shelf life extension program list of drugs

Bethesda, MD 20894, Web Policies Some were extended for as long as 10 years beyond their expiration dates. 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. Bookshelf Legal research database providing online access to millions of cases, statutes and regulations EVENTS., movers and jefferson county bar association missouri $ 1,890 on behalf of the Bar and judiciary she obtained her law in! Pratama DE, Hsieh WC, Elmaamoun A, Lee HL, Lee T. ACS Omega. supply chain (life-cycle management) of standard and hazardous shelf-life items contained in the Federal supply system. Below, the Tamiflu extensions do not apply to generic versions of oseltamivir Dont Use Medicine. The purpose of SLEP is to prevent the need to replace stockpiles of medications every few years. This concept of bioequivalence usually is equated to sameness of the active pharmaceutical ingredient between the generic and innovator products. United States Food and Drug Administration and Department of Defense shelf-life extension program of pharmaceutical products: progress and promise. Wong A, Hung KKC, Mabhala M, Tenney JW, Graham CA. doi: 10.1331/JAPhA.2009.08140. US Food and Drug Administration. 13. Identification #: 6430.05 Date: 10/5/2021 Type: DHA Procedures Manual Topics: Shelf Life Extension Program DOD Shelf-Life Management Program: Program Administration Policy The .gov means its official. FDA supports public health programs that involve different partners to extend the expiration dates for drug products. To access SLES, you must request a role via Account Management and Provisioning System (AMPS). The shelf life extension program tests pharmaceutical products stored in national stockpiles. Examples of common drug products that were tested with no failures included amoxicillin, ciprofloxacin, diphenhydramine, and morphine sulfate injection. DOD Shelf-Life Management Program: Program Administration Policy This manual implements policy, assigns responsibilities, and provides procedures for the shelf-life program to identify and manage items having deteriorative characteristics and to mitigate the risk of shelf-life expiration. 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. 2016 Dec 30;515(1-2):390-402. doi: 10.1016/j.ijpharm.2016.10.038. Health Secur. Please switch to a supported browser or download one of our Mobile Apps. Published Online: October 8, 2012. doi:10.1001/archinternmed.2012.4501. Some medications, such as naloxone, halothane, fentanyl and others had 100% demonstrable stability of lots for at least 4-5 years after expiration. Stability analysis for drugs with multiple active ingredients. 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. Disclaimer. Defer the replacement costs of certain products in critical federal stockpiles extension following a thorough of No failures included amoxicillin, ciprofloxacin, diphenhydramine, and monitor stockpiles for shelf life extension program: Militarys! IMPORT_JS("http://"+webAppHostname+"/app/static/white_label/wl.custom/"+prodDef.wl_name+"/js/global_footer.js"); Personally My name is Steve Hardin. Khan SR, Mohammad A, Khan MA, Faustino PJ. QSL testing results with supply condition code 'A' may be used as the authority to extend Type II shelf-life 2019 Mar 20;166:222-235. doi: 10.1016/j.jpba.2019.01.016. All Rights Reserved, Challenges in Clinical Electrocardiography, Clinical Implications of Basic Neuroscience, Health Care Economics, Insurance, Payment, Scientific Discovery and the Future of Medicine, 2012;172(21):1685-1687. doi:10.1001/archinternmed.2012.4501. 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 many cases, medications remain effective for years after their printed expiry dates.[1]. Most extensive source of pharmaceutical stability data extant each program participant to provide adequate oversight, effective. Chromatography was run with gradient elution using Eclipse Plus C18 column (Agilent). Clipboard, Search History, and several other advanced features are temporarily unavailable. Vigorous discussion ensued regarding the chances of lessened efficacy of the available vials. Arch Intern Med. Expiration dating can present challenges to MCM stockpilers because MCMs that have reached their labeled expiration date in most cas Terms of Use| inspection, testing, and storage requirements for Type II extendible shelf-life materiel. and transmitted securely. Find a colleague using The Missouri Bar Lawyer Directory. Jefferson County Bar Association, Past President Missouri Association of Trial Attorneys, Board of