Evaluation of a future extension of shelf-life for sotrovimab is ongoing. This authority is limited to medical products for CBRN emergencies. Stockpiling drugs, vaccines, and medical products is critical to ensure public health emergency preparedness for both the U.S. military and civilian populations. April 25, 2017: FDA announced the availability of a draft guidance for government public health and emergency response stakeholders entitled Extending Expiration Dates of Doxycycline Tablets and Capsules in Strategic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. Porcine blood product was the only effective treatment at the time for this clinical situation in which factor replacement with human material was pointless. Shelf-Life Extension Program Policy Establishes the DHA procedures to manage and provide guidance on the SLEP within the Military Health System and contingency operations. Current DoD policy is not to prolong shelf life for more than ten years, but it has been found that at least one product is safe and effective 23 years after it expires. Fact Sheet Overview. Another extended drug is Thorazine, a tranquilizer chemically known as chlorpromazine tablets. The site is secure. Since all drugs are required by law to have an expiration date and are not approved for use past their expiration date, the U.S. Department of Defense (DoD) began administrating the Shelf-Life Extension Program (SLEP) in 1986. 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. 2012 Mar;10(1):66-76. doi: 10.1089/bsp.2012.0305. The risk posed by the natural or manmade spread of biological agents among the population dictates a need for better national preparedness. Stability studies generally are sufficient to demonstrate an economically-viable stability period such as 2-3 years, yet rarely have such studies been carried out to demonstrate the success or failure of the medications stability at points later than the designated expiration period. They concluded that a stated expiry date, did not always indicate it is no longer effective or has become unsafe. 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 8 The SNS may use the federal Shelf Life Extension Program to help maintain its supply. The FDA has issued some simple advice on this matter and they believe that if you wish to extend the shelf life of any prescription drugs that you are best off storing them in your refrigerator. FOREWORD . SLEP is administered by the U.S. Department of Defense (DoD) in cooperation with the U.S. Food and Drug Administration (FDA). The U.S. Food and Drug Administration (FDA) requires that an active ingredient in a medication must be present in 90 to 110 percent of the amount indicated on a drug's label.Tablets and capsules have the longest shelf life, according to McClusky, who says on pharmacy shelves many are good for as long as five years. 2017 Aug 1;95(8):594-598. doi: 10.2471/BLT.16.186650. However, stakeholders that apply this extension to their stockpiled products should clearly note in their stockpiles that FDA has allowed for its extension (e.g., by placing a placard on the outside of a pallet or shipping box). Shelf Life Extension Program (SLEP) extends the expiration dates on qualifying drugs and other materiel in federal stockpiles. https://en.wikipedia.org/w/index.php?title=Shelf_Life_Extension_Program&oldid=1095593245, Articles needing additional references from June 2022, All articles needing additional references, Creative Commons Attribution-ShareAlike License 3.0, This page was last edited on 29 June 2022, at 07:32. 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. 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. A summary of the services and requirements for pharmacists can be found here. FDA will continue to evaluate the available data and provide updated information as soon as possible. The site is secure. This program probably contains the most extensive source of pharmaceutical stability data extant. The shelf life extension program tests pharmaceutical products stored in national stockpiles. 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.. This draft guidance was prepared in response to requests from States asking FDA what would be necessary to provide confidence that stockpiled doxycycline tablets and capsules have retained their original quality beyond the manufacturers labeled expiration date so the replacement of stockpiled product could be deferred. Available at: The purpose of SLEP is to defer replacement costs of stoc 95, No. Custom unit-of-use prepacks. Providers and patients that have the lot numbers in stock will be able to use them through the corresponding new use dates to help with supply. Contact ProPharma Group to get answers from our team of experts, who can help you with everything from FDA meetings to staying compliant with strict and sometimes confusing FDA regulations. January 1, 2020: FDA is alerting civilian health care professionals and emergency responders of 2 additional DuoDote lots that are no longer useable and should be properly disposed of. 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. December 14, 2022: On April 28, 2022, HHS issued a message (PDF, 162 KB) to state stakeholders holding antiviral drug products (Tamiflu and Relenza) about additional expiry dating extensions for properly held product. In many cases, medications remain effective for years after their printed expiry dates. FDA will not take enforcement action with regard to the storage or emergency use of these lots of Relenza, provided that the products have been stored under labeled storage conditions. 