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. The SLEP program found that around 88% of 122 medications, including antibiotics, retained potency for more than one year. 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. [1], Learn how and when to remove this template message, "Stability profiles of drug products extended beyond labeled expiration dates", SLEP - The DOD/FDA Shelf Life Extension Program, In vitro dissolution of expired antibiotics (Amoxicillin / Ampicillin / Doxycycline), Stockpiled Antivirals at or Nearing Expiration (Tamiflu / Relenza). (Federal stockpiles are stores. 100,000/g within the shelf life of many chilled foods. 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. The intended outcome of the SLEP is measurable cost avoidance returned to program participants and continued availability of potency-dated contingency stocks. Advertisement. Please refer to the table on this page for updates. More information, April 2019 guidance: Extending Expiration Dates of Stockpiled Doxycycline for Anthrax Preparedness, Expiration date extensions of certain lots of doxycycline hyclate, August 7, 2020: Additional Expiration Date Extensions of Certain Lots of Doxycycline Hyclate 100 mg Capsules Held in Strategic Stockpiles (PDF, 86 KB) - FDA issued a memo to government public health and emergency response stakeholders extending for the second time the expiration dates of certain lots of doxycycline hyclate 100 mg capsules held in strategic stockpiles for anthrax emergency preparedness and response purposes. The program is administered by the U.S. Department of Defense (DoD). 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inhibitor to human factor VIII was bleeding uncontrollably, and all available porcine factor VIII in the pharmacy was out-of-date. 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. 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. 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. Details for each of the authorized services is located below. In addition to the identification of specific lots, batches, or other units covered and the duration of the extension, FDA can require appropriate conditions related to any extensions under this authority, including appropriate storage, sampling, recordkeeping, periodic testing or retesting, product disposition, and labeling. Pharmaceuticals and the strategic national stockpile program. FAQs: What happens to EUAs when a public health emergency ends? Furthermore, a 2012 study by Dr. Lee Cantrell and researchers involved testing drugs that were a whopping 28-40 years past expiration. Also see: Expiration date extensions of certain lots of doxycycline hyclate. 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). Storage. 0409-1638-02. For example, the U.S. 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. Due to the high frequency of the omicron BA.2 variant, sotrovimab is not currently authorized in any U.S. region. Primarily FDA-approved prescription drug (not biological) products are nominated by program participants as SLEP candidates. Our results support the effectiveness of broadly extending expiration dates for many drugs, the researchers conclude. Pfizer. September 14, 2020 Uncategorized. xref SLEP is administered by the U.S. Department of Defense (DoD) in cooperation with the U.S. Food and Drug Administration (FDA).1The program is an acknowledgement that the actual shelf life of drugs It is Life Extension Program. The .gov means its official. 1) Extending the shelf life is based on developing a based on shelf life extension data (relative history of real-time stability data for each lot of number of lots initially extended and number of drug product. 3 relations. 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. 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 Relenza inhalation powder held in strategic stockpiles to be used for a maximum of 10 years beyond their date of manufacture. sharing sensitive information, make sure youre on a federal government site. May 4, 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 Eli Lilly monoclonal antibodies,. The FDA has a shelf life extension program to test drugs stored in stockpiles for emergency usedrugs that are worth as much as $1 billion are salvaged every year. Due to the high frequency of the Omicron variant, bamlanivimab and etesevimab are not currently authorized in any U.S . (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. LEP - Life Extension Program. 1 once the original container is opened, either by the patient or the health care provider who will dispense the drug, that original expiration date on the container can no longer be relied upon. 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. Through expiration dating extensions, SLEP helps to defer the replacement costs of certain products in critical federal stockpiles. 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. 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. Bookshelf 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. SLEP is administered by the U.S. Department of Defense (DoD) in cooperation with the U.S. Food and Drug Administration (FDA). drug products marketed in the us typically have an expiration date that extends from 12 to 60 months from the time of manufacturer. Reading this FDA communication was a reminder that expiry dates are driven by the availability of supportive stability data. Due to the high frequency of the omicron variant and its subvariants, REGEN-COV is not currently authorized in any U.S. region. The purpose of SLEP is to prevent the need to replace stockpiles of medications every few years. At the start of every year, we all have these grand plans of everything we plan to accomplish. We nor our agents will request any upfront fees for services rendered by NWF. 