More generally for standard, common drugs used in the US, should there be an attempt to remedy the clear conclusion that expiration dating often underestimates the shelf life of products? Through expiration dating extensions, SLEP helps to defer the replacement costs of certain products in critical federal stockpiles. A generic drug, if chemically and pharmacokinetically identical to the innovator, is assumed to have the innovators safety profile without any additional safety testing. The American Medical Association has questioned whether expiration dating markedly underestimates the actual shelf life of drug products. Please contact Brad Leissa at brad.leissa@fda.hhs.gov or Brooke Courtney at brooke.courtney@fda.hhs.gov with questions regarding this update. Before sharing sensitive information, make sure you're on a federal government site. 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. 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. 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). FAQs: What happens to EUAs when a public health emergency ends? 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. Details for each of the authorized services is located below. Chemical comparability means that the generic and innovator products have similar active ingredient potencies and similar minor components of impurities and degradation products. Food Rules: An Eater's Manual, 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. 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. (PDF) Shelf-Life Extension Program (SLEP) as a Significant Contributor to Strategic National Stockpile Maintenance: The Israeli Experience with Ciprofloxacin Shelf-Life Extension. "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 . Vigorous discussion ensued regarding the chances of lessened efficacy of the available vials. 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. Recognizing stakeholders MCM stockpiling challenges, FDA is engaged, when appropriate, in various expiration dating extension activities as described below. The program is administered by the U.S. Department of Defense (DoD). corresponds to the end of the extrapolated retest period or shelf life. Expiration dating can present challenges to MCM stockpilers because MCMs that have reached their labeled expiration date in most cases cannot be used. 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. The shelf life extension program tests pharmaceutical products stored in national stockpiles. 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. Therefore, this drug may not be administered for treatment of COVID-19 under the EUA until further notice by the Agency. Please see the most recent updates above for the latest information. 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. This program probably contains the most extensive source of pharmaceutical stability data extant. However, it also implies that it is acceptable for innovator and generic formulations to have some demonstrable differences in blood levels of the active ingredient and, by extrapolation, also of degradants in the formulations. 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. dating markedly underestimates the actual shelf life of drug products. Most extensive source of pharmaceutical stability data. 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. Nullam malesuada erat ut turpis. 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. drug products marketed in the us typically have an expiration date that extends from 12 to 60 months from the time of manufacturer. 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. FOREWORD . 1 The U.S. Food and Drug Administration (FDA) requires that an active ingredient in a medication must be present in 90 to 110 percent of the amount indicated on a drugs label. He says that if the agency extended an expiration date by 36 months, it had concluded the lot would retain all of its safety and efficacy for at least 72 months. 13. Discover the remarkable things we do with microencapsulation technology. Advertisement. All rights reserved.Olliver, Aske, Richmond, North Yorkshire, DL10 5HX, UK ProPharma Group MIS Limited,Reg No: 03671574, Registered in England and Wales. The SLEP has been administered by the Food and Drug Administration for the United States Department of Defense (DOD) for 20 years. 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. Pharmaceuticals and the strategic national stockpile program. 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. Drug expiration extension dates on these products ranged from 12 months to 184 months (over 15 years). 1-Oct-2021. 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. 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. RESULTS The 122 drug products evaluated by this study Predicting Extended Shelf Life were categorized into five groups (see Tab. 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. Here is a list of resources to help you begin implementing pharmacist care services into your practice. 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 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. 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. Front Microbiol. 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. FDA will continue to evaluate the available data and provide updated information as soon as possible. FDA will continue to evaluate the available data and provide updated information as soon as possible. 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. QSL contains the results of previously completed laboratory extension testing. Donec odio. 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. 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. I know thatHi. FDA evaluates drugs for shelf-life extension by testing samples that CDC submits. Shelf life items are products that are effective, useful or suitable for consumption for a limited time period. Identification #: 6430.05 Date: 10/5/2021 Type: DHA Procedures Manual Topics: Shelf Life Extension Program DOD Shelf-Life Management Program: Program Administration Policy Distribution. 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. 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. DoD 4140.27-M 1- i DoD 4140.27-M DLA J-373 May 5, 2003 . Dexmedetomidine HCl injection in 0.9% sodium chloride, 200 mcg/2 mL (100 mcg/mL), 2 mL single dose vial. 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. (Federal stockpiles are stores. This 0000000015 00000 n 0000003080 00000 n. Super Giant Blackheads, 100,000/g within the shelf life of many chilled foods. The FDA extended the shelf life of iHealth Covid tests by six months this summer, but many kits still . Shelf Life Extension Program (SLEP) extends the expiration dates on qualifying drugs and other materiel in federal stockpiles. government site. Investigative Report: Do Antibiotic Expiration Dates Matter? 2016 Aug 3;7:1209. doi: 10.3389/fmicb.2016.01209. Many of those drugs have had their original expiration dates extended by several years and that has saved between $13 and $94 for every $1 spent on testing, according to recent research. 3 The American Medical Association concluded in 2001, based on the Federal Shelf Life Extension Program (SLEP), that the actual shelf life of some products is longer than the labeled expiration date. This program is known as the DoD/FDA Shelf-Life Extension Program (SLEP). 