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Shelf Life Extension Program
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<h2 id="participation">Participation</h2> <p>Participating agencies pay a fee to the FDA request a specific drug or medical material to be evaluated.<a class="footnote-ref" id="fnref:5" href="#fn:5"><sup>5</sup></a> State and local programs are not permitted to participate.<a class="footnote-ref" id="fnref:6" href="#fn:6"><sup>6</sup></a> </p><p>The SLEP and FDA signed a memorandum that scientific data could not be shared with the public, public health departments, other government agencies, and drug manufacturers.<a class="footnote-ref" id="fnref:7" href="#fn:7"><sup>7</sup></a> The failure to share data has caused foreign governments to refuse donations of expired medications.<a class="footnote-ref" id="fnref:8" href="#fn:8"><sup>8</sup></a> </p> <h3>Other FDA measures</h3> <p>One exception occurred during the 2010 <a href="/facts/Swine_flu_(outbreak_in_the_US)/0mRjPl8f">Swine Flu Epidemic</a> when the FDA authorized expired <a href="/facts/Tamiflu/nmseGgx6">Tamiflu</a> based on SLEP Data.<a class="footnote-ref" id="fnref:9" href="#fn:9"><sup>9</sup></a> </p><p>The US FDA is able to extend the shelf life of drugs throughout national, state, local, tribal, and territorial stockpiles through two legal means: by issuing an <a href="/facts/Emergency_Use_Authorization/8rKfuV7l">Emergency Use Authorization</a> on using a drug past its expiration date (which is legally an unapproved use of a drug), or by a "expiration dating extension authority" established by the <a href="/facts/Pandemic_and_All-Hazards_Preparedness_Reauthorization_Act_of_2013/HfdGFRsb">Pandemic and All-Hazards Preparedness Reauthorization Act of 2013</a> (PAHPRA). The PAHPRA authority only applies to so-called medical countermeasures (MCMs), which are drugs and other tools used to counter CBRN emergencies. Furthermore, FDA can choose to <i>not</i> take enforcement action against use of a drug past its expiration date using its enforcement discretion, but this kind of discretion is not covered by <a href="/facts/Public_Readiness_and_Emergency_Preparedness_Act/JC9Anl0z">Public Readiness and Emergency Preparedness Act</a> liability protections.<a class="footnote-ref" id="fnref:10" href="#fn:10"><sup>10</sup></a> </p><p>The FDA has, using these three measures, provided shelf life extensions on Covid-19 vaccines, Covid-19 antibody therapeutics, Covid-19 <i>in vitro</i> diagnostics, flu antivirals (Tamiflu, Relenza), doxycycline, the <a href="/facts/Jynneos/r0k5af8p">Jynneos</a> Mpox vaccine (one single lot), nerve agent autoinjectors, and potassium iodide.<a class="footnote-ref" id="fnref:11" href="#fn:11"><sup>11</sup></a> </p> <h2 id="external-links">External links</h2> <ul><li><a href="https://www.health.mil/Military-Health-Topics/Health-Readiness/Medical-Logistics/Shelf-Life-Extension-Program">DoD/FDA Shelf Life Extension Program</a></li> <li><a href="https://web.archive.org/web/20110722180809/https://slep.dmsbfda.army.mil/portal/page/portal/SLEP_PAGE_GRP/SLEP_HOME_NEW">SLEP - The DOD/FDA Shelf Life Extension Program</a></li> <li><a href="https://web.archive.org/web/20160303192906/https://slep.dmsbfda.army.mil/slep/slep_info_paper_JAN_2006.doc">SLEP information paper</a></li></ul> Other studies <ul><li><a href="https://web.archive.org/web/20190802173228/http://www.formatex.info/microbiology4/vol3/1721-1725.pdf">In vitro dissolution of expired antibiotics (Amoxicillin / Ampicillin / Doxycycline)</a></li> <li><a href="https://web.archive.org/web/20171103060942/https://www.fda.gov/newsevents/publichealthfocus/ucm154962.htm">Stockpiled Antivirals at or Nearing Expiration (Tamiflu / Relenza)</a></li> <li><a href="http://thesurvivaldoctor.com/2015/08/05/expired-antibiotics/">Investigative Report: Do Antibiotic Expiration Dates Matter?</a></li></ul> <h2 id="references">References</h2> <ol> <li id="fn:1"><p>"Expiration Dating Extension". U.S Food and Drug Administration. 2023-04-27. Retrieved 2023-05-09. <a href="https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/expiration-dating-extension#:~:text=Shelf%2DLife%20Extension%20Program,-Stockpiling%20drugs%2C%20vaccines&text=SLEP%20is%20the%20federal%2C%20fee,stability%20testing%20conducted%20by%20FDA." target="_blank">https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/expiration-dating-extension#:~:text=Shelf%2DLife%20Extension%20Program,-Stockpiling%20drugs%2C%20vaccines&text=SLEP%20is%20the%20federal%2C%20fee,stability%20testing%20conducted%20by%20FDA.