A Hard-Fought Battle With Fungal Meningitis
"How the NECC Crisis Happened
Pharmaceutical manufacturers are regulated by the Food and Drug Administration. Compounders are not, because they are considered pharmacies regulated by the states. Compounding pharmacies are supposed to make custom-tailored drugs for individual patients who can't use commercially-manufactured products.
Bona Benjamin, with the American Society of Health System Pharmacists, says the difference between manufacturers and compounders is the difference between a mass-production bakery and cooking a meal at home. The rules are stricter for a manufacturer.
"I can see why you wouldn't ask a compounding pharmacy to go through the same new drug application process that a manufacturer would,” Benjamin says. “Ideally they should be operating on a much smaller scale and they should be responding to prescriptions for patients."
But in the case of NECC, they didn't. The company was mass producing and distributing the contaminated steroid injections, but because it was licensed as a compounding pharmacy, it lacked federal oversight."
No comments:
Post a Comment