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Drug Shortages


Drug Shortages
(December 1, 2010)
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It is FDA's policy to help prevent or alleviate shortages, primarily of medically necessary drug products, since these can have significant public health consequences. A drug shortage may involve either an actual or a potential shortage of a drug product. A product is considered to be medically necessary, or a medical necessity, if it is used to treat or prevent a serious disease or medical condition, and there is no other available source of that product or alternative drug or therapy that is judged by medical staff to be an adequate substitute.

The FDA website provides information on shortages and limited distribution of medically necessary drugs. It includes information about the specific drug, the reason for the shortage and the manufacturers anticipated date of availability. FDA also posts press releases and other notices of recalls from the firms involved as a service to consumers, the media, and other interested parties.

The article "FDA's Role in Responding to Drug Shortages” published in the American Journal of Health Systems Pharmacists (2002 Aug 1;59(15):1423-5), provides additional information. The ASHP guideline describes the contributing factors to drug product shortages and recommends a general process for inventory management in preparation for and working through shortage situations. ASHP Guideline on Managing Drug Shortages.

Sign up for an E-mail notification Pharmacists may sign up to receive updates of drug products added to the Current Drug Shortages, and Resolved Drug Shortages lists on the FDA website.

Return to FDA Drug Info Rounds Page