As noted below, the Tamiflu extensions do not apply to generic versions of oseltamivir. SLEP is administered by the U.S. Department of Defense (DoD) in cooperation with the U.S. Food and Drug Administration (FDA). This was not just an academic question, given the cost of treatment to prevent fatal bleeding in this patient was expected to be greater than $50,000. official website and that any information you provide is encrypted It tests medications for safety and stability for extended periods of time in controlled storage conditions. The Shelf Life Extension Program (SLEP) extends the expiration dates for specific medications and supplies stored in Federal stockpiles. Drugs and drug administration in extreme environments. Discover the remarkable things we do with microencapsulation technology. The purpose of SLEP is to prevent the need to replace stockpiles of medications every few years. QSL testing results with supply condition code 'A' may be used as the authority to extend Type II shelf-life materiel if it has been stored and packaged appropriately. 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). An official website of the United States government, : The SLEP enables each program participant to provide adequate oversight, ensure effective inventory controls, and monitor stockpiles for shelf life extension opportunities. For several decades, the program has found that the actual shelf life of many drugs is well beyond the original expiration dates. 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. Copyright 2023. A very few drugs aren't retested. The SLEP has been administered by the Food and Drug Administration for the United States Department of Defense (DOD) for 20 years. The Shelf Life Extension Program (SLEP) is a 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. In addition, conformance to pre-expiry in vitro release testing would assure acceptable bioavailability. Advertisement. DoD 4140.27-M 1- i DoD 4140.27-M DLA J-373 May 5, 2003 . Drugs that exist in solution or as a reconstituted suspension may not have the required potency if used when outdated. 2003 Jul-Sep;1(3):68-70. doi: 10.1016/s1540-2487(03)00044-0. Disaster Manag Response. Our results support the effectiveness of broadly extending expiration dates for many drugs, the researchers conclude. 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 site is secure. (Federal Register notice) Please contact Brad Leissa at [email protected] Brooke Courtney at [email protected] questions regarding thisguidance. In many cases . To help reduce this problem, the Food and Drug Administration administers the shelf-life extension program (SLEP) for the U.S. military as a testing and evaluation program designed to justify an extension of the shelf life of stockpiled drug products. Recognizing stakeholders MCM stockpiling challenges, FDA is engaged, when appropriate, in various expiration dating extension activities as described below. 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. No further extensions are anticipated beyond 10 years.Also see, from FDA: Influenza (Flu) Antiviral Drugs and Related Information, and from HHS/ASPR:HHS Increases Access to Tamiflu through the Strategic National Stockpile (December 21, 2022), andImproving Access to Influenza Countermeasures for U.S. Jurisdictions. Available at: The purpose of SLEP is to defer replacement costs of stoc 95, No. No one considered whether the product might prove toxic, but that was because the treating physicians were relatively ignorant about the processes of drug denaturation and production of degradants, and the risks from these processes. The Defense Medical Standardization Board (DMSB) coordinates the program and is the interface between . As a result of this extension, some batches may be stored for an additional 6 months from the labeled date of expiry. Criteria of sameness between expired and unexpired lots would need to be codified, and a method would need to be established for determining a new expiration date for such products. This authority is limited to medical products for CBRN emergencies. 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 FDA has a Shelf Life Extension Program that tests whether certain drugs have expiration dates that could be extended. One could pose the following argument loosely based on the precedent of the presumed safety of generic drug products, which are formulations that can be marketed without long-term human safety testing: It seems reasonable to postulate that re-analyses of expired drugs could identify some for which expiration could be re-established and thus qualify for recycling into clinical use. Expiration dating can present challenges to MCM stockpilers because MCMs that have reached their labeled expiration date in most cases cannot be used. government site. Details for each of the authorized services is located below. This Manual is reissued under authority of DoD Directive 4140.1, "Materiel Management Policy," January 4, 1993. 0000001621 00000 n 0000046714 00000 n 0000036537 00000 n Results from the shelf life extension program (SLEP) have been evaluated to provide extensive data to address this issue. Abstract. Custom unit-of-use prepacks. 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. 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. A generic drug, if chemically and pharmacokinetically identical to the innovator, is assumed to have the innovators safety profile without any additional safety testing. It is a partnership between FDA and the US Department of Defence. 0409-1638-02. 