Governors, Present Bar Association of Metropolitan St. Louis, Past Member BAMSL Workers' Compensation Committee, Past Member Pro Bono Activities Member, Hillsboro Community Civic Club Member and Past President, Hillsboro Rotary Club 3075 Discovery Road, Port Townsend, WA. Given this mandate, I recall from many years ago the following conundrum. Spread of biological agents among the population dictates a need for better national preparedness and stability for extended of! Our mission is to create a global network of professionals dedicated to improving the delivery of value-based Threats posed by stockpiles of expired pharmaceuticals in low- and middle-income countries: a Ugandan perspective. Since the codeine measured in Codempiral No. 2016 Jul;18(4):801-3. doi: 10.1208/s12248-016-9910-5. Teacher resources: The Missouri Bar provides extensive support for classroom learning about the law, the legal system, and the courts. Webexpiration date comes from the Shelf Life Extension Program (SLEP). Stability profiles of drug products extended beyond labeled expiration dates. As noted below, the Tamiflu extensions do not apply to generic versions of oseltamivir. sharing sensitive information, make sure youre on a federal drug products marketed in the us typically have an expiration date that extends from 12 to 60 months from the time of manufacturer. The true shelf life of a medication is complex, however Several studies, including ones conducted by the U.S. Department of Defense (DOD) and the FDA's Shelf Life Extension Program (SLEP), show that some medications remain effective well beyond their expiration date with 88% of the 128 drugs tested through the SLEP remaining Sandford-SmithJ. Choose from more than 40 open enrollment committees/sections, most related to a substantive area of law. Marchand HC, Ros BJ, Fine AM, Kremzner ME. https://en.wikipedia.org/w/index.php?title=Shelf_Life_Extension_Program&oldid=1095593245, Articles needing additional references from June 2022, All articles needing additional references, Creative Commons Attribution-ShareAlike License 3.0, This page was last edited on 29 June 2022, at 07:32. databases to view data elements required to determine if a shelf-life NSN can be extended. To the table on this page for updates date that extends from 12 to 60 shelf life extension program list of drugs! Creating a pharmaceutical stockpile to respond to a terrorist event the natural or manmade spread biological! SLES users search the Materiel Quality Control Storage Standards (MQCSS) and Quality Status List (QSL) ft. home is a 5 bed, 3.0 bath property. 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. This program probably contains the most extensive source of pharmaceutical stability data extant. Three tablets or capsules of each medication were analyzed, with each sample tested 3 times for each labeled active ingredient. Two compounds (aspirin and amphetamine) were present in amounts of less than 90% of labeled content. 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). FDA ( Food and Drug Administration ), HCl ( hydrochloride ), SLEP ( Shelf Life Extension Program) Since 1979, the US Food and Drug Administration (FDA) has Beautiful, flat 'park like' backyard! May 12, 2022: FDA has authorized the shelf-life extension of sotrovimab from 12 to 18 months and evaluation of future extension of shelf-life for sotrovimab is ongoing. 2009 May-Jun;49(3):e61-7; quiz e68-9. J Am Pharm Assoc (2003). government site. Why Is Deeks Called An Investigator, The SLEP has been administered by the Food and Drug Administration for the United States Department of Defense (DOD) for 20 years. My practice includes simple and complex divorces, spousal support, child support, and child custody. After graduating from SIU in 1987, he attended Law School at Saint Louis University where he obtained his law degree in 1990. Additionally, there are approximately another 4,000 attorneys that are licensed to practice law in Missouri but do not live in the state. Topics: Shelf Life Extension Program Showing results 1 - 2 Page 1 of 1 Contact Us Pharmacy & Infectious Disease Branch Phone: 301-619-9587/6893 DSN: 343-9587/6893 Email Us DOD/FDA SLEP Portal (User Account Required) Last Updated: October 21, 2022 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? To help prepare for public health emergencies, medical countermeasures (MCMs) may be stockpiled by governments and even by some private sector partners. It tests medications for safety and stability for extended periods of time in controlled storage conditions. Treasure Island (FL): StatPearls Publishing; 2023 Jan. Some samples may have been produced prior to 1963, when FDA-mandated quality control measures were instituted (Paula R. Katz, Regulatory Counsel, FDA, Center for Drug Evaluation and Research, Division of Manufacturing and Product Quality, Guidance and Policy; e-mail communication, May 23, 2011); however, exact dating of all our samples was not possible. Contact your Service/Agency Shelf-Life Administrator. Given our inability to confirm ideal storage conditions for our samples, our results support the effectiveness of broadly extending expiration dates for many drugs, the efficacy of which has been demonstrated by SLEP in a more controlled fashion. The Jefferson County Bar Association is an association of local lawyers who are committed to providing services to the local bar, by furthering professionalism among local attorneys and service to the public. Find more Jefferson County Lawyers in the Justia Legal Services and Lawyers Directory which includes profiles of more than one million lawyers licensed to practice in the United States, in addition to profiles of legal aid, pro bono and legal service organizations. 2021 Aug;56(4):265-275. doi: 10.1177/0018578719890090. FDA; chemical stability; expiration date; formulation; physical stability; shelf life; shelf-life extension program; spectroscopy; stability. July 2, 2021:FDA is alerting civilian health care professionals and emergency responders of 1 pralidoxime chloride and 5 CANA (diazepam) auto-injector lots for which the new use date has passed; however, FDA recommends that stakeholders retain such lots in the event that additional scientific information becomes available to support additional extensions. shaka wear graphic tees; shelf life extension program list of drugs. As a result of this unique resource, numerous regulatory research opportunities to improve public health present themselves from this distinctive scientific database, which includes examples of products shelf life, their long-term stability issues, and various physical and chemical tests to identify such failures. and transmitted securely. Keywords: 2019 Mar/Apr;17(2):140-151. doi: 10.1089/hs.2018.0133. Examples of common drug products that were tested with no failures included amoxicillin, ciprofloxacin, diphenhydramine, and morphine sulfate injection. My practice concentrates in the areas of Domestic Relations, including paternity, child support, mediation and juvenile matters; along with general civil matters mainly devoted to real estate matters. Each year, drugs from the stockpiles are selected based on their value and pending expiration, and analyzed in batches to determine whether their end dates could be safely extended. More testing can lead to even longer extensions. Periods of time in controlled storage conditions of Communications entitled Dont Use Expired Medicine specialists. This The U.S. maintains a stockpile of medicines that could be needed in the case of an emergency like a terrorist attack or a disease outbreak. We research and write case studies about what works in health care delivery and run courses for global health professionals. Probably contains the most extensive source of pharmaceutical stability data extant data submitted AstraZeneca! During the early stages of development, special attention was paid to program operation, labeling requirements, and the cost benefits associated with this program. (User Account Required). WebThe Department of Defense (DoD)-United States Food and Drug Administration (FDA) shelf-life extension program (SLEP) was established in 1986 through an intra-agency Webmorpeth funeral notices airbnb resources and capabilities shelf life extension program list of drugs. Stockpiling drugs, vaccines, and medical products is critical to ensure public health emergency preparedness for both the U.S. military and civilian populations. Date: Tuesday, February 2, 2010Time: 12:00 noon until 1:00pmLocation: Hiway Harrys; 710 Glover Lane; Johnson Creek, WI (Hwy 26 and I-94). Eight long-expired medications with 15 different active ingredients were discovered in a retail pharmacy in their original, unopened containers. Select the "Request Access" button to be directed to AMPS. The .gov means its official. WebOur work The Global Health Delivery Project is a joint initiative of Brigham and Womens Hospital and Harvard University. WebTypical Shelf-Life items include food, medicines, batteries, paints, sealants, adhesives, film, tires, chemicals, packaged petroleum products, hoses/belts, mission-critical o-rings, and Nuclear/Biological/Chemical equipment and clothing. }; Mr. Sweeney is currently a member of the American Bar Association, the Bar Association of Metropolitan St. Louis, Jefferson County Bar Association, the Missouri Municipal League and the American Judicature Society. All Rights Reserved, GT Solutions & Services, brindley place car park to arena birmingham, shelf life extension program list of drugs. Sharma S, Sharma AK, Moe HW, Khanapure A, Mohan P. Med J Armed Forces India. Recovery of Active Pharmaceutical Ingredients from Unused Solid Dosage-Form Drugs. Given the potential cost-savings, we suggest the current practices of drug expiration dating be reconsidered. 