VA: Hospital Settles Controlled Substance Act Violations for $4.36 Million

U.S. District Court Ruling – Misbranded & Unapproved Drugs – Tianeptine

As reported by LAPPA (August 2022)

In Re: Sovah Health, U.S. District Court for the Western District of Virginia, Case No. 1:22-mc-00009 (case filed and non-prosecution agreement entered June 8, 2022).

Between 2017 and 2019, a Sovah Health (Sovah) employee stole over 11,000 Schedule II substances from Sovah facilities. In 2020, another employee stole fentanyl and hydromorphone and replaced the vials’ contents with saline. In response, the United States alleged that Sovah failed to provide effective controls against the diversion of controlled substances, filled orders without a system to disclose suspicious orders of controlled substances, and failed to maintain retrievable records of controlled substances. On June 8, 2022, the parties reached a non-prosecution agreement in which Sovah agreed to accept a four-year period of increased oversight. As part of the agreement, Sovah will adopt new compliance measures, including installing cameras, establishing procedures for reporting losses and diversion of controlled substances, instituting disciplinary actions for employees responsible for theft, random drug testing for employees, and more frequent inventories of Schedule II substances. Sovah further agreed to pay a $4.36 million civil penalty to the United States, making it the third largest such settlement in history.