Monday, April 1, 2013

Regulators scrutinize compounding pharmacies in Tennessee, nation (with video) by Kate Harrison


Compounding pharmacies see renewed attention after meningitis outbreak
Chattanooga-area compounding pharmacies have seen renewed attention from both customers and the Tennessee Legislature after a deadly meningitis outbreak that stemmed from a Massachusetts pharmacy. Access Family Pharmacy, which fills about 60 compounding prescriptions per day, has specialized in compounding prescriptions since 1962.
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Compounding pharmacies long have been able to fill the gap between mass-produced drugs and highly personal medical needs.
These pharmacies can customize a drug product into a liquid or a gas for patients who can't swallow pills. They can make a medication without specific allergens. They can flavor a medicine with mint or tropical fruit to be more palatable. And they can compound drugs that are on back order -- such as Tamiflu for children.
"Maybe [the patient] can't take something that's commercially made because it's one-size-fits all. Or it's something that's not commercially made and they've got to have it," explains pharmacist Phil Smith at Access Pharmacy, which has been compounding drugs in the Hixson store for more than 50 years.
But over the last few months, state and federal officials have said the gap that compounding pharmacies have filled has been far too unregulated, leading to abuse by certain pharmacies.
"It has been a crazy few months for compounding," said Smith. "We have been letting our customers know that our chemicals are tested, our manufacturers are FDA tested and approved. Things like that let people know what our quality standards are."
A deadly meningitis outbreak prompted heightened scrutiny from both state and federal regulators. Just last month, there were two more recalls of sterile compounded and repackaged drug products, first from a New Jersey compounding pharmacy after fungal contamination was found at a hospital. Days later, a compounding pharmacy in Martinez, Ga., recalled syringes of the drug Avastin after it received reports of eye infections among patients.
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