to oversee compounding pharmacies could continue. "It will be difficult for us to identify compounding pharmacies that choose not to register with us. We will not be able to do proactive inspections and will have to wait until we have a complaint," FDA associate director for policy Jane Axelrad said.
Date: Dec 03, 2013
Category: Health
Source: Google
Some drug providers can elude crackdown in wake of meningitis scare, U.S. ...
But Jane Axelrad, associate policy director for the FDAs Center for Drug Evaluation and Research, noted it is up to larger-scale compounding pharmacies to register voluntarily as outsourcers, for which they will qualify for certain FDA exemptions and in turn submit to federal oversight and inspecti
Date: Dec 03, 2013
Category: Health
Source: Google
FDA hopes hospitals will switch to newly regulated pharmacies
"The more that register, the less need there would be to buy from facilities that are not registered," Jane Axelrad, associate director for policy for the FDA's Center for Drug Evaluation and Research, told reporters in a conference call.
FDA officials said they were not certain how many compounders would choose to register with the agency. "Because it's a new program and it's up to them to register, we really don't know, " said Jane Axelrad, FDA's associate director for policy. Registered compounders will be required to pay an annua
Date: Dec 02, 2013
Category: Health
Source: Google
FDA to use new drug compounding law to promote regulated pharmacies
"Itwill be difficult for us to identify compounding pharmacies that choose not toregister with us," said Jane Axelrad, associate director for policy forthe FDA's Center for Drug Evaluation and Research. "We will not be able todo proactive inspections and will have to wait unt