shortage if the demand or projected demand for the drug within the United States exceeds the supply of the drug
- Resolved - A shortage is considered resolved when FDA determines that supply is no longer exceeded by demand or projected demand.
- Discontinuation - Under section 506C of the Federal Food, Drug, and Cosmetic Act, manufacturers are required to notify FDA of a permanent discontinuance in manufacturing of certain drug products, six months in advance, or if that is not possible, as soon as practicable. These drugs include those that are life-supporting, life-sustaining, or for use in the prevention or treatment of a debilitating disease or condition, including any such drug used in emergency medical care or during surgery. The discontinuations listed on FDA's drug shortage database reflect information received from manufacturers and are for informational purposes only.
- Therapeutic category – This designation is meant to describe labeled indications and populations in which the drug is commonly used, for example Pediatrics. The therapeutic category designation does not indicate FDA approved status. A drug may be designated in more than one therapeutic category. Refer to labeled indications in the package insert for a product's FDA-approved uses.
- Available - 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. Please note that all of the presentation information posted under the individual product shortages is provided by the manufacturer and can change daily.
Whether potential alternatives may be appropriate will depend on each patient. If a patient is having a hard time acquiring a drug, they should reach out to their health care provider to discuss possible alternative treatment options. FDA does not regulate the practice of medicine.
Resolved shortages remain on the webpage for 6 months and discontinued shortages remain on the webpage for 1 year.
The Drug Shortages Staff in CDER updates the list daily with new and resolved shortages, as well as additional information we receive from product suppliers on their manufacturing capacity.