“I certify that this compounded variation produces ‘a significant difference from the marketed drug version.’ ”
If Congress’s initial, knee-jerk reaction to the 2012 New England Compounding Center (NECC) meningitis tragedy had become law, you would have had to add this federally mandated disclaimer to every prescription you wrote for a compounded drug. It seems Congress, influenced by pharmaceutical industry lobbying dollars, wanted to reward the FDA’s failure to shut down grossly negligent compounding manufacturers—but did so by granting the agency vast new powers.