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. Before sharing sensitive information, make sure you're on a federal government site. This 0000000015 00000 n 0000003080 00000 n. 564. Administered by FDA Tests 122 drug Shelf life Extension Permission for Shelf life Extension is a post registration process and is obtained from the Import & Registration Division of CDSCO. "The best evidence indicating that medications can last longer than their labeled expiration date comes from the Shelf Life Extension Program (SLEP) Whereas the shelf life of most medications in the United States is 1 to 5 years, the average additional extension length by SLEP was 5.5 years, and some lots were extended by more than 20 . Due to the high costs of prescription drugs many health insurers would like further tests and research to be conducted on this issue. The site is secure. 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. Do you have questions about SLEP, or drug expiration date restrictions? 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. Please enable it to take advantage of the complete set of features! 3 relations. 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 (PDF, 694KB) and the EUA Letter of Authorization (PDF, 293KB) for Evusheld. The drugs were worth tens of billions of dollars and were for a large-scale emergency. 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. Vigorous discussion ensued regarding the chances of lessened efficacy of the available vials. However, before FDA can issue an EUA, a specific type of determination must be in place, the HHS Secretary must issue a declaration to justify the issuance of the EUA, the section 564 statutory criteria for issuing an EUA must be met, and FDA must determine that it is safe to use the product beyond its labeled expiration date. The SLEP has been administered by the Food and Drug Administration for the United States Department of Defense (DOD) for 20 years. This 0000000015 00000 n 0000003080 00000 n. Super Giant Blackheads, 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. Bethesda, MD 20894, Web Policies The federal Shelf Life Extension Program (SLEP) extends the expiration dates on qualifying drugs and other materiel in federal stockpiles. 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. This Manual is reissued under authority of DoD Directive 4140.1, "Materiel Management Policy," January 4, 1993. 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. 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. Examples of common drug products that were tested with no failures included amoxicillin, ciprofloxacin, diphenhydramine, and morphine sulfate injection. As a result of this extension, some batches may be stored for an additional 6 months from the labeled date of expiry (see Table 1 here). Identification #: 6430.05 Date: 10/5/2021 Type: DHA Procedures Manual Topics: Shelf Life Extension Program DOD Shelf-Life Management Program: Program Administration Policy 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. States may contact their MCM Specialist or email [email protected] or [email protected] to confirm the new extended dates for their antiviral drug inventories eligible for extension. 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. 13. 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. FDA will continue to evaluate the available data and provide updated information as soon as possible. Stockpiling drugs, vaccines, and medical products is critical to ensure public health emergency preparedness for both the U.S. military and civilian populations. 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. The use of ideal temperatures in shelf life studies is bad practice and likely to be misleading. 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. (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. Shelf Life Extension Program. 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. 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. [Note: this guidance was finalized on April 24, 2019.] 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. LEP - Life Extension Program. The SLEP enables each program participant to provide adequate oversight, ensure effective inventory controls, and monitor stockpiles for shelf life extension opportunities. The federal Shelf Life Extension Program (SLEP) extends the expiration dates on qualifying drugs and other materiel in federal stockpiles. Please refer to the table on this page for the new updates. 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 sotrovimab, emerge and become prevalent in the United States. 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? For instance, in an attempt to reduce waste, the U.S. Department of Defence undertook a project called Shelf Life Extension Program (SLEP) to assess the stability, safety and usefulness of more than 100 types of expired drugs. and transmitted securely. Some medications, such as naloxone, halothane, fentanyl and others had 100% demonstrable stability of lots for at least 4-5 years after expiration. 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. doi: 10.1016/j.cden.2007.06.001. 2,7,11 Since the latter cost eats up a significant portion of the Air Force budget, the Shelf Life Extension Program (SLEP) was proposed and undertaken by the FDA in 1985 to determine the actual shelf life of stockpiled drugs. Through expiration dating extensions, SLEP helps to defer the replacement costs of certain products in critical federal stockpiles. 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. 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. 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. QSL contains the results of previously completed laboratory extension testing. Due to the high frequency of the omicron variant and its subvariants, REGEN-COV is not currently authorized in any U.S. region. 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. FDA is not requiring or recommending that such stockpiled Tamiflu or Relenza product be relabeled with the new use date. FDA will not take enforcement action with regard to the storage or emergency use of these lots of Tamiflu capsules, provided that the products have been stored under labeled storage conditions. 