News

Posted On: 09/03/2004

Prescription Wholesalers Plead Guilty in First PDMA Pedigree Conviction

Two Ohio-based prescription drug wholesalers pled guilty in U.S. District Court for failing to provide customers a “pedigree” identifying each prior sale, purchase or trade of the drug they distributed. This is one of the first convictions of its kind, according to the U.S. Food and Drug Agency (FDA) and marks a significant step in assuring that prescription drug wholesalers fully conform with laws that ensure the integrity of the nation's drug supply.

RxBazaar, Inc., and its subsidiary, FPP Distribution, Inc., each pled guilty to one misdemeanor charge under the Federal Food, Drug and Cosmetic Act for not providing the required pedigree. Each company was sentenced to five years probation and a $100,000 fine. RxBazaar, Inc., a publicly traded company, operated a web site called www.rxbazaar.com through which buyers and sellers would conduct wholesale pharmaceutical transactions. RxBazaar collected fees from sellers who utilized their web site and would distribute the pharmaceuticals to customers through FPP Distribution, Inc.

The Prescription Drug Marketing Act (PDMA), which became effective in 1988 to deter drug diversion and counterfeiting, requires that wholesalers provide a pedigree for every prescription drug they distribute. Failure to comply with the pedigree requirement of the PDMA, as well as other provisions of the Act, including the distribution of counterfeit drugs, are strict liability misdemeanors for which ignorance of the law or the lack of criminal intent is no defense.

A second conviction for the same misdemeanor offense under the Act is a felony. "These guilty pleas are part of FDA's increased effort to combat drug diversion and counterfeiting," said Acting FDA Commissioner Dr. Lester M. Crawford. "We will not tolerate any illegal action which undermines the integrity of our nation's drug supply."