on the ceiling or
with a flimsy plastic
drape separating the
sterile lab from the
construction going
on in the next room.
These poor prac-
tices suggest to
some that another
New England
Compounding
Center (NECC) is a matter of when, not if.
"The things that the FDA has seen are quite shocking," says Jane
Axelrad, who served as the FDA's lead on enacting pharmacy com-
pounding legislative provisions following the deadly 2012 fungal menin-
gitis outbreak at NECC. "Since NECC, you would think that com-
pounders would have cleaned up their acts, but in many places, that's
not the case. Many rogue compounders are still out there trying to
skate under the radar. Why? Because they make a lot of money doing it.
Or they think they'll never get caught."
The shocking NECC story has been told many times. A mom-and-pop
pharmacy in a Massachusetts strip mall shipped 17,600 mold-tainted
vials of injectable methylprednisolone acetate, a steroid commonly
used to treat spine and joint pain, to ambulatory surgical centers and
hospitals in 23 states. You know the rest: 76 patients died of meningitis
and hundreds more fell seriously ill.
Enough of a wakeup call?
The FDA and state boards of pharmacy have significantly increased
their regulatory oversight of compounding facilities in the wake of
5 6 • O U T PA T I E N T S U R G E R Y M A G A Z I N E • J A n U A R Y 2 0 1 8
• TEST SCORE One major red flag to look out for with your compounding pharmacy
is whether they send you sterility and stability test results. If not, it might be time to
walk away.
