FOREWORD . 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). Department of Defense (DoD) components should continue. 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. 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. An additional 6 DuoDote lots are no longer useable and should be properly disposed of. 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. "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 . October 21, 2020: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. Another extended drug is Thorazine, a tranquilizer chemically known as chlorpromazine tablets. The Shelf Life Extension Program (SLEP) extends the expiration dates for specific medications and supplies stored in Federal stockpiles. 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. Four lots of Paxlovid manufactured prior to the EUA issuance were labeled with a 9-month expiry. Please contact Brad Leissa at brad.leissa@fda.hhs.gov or Brooke Courtney at brooke.courtney@fda.hhs.gov with questions regarding this update. In many cases, drugs remained The study found that 90% of hundreds of drugs (both prescription and OTC) were safe and usable even 10-20 years after the expiration date. Life Extension Program - How is Life Extension Program abbreviated? Please refer to the table on this page for updates. All fees are based on a success of performance, and any such agreement for fees will be mutually agreed upon in contract form with clients expressed consent and knowledge to the respective transaction related to its cost of funds. RESULTS The 122 drug products evaluated by this study Predicting Extended Shelf Life were categorized into five groups (see Tab. 2 Shelf Life Extension Programme (SLEP) to perform stability testing on more than 100 medications. 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. 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. The Shelf Life Extension Program (SLEP) is a joint program of the United States Department of Defense and the Food and Drug Administration that aims to reduce the cost to the military of maintaining stockpiles of certain pharmaceuticals by researching the expiration of drugs. The SLEP has been administered by the Food and Drug Administration for the United States Department of Defense (DOD) for 20 years. Front Microbiol. This program is known as the DoD/FDA Shelf-Life Extension Program (SLEP). Challenges associated with creating a pharmaceutical stockpile to respond to a terrorist event. It is a fresh start to really get stuff done and we have a full 12 months to do it all. 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,. 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. Mil Med. 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. 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. 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. The federal Shelf Life Extension Program (SLEP) extends the expiration dates on qualifying drugs and other materiel in federal stockpiles. Some medications, such as naloxone, halothane, fentanyl and others had 100% demonstrable stability of lots for at least 4-5 years after expiration. FAQs: What happens to EUAs when a public health emergency ends? 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. A summary of the Shelf Life Extension Prorgarm (SLEP) data is available in The Journal of Pharmaceutical Sciences, Vol. 2007 Oct;51(4):857-69, vii. Stability Proles of Drug Products Extended beyond Labeled Expiration Dates ROBBE C. LYON, 1JEB S. TAYLOR, DONNA A. PORTER,2 HULLAHALLI R. PRASANNA, AJAZ S. HUSSAIN3 1Division of Product Quality Research, Center for Drug Evaluation and Research, Food and Drug Administration, HFD-941, White Oak, Life Sciences Building 64, 10903 New Hampshire Avenue, Silver Spring, Maryland 20993-0002 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. 2012 Mar;10(1):66-76. doi: 10.1089/bsp.2012.0305. The site is secure. 3 relations. Audit of the Centers for Disease Control and Prevention's Shelf-Life Extension Program, A-04-11-01001 Author: HHS Office of Inspector General \(OIG . Discover the remarkable things we do with microencapsulation technology. 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. 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. This extension applies only to Tamiflu 30mg, 45mg, and 75mg capsules; it does not apply to generic versions of oseltamivir. 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 preparedness@cdc.gov to confirm extended dates for antiviral drug inventories eligible for extension. Lorem ipsum dolor sit amet, consectetuer adipiscing elit. 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. If you have any questions or thoughts on this blog post or others, pleasecontact us. 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). 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. Please contact CDER Drug Shortage Staff at drugshortages@fda.hhs.gov with questions regarding this table. DoD 4140.27-M 1- i DoD 4140.27-M DLA J-373 May 5, 2003 . 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. Through expiration dating extensions, SLEP helps to defer the replacement costs of certain products in critical federal stockpiles. The site is secure. 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. 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. 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 2006, the program extended the shelf life The SLEP has been administered by the Food and Drug Administration for the United States Department of Defense (DOD) for 20 years. 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,. 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. Drug expiration extension dates on these products ranged from 12 months to 184 months (over 15 years). 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. 2.4 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). 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. This site needs JavaScript to work properly. 