95175DK. 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. Due to the high costs of prescription drugs many health insurers would like further tests and research to be conducted on this issue. 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. FDAs Office of Regulatory Affairs (ORA) Field Science Laboratories centrally manages the program, including interacting with DoD and coordinating laboratory work. 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. 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 . Custom unit-of-use prepacks. 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 program is known as the DoD/FDA Shelf-Life Extension Program (SLEP). 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. 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. 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. Before Results from the shelf life extension program (SLEP) have been evaluated to provide extensive data to address this issue. 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. Given our inability to confirm ideal storage If you need additional information please contact the CPhA Center for Advocacy at 916-779-1400. Biosecur Bioterror. At the start of every year, we all have these grand plans of everything we plan to accomplish. 2 Shelf Life Extension Programme (SLEP) to perform stability testing on more than 100 medications. An official website of the United States government, Recalls, Market Withdrawals and Safety Alerts, Drug Shortages | Additional News and Information, Frequently Asked Questions about Drug Shortages, Search List of Extended Use Dates to Assist with Drug Shortages, Epinephrine Injection, 1 mg/10 mL (0.1 mg/mL) glass syringe, individual, Epinephrine Injection, 1 mg/10 mL (0.1 mg/mL) glass syringe, pack of 10, Diltiazem Hydrochloride for Injection, 100 mg, single dose vial, tray of 10, Heparin Sodium Injection, 25,000 units/250 mL (100 units/mL) in 5% Dextrose, single dose bag, case of 24, Potassium Acetate Injection, 100 mEq/50 mL (2 mEq/mL); pharmacy bulk package glass fliptop vial, tray of 25, Dobutamine Hydrochloride Injection, 500 mg/250 mL (2 mg/mL) in 5% Dextrose, single dose bag, case of 12, Dobutamine Hydrochloride Injection, 1000 mg/250 mL (4 mg/mL) in 5% Dextrose, single dose bag, case of 12, Dobutamine Hydrochloride Injection, 250 mg/20 mL (12.5 mg/mL), single dose vial, tray of 10, Dobutamine Hydrochloride Injection, 250 mg/250 mL (1 mg/mL) in 5% Dextrose, single dose bag, case of 12, Heparin Sodium 25,000 units/250 mL (100 units/mL) in 5% Dextrose Injection, single dose bag, case of 24, Etomidate injection, 20 mg/10 mL (2 mg/mL), single dose vial, carton of 10, Etomidate injection, 20 mg/10 mL (2 mg/mL), single dose vial, individual, Etomidate injection, 40 mg/20 mL (2 mg/mL), single dose vial, carton of 10, Etomidate injection, 40 mg/20 mL (2 mg/mL), single dose vial, individual. 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. In addition to SLEP, there are other ways that, when appropriate, FDA can allow certain medical products to be used beyond their manufacturer-labeled expiration dates. The 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. 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). Threats posed by stockpiles of expired pharmaceuticals in low- and middle-income countries: a Ugandan perspective. For example, the U.S. Department of Health and Human Services (HHS) Assistant Secretary for Preparedness and Response (ASPR) oversees the Strategic National Stockpile (SNS), which has large quantities of medicine and medical supplies to protect the American public if there is a public health emergency (for example, a terrorist attack, flu outbreak, or earthquake) severe enough to cause local medical supplies to run out. Shelf Life Extension Program. Strategic National Stockpile program: implications for military medicine. 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). Retained product must be appropriately held in accordance with storage conditions detailed in the authorized Fact Sheet for Health Care Providers (PDF, 1.74MB) and the Letter of Authorization for Emergency Use Authorization (EUA) 091 (PDF, 1.03MB). Under the Shelf-Life Extension Program (SLEP), FDA conducts testing for certain products stored in federal stockpiles in environmentally controlled locations. In the first year of the testing program, the FDA tested 58 different prescription drugs, representing 157 different manufacturing lots. 1 Extend shelf life. (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. In this article, we review the Israeli experience with the national ciprofloxacin stockpile procurement and shelf-life extension program. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. During the early stages of development, speci Looking for abbreviations of LEP? 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,. FDA granted this extension following a thorough review of data submitted by AstraZeneca. 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. 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). Please refer to the table on this page for updates. (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. 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. Advertisement. 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. official website and that any information you provide is encrypted This concept of bioequivalence usually is equated to sameness of the active pharmaceutical ingredient between the generic and innovator products. No change to the container closure system in direct contact with the drug product or to the recommended storage conditions of the drug product. Drugs that exist in solution or as a reconstituted suspension may not have the required potency if used when outdated. Our results support the effectiveness of broadly extending expiration dates for many drugs, the researchers conclude. In fact, the total extension time in military storage for all drugs was 6.5 years. As a result of this extension, some batches may be stored for an additional 6 months from the labeled date of expiry. 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 .gov means its official. Recipients should contact their MCM specialists with any questions regarding confirmation. 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. PAHPRA provides FDA with the explicit authority to extend the expiration dating of eligible FDA-approved MCMs stockpiled for use in CBRN emergencies. The site is secure. /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. 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. 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. 1 The program is an acknowledgement that the actual shelf life of drugs and 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 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. 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. 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. 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. 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. SLEP is administered by the U.S. Department of Defense (DoD) in cooperation with the U.S. Food and Drug Administration (FDA). 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.
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