Some say this industry needs more regulation.
“There’s not a lot of oversight of compounding pharmacies” compared with drug manufacturers, said Allen Vaida, executive vice president of the Institute for Safe Medication Practices, a suburban Philadelphia advocacy group that tracks medication errors.
Dr. William Schaffner, an infectious-disease specialist at Vanderbilt University, agreed.
“They fall into this gray area and no one supervises in a rigorous fashion their manufacturing processes. The state pharmacy boards don’t have the resources or the knowledge or experience,” and the FDA does not get involved unless a problem occurs, he said.
The FDA has said the steroid in the current meningitis outbreak came from the New England Compounding Center, based in Framingham, Mass. The company recalled three lots of the drug last week and has said it has voluntarily suspended operations and is working with regulators to identify the source of the infection. Investigators also are looking into the antiseptic and anesthetic used during the injections.
On Thursday, investigators urged doctors nationwide to avoid all products from the New England company. At least 23 states have received vials from the three recalled lots.
Compounding pharmacies are supposed to supply products to meet unique patient needs, and to prepare drug products that are not available commercially, based on an individual prescription. They may cross a line if they supply a product on a large scale to a clinic or hospital without individual prescriptions, Miller and other experts said.
“They, in effect, since they do this on a large scale, have become mini-pharmaceutical companies,” Schaffner said.