09/22/2011
https://congress.gov...
"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 ..."
"But, honestly, all the laws in the world are not going to save a single patient if there is no one enforcing the law."
"The chair thanks the gentleman and now recognizes the gentleman from Virginia, Mr. Griffith, for 5 minutes for questions."
"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."