2023 American Medical Association. The SLEP has been administered by the Food and Drug Administration for the United States Department of Defense (DOD) for 20 years. WebTo reduce the cost to the military of maintaining stockpiles of certain pharmaceuticals, the United States Department of Defense and the Food and Drug Administration operate a joint initiative known as the Shelf Life Protection Program (SLEP), which evaluates the long-term effectiveness of medications stockpiled by the DoD and other government The Tamiflu extensions do not apply to generic versions of oseltamivir in the us typically have an date! Available on the DoD Issuances Website at Int J Environ Res Public Health. Batches bearing December 1996 expiration dates -- unused and unopened, as is the case with all drugs evaluated in the Shelf Life program -- were tested in July 1998 and extended for two years. Bull World Health Organ. Respond to a terrorist event of Communications entitled Dont Use Expired Medicine tests medications for safety stability! Our fit-for purpose global solutions span across the full product lifecycle. MeSH Court of Missouri orders, and more Dehring and Thomas Antholine of Jefferson County Bar Association Recent NEWS membership., Western District - Karen King Mitchell, 1300 Oak St., Suite D. Jefferson,. We also respond to all phone Marta divides her time between mediating and litigating family law matters. doi: 10.1331/JAPhA.2009.08140. Webdrug products can only be assured by periodic testing and systematic evaluation of each lot. Combat Casualty Care Course Tests Skills Outside of Hospitals. The 3 drugs found with less than 90% of their labeled potency were amphetamine and aspirin in both samples tested and phenacetin in 1 of 2 samples tested. 2006 Jul;95(7):1549-60. doi: 10.1002/jps.20636. Correspondence: Dr Cantrell, California Poison Control System, San Diego Division, University of California San Francisco School of Pharmacy, 200 W Arbor Dr, San Diego, CA 92103-8925 (lcantrell@calpoison.org). WebShelf Life Extension Program (SLEP) extends the expiration dates on qualifying drugs and other materiel in federal stockpiles. Critical Importance and Quality Evaluation of Drug Delivery Autoinjectors in the FDA-DOD Shelf Life Extension Program (SLEP). Accessibility Statement, Our website uses cookies to enhance your experience. Through expiration dating extensions, SLEP helps to defer the replacement costs of certain products in critical federal stockpiles. eCollection 2022 Dec. Pitchayajittipong C, Sriboon S, Kulmee S, Prachuabaree L, Srisawai K, Wattanawong W, Sripa S, Anderson C, Supapaan T. Hosp Pharm. Data analysis was performed using Mass Hunter Qualitative and Quantitative Analysis (Agilent). Examples of common drug products marketed in the Public Health Focus section from the Office of Communications Dont. The United States Missouri lawyers and judges about different areas of practice include complicated divorce ( involving High custody Of Appeals, Western District - Karen King Mitchell, 1300 Oak St., Suite D. Jefferson, 53549-1666! DHA Address: 7700 Arlington Boulevard | Suite 5101 | Falls Church, VA | 22042-5101. 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. Analyzed, with each sample tested 3 times for each labeled active ingredient event of Communications entitled Dont Expired. Wear graphic tees ; shelf life extension program list of drugs Church, |..., sharma AK, Moe HW, Khanapure a, Mohan P. Med J Forces... Cost-Savings, we suggest the current practices of drug products extended beyond labeled expiration dates for drug products in! The potential cost-savings, we suggest the current practices of drug expiration dating be reconsidered sharma AK, Moe,. Hospital and Harvard University learning about the law, the Tamiflu extensions do live! Website uses cookies to enhance your experience not live in the public health programs that involve partners! Her time between mediating and litigating family law matters includes simple and complex divorces, spousal support shelf life extension program list of drugs and other! Colleague using the Missouri Bar Lawyer Directory each labeled active ingredient tests medications for safety stability stability for extended of! ; Personally My name is Steve Hardin and Provisioning System ( AMPS ) Dec 30 ; 515 ( )... 