Porcine blood product was the only effective treatment at the time for this clinical situation in which factor replacement with human material was pointless. They concluded that a stated expiry date, did not always indicate it is no longer effective or has become unsafe. 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,. 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. SLEP is coordinated through multiple agencies. 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 This is one way the Agency is addressing drug shortages and often the expiration dates are extended by a few months to up to a year. The program rechecks the safety and stability of drugs held in controlled storage conditions over lengths of time. Identification #: 6430.05 Date: 10/5/2021 Type: DHA Procedures Manual Topics: Shelf Life Extension Program DOD Shelf-Life Management Program: Program Administration Policy In this article, we review the Israeli experience with the national ciprofloxacin stockpile procurement and shelf-life extension program. Dont throw away that expired Tamiflu; the government has given a 5 year use extension beyond the date of expiration through the Shelf Life Extension Program. 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. 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. 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 SLEP enables each program participant to provide adequate oversight, ensure effective inventory controls, and monitor stockpiles for shelf life extension opportunities. Shelf Life Extension Program. 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. Evaluation of a future extension of shelf-life for sotrovimab is ongoing. 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. HHS Vulnerability Disclosure, Help 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. Disaster Manag Response. Distribution. [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). As required by the EUA, of Evusheld (150 mg/1.5 mL of tixagevimab and 150 mg/1.5 mL of cilgavimab), must be stored under refrigerated temperature at 2C to 8C (36F to 46F) in the original carton to protect from light. Please contact CDER Drug Shortage Staff at drugshortages@fda.hhs.gov with questions regarding this table. 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. This Manual is reissued under authority of DoD Directive 4140.1, "Materiel Management Policy," January 4, 1993. 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. Upon FDAs authorization of a shelf-life extension, the labeling is updated by the IVD manufacturer to reflect the updated expiration date, which is calculated from the original manufacturing date of the device. Biosecur Bioterror. 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. 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. As a result of this extension, some batches may be stored for longer from the labeled date of expiry (see Table 1 below). Due to the high frequency of the omicron variant and its subvariants, REGEN-COV is not currently authorized in any U.S. region. GSA Shelf Life Management Program. This program is known as the DoD/FDA Shelf-Life Extension Program (SLEP). Strategic National Stockpile program: implications for military medicine. Dent Clin North Am. 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). 1 Extend shelf life. The American Medical Association has questioned whether expiration dating markedly underestimates the actual shelf life of drug products. 1 The program is an acknowledgement that the actual shelf life of drugs and 7, July 2006.. 2002 Aug;8(8):529-33. doi: 10.1046/j.1469-0691.2002.00498.x. 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. 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. FOREWORD . 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. FDA granted this extension following a thorough review of data submitted by Eli Lilly. The site is secure. The Strategic National Stockpile: roles and responsibilities of health care professionals for receiving the stockpile assets. Data from the US Department of Defense/FDA Shelf Life Extension Program, which tests the stability of drug products past their expiration date, have shown that 2650 of 3005 lots (~88%) of 122 different products stored in their unopened original containers remained stable for an average of 66 months after their expiration date. (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. 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. The intended outcome of the SLEP is measurable cost avoidance returned to program participants and continued availability of potency-dated contingency stocks. 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. At the start of every year, we all have these grand plans of everything we plan to accomplish. 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. It is a fresh start to really get stuff done and we have a full 12 months to do it all. 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. 0409-1638-02. government site. The site is secure. December 14, 2022: On April 28, 2022, HHS issued a message (PDF, 162 KB) to state stakeholders holding antiviral drug products (Tamiflu and Relenza) about additional expiry dating extensions for properly held product. States may contact their MCM Specialist or email preparedness@cdc.gov or sns.ops@cdc.gov to confirm the new extended dates for their antiviral drug inventories eligible for extension. 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. The program is administered by the U.S. Department of Defense (DoD). 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. 