Frequently Asked Questions about Drug Shortages
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 the total supply of all versions of a commercially available product cannot meet the current demand, and a registered alternative manufacturer will not meet the current and/or projected demands for the potentially medically necessary use(s) at the patient level.
Manufacturing quality issues are the major 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. Discontinuations are another factor contributing to shortages. FDA can't require a firm to keep making a drug it wants to discontinue. Sometimes these older drugs are discontinued by companies in favor of newer, more profitable drugs.
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, it is difficult for the remaining firms to increase production quickly and a shortage occurs.
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.
The CDER Drug Shortage Staff focuses on shortages that have the greatest impact on public health. Shortages that are expected to be resolved quickly or which involve only a particular strength or package size, which has a substitute strength(s) and package size(s), are not usually the focus of the Drug Shortage web page.
Questions for consumers
Occasionally, hospitals or pharmacies report local supply issues; however, these are usually temporary and may involve distribution issues. These shortages often resolve when the pharmacy is able to reorder from their distributor. When the FDA receives reports from pharmacies, hospitals, or others, we confirm with the manufacturers that supplies continue to be adequate to meet demand at the national level.
If you can’t find your prescription or over-the-counter 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. Anyone can submit drug shortage reports to email@example.com, including health care professionals, patients/individuals, and professional organizations.
Manufacturers are required to report shortages to FDA. Industry can report shortages, supply interruptions, recalls, and an increase in product demand through the CDER Direct NextGen Portal.
Pricing issues are not within the purview of FDA.
However, 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
Washington, D.C. 20580
Phone: (202) 326-3300
Website address: http://www.ftc.gov
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 changes in the production of certain finished drugs and biological products that 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 drug or biological products must notify FDA of:
- A permanent discontinuance in the manufacture of such drug and biological products
- An interruption in the manufacture of such drug and biological products that is likely to lead to a meaningful disruption in supply of the product in the United States
- A permanent discontinuance in the manufacture of active pharmaceutical ingredient (API) for such drug and products
- An interruption in the manufacture of API for such drug and biological 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.
Manufacturers must notify FDA at least 6 months in advance. 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.
Q9. When FDA takes an action such as sending a warning letter to a company or takes an enforcement action, is the shortage impact considered beforehand?
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.
Q10. Is the drug product information listed on the FDA’s Drug Shortage website the same as on the American Society of Health-System Pharmacists (ASHP) Drug Shortage website?
FDA and ASHP websites provide drug shortage information, however, there are some differences. FDA:
- Receives information provided by manufacturers regarding their ability to supply the market
- Receives market sales data on the specific products
- Lists drugs on its website once it has confirmed that overall market demand is not being met by the manufacturers of the product
- Does not consider a product to be in shortage if one or more manufacturers are able to fully supply market demand for the product
In contrast, ASHP:
- Provides information about which manufacturers have the drug available and which ones do not, since supply chain disruptions may occur when all previous manufacturers are not yet back on the market with all formulations and all dosage sizes
- Lists drugs in shortage even if the full market demand is met by the current manufacturers
FDA and ASHP work closely to share information and provide the most current information.
For more information, please visit Contrasting the FDA (CDER) and ASHP Drug Shortage Websites: What are the differences?
FDA’s role with drug shortages
FDA responds to potential 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.
For manufacturing/quality problems, FDA works with the firm to address the issues. Problems may involve very low risk (e.g. wrong expiration date on package) to high risk (particulate in product or sterility issues). Regulatory discretion may be employed to address shortages to mitigate any significant risk to patients.
FDA also works with other firms making the drugs that are in shortage to help them ramp up production if they are willing to do so. Often, they need new production lines approved or need new raw material sources approved to help increase supplies. FDA can and does expedite review of these to help resolve shortages of medically necessary drugs. FDA can't require the other 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 approve the extended dating to help increase supplies until new production is available.
When the US manufacturers are not able to resolve a shortage immediately and the shortage involves a critical drug needed for US patients, FDA may look for a firm that is willing and able to redirect product into the U.S. market to address a shortage. FDA considers a list of criteria to evaluate the product to ensure efficacy and safety. These criteria include the formulation and other attributes of the drug as well as the quality of the manufacturing site where the drug is made.
FDA works to find ways to mitigate drugs shortages; however, there are a number of factors that can cause or contribute to drugs 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.
FDA's Drug Shortage Staff (DSS) resides in the Center for Drug Evaluation & Research (CDER). It consists of a dedicated staff of 15 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, the experienced and capable staff conduct medical necessity assessments, 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
- Center for Food Safety and Nutrition (CFSAN)
Food, including medical foods and cosmetic products
Center for Food Safety and Nutrition (CFSAN) Website – 1-888-SAFEFOOD
- Center for Veterinary Medicine (CVM)
Food additives and drugs that will be given to animals
- Center for Devices and Radiological Health (CDRH)
Medical devices and radiation-emitting products
firstname.lastname@example.org – 1-800-638-2041
Contacts for Medical Devices During the COVID-19 Pandemic
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 works to communicate information about shortages on the FDA website, based on information provided by the manufacturers. FDA appreciates all information that manufacturers provide for posting on the FDA website since we realize how necessary this is for patients and health care professionals to be informed when shortages occur and how long they may last. Manufacturers can report any information for posting to email@example.com.
Q15. How does FDA address shortages of medically necessary drugs that have not received FDA approval?
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 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.
The CDER Drug Shortage team utilizes information from manufacturers, distributors and market share data to determine if a shortage exists.