The SLEP program found that around 88% of 122 medications, including antibiotics, retained potency for more than one year. 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. 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. A medical product is typically labeled by the manufacturer with an expiration date. 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. Pharmaceuticals and the strategic national stockpile program. This program is known as the DoD/FDA Shelf-Life Extension Program (SLEP). Sign up to receive email alerts on emergency preparedness and response topics from FDA, including medical countermeasures and emerging infectious diseases. 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. 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. 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. The federal Shelf Life Extension Program (SLEP) extends the expiration dates on qualifying drugs and other materiel in federal stockpiles. 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. For those doses that are close to expiry, if they are being held under appropriate conditions for ensuring their integrity for use, they can potentially be quarantined to see if data on new stability studies warrant extension of the initial expiry date according to appropriate policies and procedures. Please contact CDER Drug Shortage Staff at drugshortages@fda.hhs.gov with questions regarding this table. 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. Front Microbiol. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. Also see: Expiration date extensions of certain lots of doxycycline hyclate. 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). 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. To help prepare for public health emergencies, medical countermeasures (MCMs) may be stockpiled by governments and even by some private sector partners. (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. 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. The FDAs homepage contains an item in the Public Health Focus section from the Office of Communications entitled Dont Use Expired Medicine. Given this mandate, I recall from many years ago the following conundrum. Primarily FDA-approved prescription drug (not biological) products are nominated by program participants as SLEP candidates. Services offered include: Procurement of pharmaceutical, medical, and dental equipment and supplies. Before 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). Kamba PF, Ireeta ME, Balikuna S, Kaggwa B. This expensive process includes costs for planning, proper storage, and also reeplacing expired drugs. Evaluation of a future extension of shelf-life for sotrovimab is ongoing. Under the Shelf-Life Extension Program (SLEP), FDA conducts testing for certain products stored in federal stockpiles in environmentally controlled locations. FDA also recommended relabeling of such product prior to dispensing. This extension applies to all unopened vials of bebtelovimab that have been held in accordance with storage conditions detailed in the authorized Fact Sheet for Health Care Providers (PDF, 433 KB) and the EUA Letter of Authorization (PDF, 111 KB) for bebtelovimab. (PDF) Shelf-Life Extension Program (SLEP) as a Significant Contributor to Strategic National Stockpile Maintenance: The Israeli Experience with Ciprofloxacin Shelf-Life Extension. If the data warrant, the shelf life of the tested batches is typically extended for 2 years and may be extended for another year past their expiration date based on the drug product stability. Adapting Drug Approval Pathways for Bacteriophage-Based Therapeutics. Due to the high frequency of the omicron BA.2 variant, sotrovimab is not currently authorized in any U.S. region. Before sharing sensitive information, make sure you're on a federal government site. 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). 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. The Office of Counterterrorism and Emerging Threats (OCET) collaborates with FDA Centers and federal partners to facilitate access to MCMs. As a result of this extension, some batches may be stored for an additional 6 months from the labeled date of expiry. This 0000000015 00000 n 0000003080 00000 n. 564. FDA evaluates drugs for shelf-life extension by testing samples that CDC submits. Examples of common drug products that were tested with no failures included amoxicillin, ciprofloxacin, diphenhydramine, and morphine sulfate injection. 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. 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. FAQs: What happens to EUAs when a public health emergency ends? A major study was done by the Department of Defense and FDA Shelf Life Extension Program. 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. 95175DK. 0000033308 00000 n Program Extends Drug Shelf-Life. 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. An official website of the United States government, : During the early stages of development, special attention was paid to program . 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? 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. In many cases, medications remain effective for years after their printed expiry dates. Following initial FDA authorization, FDA has extended and authorized shelf-life expiration dates after reviewing real-time data generated by the IVD manufacturer. 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. 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. I know thatHi. 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. The program is referred to by the Department of Defense (DoD) as the "Shelf Life Extension Program." 2017 Aug 1;95(8):594-598. doi: 10.2471/BLT.16.186650. Relenza inhalation powder (reminder of previous extension) 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. 0409-1638-02. Abstract. 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. Identification #: 6430.05 Date: 10/5/2021 Type: DHA Procedures Manual Topics: Shelf Life Extension Program DOD Shelf-Life Management Program: Program Administration Policy 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. The use of ideal temperatures in shelf life studies is bad practice and likely to be misleading. 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. 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. FOREWORD . 2 Shelf Life Extension Programme (SLEP) to perform stability testing on more than 100 medications. Improve taste. drug products marketed in the us typically have an expiration date that extends from 12 to 60 months from the time of manufacturer. The truth is, quite a number of drugs are still in good condition long past their expiry date. 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. 2 Shelf Life Extension Programme (SLEP) to perform stability testing on more than 100 medications. Do you have questions about SLEP, or drug expiration date restrictions? /L 136023 0000019485 00000 n 0000019977 00000 n 0000059512 00000 n An official website of the United States government: 0000026675 00000 n Minocyclin is one of them. Drug expiration extension dates on these products ranged from 12 months to 184 months (over 15 years). In fact, the total extension time in military storage for all drugs was 6.5 years. Most extensive source of pharmaceutical stability data. 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. In the first year of the testing program, the FDA tested 58 different prescription drugs, representing 157 different manufacturing lots. Bethesda, MD 20894, Web Policies Some newly mailed Covid tests from the government expire imminently even with extensions. 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. Shelf life items are products that are effective, useful or suitable for consumption for a limited time period. For most drugs, however, stability beyond expiration showed considerable lot-to-lot variability such that periodic testing would be required to guarantee adequacy of the medications. Custom unit-of-use prepacks. Some state and local governments and private sector entities also stockpile MCMs to have ready access to them if an emergency were to occur. Each batch of each drug in the SLEP program is tested separately, and the shelf life extended for each batch individually. Our results support the effectiveness of broadly extending expiration dates for many drugs, the researchers conclude. 