Written by
Duane W. Gang
Quoted from The Tennessean
On legislation passed to strengthen the rules on compounding pharmacies in the wake of the deadly meningitis outbreak last year
“I would have preferred the Senate bill. If you are going to sell sterile products without prescriptions across state lines, you’ve got to be regulated by the FDA,” Alexander said. “I would have preferred that. But we couldn’t get that passed in the House.”
The legislation that did pass creates a new category of compounding pharmacies and gives them the option of coming under FDA regulation.
“There’s legitimate criticism of that. You could say that is a loophole. You don’t have to be regulated by the FDA,” Alexander said. “But I think this is an important step forward. Doctors and hospitals are going to think long and hard about buying big batches of sterile, compounded drugs from institutions that aren’t regulated by the FDA.”
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