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 comes a year after a multistate fungal meningitis outbreak that infected at least 750 people and killed 64 across 23 states. The outbreak was linked to contaminated steroid shots manufactured by New England Compounding Center (NECC).
Compounding pharmacies are different from traditional pharmacies, which dispense prescription medications. Compounders mix FDA-approved drug ingredients for patients according to a doctor’s prescription. Both types of pharmacies have been regulated by state pharmacy boards.
However, throughout the years, some compounding pharmacies have begun to mass produce their compounds and sell them to medical facilities across state lines. When the fungal meningitis outbreak surfaced, congress took action to allow federal regulation of compounding pharmacies that mass produce and distribute their drugs.
In the past year, the agency has recalled numerous drug products from dozens of compounding pharmacies across the country due to sterility issues and contamination.
Source: Law 360