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. The program determined that the average expiration extension should be 66 months and a maximum extension of 278 months, depending on the medication, of course. An FDA/DOD program to produce data on actual shelf lives of medications (SLEP, the Shelf Life Extension Program) has evaluated extended stability profiles for a couple of decades, finding, not surprisingly, that the majority of tested drugs retain adequate stability of at least a year, or longer, than their labeled expiration dates. This program is known as the DoD/FDA Shelf-Life Extension Program (SLEP). A 2006 study of 122 drugs tested by the program showed that two-thirds of the expired medications were stable every time a lot was tested. The U.S. government's own Shelf Life Extension Program extends the dates on some drugs in federal stockpiles to save the military from the cost of replacing them. Recognizing stakeholders MCM stockpiling challenges, FDA is engaged, when appropriate, in various expiration dating extension activities as described below. Primarily FDA-approved prescription drug (not biological) products are nominated by program participants as SLEP candidates. The FDA Center for Drug Evaluation and Research (CDER) Division of Product Quality Research analyzes the data and makes decisions regarding shelf life extensions. In fact, the total extension time in military storage for all drugs was 6.5 years. Due to the high frequency of the Omicron variant, bamlanivimab and etesevimab are not currently authorized in any U.S . Despite this data limitation, many thoughtful arguments have been espoused over the years regarding the potential for recycling expired medications, especially to avoid the waste of expensive and/or limited-availability drugs. Accessibility The U.S. government's own Shelf Life Extension Program extends the dates on some drugs in federal stockpiles to save the military from the cost of replacing them. (6 days ago) 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. FDA has authorized extended expiration dates for these lots to reflect the 12-month product shelf-life (see Table 1 below), when stored according to the storage conditions detailed in the authorized Fact Sheet for Health Care Providers and the Letter of Authorization for Emergency Use Authorization (EUA) 105 for Paxlovid. An additional 6 DuoDote lots are no longer useable and should be properly disposed of. 2 Shelf Life Extension Programme (SLEP) to perform stability testing on more than 100 medications. The best evidence of acceptable potency of the medications beyond their expiration date is provided by the Shelf Life Extension Program (SLEP) undertaken by Life Extension Program listed as LEP. Given the high costs involved in maintaining adequate drug stockpiles, attempts should be made to optimize the value of drugs; shelf-life extension is one of the easiest and most cost-effective ways of doing this. Improve taste. 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. As required by the EUA, unopened vials of bebtelovimab injection, 175 mg/2 mL, must be stored under refrigerated temperature at 2C to 8C (36F to 46F) in the original carton to protect from light. This includes working to ensure that MCM-related policy supports programs like SLEP. Shelf Life Extension Program (SLEP) extends the expiration dates on qualifying drugs and other materiel in federal stockpiles. However, if replacement product becomes available during the extension period, then the agency expects the lots in these tables will be replaced and properly disposed of as soon as possible. Some of the original drugs tested were penicillin, lidocaine, and lactated Ringer's. 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). sharing sensitive information, make sure youre on a federal This extension applies only to Tamiflu 30mg, 45mg, and 75mg capsules; it does not apply to generic versions of oseltamivir. An FDA/DOD program to produce data on actual shelf lives of medications (SLEP, the Shelf Life Extension Program) has evaluated extended stability profiles for a couple of decades, finding, not surprisingly, that the majority of tested drugs retain adequate stability of at least a year, or longer, than their labeled expiration dates. July 26, 2022 When FDA first issued the EUA authorizing Paxlovid (nirmatrelvir tablets and ritonavir tablets co-packaged for oral use), it established a 12-month product shelf-life. 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. Abstract. Drug expiration extension dates on these products ranged from 12 months to 184 months (over 15 years). The Strategic National Stockpile: roles and responsibilities of health care professionals for receiving the stockpile assets. The SLEP has been administered by the Food and Drug Administration for the United States Department of Defense (DOD) for 20 years. 2 however, the Extensions range from 66 to 278 months. It is a fresh start to really get stuff done and we have a full 12 months to do it all. He says that if the agency extended an expiration date by 36 months, it had concluded the lot would retain all of its safety and efficacy for at least 72 months. FOIA 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. (PDF) Shelf-Life Extension Program (SLEP) as a Significant Contributor to Strategic National Stockpile Maintenance: The Israeli Experience with Ciprofloxacin Shelf-Life Extension. 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. Do you have questions about SLEP, or drug expiration date restrictions? 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. The Shelf Life Extension Program (SLEP) is a joint program of the United States Department of Defense and the Food and Drug Administration which aims to reduce the cost to the military of maintaining stockpiles of certain pharmaceuticals by researching the expiration of drugs. Based on FDA's review of scientific data, FDA has concluded for emergency responses that, provided the products have been stored under labeled storage conditions, it is scientifically supportable for certain lots of Tamiflu 75 mg capsules held in strategic stockpiles to be used for a maximum of 15 years beyond their date of manufacture[and] for certain lots of Relenza inhalation powder held in strategic stockpiles to be used for a maximum of 10 years beyond their date of manufacture CDC has clarified that states should contact their MCM Specialist or email preparedness@cdc.gov to confirm extended dates for antiviral drug inventories eligible for extension. Epub 2017 May 26. The new findings are consistent with the efforts of the Shelf-Life Extension Program, which has extended the expiration dates on 88% of 122 drugs tested so far. 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. Please refer to the table on this page for updates. The program selected drugs in the stockpile based on how expensive and in-demand they were, and analyzed them to see if the expiration dates could be 2,7,11. SLEP is coordinated through multiple agencies. Before sharing sensitive information, make sure you're on a federal government site. When FDA grants or authorizes a shelf-life extension, that information may be found either in the granting letters or re-issued letters of authorization available in the listing of EUA authorized products on FDAs website. 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