Please contact Brad Leissa at brad.leissa@fda.hhs.gov or Brooke Courtney at brooke.courtney@fda.hhs.gov with questions regarding this update. Shelf-life extensions are "intentionally conservative," the FDA's Mr. Flaherty told military brass in a 1992 speech. The federal Shelf Life Extension Program (SLEP) extends the expiration dates on qualifying drugs and other materiel in federal stockpiles. 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. During the early stages of development, special attention was paid to program . The truth is, quite a number of drugs are still in good condition long past their expiry date. 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. 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). Services offered include: Procurement of pharmaceutical, medical, and dental equipment and supplies. 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. The .gov means its official.Federal government websites often end in .gov or .mil. 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. 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. Tamiflu 30mg, 45mg, and 75mg capsules The site is secure. In many cases . Results from the shelf life extension program (SLEP) have been evaluated to provide extensive data to address this issue. 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. The site is secure. 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. Our results support the effectiveness of broadly extending expiration dates for many drugs, the researchers conclude. 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. SLEP is administered by the U.S. Department of Defense (DoD) in cooperation with the U.S. Food and Drug Administration (FDA). Therefore, REGEN-COV may not be administered for treatment or post-exposure prevention of COVID-19 under the EUA until further notice by the Agency. Accessibility Bull World Health Organ. 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. Details for each of the authorized services is located below. Organizational Structure Of Ibrd, 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. MQCSS is the authority for shelf-life extension when visible inspection only is required. 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. During the early stages of development, speci Looking for abbreviations of LEP? 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). Before sharing sensitive information, make sure you're on a federal government site. 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. Providers and patients that have the lot numbers in stock will be able to use them through the corresponding new use dates to help with supply. 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. We wonder whether a mandated post-market commitment to evaluate a products potential for extended stability might be a reasonable consideration. Through expiration dating extensions, SLEP helps to defer the replacement costs of certain products in critical federal stockpiles. FDA is not requiring or recommending that such stockpiled Tamiflu or Relenza product be relabeled with the new use date. The American Medical Association has questioned whether expiration dating markedly underestimates the actual shelf life of drug products. January 1, 2020: FDA is alerting civilian health care professionals and emergency responders of 2 additional DuoDote lots that are no longer useable and should be properly disposed of. Nullam malesuada erat ut turpis. 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. Investigative Report: Do Antibiotic Expiration Dates Matter? There is, in actual fact, a program known as The Shelf Life Extension Program. FOREWORD . [Note: this guidance was finalized on April 24, 2019.] 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. 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. Disclaimer, National Library of Medicine The results found that 86% of the 14 tested drugs (12 drugs, multiple batches of each) had at least 90% of their labeled potency, which would fall within the FDAs acceptable range of potency for batches that are still within their expiration period. Custom medical, dental, and diagnostic kits and assemblies. 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. Due to the high frequency of the omicron variant and its subvariants, REGEN-COV is not currently authorized in any U.S. region. The .gov means its official.Federal government websites often end in .gov or .mil. 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. The SLEP enables each program participant to provide adequate oversight, ensure effective inventory controls, and monitor stockpiles for shelf life extension opportunities. There is, in actual fact, a program known as The Shelf Life Extension Program. Bethesda, MD 20894, Web Policies Clipboard, Search History, and several other advanced features are temporarily unavailable. 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. 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. 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. This program is known as the DoD/FDA Shelf-Life Extension Program (SLEP). 2 Shelf Life Extension Programme (SLEP) to perform stability testing on more than 100 medications. 2016 Aug 3;7:1209. doi: 10.3389/fmicb.2016.01209. As required by the EUA, of Evusheld (150 mg/1.5 mL of tixagevimab and 150 mg/1.5 mL of cilgavimab), must be stored under refrigerated temperature at 2C to 8C (36F to 46F) in the original carton to protect from light. 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. 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. PMC 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. drug products marketed in the us typically have an expiration date that extends from 12 to 60 months from the time of manufacturer. The Strategic National Stockpile: roles and responsibilities of health care professionals for receiving the stockpile assets. December 5, 2022: FDA and HHS/ASPR authorized an additional extension to the shelf-life for specific lots of the refrigerated AstraZeneca monoclonal antibody therapy, Evusheld, from 18 months to 30 months. Stockpiling drugs, vaccines, and medical products is critical to ensure public health emergency preparedness for both the U.S. military and civilian populations. Under the Shelf-Life Extension Program (SLEP), FDA conducts testing for certain products stored in federal stockpiles in environmentally controlled locations. FOIA 100,000/g within the shelf life of many chilled foods. 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). As a result of this extension, some batches may be stored for an additional 6 months from the labeled date of expiry. 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. It must be noted that that model predictions are based on observations made in artificial growth media and available product studies. Reading this FDA communication was a reminder that expiry dates are driven by the availability of supportive stability data. 1 The program is an acknowledgement that the actual shelf life of drugs Pharmaceutical shelf-life extension programs. dating markedly underestimates the actual shelf life of drug products. Storage. Available at: The purpose of SLEP is to defer replacement costs of stoc 95, No. A recording of this webinar, slides and Q&A(under Resources tab) are available in CDC TRAIN (free account required). For additional information, consult the Guidance for Government Public Health and Emergency Response Stakeholders: Extending Expiration Dates of Doxycycline Tablets and Capsules in Strategic Stockpiles, page 3, or Guidance for Industry: Changes to an Approved NDA or ANDA. Leading with strategy, our RCO model delivers bespoke / custom solutions that deliver results. 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. Please refer to the table on this page for updates. Given the high costs involved in maintaining adequate drug stockpiles, attempts should be made to optimize the value of drugs; shelf-life extension is one of the easiest and most cost-effective ways of doing this. If you have any questions or thoughts on this blog post or others, pleasecontact us. The FDA has a Shelf Life Extension Program that tests whether certain drugs have expiration dates that could be extended. 0000033308 00000 n Program Extends Drug Shelf-Life. A generic drug, if chemically and pharmacokinetically identical to the innovator, is assumed to have the innovators safety profile without any additional safety testing. 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