Tampa, Florida – United States Attorney Maria Chapa Lopez announces today that Vistapharm, Inc. has agreed to pay the United States $325,000 to resolve allegations that Vistapharm violated the Controlled Substances Act (CSA) by failing to maintain records required by the CSA. In addition to paying a civil penalty, Vistapharm has agreed to sign separately a Memorandum of Agreement with the Drug Enforcement Administration.
The United States alleges that Vistapharm failed to make available or to maintain in a readily retrievable format more than nine hundred copies of DEA 222 Forms, which are a required record for purchases and sales of Schedule II controlled substances. The United States also alleges that Vistapharm failed to maintain adequate records for six categories of controlled substances handled by its distribution facility in Largo, Florida, which led to overages or shortages in Vistapharm’s expected inventory.
“Scrupulous recordkeeping is essential to maintaining the CSA’s closed system of distribution and preventing dangerous drugs from being diverted and falling into the wrong hands,” said U.S. Attorney Chapa Lopez. “We expect all DEA registrants, regardless of the size of their organization, to be especially meticulous in their recordkeeping because the CSA and the welfare of the public demand it.”
“Pharmaceutical distributors are responsible for helping to ensure that controlled substances are not diverted.” said DEA Miami Field Division’s Special Agent in Charge Keith Weis. “In addition to monitoring employees and customers, distributors are required to inventory their controlled substances, to verify their receipt and distribution, and to maintain complete and accurate records. When one or more of these responsibilities break down, diversion can occur with the consequence of controlled substances potentially falling into the wrong hands.”
This settlement results from a coordinated effort by the U.S. Attorney’s Office for the Middle District of Florida and the Tampa District Office of the Drug Enforcement Administration’s Miami Field Division. Assistant United States Attorneys Lindsay Saxe Griffin and Christopher Emden pursued this civil settlement on behalf of the United States.
The claims resolved by the settlement are allegations only, and there has been no determination of liability.