</a> <a href="#fnref:1" class="footnote-back-ref">↩</a></p></li> <li id="fn:2"><p>Lyon, Robbe C.; Taylor, Jeb S.; Porter, Donna A.; Prasanna, Hullahalli R.; Hussain, Ajaz S. (July 2006). "Stability profiles of drug products extended beyond labeled expiration dates". Journal of Pharmaceutical Sciences. 95 (7): 1549–1560. doi:10.1002/jps.20636. PMID 16721796. <a href="https://zenodo.org/record/1229249" target="_blank">https://zenodo.org/record/1229249</a> <a href="#fnref:2" class="footnote-back-ref">↩</a></p></li> <li id="fn:3"><p>"Materiel Quality Control Storage Standards" (PDF). Archived from the original (PDF) on 2017-12-09. <a href="https://web.archive.org/web/20171209041117/http://www.usamma.army.mil/assets/docs/dlar.pdf" target="_blank">https://web.archive.org/web/20171209041117/http://www.usamma.army.mil/assets/docs/dlar.pdf</a> <a href="#fnref:3" class="footnote-back-ref">↩</a></p></li> <li id="fn:4"><p>"The Myth of Drug Expiration Dates". ProPublica. 2017-07-18. Retrieved 18 July 2017. <a href="https://www.propublica.org/article/the-myth-of-drug-expiration-dates" target="_blank">https://www.propublica.org/article/the-myth-of-drug-expiration-dates</a> <a href="#fnref:4" class="footnote-back-ref">↩</a></p></li> <li id="fn:5"><p>ASSOCIATION OF STATE AND TERRITORIAL HEALTH OFFICIALS. "Federal Shelf Life Extension Program Fact Sheet | State Public Health | ASTHO" (PDF). legacy.astho.org. <a href="https://legacy.astho.org/uploadedFiles/Programs/Preparedness/Public_Health_Emergency_Law/Emergency_Authority_and_Immunity_Legal_Toolkit/05-EUA%20SLEP%20FS%204-12%20final.pdf" target="_blank">https://legacy.astho.org/uploadedFiles/Programs/Preparedness/Public_Health_Emergency_Law/Emergency_Authority_and_Immunity_Legal_Toolkit/05-EUA%20SLEP%20FS%204-12%20final.pdf</a> <a href="#fnref:5" class="footnote-back-ref">↩</a></p></li> <li id="fn:6"><p>"Maximizing State and Local Medical Countermeasure Stockpile Investments Through the Shelf-Life Extension Program". Upmc-biosecurity.org. Archived from the original on 2013-01-18. Retrieved 2014-02-08. <a href="https://web.archive.org/web/20130118131537/http://www.upmc-biosecurity.org/website/resources/publications/2009/2009-03-27-max_st_local_med_cntr.html" target="_blank">https://web.archive.org/web/20130118131537/http://www.upmc-biosecurity.org/website/resources/publications/2009/2009-03-27-max_st_local_med_cntr.html</a> <a href="#fnref:6" class="footnote-back-ref">↩</a></p></li> <li id="fn:7"><p>"US Army Medical Materiel Agency (USAMMA)". Usamma.army.mil. 2013-11-20. Archived from the original on 2015-03-18. Retrieved 2014-02-08. <a href="https://web.archive.org/web/20150318065350/http://www.usamma.army.mil/dod_slep.cfm" target="_blank">https://web.archive.org/web/20150318065350/http://www.usamma.army.mil/dod_slep.cfm</a> <a href="#fnref:7" class="footnote-back-ref">↩</a></p></li> <li id="fn:8"><p>"Essentialdrugs.org". Essentialdrugs.org. Archived from the original on 2013-12-11. Retrieved 2014-02-08. <a href="https://web.archive.org/web/20131211033851/http://www.essentialdrugs.org/edrug/archive/200003/msg00076.php" target="_blank">https://web.archive.org/web/20131211033851/http://www.essentialdrugs.org/edrug/archive/200003/msg00076.php</a> <a href="#fnref:8" class="footnote-back-ref">↩</a></p></li> <li id="fn:9"><p>"Stockpiled Antivirals at or Nearing Expiration". Fda.gov. Retrieved 2014-02-08. <a href="https://www.fda.gov/newsevents/publichealthfocus/ucm154962.htm" target="_blank">https://www.fda.gov/newsevents/publichealthfocus/ucm154962.htm</a> <a href="#fnref:9" class="footnote-back-ref">↩</a></p></li> <li id="fn:10"><p>Office of the Commissioner (9 August 2024). "Expiration Dating Extension". FDA. <a href="https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/expiration-dating-extension" target="_blank">https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/expiration-dating-extension</a> <a href="#fnref:10" class="footnote-back-ref">↩</a></p></li> <li id="fn:11"><p>Office of the Commissioner (9 August 2024). "Expiration Dating Extension". FDA. <a href="https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/expiration-dating-extension" target="_blank">https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/expiration-dating-extension</a> <a href="#fnref:11" class="footnote-back-ref">↩</a></p></li> </ol>