Extending expiration dates of doxycycline tablets and. Research and extension activities voluntary shelf life program. This manual is reissued under authority of dod directive 4140. Eisenman said that because of concerns about the ability to extend its shelf life, epipen is not in the federal shelflife extension program, a federal program designed to aid in stockpiling. Some antibiotics, like cephalexin mean extension is 74 months past expiration, while amoxicillin as tested is 23 months. 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. Provide management control and resources for the execution of shelflife program functions. The shelf life of many drugs, it wrote, seems to be considerably longer than their expiration dates, leading to unnecessary waste, higher pharmaceutical costs. Some companies use induction sealing and vacuumoxygenbarrier pouches to assist in the extension of the shelf life of their products where oxygen causes the loss the dod shelflife program defines shelflife as the total period of time beginning with the date of manufacture, date. Shelf life extension program shelf life extension program slep should be used whenever there is a justification. Because of the economic significance of the fluid milk processing sector, the fluid milk voluntary shelflife vsl program is the focal point of the mqip at cornell university. Dla information operations how to guide how to register in the account management and provisioning system amps for sles access the purpose of this how to is to provide instructions on requesting a role in amps for access to the dod shelflife extension system sles website. We want people to learn about the sns to help ensure people understand that in a real event, there is a. The mqcss and qsl together are the authority for shelflife extension when laboratory inspection.
Shelflife extension program slep as a significant contributor to strategic national stockpile maintenance. All services participate in shelf life extension program, said dod officials. Although pathogens are usually monitored during shelflife studies, a suitable food safety program is the best way to ensure the products safety. Stability profiles of drug products extended beyond. Both intrinsic and extrinsic factors influence the shelf life of. We have the shelf life extension program slep that was initiated by fema and their long term storage planning. These standards provide the inspection, testing, and storage requirements for extendible type ii shelf life materiel. Unlike federally stockpiled drugs, which are eligible for testing by fda through the department of defense dod administered federal shelf life extension program slep, drugs stockpiled for use as medical countermeasures by nonfederal stakeholders can have their expiration dates extended under section 564ab of the food, drug, and cosmetic act. The program is an acknowledgement that the actual shelf life of drugs and other medical products may be longer than their stated expiration date, depending on. The slep has been administered by the food and drug administration for the united states department of defense dod for 20 years. Preservatives and antioxidants may be incorporated into some food and drug products to extend their shelf life. An effective shelf life extension program is a critical part of life cycle management.
To be clear, the average shelf life extension as tested in the selp program for antibiotics is 48 months mean average. Rather than disposing of billions of dollars of the militarys stockpiled medications that were set to expire in the 1980s, the fda tested various batches of the medications in their supplies to provide extensions in shelf life. 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. Shelflife extension program slep as a significant contributor to. The dmles portfolio provides a continuum of medical logistics support for the defense health agency.
The mqcss and qsl together are the authority for shelf life extension when laboratory inspection. Washington, march 29, 2000 military health officials have saved american taxpayers millions through a testing program that extends the shelf life of drugs. Eightyeight 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. An overview of the federal shelf life extension program and cost benefits, state and local antiviral and antibiotic stockpiling efforts, and recommendations for maximizing the shelf life of critical medicines stockpiled at the state and local levels. This program probably contains the most extensive source of pharmaceutical stability data extant. This program has evaluated at least 100 medications that were expired for at least 2 to 10 years at the time they were evaluated. Appoints a director for the dod shelf life program, whose duties include chairing the dod shelf life board under the charter in section 3 of this volume. Dec 28, 20 we have the shelf life extension program slep that was initiated by fema and their long term storage planning. In order to assure maximum customer use of shelf life items, each of these items must be identified, including newly procured items having limited serviceability. Government usg information system is that is provided for usgauthorized use only. Eightyeight percent of 122 different drugs stored under ideal environmental conditions had their expiration dates extended more than 1 year. Shelflife extension program stockpiling drugs, vaccines, and medical products is critical to ensure public health emergency preparedness for both the u.
Identify focal points for the shelflife program at the inventory. Both intrinsic and extrinsic factors influence the shelf life of food products. Shelf life extension program how is shelf life extension program abbreviated. Bodas m1, yuval l, zadok r, hess z, haran b, kaplan m, eisenkraft a. Mqcss is the authority for shelf life extension when visible inspection only is required. Agencies shall establish controls for such materials to prevent issuance of any unserviceable items. They are expected to deteriorate or become unstable to the degree that a storage period must be assigned to assure that the material will perform satisfactorily in service. Meanwhile the fda has long known that many remain safe and potent.
Emergency use authorization toolkit supplemental materials. Joint medical asset repository jmar is an information technology system within the defense medical logistics enterprise solutiondmles portfolio. So mileage varies and any decision to use antibiotics past expiration is a personal decision, but with. A significant portion of hazardous materials turned in for disposal are in their original packaging and meet the performance requirements as defined in the military specification. Shelf life extension program stockpiling drugs, vaccines, and medical products is critical to ensure public health emergency preparedness for both the u.
