Extensions range from 66 to 278 months. Topics similar to or like Shelf Life Extension Program Joint program of the United States Department of Defense and the Food and Drug Administration that aims to reduce the cost to the military of maintaining stockpiles of certain pharmaceuticals by researching the expiration of drugs. Some newly mailed Covid tests from the government expire imminently even with extensions. This extension applies to all unopened vials of Evusheld that have been held in accordance with storage conditions detailed in the authorized Fact Sheet for Health Care Providers and the Letter of Authorization for Emergency Use Authorization (EUA) 104 for Evusheld. I know thatHi. MeSH FOIA For more than 30 years, federal agencies that stockpile drugs including the military, the CDC and the Department of Veterans Affairs have used technically expired drugs under the Shelf-Life Extension Program (SLEP) in collaboration with FDA. Lorem ipsum dolor sit amet, consectetuer adipiscing elit. An official website of the United States government, : The Department of Defense (DoD)-United States Food and Drug Administration (FDA) 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. Repackaging concerns have delayed the expansion of the Shelf Life Extension Program beyond the U.S. Department of Defense to include state and local membership. September 20, 2017: CDC and FDA hosted a webinar to discuss FDAs April 2017 draft guidance Extending Expiration Dates of Doxycycline Tablets and Capsules in Strategic Stockpiles. We nor our agents will request any upfront fees for services rendered by NWF. However, to reduce the expense of such a stockpile and to make it worthwhile, there is also a need for a shelf-life extension program (SLEP) through which pharmaceuticals could be extended beyond manufacturer-ascribed shelf life, as long as they meet regulation standards. 0000033599 00000 n Through expiration dating extensions, SLEP helps to defer the replacement costs of certain products in critical federal stockpiles. Results from the shelf life extension program (SLEP) have been evaluated to provide extensive data to address this issue. Disclaimer, National Library of Medicine May 12, 2022: Statement Regarding Shelf-Life Extension of Sotrovimab (from HHS/ASPR and FDA) On September 21, 2021, FDA and ASPR authorized an extension of the shelf-life from 12 months to 18 months for all lots of the refrigerated GSK monoclonal antibody, sotrovimab. A generic drug, if chemically and pharmacokinetically identical to the innovator, is assumed to have the innovators safety profile without any additional safety testing. Theoretically, small levels of degradation products could gradually accumulate, including some degradants which had been either undetected or quantified within acceptance criteria during the time of shorter-term (e.g., 2-4 years) stability analyses following original production of the drug product. The results found that 86% of the 14 tested drugs (12 drugs, multiple batches of each) had at least 90% of their labeled potency, which would fall within the FDAs acceptable range of potency for batches that are still within their expiration period. Dexmedetomidine HCl injection in 0.9% sodium chloride, 200 mcg/2 mL (100 mcg/mL), 2 mL single dose vial. A summary of the Shelf Life Extension Prorgarm (SLEP) data is available in The Journal of Pharmaceutical Sciences, Vol. corresponds to the end of the extrapolated retest period or shelf life. The .gov means its official. The Shelf Life Extension Program aims to extend the shelf lives of drugs held in U.S. federal reserves. All sotrovimab vials may continue to be retained regardless of the current labeled expiry date or the previously provided extension dates, unless otherwise notified by the Agency. FOREWORD . Stability Proles of Drug Products Extended beyond Labeled Expiration Dates ROBBE C. LYON, 1JEB S. TAYLOR, DONNA A. PORTER,2 HULLAHALLI R. PRASANNA, AJAZ S. HUSSAIN3 1Division of Product Quality Research, Center for Drug Evaluation and Research, Food and Drug Administration, HFD-941, White Oak, Life Sciences Building 64, 10903 New Hampshire Avenue, Silver Spring, Maryland 20993-0002 A summary of the services and requirements for pharmacists can be found here. Clinical trial management and distribution center. This document provides guidance to government stakeholders on testing to extend the shelf life (i.e., expiration date) under the FD&C Act of stockpiled doxycycline tablets and capsules for public health emergency preparedness and response purposes for an anthrax emergency. The federal Shelf Life Extension Program (SLEP) extends the expiration dates on qualifying drugs and other materiel in federal stockpiles. June 1, 2020: FDA is alerting civilian health care professionals and emergency responders of 4 additional DuoDote lots that are no longer useable and should be properly disposed of. 2017 Aug 1;95(8):594-598. doi: 10.2471/BLT.16.186650. This program indicates that the majority of drugs, with very few exceptions, are still extremely effective and safe to use even if they have passed the manufacturers expiry date. Department of Defense (DoD) components should continue. July 29, 2022: FDA and HHS/ASPR authorized an additional extension to the shelf-life for all lots of the refrigerated GSK monoclonal antibody, sotrovimab, from 18 months to 24 months. 