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