Federal Shelf Life Extension Program

Federal Shelf Life Extension Program

Fact Sheet

Overview
The federal Shelf Life Extension Program (SLEP) extends the expiration dates on qualifying drugs and other materiel in federal stockpiles. SLEP is administered by the U.S. Department of Defense (DoD) in cooperation with the U.S. Food and Drug Administration (FDA).1 The program is an acknowledgement that the actual shelf life of drugs and other medical products may be longer than their stated expiration date, depending on their storage conditions. The purpose of SLEP is to defer replacement costs of stockpiled drugs by extending their useful life.

The program was established in 1986 through an interagency agreement between the DoD and the FDA in response to a Congressional directive to address U.S. Air Force drug stockpiles.2 This initial SLEP program was intended to extend the useful shelf life of medicines with limited commercial use (e.g., chemical agent antidotes) or which the government held in such large quantities that the manufacturer would not accept them for credit when the drugs expired.3 Since then, other federal agencies have entered into a memorandum of agreement with the DoD to participate in SLEP, including other branches of the military, the Strategic National Stockpile (SNS), the Department of Veterans Affairs (VA), the U.S. Postal Service, and the Bureau of Federal Prisions.2

SLEP is currently available only for federally-maintained stockpiles, although there have been ongoing deliberations between the federal government and the states about extending SLEP to state-maintained stockpiles or creating a separate SLEP-like program for state stockpiles. (See “State Stockpiles” discussion below.)

Note: As of March 2012, Congress is in the process of reauthorizing the Pandemic and All-Hazards Preparedness Act (PAHPA), which may impact a number of laws and programs described below. Please see ASTHO EUA Current Issues Winter 2012 for more information about reauthorization and its potential impact on EUAs and related issues. (Download a printable PDF.)