FDA regulation of compounding pharamcies News

‘I Wish We Had Acted Earlier,’ Says FDA Chief on Meningitis Outbreak

The head of the U.S. Food and Drug Administration conceded on Tuesday that the agency could have been more aggressive in its oversight of the compounding pharmacy at the center of a deadly meningitis outbreak. Testifying at a contentious congressional …

FDA Finds Safety Issues at Specialty Pharmacies

The Food and Drug Administration says it has uncovered potential safety problems at 30 specialty pharmacies that were inspected in the wake of a recent outbreak of meningitis caused by contaminated drugs. The agency said its inspectors targeted 31 compounding …

FDA Needs New Authority Over Compounding Pharmacies: Report

The U.S. Food and Drug Administration’s power to regulate compounded drugs similar to those linked to a deadly meningitis outbreak is legally nonbinding and lacks the authority of stringent standards imposed on drug manufacturers, according to a congressional report released …