04/17/2013
https://congress.gov...
"Under the proposed Senate framework, FDA would be barred from requiring compounding manufacturers to submit NDAs and ANDAs pre-inspection and labeling requirements before these drugs reach patients."
"My goal has always been to draw a clear line on defining what a traditional compounding pharmacy is, and that should be regulated by the States, and what a manufacturer, a drug manufacturer is, which ..."
"Who at the Food and Drug Administration has been fired over this incident? Again, 53 Americans died, 700 are living with a disability."
"Would it be better to regulate large-scale compounders under the manufacturing standards rather than establishing a new category?"