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 U.S. Food & Drug Administration has extended the shelf life of the Johnson & Johnson single-dose Covid-19 vaccine from four-and-a-half months to - shelf life extension program drug list exelon -. Copyright 2023. Product that passes testing is relabeled with a new expiration date and passed on to agencies receiving SNS. They tested 122 different products and found that most (88%) of them were good for at least 1 year after the expiration date, with an average of 5 years after the expiration date. 100,000/g within the shelf life of many chilled foods. 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. 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. 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. 2012 Mar;10(1):66-76. doi: 10.1089/bsp.2012.0305. 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. dating markedly underestimates the actual shelf life of drug products. 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. In many cases . 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. 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). RESULTS The 122 drug products evaluated by this study Predicting Extended Shelf Life were categorized into five groups (see Tab. Pfizer. 1 Extend shelf life. A medical product is typically labeled by the manufacturer with an expiration date. The intended outcome of the SLEP is measurable cost avoidance returned to program participants and continued availability of potency-dated contingency stocks. Shelf-life extensions are "intentionally conservative," the FDA's Mr. Flaherty told military brass in a 1992 speech. There is, in actual fact, a program known as The Shelf Life Extension Program. The FDA has a Shelf Life Extension Program that tests whether certain drugs have expiration dates that could be extended. The truth is, quite a number of drugs are still in good condition long past their expiry date. The American Medical Association has questioned whether expiration dating markedly underestimates the actual shelf life of drug products. Clinical trial management and distribution center. 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. U.S. medical countermeasure development since 2001: a long way yet to go. Improve taste. 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. 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. Primarily FDA-approved prescription drug (not biological) products are nominated by program participants as SLEP candidates. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. 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. 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 federal Shelf Life Extension Program, a joint venture between the Department of Defense and the FDA, aims to extend the use of certain stockpiled medications in certain storage conditions to help allay the costs of replacing such stored quantities. 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. Some of the original drugs tested were penicillin, lidocaine, and lactated Ringer's. Disaster Manag Response. SLEP is administered by the U.S. Department of Defense (DoD) in cooperation with the U.S. Food and Drug Administration (FDA). 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. 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. Reg No: 03671574, Registered in England and Wales. FDAs Office of Regulatory Affairs (ORA) Field Science Laboratories centrally manages the program, including interacting with DoD and coordinating laboratory work. (Federal stockpiles are stores. The SLEP has been administered by the Food and Drug Administration for the United States Department of Defense (DOD) for 20 years. Furthermore, a 2012 study by Dr. Lee Cantrell and researchers involved testing drugs that were a whopping 28-40 years past expiration. Discover the remarkable things we do with microencapsulation technology. 2 Shelf Life Extension Programme (SLEP) to perform stability testing on more than 100 medications. Clipboard, Search History, and several other advanced features are temporarily unavailable. 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 [email protected] to confirm extended dates for antiviral drug inventories eligible for extension. (Federal Register notice) Please contact Brad Leissa at [email protected] Brooke Courtney at [email protected] questions regarding thisguidance. (PDF) Shelf-Life Extension Program (SLEP) as a Significant Contributor to Strategic National Stockpile Maintenance: The Israeli Experience with Ciprofloxacin Shelf-Life Extension. 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. 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. 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. This program with the U.S. Food and Drug Administration (FDA). 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. As a result of this extension, some batches may be stored for longer from the labeled date of expiry (see Table 1 below). The .gov means its official.Federal government websites often end in .gov or .mil. 2007 Oct;51(4):857-69, vii. Bookshelf 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. 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). In addition, if extended Tamiflu or Relenza product is dispensed during an influenza emergency response, stakeholders should inform health care providers and recipients about this products expiration dating extension. MQCSS is the authority for shelf-life extension when visible inspection only is required. Actinium Belongs To Which Block, Most extensive source of pharmaceutical stability data. 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. For several decades, the program has found that the actual shelf life of many drugs is well beyond the original expiration dates. 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. 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. Accessibility November 26, 2019: This posting and FDAs November 18, 2019, memorandum (PDF, 230 KB) provide expiration dating updates for health care professionals and emergency responders for certain lots of MMT AtroPen (atropine), CANA (diazepam), DuoDote, Morphine Sulfate, and Pralidoxime Chloride auto-injectors for use during nerve agent emergencies. 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. 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. As data become available, this list can continue to expand. Chemical comparability means that the generic and innovator products have similar active ingredient potencies and similar minor components of impurities and degradation products. LEP - Life Extension Program. Please contact CDER Drug Shortage Staff at [email protected] with questions regarding this table. 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