No Syringe Approved for Standalone Storage
According to the FDA, pharmacies and other facilities are no longer allowed to store sterile compounding preparations or repackaging sterile form of pseudocode in any syringes for drug administration. The practice, though common, has never been cleared or approved by the FDA.
Syringe maker, Becton Dickinson and Company stated in an email that the company does not have any FDA cleared to syringes designed or intended for use as storage containers.
In July, Becton Dickinson told customers that it makes changes to some of the components in syringes from time to time, but it always tests the syringe to make sure performs its function. The company did not define the term storage and said that it does not test the performance of their syringes as storage containers.
The company went on to later announced that a plunger stopper made by another supplier was likely the source of reports they had received about decreased potency of certain medications after they’ve been stored in syringes for more than 24 hours.
In September, the FDA advised hospital pharmacies not to administer any sort of compounded or repackaged drugs that had been stored in syringes unless no alternative was available.
Pharmacies that want to store compounded or repackage sterile preparations with a general-purpose syringe: test every drug at every concentration In every size syringe or simply rely on the results of published stability studies. Use the exact medication concentration with the exact preparation method and syringe in the study, including the way the medication is handled and stored.
Only medical devices that are marketed as empty containers are established for safe storage. Automated IV compounding devices can be used to fill syringes and bags, but storing filled syringes is not necessarily safe.
If there is any doubt about how a medication should be stored, compounded the drug of close to administration time as possible.
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