FDA: Syringes not approved for storing sterile pharmaceuticals

The apparently common practice of storing sterile compounded preparations or repackaging sterile pharmaceuticals in drug-administration syringes is an unapproved use of these medical devices, the U.S. Food and Drug Administration said this week.

“FDA has not cleared or approved any syringes for stand-alone use as ‘closed container systems,’ ” the FDA told the American Society of Health-System Pharmacists (ASHP) in a recent letter.

Syringe maker Becton, Dickinson and Company (BD) likewise said 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 up in July after BD told customers 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 said it does not test the performance of its general-purpose syringes as storage containers for compounded pharmaceuticals.

BD later said a plunger stopper made by an “alternate” supplier was the likely source of reports the company received alleging decreased potency of certain medications stored in certain BD syringes for more than 24 hours.

Bona Benjamin, ASHP’s director of medication-use quality improvement, said the recent announcements about general-purpose syringes emphasize the need for pharmacists to choose the appropriate container for a particular compounded sterile preparation.

“We now know that general-purpose syringes are not approved, nor have been tested for feasibility as drug-storage containers,” Benjamin said.

Benjamin said pharmacies who want to store their own compounded or repackaged sterile preparations in general-purpose syringes should either test every drug at every concentration or rely on the results of published stability studies.
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