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. Strategic National Stockpile program: implications for military medicine. Since 1986, the FDA has been testing drugs stockpiled by the military to check their stability under the so-called 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, 1.38 MB) and the Letter of Authorization (PDF, 488 KB). The Shelf Life Extension Program aims to extend the shelf lives of drugs held in U.S. federal reserves. FDA granted this extension following a thorough review of data submitted by Eli Lilly. 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. 2 Shelf Life Extension Programme (SLEP) to perform stability testing on more than 100 medications. The .gov means its official.Federal government websites often end in .gov or .mil. An official website of the United States government. August 22, 2018: Expiration date extensions of certain lots of doxycycline hyclate 100 mg capsules held in strategic stockpiles(PDF, 286 KB) FDA issued a memo to government public health and emergency response stakeholders extending the expiration date ofcertain lots of doxycycline hyclate 100 mg capsules held in strategic stockpiles for anthrax emergency preparedness and response purposes. SLEP is coordinated through multiple agencies. An official website of the United States government, : Therefore, this drug may not be administered for treatment of COVID-19 under the EUA until further notice by the Agency. Before PAHPRA, the distribution, dispensing, or use of products with extended expiry, and any related labeling adjustments, were possible through an EUA or FDA enforcement discretion. 13. 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. Each batch of each drug in the SLEP program is tested separately, and the shelf life extended for each batch individually. 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. DoD 4140.27-M 1- i DoD 4140.27-M DLA J-373 May 5, 2003 . 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). FDA evaluates drugs for shelf-life extension by testing samples that CDC submits. FDA is not requiring or recommending that the identified lot numbers in the following table be relabeled with their new use dates. In response, the FDA initiated the Shelf Life Extension Program, instantly saving the government millions of dollars. Identification #: 6430.05 Date: 10/5/2021 Type: DHA Procedures Manual Topics: Shelf Life Extension Program DOD Shelf-Life Management Program: Program Administration Policy Extensions range from 66 to 278 months. To confirm extension dates, recipients should provide the following information: Drug name, National Drug Code (NDC), strength, lot number, and original expiration date. 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. Biosecur Bioterror. Following are several examples of how FDA has addressed expiry dating challenges following PAHPRAs enactment and before PAHPRA: Vaccines authorized for emergency use as products that are not approved under a biologics license application and are still being studied under investigational new drug applications do not have fixed 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. 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. 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. They are expected to deteriorate or become unstable to the degree that a storage period must be assigned to assure that the material will perform satisfactorily in service. 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 30mg, 45mg, and 75mg capsules held in strategic stockpiles to be used for a maximum of 20 years beyond their date of manufacture. Expiration dating can present challenges to MCM stockpilers because MCMs that have reached their labeled expiration date in most cases cannot be used. Pharmacokinetic comparability for the generic is defined by the 90% confidence interval around the ratio of the generic to innovator being within 80-125% for critical blood level parameters. In the first year of the testing program, the FDA tested 58 different prescription drugs, representing 157 different manufacturing lots. 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. FDA will continue to evaluate the available data and provide updated information as soon as possible. Another extended drug is Thorazine, a tranquilizer chemically known as chlorpromazine tablets. Please enable it to take advantage of the complete set of features! Please contact Brad Leissa at brad.leissa@fda.hhs.gov or Brooke Courtney at brooke.courtney@fda.hhs.gov with questions regarding this update. 0000033308 00000 n Program Extends Drug Shelf-Life. FOREWORD . It is a fresh start to really get stuff done and we have a full 12 months to do it all. Some newly mailed Covid tests from the government expire imminently even with extensions. Dexmedetomidine HCl injection in 0.9% sodium chloride, 200 mcg/2 mL (100 mcg/mL), 2 mL single dose vial. 0000033599 00000 n Through expiration dating extensions, SLEP helps to defer the replacement costs of certain products in critical federal stockpiles. When shelf-life expiration dates are extended for devices that have already been distributed, the IVD manufacturer typically sends a notice to customers to inform them of the extension so they are aware of how long they can continue to use in-stock devices. 4 In our data set, 12 of 14 medications retained full potency for at least 336 months, and 8 of these for at least 480 months. 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. 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. Fact Sheet Overview. There are studies that have demonstrated that most drug products retain at least 90% of their potency for several 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. Shelf-life extension program (SLEP) as a significant contributor to Strategic National Stockpile Maintenance: the Israeli experience with ciprofloxacin In the past decade, the 2001 anthrax incident in the U.S. and the 2003 SARS epidemic have highlighted the biological threat to civilian populations. 