FAQs: What happens to EUAs when a public health emergency ends? 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. It tests medications for safety and stability for extended periods of time in controlled storage conditions. The intended outcome of the SLEP is measurable cost avoidance returned to program participants and continued availability of potency-dated contingency stocks. government site. 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. Recipients should contact their MCM specialists with any questions regarding confirmation. 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. SLEP is coordinated through multiple agencies. Could such medications, if shown by evaluation such as SLEP to retain adequate potency, be donated to developing countries in which the usual commercial product is either prohibitively expensive or not readily available, or be used in the US during periods of critical drug shortages? 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. 2 however, the 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. LEP - Life Extension Program. 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 Some newly mailed Covid tests from the government expire imminently even with extensions. If appropriate, FDA can also choose to not take enforcement action with respect to products that are held or used beyond their labeled expiration date. Results from the shelf life extension program (SLEP) have been evaluated to provide extensive data to address this issue. 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. FDA will not take enforcement action with regard to the storage or emergency use of these lots of Relenza, provided that the products have been stored under labeled storage conditions. This program probably contains the most extensive source of pharmaceutical stability data extant. 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. As a result of this extension, some batches may be stored for longer from the labeled date of expiry (see Table 1 below). 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). 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. Olliver, Aske, Richmond, North Yorkshire, DL10 5HX, UK ProPharma Group MIS Limited. Examples of common drug products that were tested with no failures included amoxicillin, ciprofloxacin, diphenhydramine, and morphine sulfate injection. 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). Available at: The purpose of SLEP is to defer replacement costs of stoc 95, No. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. SLEP is coordinated through multiple agencies. 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. The FDA has a shelf life extension program to test drugs stored in stockpiles for emergency usedrugs that are worth as much as $1 billion are salvaged every year. 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. 1-Oct-2021. [1], 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). Results from the shelf life extension program (SLEP) have been evaluated to provide extensive data to address this issue. Pharmaceuticals and the strategic national stockpile program. 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. 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. This extension applies to all unopened vials of Evusheld that have been held in accordance with storage conditions detailed in the authorized Fact Sheet for Health Care Providers and the Letter of Authorization for Emergency Use Authorization (EUA) 104 for Evusheld. 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. Please enable it to take advantage of the complete set of features! The purpose of SLEP is to prevent the need to replace stockpiles of medications every few years. 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. 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. 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. 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. 1 Extend shelf life. Another way FDA can approach expiration dating challenges is through FDAs expiration dating extension authority under section 564A(b) of the FD&C Act, which was established by PAHPRA in 2013. 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. This site needs JavaScript to work properly. Custom medical, dental, and diagnostic kits and assemblies. 0409-1638-02. eCollection 2016. This program is known as the DoD/FDA Shelf-Life Extension Program (SLEP). 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. 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 Defense Health Agency (DHA), in coordination with the Food and Drug The program allows extensions to the expiration date on medications after testing for safety and efficacy. This expensive process includes costs for planning, proper storage, and also reeplacing expired drugs. 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. FDAs Office of Regulatory Affairs (ORA) Field Science Laboratories centrally manages the program, including interacting with DoD and coordinating laboratory work. 2006 Aug;171(8):698-702. doi: 10.7205/milmed.171.8.698. June 28, 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 AstraZeneca monoclonal antibody therapy, Evusheld (tixagevimab co-packaged with cilgavimab), which is currently authorized for emergency use for pre-exposure prophylaxis of COVID-19 in certain adults and pediatric individuals. [Note: this guidance was finalized on April 24, 2019.] 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. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. 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. In the first year of the testing program, the FDA tested 58 different prescription drugs, representing 157 different manufacturing lots. Fact Sheet Overview. The site is secure. 2 Shelf Life Extension Programme (SLEP) to perform stability testing on more than 100 medications. 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. We wonder whether a mandated post-market commitment to evaluate a products potential for extended stability might be a reasonable consideration. 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. Safety and stability for extended stability might be a reasonable consideration a products potential for extended stability might a! 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