FDA Inspections Triggered More Pharmacy Recalls in 2015
This article was originally published in The Gold Sheet
Agency forces pharmacies to acknowledge they haven't been assuring the sterility of the injectable drugs they compound, spurring recalls and perhaps hope and change for their quality systems.
You may also be interested in...
NECC Crisis Festered in Ambiguity That Reigns Over Compounding
As FDA, Congress and the courts stumbled, compounding pharmacies such as NECC took advantage of a gray area of the law. Legislators will get another try; one proposed subjecting such pharmacies to cGMP requirements.
What FDA Saw at Compounder Behind Fungal Meningitis Outbreak
There was greenish-black and white filamentous matter in vials that had been recalled. The question confronting FDA investigators at NECC: How could it have gotten there?
Transparency Looms Large In US FDA’s Next-Pandemic Legislative Agenda
Agency’s proposals for pandemic preparedness reauthorization would build on CARES Act provisions to gain greater visibility into global pharmaceutical supply chains, while also seeking deeper understanding of manufacturing quality management activities. Also included in FY 2024 budget request: long-sought drug destruction and drug recall authorities.