This is a matter of urgent concern, and I would suspect that my people at St. Joe's are concerned...
To me, that is the definition of 'manufacturing.'
I would ask that they be inserted in the record and the response that will be received by the committee.
I think that is at the heart of us trying to figure out where our jurisdiction lies or doesn't lie with the FDA and our role.
Thank you, Mr. Chairman.
I would urge you to just cooperate with us and with my good friend and give us the answers that we need.
Please submit to us your suggestions for that authority to be given.
Would you please submit to us the authority that you require?
Please submit to us the authorities that are needed so that we can address that problem.
When will you submit to us a response to those letters so that we can have that information available to us as the committee proceeds?
It does not sound to me like FDA has authorities to oversee compounding pharmacies.