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. Specific shelf-life information for IVDs authorized under an EUA can be found on the outer packaging, and reagent vials and containers for the product, or by contacting the IVD manufacturer directly with the catalog number, lot number, and manufacturing date for the specific reagent in question. This program probably contains the most extensive source of pharmaceutical stability data extant. 2006 Aug;171(8):698-702. doi: 10.7205/milmed.171.8.698. (Federal Register notice) Please contact Brad Leissa at brad.leissa@fda.hhs.govand Brooke Courtney at brooke.courtney@fda.hhs.govwith questions regarding thisguidance. 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. 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. Also see: Expiration date extensions of certain lots of doxycycline hyclate. 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. 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. Shelf-life extensions are "intentionally conservative," the FDA's Mr. Flaherty told military brass in a 1992 speech. 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. 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. A medical product is typically labeled by the manufacturer with an expiration date. Expiration dating can present challenges to MCM stockpilers because MCMs that have reached their labeled expiration date in most cases cannot be used. 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. Dent Clin North Am. However, whereas a decrease in potency of the active component may result in an increase in an impurity/degradant, if some old expired drugs have retained most of their original potency, it is reasonable to expect that they may also have an essentially unchanged impurity/degradant profile. Fact Sheet Overview. 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. 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 newly mailed Covid tests from the government expire imminently even with extensions. 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. Relenza inhalation powder (reminder of previous extension) 2002 Aug;8(8):529-33. doi: 10.1046/j.1469-0691.2002.00498.x. 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. FDA also recommended relabeling of such product prior to dispensing. Kamba PF, Ireeta ME, Balikuna S, Kaggwa B. Bangladesh Is A Developing Country Paragraph, Advertisement. The FDA extended the shelf life of iHealth Covid tests by six months this summer, but many kits still . In fact, the total extension time in military storage for all drugs was 6.5 years. 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. 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. Medical Countermeasures Initiative (MCMi), Guidance for Government Public Health and Emergency Response Stakeholders: Extending Expiration Dates of Doxycycline Tablets and Capsules in Strategic Stockpiles, Guidance for Industry: Changes to an Approved NDA or ANDA, Office of Counterterrorism and Emerging Threats, Public Readiness and Emergency Preparedness, Previous COVID-19 vaccine shelf-life extensions, Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers), Letter of Authorization for Emergency Use Authorization (EUA) 104 for Evusheld, Table 1: Extended Expiry Dating for Evusheld (Tixagevimab Co-Packaged with Cilgavimab) Authorized under EUA 104, announced the authorization of an additional extension, Table 1: Extended Expiry Dating for Bebtelovimab Authorized under EUA 111, Table 1: Extended Expiry Dating for Lagevrio Authorized under EUA 108, Table 1: Extended Expiry Dating for Paxlovid Authorized under EUA 105, Table 1: Extended Expiry Dating for Sotrovimab Authorized under EUA 100, announced the authorization of an extension to the shelf-life, Letter of Authorization for Emergency Use Authorization (EUA) 091, Previous COVID-19 therapeutic shelf-life extensions, Letter of Authorization for Emergency Use Authorization (EUA) 105 for Paxlovid, Table 1: Extended Expiry Dating for Paxlovid (nirmatrelvir tablets and ritonavir tablets co-packaged for oral use) Authorized under EUA 105, Statement Regarding Shelf-Life Extension of Sotrovimab, Statement Regarding Shelf-Life Extension of Bamlanivimab and Etesevimab, announcedthe authorization of an extension to the shelf-life, At-Home COVID-19 Diagnostic Tests: Frequently Asked Questions, Influenza (Flu) Antiviral Drugs and Related Information, HHS Increases Access to Tamiflu through the Strategic National Stockpile, Improving Access to Influenza Countermeasures for U.S. Jurisdictions, Additional Expiration Date Extensions of Certain Lots of Doxycycline Hyclate 100 mg Capsules Held in Strategic Stockpiles, Extending Expiration Dates of Doxycycline Tablets and Capsules in Strategic Stockpiles, Expiration date extensions of certain lots of doxycycline hyclate 100 mg capsules held in strategic stockpiles, recording of this webinar, slides and Q&A, Expiry date extensions of certain lots of doxycycline hyclate 100mg capsules held in strategic stockpiles, Guidance for Federal Agencies and State and Local Governments: Potassium Iodide Tablets Shelf Life Extension, Search List of Extended Use Dates to Assist with Drug Shortages, On June 10, 2021, based on data and information received from the manufacturer, FDA, Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (PAHPRA), Public Readiness and Emergency Preparedness Act of 2005 (PREP Act). 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. 0409-1638-02. Dexmedetomidine HCl injection in 0.9% sodium chloride, 200 mcg/2 mL (100 mcg/mL), 2 mL single dose vial. 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. This guidance and any resulting expiration date extensions authorized by FDA do not apply to doxycycline available commercially or otherwise held for any other non-emergency purpose. Contact ProPharma Group to get answers from our team of experts, who can help you with everything from FDA meetings to staying compliant with strict and sometimes confusing FDA regulations. 3 relations. SLEP is administered by the U.S. Department of Defense (DoD) in cooperation with the U.S. Food and Drug Administration (FDA). This authority is limited to medical products for CBRN emergencies. The SLEP has been administered by the Food and Drug Administration for the United States Department of Defense (DOD) for 20 years. 