Archive January 2018 XIX, No. 1

Select the Right Compounding Pharmacy

Be sure you're working with a pharmacy that shares your commitment to keeping patients safe.

Brielle Gregory

Brielle Gregory, Associate Editor


Watchful Eye
WATCHFUL EYE Compounding pharmacies are now under greater scrutiny and more regulatory oversight from both the FDA and state boards of pharmacy since the New England Compounding Center disaster.

You'd think the worst pharmaceutical disaster in decades would have scared compounding pharmacies straight, but FDA investigators and state boards of pharmacy continue to see rogue pharmacies mixing supposedly sterile drug products in unsanitary conditions. During recent facility inspections, investigators have observed pharmacies sterilizing glassware in toaster ovens and in dishwashers, straining liquids with coffee filters, and mixing drugs in rooms with dirt stains on the ceiling or with a flimsy plastic drape separating the sterile lab from the construction going on in the next room. These poor practices 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 compounding legislative provisions following the deadly 2012 fungal meningitis outbreak at NECC. "Since NECC, you would think that compounders 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 NECC. In 2012, the FDA inspected 4 compounders. Since 2013, the FDA has inspected more than 400 pharmacies, says Ms. Axelrad. But it's fair to question whether NECC was enough of a wakeup call for the industry.

"Have things gotten better since NECC?" asks Ms. Axelrad. "Absolutely not."

While increased scrutiny has shuttered some rogue pharmacies — "not enough, but some," says Ms. Axelrad — who didn't want to pay to bring their facilities up to standards, it's still relatively easy for a compounder to locate in a state with lax governance and ship products produced in unsanitary conditions to unsuspecting surgical facilities all over the country, says Ms. Axelrad.

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