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10/8/2015

No Syringe Is Approved as a Standalone Storage Container, FDA Says

Cheryl Thompson

Cheryl A. ThompsonDirector
News Center

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.

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

Those medications numbered 10 by September 1: atropine, cisatracurium, fentanyl, hydromorphone, methadone, midazolam, morphine, neostigmine, remifentanyl, and rocuronium.

On September 8, FDA advised hospital pharmacies and staff not to administer compounded or repackaged drugs that have been stored in BD’s 1-, 3-, 5-, 10-, 20-, or 30-mL syringes “unless there is no suitable alternative available.”

According to Troy Kirkpatrick, BD’s public relations director, the company has not studied the plunger stoppers—whether supplied by its longtime primary supplier or the alternate supplier—in the context of general-purpose syringe use for drug storage.

The company has used the same primary supplier of plunger stoppers for more than 20 years, Kirkpatrick indicated.

Bona E. Benjamin, ASHP’s director of medication-use quality improvement, said the recent announcements about general purpose syringes highlight the need for pharmacists to select 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.

Therefore, she said, pharmacies that want to store their own compounded or repackaged sterile preparations in general purpose syringes have two choices: (1) “Test every drug at every concentration that you use and in every size syringe that you use” or (2) rely on the results of published stability studies “if you have the exact same syringe, the exact same concentration, and the exact same drug and you . . . handle it and store it just like the drug in the study was stored.”

Benjamin cautioned that the beyond-use dates in United States Pharmacopeia chapter 797 address the sterility of a compounded sterile preparation in a final sterile container—not the potency or stability of the drug.

According to a guidance document issued by FDA in 1993, companies seeking to market piston syringes, which are used to inject fluids into or withdraw fluids from the body, must provide stability data if the device’s labeling mentions a specific drug or biological agent.

The glass and plastic syringes that BD makes specifically for use by the pharmaceutical industry in manufacturing prefilled medication syringes are tested for storage capabilities by the pharmaceutical companies, Kirkpatrick stated.

As an example of that type of product, FDA’s communication to ASHP cited BD syringes marketed under the Hypak brand, whose sole established use is for the storage of specific medications that FDA has approved for marketing in prefilled syringes.

Medical devices marketed as empty containers for i.v. fluid mixtures, however, have been established as suitable for storage.

When Baxter Healthcare Corporation notified FDA in 1996 that the company wanted to change materials and the sterilization method for its Viaflex plastic containers and market the resultant devices under the trade name IntraVia, the company said it tested their performance.

The company, according to a publicly available document, also conducted drug compatibility studies “with commonly admixed drugs or those that have a high potential to adsorb to the container under representative storage conditions.”

As for automated i.v. compounding devices, brochures laud the devices’ use in filling syringes and bags but do not state outright that filled syringes can be stored for later use.

Kirkpatrick indicated that BD continues to use plunger stoppers from both its primary and alternate suppliers in manufacturing general purpose syringes.

Notices regarding BD syringes and a search tool for identifying the type of plunger stopper used in a specific syringe lot can be obtained at the company’s website (www1.bd.com/alerts-notices).

“BD,” Kirkpatrick stated, “is an important supplier of general use syringes worldwide and has a responsibility to take steps to reduce the possibility of syringe shortages.”

Such steps include having a second supplier in case a natural or manmade disaster strikes the primary supplier of a device component.

In 2003, after an explosion at the North Carolina manufacturing facility of West Pharmaceutical Services, which supplied plunger stoppers for certain BD syringes, BD notified customers to expect a short-term interruption in the supply of the affected syringes.

[This news story appears in the November 1, 2015, issue of AJHP.]