The shelf-life extension program (SLEP) was established in 1986 through an intra-agency agreement between the DoD and the FDA to extend the shelf life of product nearing expiry. The mission of the SLEP program is to maintain the availability of the national drug stockpiles for military operations and civilian readiness for national emergencies, and to reduce the need to fully replace the stockpiles at expiry. The SLEP program saves the US government substantial amount of over 1 billion dollars a year. The SLEP is a post-marketing monitoring of the drug lots that ensures the products stored in strategic stockpiles continue to meet quality standards beyond the assigned manufacturers expiration date. FDA has developed a systematic regulatory quality centered approach, for the laboratory testing of the original and aged products beyond expiry to predict the continued products stability, and to ensure pharmaceutical stockpiled products especially medical countermeasures meet quality standards after the “expiration date”. On-going SLEP research is an example of the Agency’s Regulatory Science Initiative to advance the regulatory science and to help ensure product performance past the original shelf-life.<br/> <br/>SLEP is fee for service program administered by FDA for DOD and other participating government agencies such as VA, Army, Airforce. SLEP make use of either compendial or innovator based comprehensive testing and evaluation program is designed to justify the extension of drug products beyond the labeled expiration date. Examples of MCM products tested include therapeutics for chemical and biological threat antidotes such as DuoDote ATNAA and CANA, and essential antibiotics and antiviral agents in different formulation types such as tablets, capsules, steriles etc. Data from 1500 lots (50 drug products) that were evaluated for the past two years indicated 85% of the lots were extended for an average of 84 months past the original expiration date, and 5% were eventually terminated due to failure. The SLEP workflow is a complex multi-step operational process. The multitude of retested drugs were hosted on secured relational database which is a unique national resource database presently under automation development serves as a scientific platform for a product quality research and improvement, and to understand why some drugs with specific formulations fails stability, while same drugs from other manufactures could easily pass the SLEP retesting.

FDA-DOD shelf-life extension program a 21<sup>st</sup> century platform to extend the expiration of medical drug products to support US strategic national stockpiles and public health national emergencies

ACS Spring 2022

The official archive and repository for all ACS Meetings & Expositions abstracts and select posters or presentations.

FDA-DOD shelf-life extension program a 21st century platform to extend the expiration of medical drug products to support US strategic national stockpiles and public health national emergencies

FDA-DOD shelf-life extension program a 21^st century platform to extend the expiration of medical drug products to support US strategic national stockpiles and public health national emergencies