Pdf on dec 1, 2016, kamla pathak and others published shelf life extension program. Gsa shelf life management program shelf life items are products that are effective, useful or suitable for consumption for a limited time period. Hospitals and pharmacies are required to toss expired drugs, no matter how expensive or vital. It tests medications for safety and stability for extended periods of time in controlled storage conditions. Dd form 24773, shelflife extension notice 3x1, april. These standards provide the inspection, testing, and storage requirements for extendible type ii. Dd form 24773, shelflife extension notice 3x1, april 1999. The shelf life extension program isnt something most people know about. The first piece is the materiel quality storage standards as prescribed by ar 70218. Department of defense dod in cooperation with the u. Mqcss is the authority for shelflife extension when visible inspection only is required. Establish and maintain a workable shelflife program, in accordance with volume 5 of dodm 4140. Slep shelflife extension program fda term sles shelflife extension system.
The military stockpiles such large quantities of the drug that the manufacturer will not permit the expired drugs to be returned for credit. The shelflife extension program slep checks longterm stability of federal drug stockpiles. Administration, office of regulatory affairs and defense medical material program. Unlike federally stockpiled drugs, which are eligible for testing by fda through the department of defense dod administered federal shelflife extension program slep, drugs stockpiled for use as medical countermeasures by nonfederal stakeholders can have their expiration dates extended under section 564ab of the food, drug, and cosmetic act. The defense logistics agency maintains a dod shelf life program extension program sles web page login required that has access to a quality status list qsl which extends certain type ii federal stock class fsc material. Dod shelf life extension system quartermaster corps. Department of defense shelf life extension program. Revalidating expiry date find, read and cite all the. Shelf life extension program how is shelf life extension. An effective shelflife extension program is a critical part of lifecycle management. Fda finalizes guidance on extending stockpiled doxycycline. Jmar provides 247 access to medical asset information for users, on any computer.
The mqcss is the authority for shelflife extension when visual inspection only is required. Jul 18, 2017 the shelf life of many drugs, it wrote, seems to be considerably longer than their expiration dates, leading to unnecessary waste, higher pharmaceutical costs, and possibly reduced access to. Included on the qsl are federal stock classes fscs. The mqcss is the authority for shelf life extension when visual inspection only is required. The defense health agency dha, in coordination with the fda, the military departments, the defense logistics agency, center. Dod shelflife extension system sles defense logistics agency. All desired perishable pharmaceuticals should be identified 210 days prior to the.
The director, dod shelf life program will provide a monthly data pull of type ii shelf life national stock numbers nsns whose shelf life extension information is omitted from the mqcss portion of shelf life extension system sles to the managing dod components and gsa. The sns participates in the federal shelf life extension program for federal stockpiles which is managed by the department of defense and the fda. For doxy specifically it states anywhere from 173 month extensions have been granted. Federal shelf life extension program fact sheet state public. 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.
Most drugs are still safe to use years after their. Federal shelf life extension program fact sheet overview. Slep is the federal, feeforservice program through which the labeled shelf life of certain federally stockpiled medical materiel e. Qsl contains the results of previously completed laboratory extension testing. Both food safety and quality are important aspects of acceptable shelf life. The defense logistics agency maintains a dod shelflife program extension program sles web page login required that has access to a quality status list qsl which extends certain type ii federal stock class fsc material.
When people dont understand the process behind the relabeling, it can cause confusion and misinformation. The slep enables each program participant to provide adequate oversight, ensure effective inventory controls, and monitor stockpiles for shelf life extension opportunities. Results from the shelf life extension program slep have been evaluated to provide extensive data to address this issue. Shelf life management program frequently asked questions gsa. Stability profiles of drug products extended beyond labeled. The intended outcome of the slep is measurable cost avoidance returned to program participants and continued availability of potencydated contingency stocks. Administers the dod shelf life program in accordance with volume 5 of dodm 4140. Maximizing state and local medical countermeasure stockpile. Once the fda conducts stability testing and determines that products are stable and safe for continued use, the program will extend the useby dates of. Medical countermeasures, strategic national stockpile.
Qsl testing results with supply condition code a may be used as the authority to extend type ii shelflife materiel if it has been stored and packaged appropriately. Federal shelf life extension program fact sheet state. The federal shelf life extension program slep extends the expiration dates on qualifying drugs and other materiel in federal stockpiles. Pdf shelflife extension program slep as a significant. Expired shelf life items no longer support the customers. The fda regularly tests the dods expired doxycycline and extends the shelf life. Research and extension activities food safety laboratory.
The shelf life extension program slep is a program jointly launched by the united states department of defense and the food and drug administration, initially only for the purpose of reducing. Government usg information system is use and consent. Expired medications have not necessarily lost potency, since. 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. Defense medical materiel program office dmmpo see shelf life extension program emergency use authorization eua public law, statute, and regulations federal food, drug, and cosmetic act 564, as amended. Dod shelf life extension system the dod shelf life extension system sles consists of two main components. United states food and drug administration and department of. Stability of active ingredients in longexpired prescription.
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