Every pharmaceutical product marketed in the USA has an expiration date also referred to as the expiry date. Performance of the drug product beyond the manufacturer set expiry date or shelf life has been a subject of study over several decades. Scientific studies including FDA studies have shown that certain drug products can retain their shelf life characteristics such as quality, potency and efficacy, several years beyond the expiration date if stored properly. The Department of Defense (DOD) shelf life extension program (SLEP) was established with FDA to maintain the availability of the national drug stockpiles for military operations and civilian readiness for national disasters. The primary objective was to reduce the need to fully replace the stockpiles at expiry. FDA has developed a systematic approach for shelf life extension of drugs by laboratory testing of the original and aged products beyond expiry to predict the continued stability of these products. SLEP is very important in maintaining both national security and Public Health and welfare by confirming that stockpiled pharmaceutical products meet quality standards after the “expiration date”.  SLEP research is an example of the Agency’s regulatory science framework to help best ensure product performance past the original shelf-life. Regression approaches have helped to develop a test platform to assess and to understand the chemical degradation behavior and the critical stability attributes of these drug products. The drug products are diverse and range from antibiotics to drug device delivery systems such as auto-injectors. Various sophisticated analytical techniques that were employed to evaluate the usability of complex drug delivery systems beyond its currently approved shelf life. The SLEP program and its evolving database are unique national resources that may ultimately serve as a model scientific platform for product quality research with the potential to support FDA’s broader product quality initiatives and better address US and Global Public Health issues.<br/>

FDA-DOD Shelf life Extension Program (SLEP): A public health model for emergency readiness

254th National Meeting (2017)

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