Since 2013 when Congress amended the Federal Food, Drug, and Cosmetic Act to address serious safety issues surrounding compounded drugs, the FDA has inspected hundreds of facilities and issued dozens of warnings to protect consumers from contaminated compounded products.
Lawmakers passed the amendment in response to a 2012 fungal meningitis outbreak that resulted from injectable methylprednisolone acetate distributed nationally by the New England Compounding Center in Framingham, Massachusetts. The outbreak caused 753 fungal infections and 64 deaths in 20 states, according to the US Centers for Disease Control and Prevention.
Voelker R. Inspections Turn up Insects, Mold in Drug Compounding Facilities. JAMA. 2017;317(7):688. doi:10.1001/jama.2017.0453