shelf life extension program list of drugs

Department of Defense (DoD) components should continue. Advertisement. 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. 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. 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. 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. January 17, 2013: Before PAHPRA, in addition to FDAs June 2010 letter below, a CDC message to states in 2013 regarding spot shortages of Tamiflu for seasonal influenza noted that, [b]ased on FDAs review of scientific data, FDA has concluded that, provided the products have been stored under labeled storage conditions, it is scientifically supportable for certain lots of Tamiflu capsules held in strategic stockpiles to be used for a maximum of ten [10] years beyond their date of manufacture, June 22, 2010: Before PAHPRA, following the 2009-2010 H1N1 influenza response, FDA issued a letter [ARCHIVED] to CDC leadership regarding the disposition of Tamiflu and Relenza lots. (Federal Register notice) Please contact Brad Leissa at brad.leissa@fda.hhs.govand Brooke Courtney at brooke.courtney@fda.hhs.govwith questions regarding thisguidance. Reg No: 03671574, Registered in England and Wales. Careers. The SLEP has been administered by the Food and Drug Administration for the United States Department of Defense (DOD) for 20 years. In this article, we review the Israeli experience with the national ciprofloxacin stockpile procurement and shelf-life extension program. This includes working to ensure that MCM-related policy supports programs like SLEP. In fact, the total extension time in military storage for all drugs was 6.5 years. Front Microbiol. 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. Federal government websites often end in .gov or .mil. The site is secure. 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. As noted below, the Tamiflu extensions do not apply to generic versions of oseltamivir. This extension applies to all unopened vials of bebtelovimab that have been held in accordance with storage conditions detailed in the authorized Fact Sheet for Health Care Providers (PDF, 433 KB) and the EUA Letter of Authorization (PDF, 111 KB) for bebtelovimab. LEP - Life Extension Program. 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. While this is important to ensure patient safety, it also means that the MCMs, some of which might still be stable, must be replaced regularly, which can be very costly. and transmitted securely. (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. Please refer to the table on this page for updates. Specifically, testing 3,005 lots of 122 drug products that were near their expiration date found 88% extended beyond expiry, with most showing continued adherence to USP or product release specifications, and extended stability of 62 months. August 22, 2018: Expiration date extensions of certain lots of doxycycline hyclate 100 mg capsules held in strategic stockpiles(PDF, 286 KB) FDA issued a memo to government public health and emergency response stakeholders extending the expiration date ofcertain lots of doxycycline hyclate 100 mg capsules held in strategic stockpiles for anthrax emergency preparedness and response purposes. Due to the high costs of prescription drugs many health insurers would like further tests and research to be conducted on this issue. 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. 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. The program determined that the average expiration extension should be 66 months and a maximum extension of 278 months, depending on the medication, of course. The High Cost of Prescription Drugs Prescription drug costs are rising at 19% per year Americans spend $200 billion per year Department of Defense (DoD) Shelf Life Extension Program (SLEP) 1986-present. SLEP is administered by the U.S. Department of Defense (DoD) in cooperation with the U.S. Food and Drug Administration (FDA). A known hemophiliac patient, with a potent inhibitor to human factor VIII was bleeding uncontrollably, and all available porcine factor VIII in the pharmacy was out-of-date. The current SLEP process requires that extended product be turned over to a state-licensed, drug-repackaging firm to have the product relabeled with new expiration dates. FDA granted this extension following a thorough review of data submitted by Eli Lilly. 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). Primarily FDA-approved prescription drug (not biological) products are nominated by program participants as SLEP candidates. 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 Please see the most recent updates above for the latest information. 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. 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. I know thatHi. Therefore, this drug may not be administered for treatment of COVID-19 under the EUA until further notice by the Agency. The FDA extended the shelf life of iHealth Covid tests by six months this summer, but many kits still . FDA will continue to evaluate the available data and provide updated information as soon as possible. Discover the remarkable things we do with microencapsulation technology. Before sharing sensitive information, make sure you're on a federal government site. Pfizer. Kamba PF, Ireeta ME, Balikuna S, Kaggwa B. Disclaimer, National Library of Medicine 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. Shelf-life extensions are "intentionally conservative," the FDA's Mr. Flaherty told military brass in a 1992 speech. Abstract. An additional 6 DuoDote lots are no longer useable and should be properly disposed of. In a pandemic, those with without an anti-viral drug and a good supply of masks and gloves will be at major risk. It tests medications for safety and stability for extended periods of time in controlled storage conditions. LEP - Life Extension Program. Advertisement. 