Recalls from compounding pharmacies also continue to be a prominent source of pharmaceutical recalls according to the Index. In the second quarter, two compounding pharmacies accounted for 104 recall events, more than 43 percent of all pharmaceutical recalls reported for the quarter. Because of these serious events and the resulting media attention, the FDA has significantly increased its inspections of compounding pharmacies. In addition, the Government Accountability Office (GAO) recently recommended that the FDA be granted greater oversight and regulatory control of compounding pharmacies.
"Compounding pharmacies continue to face multiple events a quarter, which has attracted a lot of regulatory attention. It is more important than ever for these manufacturers to be vigilant and pay close attention to current safety compliance programs and best recall preparedness practices," Rozembajgier continued. "It is no longer a matter of if the FDA shows up at their door, it is when."
quoted from here
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