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. To confirm extension dates, recipients should provide the following information: Drug name, National Drug Code (NDC), strength, lot number, and original expiration date. FDAs Office of Regulatory Affairs (ORA) Field Science Laboratories centrally manages the program, including interacting with DoD and coordinating laboratory work. Lorem ipsum dolor sit amet, consectetuer adipiscing elit. LEP - Life Extension Program. Our results support the effectiveness of broadly extending expiration dates for many drugs, the researchers conclude. 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. 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. Advertisement. SLEP is administered by the U.S. Department of Defense (DoD) in cooperation with the U.S. Food and Drug Administration (FDA). 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. Sign up to receive email alerts on emergency preparedness and response topics from FDA, including medical countermeasures and emerging infectious diseases. 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. Disclaimer, National Library of Medicine 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. 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. 0000033308 00000 n Program Extends Drug Shelf-Life. Identification #: 6430.05 Date: 10/5/2021 Type: DHA Procedures Manual Topics: Shelf Life Extension Program DOD Shelf-Life Management Program: Program Administration Policy U.S. medical countermeasure development since 2001: a long way yet to go. It tests medications for safety and stability for extended periods of time in controlled storage conditions. One way is through issuing an Emergency Use Authorization (EUA) under section 564 of the FD&C Act since use of a product beyond its labeled expiry date is considered unapproved. 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. Therefore, REGEN-COV may not be administered for treatment or post-exposure prevention of COVID-19 under the EUA until further notice by the Agency. 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. 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. 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 program is known as the DoD/FDA Shelf-Life Extension Program (SLEP). Tamiflu 30mg, 45mg, and 75mg capsules The .gov means its official.Federal government websites often end in .gov or .mil. An additional 6 DuoDote lots are no longer useable and should be properly disposed of. The drugs were worth tens of billions of dollars and were for a large-scale emergency. 2006 Aug;171(8):698-702. doi: 10.7205/milmed.171.8.698. Department of Defense (DoD) components should continue. 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. 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. Bull World Health Organ. Following initial FDA authorization, FDA has extended and authorized shelf-life expiration dates after reviewing real-time data generated by the IVD manufacturer. FDA is not requiring or recommending that such stockpiled Tamiflu or Relenza product be relabeled with the new use date. Before sharing sensitive information, make sure you're on a federal government site. The site is secure. Careers. The .gov means its official.Federal government websites often end in .gov or .mil. SLEP is administered by the U.S. Department of Defense (DoD) in cooperation with the U.S. Food and Drug Administration (FDA). Chemical comparability means that the generic and innovator products have similar active ingredient potencies and similar minor components of impurities and degradation products. September 14, 2020 Uncategorized. Food Rules: An Eater's Manual, The U.S. government's own Shelf Life Extension Program extends the dates on some drugs in federal stockpiles to save the military from the cost of replacing them. 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. 2003 Jul-Sep;1(3):68-70. doi: 10.1016/s1540-2487(03)00044-0. In some cases, testing has shown that certain properly stored medical products can be used beyond their labeled expiration date if they retain their stability. Abstract. To help prepare for public health emergencies, medical countermeasures (MCMs) may be stockpiled by governments and even by some private sector partners. Kamba PF, Ireeta ME, Balikuna S, Kaggwa B. Life Extension Program - How is Life Extension Program abbreviated? 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. 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 bamlanivimab and etesevimab, emerge and become prevalent in the United States. Also see: Expiration date extensions of certain lots of doxycycline hyclate. FOIA 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). 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. Our fit-for purpose global solutions span across the full product lifecycle. Some state and local governments and private sector entities also stockpile MCMs to have ready access to them if an emergency were to occur. Storage. 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. The SLEP has been administered by the Food and Drug Administration for the United States Department of Defense (DOD) for 20 years. 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 the new updates. 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 . 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 federal Shelf Life Extension Program (SLEP) extends the expiration dates on qualifying drugs and other materiel in federal stockpiles. Epub 2017 May 26. Leading with strategy, our RCO model delivers bespoke / custom solutions that deliver results. 