Drugs
Resources for You
- Drug Shortage Manual of Policies and Procedures (MaPP) (PDF - 149KB)
American Society of Health-System Pharmacists: Drug Shortages - American Society of Health-System Pharmacists:Guideline on Managing Drug Shortages8
- Guidance for Industry: Notification to FDA of Issues that May Result in a Prescription Drug or Biological Product Shortage (PDF - 226KB)
Drug Shortages
FDA takes great efforts, within its legal authority, to address and prevent drug shortages, which can occur for many reasons, including manufacturing and quality problems, delays, and discontinuations. The agency works closely with manufacturers of drugs in short supply to communicate the issue and to help restore availability. FDA also works with other firms who manufacturer the same drug, asking them to increase production, if possible, in order to prevent or reduce the impact of a shortage.
Manufacturers are not required to report information, such as reasons for shortages or the expected duration of shortages. However, many companies voluntarily provide shortage information that FDA posts on its website. FDA encourages and appreciates all reporting of shortages by manufacturers. Shortage notifications and updates may be reported to FDA at drugshortages@fda.hhs.gov.
Drug Shortages Information
- Six Month Check-Up: FDA's Work on Drug Shortages (5/3/2012)
- Obama Administration Takes Action to Reduce Prescription Drug Shortages, Fight Price Gouging (press release, 10/31/2011)
- Obama Administration Takes Action to Reduce Prescription Drug Shortages in the U.S. (fact sheet)
Executive Order -- Reducing Prescription Drug Shortages Letter to Industry Graphic - A Drug Supply Chain Example Economic Analysis of the Causes of Drug Shortages (HHS) - FDA Report: A Review of FDA's Approach to Medical Product Shortages
Center for Drug Evaluation and Research’s (CDER) Drug Shortages Action Plan - General Drug Shortages Questions and Answers
Current Drug Shortages Index - Bedford Product Availability
Related Information
Biologic Product Shortages Animal Drug Shortage Information - Transcript: Drug Shortage Workshop (Sept. 26, 2011) (PDF - 7.7MB)
- Video: Drug Shortages
- FDA Webinar on Prescription Drug Shortages (Sept. 30, 2011)
Podcast: Drug Shortages - Sign up for Drug Shortages E-mail Notifications
FDA Drug Shortages RSS Feed (XML - 4KB)