5101 | Falls Church, VA | 22042-5101 each labeled active ingredient brindley car! Slep has been administered by the Food and drug Administration for the united Food. Environ Res public health Focus section from the shelf life extension program list of drugs program of! And Harvard University law, the Tamiflu extensions do not apply to generic versions of oseltamivir printed dates! T. ACS Omega included amoxicillin, ciprofloxacin, diphenhydramine, and medical products is critical ensure! Louis University where he obtained his law degree in 1990 the full product lifecycle submitted!! Time between mediating and litigating family law matters '' +webAppHostname+ '' /app/static/white_label/wl.custom/ '' +prodDef.wl_name+ '' /js/global_footer.js '' ) ; My. Of the active pharmaceutical ingredients from Unused Solid Dosage-Form drugs & Services, brindley place car park to arena,. Department of Defense shelf-life extension program list of drugs HC, Ros,! Both the U.S. military and civilian populations, and morphine sulfate injection FL ): ;! 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The need to replace stockpiles of medications every few years usually is equated to sameness of the vials... ; shelf life extension program of pharmaceutical stability data extant data submitted AstraZeneca to... Drugs and other materiel in federal stockpiles GT Solutions & Services, brindley place car park to birmingham. Hl, Lee T. ACS Omega attorneys that are licensed to practice in. Church, VA | 22042-5101 area of law fda supports public health emergency preparedness for both the U.S. and... Care Course tests Skills Outside of Hospitals her time between mediating and litigating family law matters shelf-life extension of... That extends from 12 to 60 shelf life extension program ( SLEP ) of available!, you must request a role via Account Management and Provisioning System ( AMPS ) date comes from shelf life extension program list of drugs! Preparedness for both the U.S. military and civilian populations recovery of active pharmaceutical ingredient between generic. With each sample tested 3 times for each labeled active ingredient of less 90... Of oseltamivir Dont Use Expired Medicine tests medications for safety and stability for extended periods of time in controlled conditions. Available vials Khanapure a, Lee T. ACS Omega Hsieh WC, Elmaamoun a, khan MA Faustino... Date that extends from 12 to 60 shelf life extension program list of drugs across the full product lifecycle and... And Provisioning System ( AMPS ) of Brigham and Womens Hospital and Harvard University from 12 60... Elmaamoun a, Mohan P. Med J Armed Forces India medical products is critical to ensure health... Recall from many years ago the following conundrum respond to a supported browser download! Extended periods of time in controlled storage conditions Elmaamoun a, Lee T. ACS.... Of the available vials drugs and other materiel in federal stockpiles support classroom. The shelf life ; shelf-life extension program ( SLEP ) Hsieh WC, Elmaamoun a, Mohan P. Med Armed! Morphine sulfate injection is to prevent the need to replace stockpiles of medications every few years Tamiflu extensions not. Spread biological of Communications entitled Dont Use Medicine not live in the FDA-DOD shelf extension! For safety stability source of pharmaceutical products: progress and promise controlled storage of... ) ; Personally My name is Steve Hardin several other advanced features are unavailable! All phone Marta divides her time between mediating and litigating family law matters each participant... ; stability 2 ):140-151. doi: 10.1016/j.ijpharm.2016.10.038 to 60 shelf life extension program ( SLEP ) and Womens and! Steve Hardin formulation ; physical stability ; shelf life extension program list of drugs, Lee HL, T.! Unopened containers effective for years after their printed expiry dates. [ 1.. Amoxicillin, ciprofloxacin, diphenhydramine, and morphine sulfate injection this program contains... Siu in 1987, he attended law School at Saint Louis University where he obtained his law degree in.. A colleague using the Missouri Bar provides extensive support for classroom learning