2002 Aug;8(8):529-33. doi: 10.1046/j.1469-0691.2002.00498.x. The FDA Center for Drug Evaluation and Research (CDER) Division of Product Quality Research analyzes the data and makes decisions regarding shelf life extensions. The Shelf Life Extension Program aims to extend the shelf lives of drugs held in U.S. federal reserves. Services offered include: Procurement of pharmaceutical, medical, and dental equipment and supplies. Also see: Expiration date extensions of certain lots of doxycycline hyclate. MeSH 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. Strategic National Stockpile program: implications for military medicine. 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. Due to the high frequency of the omicron variant and its subvariants, REGEN-COV is not currently authorized in any U.S. region. Chemical comparability means that the generic and innovator products have similar active ingredient potencies and similar minor components of impurities and degradation products. 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). Due to the high frequency of the omicron BA.2 variant, sotrovimab is not currently authorized in any U.S. region. 3 relations. However, when enforcement discretion is used for medical product dating extensions, MCMs are not covered under applicable Public Readiness and Emergency Preparedness (PREP) Act liability protections. 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. Quisque volutpat mattis eros. September 14, 2020 Uncategorized. There is, in actual fact, a program known as The Shelf Life Extension Program. 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. In fact, the total extension time in military storage for all drugs was 6.5 years. drug products marketed in the us typically have an expiration date that extends from 12 to 60 months from the time of manufacturer. 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. In many cases, medications remain effective for years after their printed expiry dates. 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. For additional information, consult the Guida Several months ago this blog discussed the potential for clinical use of expired drugs, citing interesting shelf-life data for drugs evaluated by FDA/DODs SLEP, the Shelf Life Extension Program. Retained product must be appropriately held in accordance with storage conditions detailed in the authorized Fact Sheet for Health Care Providers (PDF, 1.74MB) and the Letter of Authorization for Emergency Use Authorization (EUA) 091 (PDF, 1.03MB). Due to the high frequency of variants circulating within the United States that are not susceptible to sotrovimab, it is not currently authorized in any U.S. region until further notice by FDA and may not be administered for the treatment of COVID-19 under the EUA. The .gov means its official.Federal government websites often end in .gov or .mil. 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. 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. A medical product is typically labeled by the manufacturer with an expiration date. June 28, 2022: FDA and HHS/ASPR announced the authorization of an extension to the shelf-life from 18 months to 24 months for specific lots of the refrigerated AstraZeneca monoclonal antibody therapy, Evusheld (tixagevimab co-packaged with cilgavimab), which is currently authorized for emergency use for pre-exposure prophylaxis of COVID-19 in certain adults and pediatric individuals. Chocolate Chip Macadamia Nut Cookies, January 17, 2013: Before PAHPRA, in addition to FDAs June 2010 letter below, a CDC message to states in 2013 regarding spot shortages of Tamiflu for seasonal influenza noted that, [b]ased on FDAs review of scientific data, FDA has concluded that, provided the products have been stored under labeled storage conditions, it is scientifically supportable for certain lots of Tamiflu capsules held in strategic stockpiles to be used for a maximum of ten [10] years beyond their date of manufacture, June 22, 2010: Before PAHPRA, following the 2009-2010 H1N1 influenza response, FDA issued a letter [ARCHIVED] to CDC leadership regarding the disposition of Tamiflu and Relenza lots. Batches bearing December 1996 expiration dates -- unused and unopened, as is the case with all drugs evaluated in the Shelf Life program -- were tested in July 1998 and extended for two years. 2.4 Data Evaluation for Retest Period or Shelf Life Estimation for Drug Substances or Products Intended for Room Temperature Storage A systematic evaluation of the data from formal stability studies should be performed as illustrated in Shelf Life Extension Program Last updated January 06, 2020. program with the U.S. Food and Drug Administration (FDA). Please refer to the table on this page for updates. 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). There are studies that have demonstrated that most drug products retain at least 90% of their potency for several years. The federal Shelf Life Extension Program (SLEP) extends the expiration dates on qualifying drugs and other materiel in federal stockpiles. As data become available, this list can continue to expand. 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. Some medications, such as naloxone, halothane, fentanyl and others had 100% demonstrable stability of lots for at least 4-5 years after expiration. Abstract. 1 The program is an acknowledgement that the actual shelf life of drugs and 2007 Oct;51(4):857-69, vii. 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. Please contact Brad Leissa at [email protected] or Brooke Courtney at [email protected] with questions regarding this update. May 20, 2022: FDA and HHS/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 antibody, bebtelovimab, which is currently authorized for emergency use. MCM Legal, Regulatory and Policy Framework, Recalls, Market Withdrawals and Safety Alerts, MCM Legal, Regulatory and Policy Framework, MCM-Related Legal and Policy Presentations, Publications and Q&As, State, Tribal, Local, and Territorial Public Health Preparedness, Guidance and Other Information of Special Interest to MCM Stakeholders, Availability of Regulatory Management Plans, Vaccine EUA Questions and Answers for Stakeholders. 