Shelf life items are products that are effective, useful or suitable for consumption for a limited time period. 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. Relenza inhalation powder (reminder of previous extension) 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. official website and that any information you provide is encrypted 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. This authority is limited to medical products for CBRN emergencies. 8600 Rockville Pike April 25, 2017: FDA announced the availability of a draft guidance for government public health and emergency response stakeholders entitled Extending Expiration Dates of Doxycycline Tablets and Capsules in Strategic Stockpiles. Another extended drug is Thorazine, a tranquilizer chemically known as chlorpromazine tablets. eCollection 2016. The .gov means its official.Federal government websites often end in .gov or .mil. The risk posed by the natural or manmade spread of biological agents among the population dictates a need for better national preparedness. Please refer to the table on this page for updates. Bangladesh Is A Developing Country Paragraph, The federal Shelf Life Extension Program (SLEP) extends the expiration dates on qualifying drugs and other materiel in federal stockpiles. Abstract. Examples of common drug products that were tested with no failures included amoxicillin, ciprofloxacin, diphenhydramine, and morphine sulfate injection. Primarily FDA-approved prescription drug (not biological) products are nominated by program participants as SLEP candidates. 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. Shelf Life Extension Program. (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. 0000033599 00000 n Through expiration dating extensions, SLEP helps to defer the replacement costs of certain products in critical federal stockpiles. Distribution. GSA Shelf Life Management Program. 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. 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. 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. 2 Shelf Life Extension Programme (SLEP) to perform stability testing on more than 100 medications. 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. 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. Shelf Life Extension Program. sharing sensitive information, make sure youre on a federal 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. Theoretically, small levels of degradation products could gradually accumulate, including some degradants which had been either undetected or quantified within acceptance criteria during the time of shorter-term (e.g., 2-4 years) stability analyses following original production of the drug product. 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. 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. drug products marketed in the us typically have an expiration date that extends from 12 to 60 months from the time of manufacturer. A very few drugs aren't retested. 2 however, the The Shelf Life Extension Program (SLEP) extends the expiration dates for specific medications and supplies stored in Federal stockpiles. It tests medications for safety and stability for extended periods of time in controlled storage conditions. Unable to load your collection due to an error, Unable to load your delegates due to an error. U.S. medical countermeasure development since 2001: a long way yet to go. At the start of every year, we all have these grand plans of everything we plan to accomplish. The program rechecks the safety and stability of drugs held in controlled storage conditions over lengths of time. Drug expiration extension dates on these products ranged from 12 months to 184 months (over 15 years). The Office of Counterterrorism and Emerging Threats (OCET) collaborates with FDA Centers and federal partners to facilitate access to MCMs. To help prepare for public health emergencies, medical countermeasures (MCMs) may be stockpiled by governments and even by some private sector partners. 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. 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. Services offered include: Procurement of pharmaceutical, medical, and dental equipment and supplies. 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. Identification #: 6430.05 Date: 10/5/2021 Type: DHA Procedures Manual Topics: Shelf Life Extension Program DOD Shelf-Life Management Program: Program Administration Policy 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. Medical Device Product Development & Consulting, Research & Development Solutions Consulting, Commissioning, Qualification & Validation, Adverse Event Intake & Follow-Up Services, Product Complaint Intake & Follow-Up Services, Medical Communications, Content Management & Translation. Each batch of each drug in the SLEP program is tested separately, and the shelf life extended for each batch individually. Please contact Brad Leissa at brad.leissa@fda.hhs.gov or Brooke Courtney at brooke.courtney@fda.hhs.gov with questions regarding this update. The Strategic National Stockpile: roles and responsibilities of health care professionals for receiving the stockpile assets. The SLEP has been administered by the Food and Drug Administration for the United States Department of Defense (DOD) for 20 years. 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. All fees are based on a success of performance, and any such agreement for fees will be mutually agreed upon in contract form with clients expressed consent and knowledge to the respective transaction related to its cost of funds. It is a partnership between FDA and the US Department of Defence. As a result of this extension, some batches may be stored for an additional 6 months from the labeled date of expiry. Clipboard, Search History, and several other advanced features are temporarily unavailable. September 20, 2017: CDC and FDA hosted a webinar to discuss FDAs April 2017 draft guidance Extending Expiration Dates of Doxycycline Tablets and Capsules in Strategic Stockpiles. Disclaimer, National Library of Medicine 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. 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. No further extensions are anticipated beyond 10 years.Also see, from FDA: Influenza (Flu) Antiviral Drugs and Related Information, and from HHS/ASPR:HHS Increases Access to Tamiflu through the Strategic National Stockpile (December 21, 2022), andImproving Access to Influenza Countermeasures for U.S. Jurisdictions. The site is secure. 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. 1-Oct-2021. They concluded that a stated expiry date, did not always indicate it is no longer effective or has become unsafe. 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. 7, July 2006.. Specific shelf-life information for IVDs authorized under an EUA can be found on the outer packaging, and reagent vials and containers for the product, or by contacting the IVD manufacturer directly with the catalog number, lot number, and manufacturing date for the specific reagent in question. Upon FDAs authorization of a shelf-life extension, the labeling is updated by the IVD manufacturer to reflect the updated expiration date, which is calculated from the original manufacturing date of the device. 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. In the first year of the testing program, the FDA tested 58 different prescription drugs, representing 157 different manufacturing lots. 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,. To confirm extension dates, recipients should provide the following information: Drug name, National Drug Code (NDC), strength, lot number, and original expiration date. 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 . 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. This site needs JavaScript to work properly. Results from the shelf life extension program (SLEP) have been evaluated to provide extensive data to address this issue. Dexmedetomidine HCl injection in 0.9% sodium chloride, 200 mcg/2 mL (100 mcg/mL), 2 mL single dose vial. Vigorous discussion ensued regarding the chances of lessened efficacy of the available vials. The shelf life extension program tests pharmaceutical products stored in national stockpiles. 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). 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