Third Question of the Day In light of the fact that outsourcing facilities who voluntarily register with the FDA will be regulated by the FDA under manufacturing standards will state boards of pharmacies have any authority over them? Will it depend on whether they are strictly an outsourcing facility in which case?

In which case, the state board of pharmacy will have no authority over them if they voluntarily submit to FDA authority.  If they are both an outsourcing facility who voluntarily submits to FDA jurisdiction and a pharmacy filling prescriptions etc. then the FDA will regulate the outsourcing facility and the state board will regulate the pharmacy.  And if they are a pharmacy filling prescriptions, or doing traditional compounding then they remain under the state boards of  pharmacies' jurisdiction.   Here is one flaw with this legislation if you are an outsourcing facility but do not voluntarily register then it is up to state boards of pharmacy to regulate you--assume you are clearly producing large quantities of compounds and the market hasn't driven you out of business--under the current system the states would report you to the FDA as manufacturer--but under House Bill 3204 what happens--you didn't voluntarily agree to FDA authority, so now what happens?   If we thought we had a patchwork of authority before what will we have after this legislation passes?