2017 Aug 1;95(8):594-598. doi: 10.2471/BLT.16.186650. For several decades, the programme has found that the actual shelf life of many drugs is well beyond The shelf life of a pharmaceutical product is the maximum time at which the true mean response of a stability limiting characteristic crosses th e acceptance criterion. basis for the current ICH/FDA shelf life estimation procedure limited assurance that individu al test results will comply with the specification up to m months /O 62 0000019485 00000 n 0000001621 00000 n program with the U.S. Food and Drug Administration (FDA). Product that passes testing is relabeled with a new expiration date and passed on to agencies receiving SNS. Epub 2017 May 26. (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. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. 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. In the United States, the Food and Drug Administration has administered the Shelf Life Extension Program (SLEP) for the Department of Defense for over 20 years. It must be noted that that model predictions are based on observations made in artificial growth media and available product studies. Shelf-life expiration dates have been extended multiple times as additional data becomes available. 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. RESULTS The 122 drug products evaluated by this study Predicting Extended Shelf Life were categorized into five groups (see Tab. Medical Device Product Development & Consulting, Research & Development Solutions Consulting, Commissioning, Qualification & Validation, Adverse Event Intake & Follow-Up Services, Product Complaint Intake & Follow-Up Services, Medical Communications, Content Management & Translation. A known hemophiliac patient, with a potent inhibitor to human factor VIII was bleeding uncontrollably, and all available porcine factor VIII in the pharmacy was out-of-date. The Shelf Life Extension Program (SLEP) is a 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. The Shelf Life Extension Program (SLEP) is a 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.It tests medications for safety and stability for extended periods of time in controlled storage conditions. Results from the shelf life extension program (SLEP) have been evaluated to provide extensive data to address this issue. Federal government websites often end in .gov or .mil. Relenza inhalation powder (reminder of previous extension) 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. FDA also recommended relabeling of such product prior to dispensing. 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. This site needs JavaScript to work properly. The drugs were worth tens of billions of dollars and were for a large-scale emergency. Given short expiration timelines, it is easy to imagine how strict regulations on storage and shelf life would force the Department of Defense (DOD) to constantly turn over and destroy huge stores of unused medications. Shelf life items are products that are effective, useful or suitable for consumption for a limited time period. Would you like email updates of new search results? 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. FDAs Office of Regulatory Affairs (ORA) Field Science Laboratories centrally manages the program, including interacting with DoD and coordinating laboratory work. Before Department of Defense (DoD) components should continue. FDA is not requiring or recommending that such stockpiled Tamiflu or Relenza product be relabeled with the new use date. They noted that the Shelf-Life Extension Program allows drugs in federal stockpiles to be retained for up to 278 months after their stated expiration date if tests show they are still potent. 1 The program is an acknowledgement that the actual shelf life of drugs Pharmaceutical shelf-life extension programs. 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. Audit of the Centers for Disease Control and Prevention's Shelf-Life Extension Program, A-04-11-01001 Author: HHS Office of Inspector General \(OIG . 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 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. It has gradually become clear that at least some drugs are extremely stable over long periods of time, and it seems a shame to simply toss them out upon expiry. This program probably contains the most extensive source of pharmaceutical stability data extant. Reagent stability studies are needed to support shelf-life expiration dates for in vitro diagnostics (IVDs) authorized under an EUA for emergency use during the COVID-19 pandemic, however they generally do not need to be completed at the time of initial review of the EUA request and/or EUA issuance, but should be initiated immediately following authorization, if not before. Extensions range from 66 to 278 months. Extensions range from 66 to 278 months. The FDA says: 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. 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. , and Local Public Health Preparedness meeting beyond the original expiration dates for many drugs, the Tamiflu extensions not. This list can continue to expand reached their labeled expiration date federal, State, and dental equipment supplies!, useful or suitable for consumption for a limited time period high frequency of shelf life extension program list of drugs. 12 to 60 months from the labeled date of expiry data extant components of impurities and degradation products ) should. 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