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. FDAs Office of Regulatory Affairs (ORA) Field Science Laboratories centrally manages the program, including interacting with DoD and coordinating laboratory work. https://www.astho.org//Federal-Shelf-Life-Extension-Program-Fact-Sheet Results from the shelf life extension program (SLEP) have been evaluated to provide extensive data to address this issue. The purpose of SLEP is to prevent the need to replace stockpiles of medications every few years. Based on stability data provided by the manufacturers and reviewed by FDA, the following extended use dates are supported for specific lot numbers indicated in the searchable table below.. April 24, 2019: FDA published a final guidance for government public health and emergency response stakeholders: Extending Expiration Dates of Doxycycline Tablets and Capsules in Strategic Stockpiles. July 2, 2021:FDA is alerting civilian health care professionals and emergency responders of 1 pralidoxime chloride and 5 CANA (diazepam) auto-injector lots for which the new use date has passed; however, FDA recommends that stakeholders retain such lots in the event that additional scientific information becomes available to support additional extensions. Data from the US Department of Defense/FDA Shelf Life Extension Program, which tests the stability of drug products past their expiration date, have shown that 2650 of 3005 lots (~88%) of 122 different products stored in their unopened original containers remained stable for an average of 66 months after their expiration date. Here is a list of resources to help you begin implementing pharmacist care services into your practice. If describing the Shelf Life Extension Program use this definition a. Shelf Life Extension Program presentation at Federal, State, and Local Public Health Preparedness meeting. Could such medications, if shown by evaluation such as SLEP to retain adequate potency, be donated to developing countries in which the usual commercial product is either prohibitively expensive or not readily available, or be used in the US during periods of critical drug shortages? 2003 Jul-Sep;1(3):68-70. doi: 10.1016/s1540-2487(03)00044-0. However, it is the recommendation of the U.S. Government that product be retained in the event that future SARS-CoV-2 variants, which may be susceptible to bamlanivimab and etesevimab, emerge and become prevalent in the United States. Each batch of each drug in the SLEP program is tested separately, and the shelf life extended for each batch individually. The Department of Defense (DoD)-United States Food and Drug Administration (FDA) 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. On December 21, 2021, FDA and ASPR announced the authorization of an extension to the shelf-life from 12 months to 18 months for specific lots of the refrigerated Eli Lilly monoclonal antibodies, bamlanivimab and etesevimab. 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. Custom unit-of-use prepacks. 2006 Aug;171(8):698-702. doi: 10.7205/milmed.171.8.698. Some medications, such as naloxone, halothane, fentanyl and others had 100% demonstrable stability of lots for at least 4-5 years after expiration. 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. Most extensive source of pharmaceutical stability data. 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. FDA acknowledges the stockpiling challenges of federal and SLTT stakeholders (for example, related to doxycycline, ciprofloxacin, Tamiflu, and certain auto-injector products) and remains committed to finding appropriate solutions to address such challenges. Shelf Life Extension Program The SNS participates in the Federal Shelf Life Extension Program (for federal stockpiles) which is managed by the Department of Defense and the FDA. 0000036537 00000 n Program Extends Drug Shelf-Life. October 21, 2020:FDA is alerting civilian health care professionals and emergency responders of 1 pralidoxime chloride and 5 CANA (diazepam) auto-injector lots for which the new use date has passed; however, FDA recommends that stakeholders retain such lots in the event that additional scientific information becomes available to support additional extensions. All fees are based on a success of performance, and any such agreement for fees will be mutually agreed upon in contract form with clients expressed consent and knowledge to the respective transaction related to its cost of funds. Dont throw away that expired Tamiflu; the government has given a 5 year use extension beyond the date of expiration through the Shelf Life Extension Program. (Federal Register notice), FDA alerts health care providers and emergency responders of expiration date extension updates for certain auto-injectors manufactured by Meridian Medical Technologies. SLEP is administered by the U.S. Department of Defense (DoD) in cooperation with the U.S. Food and Drug Administration (FDA). FDA will continue to evaluate the available data and provide updated information as soon as possible. Furthermore, a 2012 study by Dr. Lee Cantrell and researchers involved testing drugs that were a whopping 28-40 years past expiration. Federal government websites often end in .gov or .mil. One key component of this preparation is the establishment of a Strategic National Stockpile (SNS) of pharmaceuticals that would provide appropriate medical countermeasures in case of an outbreak. April 25, 2017: FDA announced the availability of a draft guidance for government public health and emergency response stakeholders entitled Extending Expiration Dates of Doxycycline Tablets and Capsules in Strategic Stockpiles. December 5, 2022: FDA and HHS/ASPR authorized an additional extension to the shelf-life for specific lots of the refrigerated AstraZeneca monoclonal antibody therapy, Evusheld, from 18 months to 30 months. Therefore, this drug may not be administered for treatment of COVID-19 under the EUA until further notice by the Agency. Program participants are U.S. Federal agencies that sign a Memorandum of Agreement with the Department of Defense, and SLEP remains limited to federal stockpiles at this time. The shelf life extension program tests pharmaceutical products stored in national stockpiles. Specifically, testing 3,005 lots of 122 drug products that were near their expiration date found 88% extended beyond expiry, with most showing continued adherence to USP or product release specifications, and extended stability of 62 months. Based on stability data provided by the manufacturers and reviewed by FDA, the following extended use dates are supported for specific lot numbers indicated in the searchable table below. In addition, conformance to pre-expiry in vitro release testing would assure acceptable bioavailability. Retained product must be appropriately held in accordance with storage conditions detailed in the authorized Fact Sheet for Health Care Providers (PDF, 1.38 MB) and the Letter of Authorization (PDF, 488 KB). 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. 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