Earlier this week, a compounding pharmacy recalled a spinal steroid injection after the Food and Drug Administration discovered fungal meningitis in containers of the product. New England Compounding Center, a company that mixes specialized varieties of medicines, recalled its methylprednisolone acetate, along with a number of other products, after an outbreak of a rare type of meningitis, a disease that causes inflammation of the brain and spinal cord.
The Centers for Disease Control and Prevention have not yet determined the cause of the rash of meningitis cases, but over 100 people have developed meningitis in a number of states to which NECC shipped the contaminated product. 14 people have died in the outbreak, and the CDC estimates that up to 13,000 people in 23 states may have been exposed to the tainted steroid.
In the wake of the meningitis outbreak, legislators have complained publicly that compounding pharmacies should be subject to greater regulatory scrutiny. Currently, the FDA regulates these businesses as pharmacies, not manufacturers, and therefore does not require clinical trials on their products prior to release on the market. The law does not require that a compounding pharmacy test every batch of its products or record where the products are shipped.