Ameridose voluntarily suspends production - WSMV Channel 4

Ameridose voluntarily suspends production

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NASHVILLE, TN (WSMV) -

Massachusetts regulators announced Wednesday that two more drug companies who have common ownership with the New England Compounding Center are voluntarily shutting down their manufacturing processes. One of those companies, Ameridose, has important ties to the Nashville area.

"This afternoon, Ameridose proactively agreed to voluntarily cease all manufacturing and compounding activities immediately," said Dr. Madeleine Biondolillo, the director of the Bureau of Healthcare Safety in Massachusetts.

Ameridose drugs are distributed to HCA member hospitals. Biondolillo said the products that have already been produced and distributed by Ameridose will not be recalled and doctors will be allowed to use them.

Meanwhile, state and federal regulators continue to investigate why NECC was acting more like a major drug manufacturer in spite of being licensed only as a pharmacy.

Tennessee state Rep. David Shepard, who is also a pharmacist, said Tennessee should take a closer look at how it licenses pharmacies.

"What should happen, if someone is applying for a license to practice pharmacy, and they're not a pharmacy by most people's standards, they at least should be checked out," Shepard said.

NECC is licensed in Tennessee as a pharmacy. When a business operates as a compounding pharmacy, it is not subjected to the rigorous standards imposed by the FDA on drug manufacturers.

"I was surprised when I saw how big they were. They're like a pharmaceutical company that makes all kinds of products," Shepard said.

Investigators have yet to be able to answer a central question in the investigation - how did a fungus get into what was supposed to be sterile product?

Monday night, CNN aired video showing an active recycling center operating next to the building where drugs are being produced.

"I'd have a lot of concern about that. I mean, it's the environment. This was a contaminated batch of product," Shepard said.

Biondolillo addressed the question of possible contamination from the recycling products at the news conference.

"As with every other factor that could have an impact on the processes, that will be under consideration as part of the investigation," Biondolillo said.

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