BOSTON, Mass. (WWLP) - Unsterile conditions, omitting medical risks, and profits over patients – These are some of the dire observations on the compounding pharmacy industry made by Dr. Sarah Sellers, a former FDA official and compound pharmacist.
"What I felt was ethically inappropriate was that pharmacies were choosing to substitute non-FDA approved products for profit reasons," said Sellers.
Compounding pharmacies are pharmacies that make custom medications, like adding cherry flavor to cough syrup. Any pharmacy can compound medications, and without adequate regulation, experts say we could have another major public health crisis on our hands.
In one case in South Carolina, Dr. Sellers showed the Senate Committee on Post Audit and Oversight a photo of medications stored in a fridge with take-out boxes. Committee Chairman Mark Montigny of New Bedford has filed specific legislation that implements random inspections of pharmacies and their products – as well as various other regulations.
"We need very strong licensure for those that are compounding in a non-traditional way. And if they're truly manufacturing, then they shouldn't be compounding at all, they should be regulated as manufacturers which is a federal role," said Montigny.
But the state can only do so much. Lawmakers and experts say congress must pass federal legislation to better regulate compounding pharmacies. For many years, lawmakers say lobbyists have successfully pushed back those efforts, but with compounding in the national spotlight, they believe things could change.
40 people are dead nationwide because of a meningitis outbreak linked to tainted medications manufactured at the New England Compound Center in central Massachusetts.