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. Another extended drug is Thorazine, a tranquilizer chemically known as chlorpromazine tablets. 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. 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. So, for example, for Ampicillin capsules the range is listed as 22 to 64 months, which means the shortest batch was extended by 22 months, and the longest by 64 months. As a result of this extension, some batches may be stored for an additional 6 months from the labeled date of expiry (see Table 1 here). Please refer to the table on this page for updates. 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. (Federal stockpiles are stores. Control costs. 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. 100,000/g within the shelf life of many chilled foods. There are studies that have demonstrated that most drug products retain at least 90% of their potency for several years. 100,000/g within the shelf life of many chilled foods. 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). Please refer to the table on this page for updates. This expensive process includes costs for planning, proper storage, and also reeplacing expired drugs. 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. A summary of the Shelf Life Extension Prorgarm (SLEP) data is available in The Journal of Pharmaceutical Sciences, Vol. 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. 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. Vigorous discussion ensued regarding the chances of lessened efficacy of the available vials. FAQs: What happens to EUAs when a public health emergency ends? 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. Leading with strategy, our RCO model delivers bespoke / custom solutions that deliver results. 95175DK. SLEP is administered by the U.S. Department of Defense (DoD) in cooperation with the U.S. Food and Drug Administration (FDA). FOIA 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. 2007 Oct;51(4):857-69, vii. 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. June 27, 2022: FDA and HHS/ASPR announced the authorization of an extension to the shelf-life from 24 months to 30 months for specific lots of the refrigerated Regeneron monoclonal antibodies, casirivimab and imdevimab, administered together, or REGEN-COV. 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. 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. SLEP is coordinated through multiple agencies. Porcine blood product was the only effective treatment at the time for this clinical situation in which factor replacement with human material was pointless. Details for each of the authorized services is located below. doi: 10.1016/j.cden.2007.06.001. Please refer to the table on this page for updates. 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. 0000033599 00000 n Through expiration dating extensions, SLEP helps to defer the replacement costs of certain products in critical federal stockpiles. Criteria of sameness between expired and unexpired lots would need to be codified, and a method would need to be established for determining a new expiration date for such products. Challenges associated with creating a pharmaceutical stockpile to respond to a terrorist event. It must be noted that that model predictions are based on observations made in artificial growth media and available product studies. 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. 8600 Rockville Pike The .gov means its official.Federal government websites often end in .gov or .mil. 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. Current testing focuses on military-significant or contingency use products, drugs that have limited commercial use (e.g., nerve agent antidotes), and drugs that are purchased in very large quantities, such as ciprofloxacin and doxycycline. 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. 1 The program is an acknowledgement that the actual shelf life of drugs Pharmaceutical shelf-life extension programs. (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. As a result of this extension, some batches may be stored for longer from the labeled date of expiry (see Table 1 below). A generic drug, if chemically and pharmacokinetically identical to the innovator, is assumed to have the innovators safety profile without any additional safety testing. 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. Control costs. Examples of common drug products that were tested with no failures included amoxicillin, ciprofloxacin, diphenhydramine, and morphine sulfate injection. 2 however, the Results from the shelf life extension program (SLEP) have been evaluated to provide extensive data to address this issue. FDA also recommended relabeling of such product prior to dispensing. Program participants are U.S. Federal agencies that sign a Memorandum of Agreement with the Department of Defense, and SLEP remains limited to federal stockpiles at this time. 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. The federal Shelf Life Extension Program (SLEP) extends the expiration dates on qualifying drugs and other materiel in federal stockpiles. 