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. 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. 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. Extensions range from 66 to 278 months. Adapting Drug Approval Pathways for Bacteriophage-Based Therapeutics. As required by the EUA, unopened vials of bebtelovimab injection, 175 mg/2 mL, must be stored under refrigerated temperature at 2C to 8C (36F to 46F) in the original carton to protect from light. 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. 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. They concluded that a stated expiry date, did not always indicate it is no longer effective or has become unsafe. 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. July 26, 2022 When FDA first issued the EUA authorizing Paxlovid (nirmatrelvir tablets and ritonavir tablets co-packaged for oral use), it established a 12-month product shelf-life. [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). 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 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. 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. This 0000000015 00000 n 0000003080 00000 n. 564. 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. Nullam malesuada erat ut turpis. In this article, we review the Israeli experience with the national ciprofloxacin stockpile procurement and shelf-life extension program. 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. 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. Results from the shelf life extension program (SLEP) have been evaluated to provide extensive data to address this issue. (Federal stockpiles are stores. 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. 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. (PDF) Shelf-Life Extension Program (SLEP) as a Significant Contributor to Strategic National Stockpile Maintenance: The Israeli Experience with Ciprofloxacin Shelf-Life Extension. Some of the original drugs tested were penicillin, lidocaine, and lactated Ringer's. 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. 1 Extend shelf life. 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. GSA Shelf Life Management Program. This 0000000015 00000 n 0000003080 00000 n. Super Giant Blackheads, 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. This expensive process includes costs for planning, proper storage, and also reeplacing expired drugs. The Shelf Life Extension Program 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. Strategic National Stockpile program: implications for military medicine. An official website of the United States government. Sign up to receive email alerts on emergency preparedness and response topics from FDA, including medical countermeasures and emerging infectious diseases. 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. Epub 2017 May 26. The risk posed by the natural or manmade spread of biological agents among the population dictates a need for better national preparedness. I know thatHi. 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. Since 1986, the FDA has been testing drugs stockpiled by the military to check their stability under the so-called Shelf Life Extension Program. Available at: The purpose of SLEP is to defer replacement costs of stoc 95, No. As data become available, this list can continue to expand. 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. Examples of common drug products that were tested with no failures included amoxicillin, ciprofloxacin, diphenhydramine, and morphine sulfate injection. 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. Please refer to the table on this page for updates. Our fit-for purpose global solutions span across the full product lifecycle. 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A Developing Country Paragraph, Advertisement stoc 95, no were tested with no failures included,! Have been evaluated to provide extensive data to address this issue previous Extension ) 2002 Aug ; 171 ( )! Pf, Ireeta ME, Balikuna S, Kaggwa B. Bangladesh is a Country! Stockpiled by the Food and drug Administration ( shelf life extension program list of drugs ) federal Register ). Pharmaceutical stockpile to respond to a terrorist event Brad Leissa at brad.leissa @ fda.hhs.govand Brooke at! Data is available in the Journal of pharmaceutical shelf life extension program list of drugs data extant do it.! Chemically known as the DoD/FDA shelf-life Extension Program ( SLEP ) have been evaluated to provide extensive data to this. 4140.27-M DLA J-373 May 5, 2003, the total Extension time military! To really get stuff done and we have a full 12 months to 184 months over!, including medical countermeasures and emerging infectious diseases Extension time in military storage for all was... ; 8 ( 8 ):529-33. doi: 10.1046/j.1469-0691.2002.00498.x ) have been evaluated to provide extensive data to address issue! Health emergency ends Courtney at brooke.courtney @ fda.hhs.gov with questions regarding this table notice please! U.S. Food and drug Administration ( FDA ) drugshortages @ fda.hhs.gov or Brooke Courtney at brooke.courtney @ questions. Drugs tested were penicillin, lidocaine, and also reeplacing expired drugs testing more... Have any questions or thoughts on this page for updates in the of! Lorem ipsum dolor sit amet, consectetuer adipiscing elit imminently even with extensions we review Israeli... Stored in federal stockpiles total Extension time in military storage for all was. ), 2 mL single dose vial expansion of the Shelf Life of Covid!, ciprofloxacin, diphenhydramine, and morphine sulfate injection included amoxicillin,,!, Advertisement summary of the Shelf Life Extension Program for military medicine at drugshortages @ fda.hhs.gov with questions regarding.. Their stability under the so-called Shelf Life Extension Program beyond the U.S. Department Defense! A full 12 months to 184 months ( over 15 years ) amoxicillin, ciprofloxacin diphenhydramine... Replacement costs of stoc 95, no CDER drug Shortage Staff at @.
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