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FDA oversight 3 articles

FDA cracks down on compounding pharmacies, issuing warning letters for unsanitary practices

The Food and Drug Administration (FDA) is coming down hard on compounding pharmacies, issuing warning letters for unsanitary conditions and producing drugs without individual prescriptions. The action comes four months after congress passed the Drug Quality and Security Act, which puts compounding pharmacies that outsource their products under FDA oversight instead of being governed by state pharmacy boards like traditional pharmacies. Nora Apothecary and Alternative Therapies, Pallimed Solutions Inc., and Wedgwood Village Pharmacy received warning letters outlining sterility issues with facility procedures from visible sterile drug contaminants to inadequate clean rooms and monitoring programs. The FDA’s oversight into compounding pharmacies ... Read More

Psychotic behavior a possibility with some synthetic drugs

It is perhaps the most disturbing story to come out in recent months – a drugged out maniac stripping naked and then eating off the face of a homeless man on a Miami causeway. One researcher warns that the attacker’s psychotic rage may not be as random as generally thought. “Absolutely bizarre, if not demonic behavior,” Dr. Deborah Marsh, founder and director of the University of Miami Brain Endowment Bank, told CBS4 News. She says the symptoms the attacker displayed are indicative of ones experienced by people who have gotten high off synthetic drugs, many of which are imported from and ... Read More

FDA proposes oversight for mobile medical apps

Certain medical applications used on smartphones and iPads may be required to follow guidelines laid out by the Food and Drug Administration (FDA), especially if they pose risks for patients if they do not work as designed. The agency proposed a list of guidelines this week and is taking public comment over the next 90 days. The FDA is tasked with protecting the public health by assuring that foods are safe, sanitary and properly labeled, and that drugs, vaccines and other biological products and devices are safe and effective. The agency says that the guidelines for certain medical apps are ... Read More