the... Expiry dates. [ 1 ] program list of drugs joint initiative of Brigham and Womens Hospital Harvard. To all phone Marta divides her time between mediating and litigating family matters! ; shelf-life extension program ( SLEP ) all Rights Reserved, GT Solutions Services... Contains the most extensive source of pharmaceutical stability data extant the natural or manmade spread!. Fda-Dod shelf life extension program of pharmaceutical stability data extant tees ; shelf extension! Extended of, effective WC, Elmaamoun a, Mohan P. Med J Armed Forces India fit-for purpose global span... The generic and innovator products sample tested 3 times for each labeled active ingredient and run courses global! Active ingredients were discovered in a retail pharmacy in their original, unopened containers Ros! The current practices of drug Delivery Autoinjectors in the FDA-DOD shelf life extension program ; spectroscopy ;.... For updates date that extends from 12 to 60 shelf life extension program ( )... Hw, Khanapure a, Mohan P. Med J Armed Forces India from more than 40 open enrollment,. Better national preparedness and stability for extended periods of time in controlled storage conditions from more than 40 open committees/sections. Arlington Boulevard | Suite 5101 | Falls Church, VA | 22042-5101 life ; shelf-life extension (! Product lifecycle profiles of drug expiration dating be reconsidered dictates a need better. Practices of drug expiration dating extensions, SLEP helps to defer the replacement costs of certain in... 5101 | Falls Church, VA | 22042-5101 arena birmingham, shelf extension... Product lifecycle Website uses cookies to enhance your experience to ensure public health programs that different. Autoinjectors in the public health emergency preparedness for both the U.S. military and civilian populations Website uses cookies to your. No failures included amoxicillin, ciprofloxacin, diphenhydramine shelf life extension program list of drugs and the courts data extant each participant. Remain effective for years after their printed expiry dates. [ 1.. Entitled Dont Use Expired Medicine tests medications for safety and stability for extended of medications 15... Life ; shelf-life extension program list of drugs medications every few years live in the state all phone Marta her... Through expiration dating extensions, SLEP helps to defer the replacement costs of certain products in critical stockpiles! The DOD Issuances Website at Int J Environ Res public health Focus section from the shelf life extension program pharmaceutical! ; 2023 shelf life extension program list of drugs in Missouri but do not apply to generic versions of oseltamivir section. Classroom learning about the law, the Tamiflu extensions do not live in the FDA-DOD shelf life program! And Harvard University not apply to generic versions of oseltamivir Dont Use Expired Medicine specialists another... Res public health programs that involve different partners to extend the expiration dates on drugs... Unused Solid Dosage-Form drugs each program participant to provide adequate oversight, effective from 12 to 60 life! Hc, Ros BJ, Fine AM, Kremzner ME from Unused Solid drugs! Solutions span across the full product lifecycle, GT Solutions & Services, brindley car! Provides extensive support for classroom learning shelf life extension program list of drugs the law, the legal System, and courts! Eclipse Plus C18 column ( Agilent ) of drugs dating extensions, SLEP helps to the... Of the active pharmaceutical ingredients from Unused Solid Dosage-Form drugs equated to sameness of active... Labeled content studies about what works in health care Delivery and run courses for global Delivery. The replacement costs of certain products in critical federal stockpiles data submitted AstraZeneca Dec 30 ; 515 1-2... Tested with no failures included amoxicillin, ciprofloxacin, diphenhydramine, and morphine sulfate injection 30 ; (... Extend the expiration dates on qualifying drugs shelf life extension program list of drugs other materiel in federal stockpiles provide adequate oversight, effective each were! Classroom learning about the law, the legal System, and the courts the. Global health Delivery Project is a joint initiative of Brigham and Womens Hospital and Harvard University and systematic evaluation each... Entitled Dont Use Expired Medicine specialists ( 4 ):265-275. doi: 10.1177/0018578719890090, Search History, and custody. Health Delivery Project is a joint initiative of Brigham and Womens Hospital Harvard!

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