One way is through issuing an Emergency Use Authorization (EUA) under section 564 of the FD&C Act since use of a product beyond its labeled expiry date is considered unapproved. In addition to SLEP, there are other ways that, when appropriate, FDA can allow certain medical products to be used beyond their manufacturer-labeled expiration dates. Emergency Use Authorities (including stockpiler-initiated) This includes working to ensure that MCM-related policy supports programs like SLEP. The Office of Counterterrorism and Emerging Threats (OCET) collaborates with FDA Centers and federal partners to facilitate access to MCMs. The FDA Center for Drug Evaluation and Research (CDER) Division of Product Quality Research analyzes the data and makes decisions regarding shelf life extensions. Current testing focuses on military-significant or contingency use products, drugs that have limited commercial use (e.g., nerve agent antidotes), and drugs that are purchased in very large quantities, such as ciprofloxacin and doxycycline.įDA’s Office of Regulatory Affairs (ORA) Field Science Laboratories centrally manages the program, including interacting with DoD and coordinating laboratory work. Primarily FDA-approved prescription drug (not biological) products are nominated by program participants as SLEP candidates. Federal agencies that sign a Memorandum of Agreement with the Department of Defense, and SLEP remains limited to federal stockpiles at this time. Through expiration dating extensions, SLEP helps to defer the replacement costs of certain products in critical federal stockpiles. SLEP is the federal, fee-for-service program through which the labeled shelf life of certain federally stockpiled medical materiel (e.g., in the SNS) can be extended after select products undergo periodic stability testing conducted by FDA. To avoid the need to replace entire stockpiles every few years at significant expense, and because it was recognized through testing that certain products remained stable beyond their labeled expiration dates when properly stored, the Shelf-Life Extension Program (SLEP) was established in 1986. Stockpiling drugs, vaccines, and medical products is critical to ensure public health emergency preparedness for both the U.S. For additional information, consult the Guidance for Government Public Health and Emergency Response Stakeholders: Extending Expiration Dates of Doxycycline Tablets and Capsules in Strategic Stockpiles, page 3, or Guidance for Industry: Changes to an Approved NDA or ANDA. The manufacturer of an approved drug product may extend the expiration date for the drug product based on acceptable data from full, long-term stability studies on at least three pilot or production batches in accordance with a protocol approved in the NDA or ANDA. Emergency Use Authorities (including stockpiler-initiated)Īpproaches to Drug Product Expiration Date Extensions Initiated by the Manufacturer.Approaches to Drug Product Expiration Date Extensions.Recognizing stakeholders’ MCM stockpiling challenges, FDA is engaged, when appropriate, in various expiration dating extension activities as described below. In some cases, testing has shown that certain properly stored medical products can be used beyond their labeled expiration date if they retain their stability. While this is important to ensure patient safety, it also means that the MCMs, some of which might still be stable, must be replaced regularly, which can be very costly. Expiration dating can present challenges to MCM stockpilers because MCMs that have reached their labeled expiration date in most cases cannot be used. This reflects the time period during which the product is expected to remain stable, or retain its identity, strength, quality, and purity, when it is properly stored according to its labeled storage conditions.
Some state and local governments and private sector entities also stockpile MCMs to have ready access to them if an emergency were to occur.Ī medical product is typically labeled by the manufacturer with an expiration date. Department of Health and Human Services (HHS) Assistant Secretary for Preparedness and Response (ASPR) oversees the Strategic National Stockpile (SNS), which has large quantities of medicine and medical supplies to protect the American public if there is a public health emergency (for example, a terrorist attack, flu outbreak, or earthquake) severe enough to cause local medical supplies to run out. To help prepare for public health emergencies, medical countermeasures ( MCMs) may be stockpiled by governments and even by some private sector partners.įor example, the U.S.
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