Products that fail testing or are not tested must be destroyed upon reaching their expiration date.The FDA will not test biological products such as vaccines, serums, blood products or toxoids.

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Individual units must be properly labeled with stickers containing the detailed information about the extension before they leave centralized storage.

Changes in the supply system for medications during the past decade have altered the focus of SLEP.

While many medications have a strong history of successful extension, others are predictably unpredictable, meaning sometimes they can be extended the full timeframe and sometimes they fail testing with no discernible pattern.” Extended or Not For military pharmacists, telling whether a particular product has been extended is simple enough.

The FDA Center for Drug Evaluation and Research recommends that extended medications within the Do D have the lot number, new expiration date and FDA project number imprinted on a new sticker.

SLEP restricts testing to “military significant” medications, “those that are either military-unique, possessing no commercial (non-Do D) market or those drugs for which the Do D procures such large quantities for pre-positioned stocks that vendors are unwilling to accept them for credit upon expiration,” Guill told U. Significant savings Even with a restricted number of medications eligible for the program, Do D’s savings have been substantial.

According to the authors of the research letter, “each dollar spent on SLEP to demonstrate longer than labeled drug stability results in to saved on reacquisition costs.” To convert those dollars to savings per drug, Guill noted that, “in 2006, we tested ciprofloxacin and extended it for two years, saving the U. government in excess of

According to the authors of the research letter, “each dollar spent on SLEP to demonstrate longer than labeled drug stability results in $13 to $94 saved on reacquisition costs.” To convert those dollars to savings per drug, Guill noted that, “in 2006, we tested ciprofloxacin and extended it for two years, saving the U. government in excess of $1.5 million on that one product alone.” She added that, “in Israel, the only other country with a shelf life extension program, testing of ciprofloxacin is predicted to result in savings of more than 60 million shekels [$15.3 million] over a period of 10 years.” These extensions — and savings — are possible because the FDA does not require manufacturers to actually determine how long a drug will remain stable.The group tested eight-decades-old prescription medications unearthed in a retail pharmacy and found that 12 of the 14, or 86%, of the compounds tested in the drugs retained at least 90% of their potency 28 to 40 years after their expiration dates.1 Those results came as no surprise to those involved in the Do D/U. Food and Drug Administration Shelf Life Extension Program (SLEP), which has been testing pharmaceuticals for more than 25 years to estimate when drugs actually will lose their potency.The medications tested by Cantrell and colleagues contained several common ingredients.Of these, only aspirin and amphetamine had deteriorated below generally recognized minimum acceptable potency.One other, phenacetin, showed a concentration of less than 60% when tested in one medication, but 110% in another.The expiration date, typically 12 to 60 months from date of production, reflects a minimum window, the period through which the manufacturer guarantees the medication’s potency.

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According to the authors of the research letter, “each dollar spent on SLEP to demonstrate longer than labeled drug stability results in $13 to $94 saved on reacquisition costs.” To convert those dollars to savings per drug, Guill noted that, “in 2006, we tested ciprofloxacin and extended it for two years, saving the U. government in excess of $1.5 million on that one product alone.” She added that, “in Israel, the only other country with a shelf life extension program, testing of ciprofloxacin is predicted to result in savings of more than 60 million shekels [$15.3 million] over a period of 10 years.” These extensions — and savings — are possible because the FDA does not require manufacturers to actually determine how long a drug will remain stable.

The group tested eight-decades-old prescription medications unearthed in a retail pharmacy and found that 12 of the 14, or 86%, of the compounds tested in the drugs retained at least 90% of their potency 28 to 40 years after their expiration dates.1 Those results came as no surprise to those involved in the Do D/U. Food and Drug Administration Shelf Life Extension Program (SLEP), which has been testing pharmaceuticals for more than 25 years to estimate when drugs actually will lose their potency.

The medications tested by Cantrell and colleagues contained several common ingredients.

Of these, only aspirin and amphetamine had deteriorated below generally recognized minimum acceptable potency.

One other, phenacetin, showed a concentration of less than 60% when tested in one medication, but 110% in another.

The expiration date, typically 12 to 60 months from date of production, reflects a minimum window, the period through which the manufacturer guarantees the medication’s potency.

||

According to the authors of the research letter, “each dollar spent on SLEP to demonstrate longer than labeled drug stability results in $13 to $94 saved on reacquisition costs.” To convert those dollars to savings per drug, Guill noted that, “in 2006, we tested ciprofloxacin and extended it for two years, saving the U. government in excess of $1.5 million on that one product alone.” She added that, “in Israel, the only other country with a shelf life extension program, testing of ciprofloxacin is predicted to result in savings of more than 60 million shekels [$15.3 million] over a period of 10 years.” These extensions — and savings — are possible because the FDA does not require manufacturers to actually determine how long a drug will remain stable.

The group tested eight-decades-old prescription medications unearthed in a retail pharmacy and found that 12 of the 14, or 86%, of the compounds tested in the drugs retained at least 90% of their potency 28 to 40 years after their expiration dates.1 Those results came as no surprise to those involved in the Do D/U. Food and Drug Administration Shelf Life Extension Program (SLEP), which has been testing pharmaceuticals for more than 25 years to estimate when drugs actually will lose their potency.

The medications tested by Cantrell and colleagues contained several common ingredients.

Of these, only aspirin and amphetamine had deteriorated below generally recognized minimum acceptable potency.

.5 million on that one product alone.” She added that, “in Israel, the only other country with a shelf life extension program, testing of ciprofloxacin is predicted to result in savings of more than 60 million shekels [.3 million] over a period of 10 years.” These extensions — and savings — are possible because the FDA does not require manufacturers to actually determine how long a drug will remain stable.

The group tested eight-decades-old prescription medications unearthed in a retail pharmacy and found that 12 of the 14, or 86%, of the compounds tested in the drugs retained at least 90% of their potency 28 to 40 years after their expiration dates.1 Those results came as no surprise to those involved in the Do D/U. Food and Drug Administration Shelf Life Extension Program (SLEP), which has been testing pharmaceuticals for more than 25 years to estimate when drugs actually will lose their potency.

The medications tested by Cantrell and colleagues contained several common ingredients.

Of these, only aspirin and amphetamine had deteriorated below generally recognized minimum acceptable potency.