About FDA
How does FDA help consumers when drug shortages happen?
Drug shortages can occur for many reasons, such as 1) manufacturers being unable to obtain raw materials, 2) drug makers having manufacturing problems which result in safety risks for patients and not able to produce more product until the issues are corrected, and 3) business decisions being made by a company to discontinue a drug.
FDA established the Drug Shortage Program to help address shortages of over-the- counter and prescription medications. The ways that FDA can address shortages are:
- Working with firms to resolve manufacturing issues to allow medications to return to the market.
- Speeding up FDA’s review process so that new manufacturers interested in making drugs in shortage can supply their products as soon as possible.
- Helping firms with getting new sources of raw material.
When firms decide to discontinue making a drug, this is often due to business reasons. It is important to know that FDA is not able to force a company to continue making a medication. If a product is medically necessary and a shortage will occur due to a company’s decision to discontinue a medication, FDA can look for alternate manufacturers and work with the alternate manufacturers to bring the product back to the market.
To inquire about a drug’s availability or to report a shortage to FDA, please use the e-mail account drugshortages@fda.hhs.gov
Show all related FDA Basics Questions
- Where can I find information about adverse reactions to a medicine prescribed for my child?
- Where can I find information about medicines prescribed for my child?
- Materials from Webinar on Access to Investigational Drugs
- FDA Basics Webinar: "Mini-Sentinel," FDA's New Tool for Monitoring the Safety of FDA-Approved Medical Products
- How FDA Evaluates Regulated Products: Drugs
- FDA Webinar on Prescription Drug Shortages
- FDA Webinar on "Bad Ads" Program
- FDA Basics Webinar on Generic Drugs
- FDA Basics Videos: Tim Coté on Orphan Drugs
- What is an FDA Drug Safety Communication?
- What is counterfeit medicine?
- FDA Basic Video: Interview with John Jenkins on New Drugs (Video)
- What are unapproved drugs and why are they on the market?
- How can I stay better informed about drugs? Is there a reliable website FDA recommends?
- How do I discard medicine that I no longer need, do I just throw it in the garbage?
- How do I report a bad reaction to medicine or medication error to FDA?
- Does FDA approve the proprietary names of prescription drugs?
- What does FDA require drug manufacturers to do to prevent contaminated drugs? If contamination occurs, how must they correct the problem?
- How does FDA help consumers when drug shortages happen?
- Does FDA approve the information given out by pharmacies when I pick up my medicine?
- How does FDA decide when a drug is not safe enough to stay on the market?
- How do I find out if a drug is approved? Is there a Web site I can go to?
- What is the approval process for a new prescription drug?
- What is a Warning Letter?
- Can FDA ban direct-to-consumer drug advertising?
How helpful was this information?
