Staff Writer
Ohio is cracking down on pharmacies that custom-mix individualized prescriptions in the wake of a deadly fungal meningitis outbreak tied to a Massachusetts compounding pharmacy.
Statewide, 17 pharmacies are now specially designated as compounding sites, said Jesse L. Wimberly, spokesman and pharmacy inspector for the Ohio State Board of Pharmacy. Inspectors check pharmacies at least every three years, though they will go more often if complaints are filed or violations are reported. “Now we’re going to every one of these pharmacies that are designated for compounding,” he said.
The state now requires pharmacies to spell out how much of their business is strictly retail sales and how much is mixing up custom preparations, Wimberly said. And when a state inspector comes to call, they have to be able to demonstrate both that their facilities meet cleanliness standards set out by the U.S. Pharmacopoeia, a kind of governing board for pharmacists, and to show that their products are being prepared for specific patients — not mixed up in advance and set aside so it’s ready when and if the order comes in.
“The issue we’re having now is are you doing patient-specific compounding,” Wimberly said. “We don’t do manufacturing. We do compounding for specific patients. We check the records and make sure that they’re in compliance so that when you get a prescription it’s for a specific person and you’re compounding that prescription for that person and giving that prescription to that person,” he said.
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