One year after a multistate fungal meningitis outbreak linked to contaminated steroid shots manufactured by a compounding pharmacy, Congress is considering legislation that will clarify the Food and Drug Administration’s (FDA) role in the oversight of large-operation compounding pharmacies that act much like drug manufacturers.
Compounding pharmacies custom-mix FDA-approved drug ingredients according to a physician’s prescription generally on a per patient basis. Pharmacies are currently regulated by state pharmacy boards. Comparatively, the FDA oversees drug companies that manufacture drugs.
However, some compounding pharmacies have started mass-producing these custom drugs and shipping them to medical facilities across state lines, which has raised questions about the safety of the drug products. Those concerns came to light last year when the source of contaminated steroid shots was determined to be New England Compounding Center (NECC). At least 750 people developed fungal infections including fungal meningitis after receiving the shots, and at least 64 people died.
Since the outbreak, the FDA has stepped in, conducting inspections of compounding pharmacies across the country, resulting in numerous recalls due to the inability to assure sterility of products manufactured at the pharmacies.
The new bill aims to differentiate between traditional compounding pharmacies and the larger shops that sell products in bulk. The traditional compounding pharmacies would be subjected to a uniform safety standard and be allowed custom-mix drugs according to patient need. Larger operations would be regulated as “outsourcing facilities” and would be required to undergo inspections, reporting and registration.