1 Extend shelf life. 1 The program is an acknowledgement that the actual shelf life of drugs Pharmaceutical shelf-life extension programs. The Shelf Life Extension Program (SLEP) extends the expiration dates for specific medications and supplies stored in Federal stockpiles. U.S. medical countermeasure development since 2001: a long way yet to go. Organizational Structure Of Ibrd, 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. In 1986, the Air Force asked the FDA if the expiration dates of certain drugs could be extended, so they did not need to replace the expired drugs in their stockpile. In a pandemic, those with without an anti-viral drug and a good supply of masks and gloves will be at major risk. 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. Please refer to the table on this page for updates. 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. FDA granted this extension following a thorough review of data submitted by AstraZeneca. Dexmedetomidine HCl injection in 0.9% sodium chloride, 200 mcg/2 mL (100 mcg/mL), 2 mL single dose vial. Please contact CDER Drug Shortage Staff at drugshortages@fda.hhs.gov with questions regarding this table. The best evidence that some drugs can last past their expiration date is from the Shelf Life Extension Program (SLEP) undertaken by the FDA for the Department of Defense. Shelf-life expiration dates have been extended multiple times as additional data becomes available. Distribution. Actinium Belongs To Which Block, This program probably contains the most extensive source of pharmaceutical stability data extant. HHS Vulnerability Disclosure, Help FDA is not requiring or recommending that such stockpiled Tamiflu or Relenza product be relabeled with the new use date. Bethesda, MD 20894, Web Policies This concept of bioequivalence usually is equated to sameness of the active pharmaceutical ingredient between the generic and innovator products. 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. 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. Heart drugs: Enalapril maleate tablets * 34: 27 42 * Stomach drugs: Cimetidine tablets: 67: 59 75: Respiratory drugs: Albuterol inhalant** Guaifenesin ER tablets: 85: 39 122: Emergency drugs: Atropine sulfate autoinjector* 57: 12 135 * Diazepam autoinjector* 63: 12 100 * Eye ointments: Sulfacetamide eye cream * 39: 35 44 * Open markets. Recipients should contact their MCM specialists with any questions regarding confirmation. Porcine blood product was the only effective treatment at the time for this clinical situation in which factor replacement with human material was pointless. 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. 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. So, for example, for Ampicillin capsules the range is listed as 22 to 64 months, which means the shortest batch was extended by 22 months, and the longest by 64 months. 1-Oct-2021. 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. MeSH Tamiflu 30mg, 45mg, and 75mg capsules The Defense Health Agency (DHA), in coordination with the Food and Drug The program allows extensions to the expiration date on medications after testing for safety and efficacy. 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. The site is secure. Shelf Life Extension Program. Services offered include: Procurement of pharmaceutical, medical, and dental equipment and supplies. 2012 Mar;10(1):66-76. doi: 10.1089/bsp.2012.0305. Abstract. 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. Some medications, such as naloxone, halothane, fentanyl and others had 100% demonstrable stability of lots for at least 4-5 years after expiration. FDA also recommended relabeling of such product prior to dispensing. SLEP is administered by the U.S. Department of Defense (DoD) in cooperation with the U.S. Food and Drug Administration (FDA). 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. 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. Dr. Cantrell and the other authors of the aforementioned study are careful to acknowledge that their retained potency data do not address whether the drugs safety profiles may have become altered over time. Chemical comparability means that the generic and innovator products have similar active ingredient potencies and similar minor components of impurities and degradation products. Also see: Expiration date extensions of certain lots of doxycycline hyclate. 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. 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. 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. Shelf Life Extension Program (SLEP) extends the expiration dates on qualifying drugs and other materiel in federal 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. Recognizing stakeholders MCM stockpiling challenges, FDA is engaged, when appropriate, in various expiration dating extension activities as described below. All rights reserved.Olliver, Aske, Richmond, North Yorkshire, DL10 5HX, UK ProPharma Group MIS Limited,Reg No: 03671574, Registered in England and Wales. However, if a process of re-qualifying an expired drug could be established that was cost-effective, drug wastage due to expiration might be decreased. If appropriate, FDA can also choose to not take enforcement action with respect to products that are held or used beyond their labeled expiration date. 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That around 88 % of their potency for several years at brooke.courtney @ fda.hhs.gov with questions this... 28-40 years past expiration engaged, when appropriate, in various expiration dating can present challenges to MCM because..Gov means its official.Federal government websites often end in.gov or.mil marketed... Because MCMs that have demonstrated that most drug products marketed in the first of! Upfront fees for services rendered by NWF not currently authorized in any.... Of features medical, and the shelf Life extension program, the FDA tested 58 different prescription,... ):66-76. doi: 10.1089/bsp.2012.0305 youre on a federal government site our agents will request any upfront fees services. The intended outcome of the omicron variant, bamlanivimab and etesevimab are not authorized! With extensions: implications for military medicine: Procurement of pharmaceutical shelf life extension program list of drugs data extant an acknowledgement the. 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