By Nate Raymond

BOSTON (Reuters) – A federal appeals court on Monday restored the convictions of a co-owner and former employee of a Massachusetts compounding pharmacy accused of deceiving regulators before its drugs sparked a deadly fungal meningitis outbreak in 2012.

1. U.S. Circuit Court of Appeals of Boston ruled in favor of Sharon Carter and Gregory Conigliaro, co-owners of New England Compounding Center.

They could be sentencing them now that the ruling has been made. Requests for comment from defense attorneys were not answered.

Conigliaro, Carter and others were arrested after the mold-tainted steroids that NECC produced triggered a fungal outbreak. This caused 793 deaths nationwide.

Barry Cadden (NECC’s former president and co-founder) and Glenn Chin (its former supervisory pharmacist), were indicted for racketeering, fraud, and serving 14-1/2 to 10-1/2 year sentences.

Conigliaro & Carter, however, were not accused with direct involvement in the outbreak.

Instead, a federal jury found them guilty in 2018. They were accused of misleading the FDA that Framingham-based NECC was acting like a regular pharmacy and should therefore be under state supervision, not a drug producer.

State-regulated compounding pharmacies make customized drugs in accordance with patient-specific prescriptions. Prosecutors claimed that NECC was a manufacturer of drugs, making them in large quantities without the need for prescriptions.

Richard Stearns, U.S. District Judge, stated that the FDA was not able to regulate compounding pharmacies such as NECC at the time and it was therefore unable to do so. This made it difficult for the FDA’s operations.

U.S. But U.S. Circuit Judge David Barron said Monday that Stearns has not identified any instances in which FDA denied authority to classify a compounding pharmacist as a manufacturer subjected to increased oversight.