The seemingly common practice at pharmacies and outsourcing facilities of storing sterile compounded preparations or repackaging sterile pharmaceuticals in drug-administration syringes is actually an unapproved use of these medical devices, according to FDA.
“FDA has not cleared or approved any syringes for stand-alone use as ‘closed container systems,’” the agency informed ASHP via e-mail in September.
Syringe maker Becton, Dickinson and Company (BD) likewise stated in an e-mail that the company “has no FDA-cleared syringes designed or intended for hospital pharmacies and outsourcing facilities to use as storage containers.”
The matter came to light in late July after BD informed customers that it periodically modifies some components of BD syringes but always tests that the modified syringes perform as intended (i.e., for general purpose fluid aspiration or injection) when filled and used promptly. Without defining the term storage, the company stated that it does not test the performance of its general purpose syringes as storage containers for compounded pharmaceuticals.
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