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. 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. FDA granted this extension following a thorough review of data submitted by Eli Lilly. 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. eCollection 2016. April 25, 2017: FDA announced the availability of a draft guidance for government public health and emergency response stakeholders entitled Extending Expiration Dates of Doxycycline Tablets and Capsules in Strategic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. Before sharing sensitive information, make sure you're on a federal government site. Accessibility 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. 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. Reg No: 03671574, Registered in England and Wales. GSA Shelf Life Management Program. Some medications, such as naloxone, halothane, fentanyl and others had 100% demonstrable stability of lots for at least 4-5 years after expiration. Olliver, Aske, Richmond, North Yorkshire, DL10 5HX, UK ProPharma Group MIS Limited. Please refer to the table on this page for the new updates. The Shelf Life Extension Program 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. 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. The program rechecks the safety and stability of drugs held in controlled storage conditions over lengths of time. To confirm extension dates, please provide the following information: drug name, NDC, strength, lot number, and original labeled expiration date. 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. Due to the high frequency of the omicron variant and its subvariants, REGEN-COV is not currently authorized in any U.S. region. When shelf-life expiration dates are extended for devices that have already been distributed, the IVD manufacturer typically sends a notice to customers to inform them of the extension so they are aware of how long they can continue to use in-stock devices. April 24, 2019: FDA published a final guidance for government public health and emergency response stakeholders: Extending Expiration Dates of Doxycycline Tablets and Capsules in Strategic Stockpiles. Recipients should contact their MCM specialists with any questions regarding confirmation. Shelf Life Extension Program (SLEP) extends the expiration dates on qualifying drugs and other materiel in federal stockpiles. This draft guidance was prepared in response to requests from States asking FDA what would be necessary to provide confidence that stockpiled doxycycline tablets and capsules have retained their original quality beyond the manufacturers labeled expiration date so the replacement of stockpiled product could be deferred. 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. However, to reduce the expense of such a stockpile and to make it worthwhile, there is also a need for a shelf-life extension program (SLEP) through which pharmaceuticals could be extended beyond manufacturer-ascribed shelf life, as long as they meet regulation standards. 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. The .gov means its official. Therefore, this drug may not be administered for treatment of COVID-19 under the EUA until further notice by the Agency. Stockpiling drugs, vaccines, and medical products is critical to ensure public health emergency preparedness for both the U.S. military and civilian populations. September 14, 2020 Uncategorized. Bangladesh Is A Developing Country Paragraph, 8600 Rockville Pike FDAs Office of Regulatory Affairs (ORA) Field Science Laboratories centrally manages the program, including interacting with DoD and coordinating laboratory work. July 29, 2022: FDA and HHS/ASPR authorized an additional extension to the shelf-life for all lots of the refrigerated GSK monoclonal antibody, sotrovimab, from 18 months to 24 months. QSL contains the results of previously completed laboratory extension testing. 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. Please contact Brad Leissa at brad.leissa@fda.hhs.gov or Brooke Courtney at brooke.courtney@fda.hhs.gov with questions regarding this update. This authority is limited to medical products for CBRN emergencies. 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. Bethesda, MD 20894, Web Policies For more than 30 years, federal agencies that stockpile drugs including the military, the CDC and the Department of Veterans Affairs have used technically expired drugs under the Shelf-Life Extension Program (SLEP) in collaboration with FDA. FDA granted this extension following a thorough review of data submitted by AstraZeneca. FDA will continue to evaluate the available data and provide updated information as soon as possible. Evaluation of a future extension of shelf-life for sotrovimab is ongoing. Before sharing sensitive information, make sure you're on a federal government site. SLEP is coordinated through multiple agencies. Shelf life items are products that are effective, useful or suitable for consumption for a limited time period. Also see: Expiration date extensions of certain lots of doxycycline hyclate. 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. The drugs were worth tens of billions of dollars and were for a large-scale emergency. This guidance and any resulting expiration date extensions authorized by FDA do not apply to doxycycline available commercially or otherwise held for any other non-emergency purpose. Results from the shelf life extension program (SLEP) have been evaluated to provide extensive data to address this issue. 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. No change to the container closure system in direct contact with the drug product or to the recommended storage conditions of the drug product. A summary of the services and requirements for pharmacists can be found here. The SLEP program found that around 88% of 122 medications, including antibiotics, retained potency for more than one year. Stability studies generally are sufficient to demonstrate an economically-viable stability period such as 2-3 years, yet rarely have such studies been carried out to demonstrate the success or failure of the medications stability at points later than the designated expiration period. 1) Extending the shelf life is based on developing a based on shelf life extension data (relative history of real-time stability data for each lot of number of lots initially extended and number of drug product. Due to the high costs of prescription drugs many health insurers would like further tests and research to be conducted on this issue. Tamiflu 30mg, 45mg, and 75mg capsules The Defense Medical Standardization Board (DMSB) coordinates the program and is the interface between . 2.4 Data Evaluation for Retest Period or Shelf Life Estimation for Drug Substances or Products Intended for Room Temperature Storage A systematic evaluation of the data from formal stability studies should be performed as illustrated in Shelf Life Extension Program Last updated January 06, 2020. program with the U.S. Food and Drug Administration (FDA). The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. 13. Abstract. Extensions range from 66 to 278 months. The purpose of SLEP is to prevent the need to replace stockpiles of medications every few years. Fact Sheet Overview. FDA has authorized extended expiration dates for these lots to reflect the 12-month product shelf-life (see Table 1 below), when stored according to the storage conditions detailed in the authorized Fact Sheet for Health Care Providers and the Letter of Authorization for Emergency Use Authorization (EUA) 105 for Paxlovid. However, before FDA can issue an EUA, a specific type of determination must be in place, the HHS Secretary must issue a declaration to justify the issuance of the EUA, the section 564 statutory criteria for issuing an EUA must be met, and FDA must determine that it is safe to use the product beyond its labeled expiration date. 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. 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