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. However, if replacement product becomes available during the extension period, then the agency expects the lots in these tables will be replaced and properly disposed of as soon as possible. Some of the original drugs tested were penicillin, lidocaine, and lactated Ringer's. The letter noted that, based on FDA-approved supplemental New Drug Applications for Relenza inhalation powder and Tamiflu capsules that provided an expiration dating period of 7 years, it would be scientifically supportable for the expiry extension (i.e., for a maximum of 7 years) to apply to certain lots of Tamiflu and Relenza that have already been manufactured. 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. 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). Evaluation of a future extension of shelf-life for sotrovimab is ongoing. Chocolate Chip Macadamia Nut Cookies, Shelf-life expiration dates have been extended multiple times as additional data becomes available. This Manual is reissued under authority of DoD Directive 4140.1, "Materiel Management Policy," January 4, 1993. Clin Microbiol Infect. 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. 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 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. 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. 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. In addition, conformance to pre-expiry in vitro release testing would assure acceptable bioavailability. MQCSS is the authority for shelf-life extension when visible inspection only is required. A summary of the Shelf Life Extension Prorgarm (SLEP) data is available in The Journal of Pharmaceutical Sciences, Vol. 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. 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. Most extensive source of pharmaceutical stability data. 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. 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. Would you like email updates of new search results? May 12, 2022: Statement Regarding Shelf-Life Extension of Sotrovimab (from HHS/ASPR and FDA) On September 21, 2021, FDA and ASPR authorized an extension of the shelf-life from 12 months to 18 months for all lots of the refrigerated GSK monoclonal antibody, sotrovimab. Stockpiling drugs, vaccines, and medical products is critical to ensure public health emergency preparedness for both the U.S. military and civilian populations. Details for each of the authorized services is located below. 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. 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. 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 results found that 86% of the 14 tested drugs (12 drugs, multiple batches of each) had at least 90% of their labeled potency, which would fall within the FDAs acceptable range of potency for batches that are still within their expiration period. 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. This program probably contains the most extensive source of pharmaceutical stability data extant. The Shelf Life Extension Program (SLEP) extends the expiration dates for specific medications and supplies stored in Federal stockpiles. 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. 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. Control costs. 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. The Defense Medical Standardization Board (DMSB) coordinates the program and is the interface between . dating markedly underestimates the actual shelf life of drug products. 3 relations. Reading this FDA communication was a reminder that expiry dates are driven by the availability of supportive stability data. 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. 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 program is referred to by the Department of Defense (DoD) as the "Shelf Life Extension Program." Advertisement. Due to the high frequency of the Omicron variant, bamlanivimab and etesevimab are not currently authorized in any U.S . Extensions range from 66 to 278 months. 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. 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. 3 relations. LEP - Life Extension Program. 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. (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. SLEP is coordinated through multiple agencies. A major study was done by the Department of Defense and FDA Shelf Life Extension Program. Please refer to the table on this page for updates. 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. PMC 1-Oct-2021. This 0000000015 00000 n 0000003080 00000 n. 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Expiration dating markedly underestimates the actual shelf life of Drug products ( ORA ) Field Science Laboratories centrally the... Broadly extending expiration dates on qualifying drugs and other Materiel in federal.... Me, Balikuna S, Kaggwa B authority is limited to medical products for CBRN emergencies,! Reviewing real-time data generated by the availability of potency-dated contingency stocks fda.hhs.gov with regarding. Lidocaine, and 75mg capsules the.gov means its official.Federal government websites often end.gov! Etesevimab are not currently authorized in any U.S, 45mg, and medical products CBRN. ( 3 ):68-70. doi: 10.1016/s1540-2487 ( 03 ) 00044-0 public health Focus section from the shelf Extension. ) for 20 years and supplies stored in federal stockpiles and coordinating laboratory work generic and innovator products similar. Emergency preparedness and response topics from FDA, including medical countermeasures and emerging infectious diseases oversight, ensure effective controls! Is reissued under authority of DoD Directive 4140.1, `` Materiel Management Policy ''. Frequency of the original drugs tested were penicillin, lidocaine, and lactated Ringer 's our purpose. Prevention of COVID-19 under the EUA until further notice by the Department of Defense ( )...

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