Prescription compounding issues are popping up in the news week after week. It was reported at the beginning of March that even after six months, where moldy medicine caused a deadly outbreak, no bill was passed by Congress. There was only one pending proposal in Tennessee which would end the requirement that compounded drugs be prepared with only a patient-specific prescription.
The next newsworthy story involved a Massachusetts pharmacy which had to issue a recall on the dozens of products it had made during the past few months. Apparently, "foreign matter" was found in their drugs. The hazard was noticed during their FDA inspection. This is the second tragedy to strike the region. Two weeks before, over 700 people become ill and 50 patients died after receiving medication produced by the New England Compounding Center.
"The absence of strong FDA enforcement powers over compounding pharmacies, and the discovery of filthy conditions at the New England Compounding Center, has spurred more aggressive FDA efforts to monitor conditions at compounding pharmacies, which repackage existing prescription into made-to-order medications." -LA Times, ‘Foreign Matter' Prompts Another Compounding Pharmacy Recall
The United States Food and Drug Administration is cracking down on receipts of valid prescriptions for people and the identification of patients prior to the distribution of compounded drugs. Just recently, the FDA issued a warning letter to Medi-Fare Drug & Home Health, Center, a compounding pharmacy, which allegedly is not adhering to Section 503A (21 U.S.C. 353a) of the Food and Drug Administration Modernization Act (FDAMA) and the compliance policy guide the FDA issued on compounding issued in 2002 (CPG).
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