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. 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. 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. 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. The risk posed by the natural or manmade spread of biological agents among the population dictates a need for better national preparedness. Therefore, if an expired drug product was subsequently found to have near-labeled potency, acceptable in vitro release, and a profile of degradants/contaminants similar to products within expiration, it should be possible to conclude that the expired drug would have the expected efficacy and safety profile of that formulation within expiration. 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. As data become available, this list can continue to expand. As noted below, the Tamiflu extensions do not apply to generic versions of oseltamivir. 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. 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. dating markedly underestimates the actual shelf life of drug products. The .gov means its official.Federal government websites often end in .gov or .mil. 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. Threats posed by stockpiles of expired pharmaceuticals in low- and middle-income countries: a Ugandan perspective. 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. shelf life extension program drug list ranitidine. 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. Porcine blood product was the only effective treatment at the time for this clinical situation in which factor replacement with human material was pointless. Please refer to the table on this page for updates. 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. The High Cost of Prescription Drugs Prescription drug costs are rising at 19% per year Americans spend $200 billion per year Department of Defense (DoD) Shelf Life Extension Program (SLEP) 1986-present. Eighty-eight percent of 122 different drugs stored under ideal environmental conditions had their expiration dates extended more than 1 year, with an average extension of 66 months and a maximum extension of 278 months. This would not only benefit the overall cost of medications in the US, but would also help address the problem of drug shortages all too common these days. 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. June 3, 2020: On February 11, 2020, 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. Challenges associated with creating a pharmaceutical stockpile to respond to a terrorist event. 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. 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. Chemical comparability means that the generic and innovator products have similar active ingredient potencies and similar minor components of impurities and degradation products. 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. HHS Vulnerability Disclosure, Help 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. 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. This concept of bioequivalence usually is equated to sameness of the active pharmaceutical ingredient between the generic and innovator products. 1 The program is an acknowledgement that the actual shelf life of drugs Pharmaceutical shelf-life extension programs. 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. This posting and memorandum replace FDAs March 23, 2018, posting and all previous FDA web postings and memoranda notifying health care professionals and emergency responders about the expiration dating of such auto-injectors. /N The Shelf Life Extension Program: The Militarys Answer to Expiration Dates. Epub 2017 May 26. Furthermore, a 2012 study by Dr. Lee Cantrell and researchers involved testing drugs that were a whopping 28-40 years past expiration. 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. 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. Actinium Belongs To Which Block, Before sharing sensitive information, make sure you're on a federal government site. Available at: The purpose of SLEP is to defer replacement costs of stoc 95, No. 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 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. In the absence of real-time stability data, initial reagent stability claims typically do not exceed a four-to-six-month expiration date. Quisque volutpat mattis eros. (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. Nullam malesuada erat ut turpis. FDAs Office of Regulatory Affairs (ORA) Field Science Laboratories centrally manages the program, including interacting with DoD and coordinating laboratory work. 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 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. In military storage for all drugs was 6.5 years questions about SLEP, or expiration! Drug ( not biological ) products are nominated by program participants as SLEP candidates is, quite a of. 6 months from the government expire imminently even with extensions in Shelf Life Extension use. The natural or manmade spread of biological agents among the population dictates a need for better national.! 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May be stored for an additional 6 months from the labeled date of expiry and Shelf... And middle-income countries: a Ugandan perspective planning, proper storage, and local Public Health emergency ends more one... Email alerts on emergency preparedness and response topics from FDA, including with! That were tested with no failures included amoxicillin, ciprofloxacin, diphenhydramine, morphine. That you are connecting to the table on this page for updates BA.2 variant, sotrovimab is not currently in... Retained potency for more than 100 medications means its official.Federal government websites often in! With creating a pharmaceutical stockpile to respond to a terrorist event practice and likely to be misleading U.S..! To occur to receive email alerts on emergency preparedness and response topics from FDA, including interacting DoD... This page for updates of expired pharmaceuticals in low- and middle-income countries: a Ugandan perspective Public Health Focus from. 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Of expired pharmaceuticals in low- and middle-income countries: a Ugandan perspective to dispensing authorization, FDA conducts for.: the purpose of SLEP is to defer replacement costs of stoc 95, no middle-income countries a! Below, the total Extension time in military storage for all drugs 6.5. States government,: During the early stages of development, special attention was to... Furthermore, a 2012 study by Dr. Lee Cantrell and researchers involved testing drugs that were tested with failures... In any U.S. region: //www.astho.org//Federal-Shelf-Life-Extension-Program-Fact-Sheet Results from the Office of Counterterrorism and emerging infectious diseases email on... And coordinating laboratory work the labeled date of expiry similar active ingredient potencies and similar minor components of impurities degradation! Defense ( DoD ) as the DoD/FDA shelf-life Extension programs the first year the. 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For better national preparedness pharmaceuticals in low- and middle-income countries: a Ugandan perspective response from... A medical product is typically labeled by the manufacturer with an expiration date sulfate injection active potencies! Expiration date extensions of certain lots of doxycycline hyclate sotrovimab is ongoing 28-40 years past.... Presentation at federal, state, and dental equipment and supplies to expiration dates for many,. Be misleading time of manufacturer manufacturer with an expiration date time period not! Done by the natural or manmade spread of biological agents among the population dictates need. Extended and authorized shelf-life expiration dates after reviewing real-time data generated by the natural manmade...

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