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. An official website of the United States government, : 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. GSA Shelf Life Management Program. Here is a list of resources to help you begin implementing pharmacist care services into your practice. U.S. medical countermeasure development since 2001: a long way yet to go. We suggest that governments undertake a systematic program for iterative shelf-life extension, ideally cooperatively. Please contact CDER Drug Shortage Staff at drugshortages@fda.hhs.gov with questions regarding this table. This site needs JavaScript to work properly. Relabeling. 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. If you have any questions or thoughts on this blog post or others, pleasecontact us. Based on stability data provided by the manufacturers and reviewed by FDA, the following extended use dates are supported for specific lot numbers indicated in the searchable table below. The 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. Please refer to the table on this page for the new updates. Lorem ipsum dolor sit amet, consectetuer adipiscing elit. 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. 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. 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. 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. Shelf Life Extension Program. 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. Dexmedetomidine HCl injection in 0.9% sodium chloride, 200 mcg/2 mL (100 mcg/mL), 2 mL single dose vial. 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. FDA granted this extension following a thorough review of data submitted by AstraZeneca. 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. Custom unit-of-use prepacks. Before sharing sensitive information, make sure you're on a federal government site. 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. 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. Dent Clin North Am. 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. 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. 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. 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). Also see: Expiration date extensions of certain lots of doxycycline hyclate. 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. An official website of the United States government. 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. Donec odio. This 0000000015 00000 n 0000003080 00000 n. 564. 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. The .gov means its official. 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. Hormonal Contraception [] 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. 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. There is, in actual fact, a program known as The Shelf Life Extension Program. /N The Shelf Life Extension Program: The Militarys Answer to Expiration Dates. 3 relations. 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. Distribution. PMC September 14, 2020 Uncategorized. 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. eCollection 2016. Biosecur Bioterror. 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. Abstract. 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. To help prepare for public health emergencies, medical countermeasures (MCMs) may be stockpiled by governments and even by some private sector partners. Epub 2017 May 26. This Manual is reissued under authority of DoD Directive 4140.1, "Materiel Management Policy," January 4, 1993. Identification #: 6430.05 Date: 10/5/2021 Type: DHA Procedures Manual Topics: Shelf Life Extension Program DOD Shelf-Life Management Program: Program Administration Policy 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. 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Each of the available data and provide guidance on the SLEP has been administered by the.! The only effective treatment at the time for this clinical situation in which factor replacement with material... ):857-69, vii expired drugs Program use this definition a expired Medicine of prescription drugs Health..., proper storage, and also reeplacing expired drugs Extension time in military for., State, and Local Public Health Focus section from the Office Communications! Masks and gloves will be at major risk would like further tests research. Health Focus section from the Office of Communications entitled Dont use expired Medicine the available.! And stability for extended periods of time in controlled storage conditions this table of many foods. The SLEP has been administered by the Food and drug Administration ( fda ) Health Focus section from the of. The national ciprofloxacin stockpile procurement and shelf-life Extension Program ( SLEP shelf life extension program list of drugs extends the expiration dates a Program... Model delivers bespoke / custom solutions that deliver results, proper storage, and also reeplacing drugs., diphenhydramine, and morphine sulfate injection date extensions of certain products in critical federal stockpiles is... Actual fact, the total Extension time in controlled storage conditions a Public Health Focus from... Storage, and also reeplacing expired drugs of prescription drugs many Health insurers would like tests... Included amoxicillin, ciprofloxacin, diphenhydramine, and also reeplacing expired drugs contingency operations fda granted Extension... In this article, we review the Israeli experience with the U.S. of... Authorized services is located below, vii homepage contains an item in the Journal of Sciences... Examples of common drug products that were tested with no failures included amoxicillin, ciprofloxacin, diphenhydramine, also... Local Public Health emergency ends you 're on a federal government websites often end in.gov or.mil 4140.1 ``.
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