Drug Shortages

Introduction

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.

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.

Drug Shortage Manual of Policies and Procedures (MaPP)

MaPPs are approved instructions for internal practices and procedures followed by CDER staff to help standardize the new drug review process and other activities. MaPPs define external activities as well. All MaPPs are available for the public to review to get a better understanding of office policies, definitions, staff responsibilities,and procedures.

• MaPP 6003.1 Drug Shortage Management

Medical Necessity

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. Patient "inconvenience" alone is an insufficient basis to classify a product as a medical necessity.

Practical Steps for Practitioners Facing Drug Shortage Situations

• ASHP Guideline on Managing Drug Shortages. The American Society of Health-System Pharmacists 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.

More Information on Drug Shortages, Product Recalls and Warnings

• FDA Product Recalls, Alerts, and Warnings. FDA posts press releases and other notices of recalls from the firms involved as a service to consumers, the media, and other interested parties.
• Cderrecalls@cder.fda.gov, or phone 301-796-3120