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Audit (A-04-11-01001)

Audit of the Centers for Disease Control and Prevention's Shelf-Life Extension Program

Executive Summary

To ensure preparedness for war or other contingencies, the Department of Defense (DoD) maintains significant pre-positioned reserves of critical medical material. The Shelf Life Extension Program (SLEP) is a joint DoD and Food and Drug Administration (FDA) program. It was created to enable DoD to defer drug replacement costs by delaying the replacement of certain drugs that have useful lives beyond their expiration dates.

The Centers for Disease Control and Prevention (CDC) maintains the Strategic National Stockpile (Stockpile), which contains significant amounts of pre-positioned drugs for use in responding to emergencies throughout the United States.

CDC used the SLEP to extend the expiration dates of Stockpile drugs when possible. Of the 17 SLEP-eligible drug lots included in our sample, FDA did not accept 9 lots for testing. CDC destroyed or returned these drug lots to the drug manufacturer for credit. FDA tested the remaining eight drug lots and extended their expiration dates. CDC had relabeled or was in the process of relabeling these eight drug lots at the conclusion of our audit.

This report contains no recommendations.

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