Showing posts with label jurisdiction under proposed federal legislaiton. Show all posts
Showing posts with label jurisdiction under proposed federal legislaiton. Show all posts

Saturday, May 11, 2013

Question of the Day May 11, 2013: “We need to get into pharmacies to make sure they are not posing as traditional pharmacies,” she told the hearing. “Sometimes, if there is an outbreak, we get reports and they say, ‘no you can’t come into our pharmacy’. “ Without seeing records, Woodcock says, FDA can’t tell where a contaminated drug may have been shipped.

Based on this comment wouldn't the FDA need jurisdiction over all compounders to accomplish this goal?  In other words wouldn't the FDA need to look at all compounders records to determine which ones are posing as traditional compounder or at least more jurisdiction than what the current proposed legislation grants the FDA? Or will it be enough if the FDA has a reasonable belief a pharmacy is a manufacturing compounder for it to see the pharmacies records? If the answer is that the FDA and the state will go together to look at the pharmacies records, how is that any different from the way it is now?