6 0 • O U T PA T I E N T S U R G E R Y M A G A Z I N E • A P R I L 2 0 1 6
As a pharmacy and safe medication consultant to ambulatory surgery centers, I can honestly say
that once you understand the myriad benefits of using pre-packaged, pre-filled syringes, there's
really no more discussion to be had. I'd give them 3 thumbs up, if I had 3 thumbs.
Unfortunately, largely as a result of the 2012 meningitis outbreak, which was linked to the New
England Compounding Center (NECC) (osmag.net/Gb3xHT), there's a lingering temptation to put
all compounders into a bucket of hesitation. That bucket says they're not as good, or as safe, as
pharmaceutical manufacturers. Here's what people need to understand: As a result of the NECC
fiasco, the FDA stepped up — and quickly — by, among other things, developing categories of
compounders. The resultant 503B compounders — those qualified to dispense not just to a single
patient, but also to provide broader distribution to healthcare providers — represent a big step
forward. I've collaborated with this select group. They're well aware of provider concerns, are
clearly focused on excellence and are achieving exceptional results. In fact, they appear to be
achieving a recall rate that equals or surpasses that of pharmaceutical manufacturers.
But there's one caveat. Your pharmacy consultant needs to help facilities in the due diligence
of provider selection, because registering with the FDA as a 503B is just the first step. An ensu-
ing FDA inspection is an integral part of the process. I urge my clients not to do business with a
503B compounder until after the FDA has visited the facility and provided its formal assessment.
But once that hurdle is cleared, it should be smooth sailing in terms of regulatory compliance
and quality. No surgical facility preparing syringes on as-needed basis can match the levels of
control, sterility and competence that FDA-approved 503B compounders achieve.
If you're on the fence because you're concerned about costs, I recommend you work with your
THUMBS UP
Compounders Are Stepping Up, Achieving Impressive Safety
• ON POINT It's doubtful that any surgical facility can match the levels of control, sterility and competence that FDA-approved 503B compounders offer.
Pamela
Bevelhymer,
RN,
BSN
