The cost of poor record keeping $300 K – even though nothing was diverted ?

hydrocodone

Huntsville drug distributor will pay record $300,000 federal settlement for faulty records of opiods

http://www.al.com/news/huntsville/index.ssf/2015/02/huntsville_drug_distributor_wi.html

A Huntsville pharmaceutical distributor will pay the federal government $300,000 to settle allegations it kept incomplete and inaccurate records of opiod painkillers like hydrocodone, federal officials said Friday. The company, Generics Bidco, will not face charges in federal court or civil liability.

“The $300,000 penalty in this matter represents the largest penalty collected in Alabama in a (Drug Enforcement Administration) compliance investigation,” U.S. Attorney Joyce White Vance said in a joint statement with Drug Enforcement Administration Special Agent in Charge Clay A. Morris.

Vance said companies must register with DEA and keep “clear and current records of receipt and distribution” of narcotics to prevent their diversion to the illegal street market.

DEA agents audited Generics for a 19-month period ending July 14, 2014. The audit “raised allegations” that the company violated the federal Control Substances Act by not keeping separate bi-annual inventories of Schedule II drugs and less-restricted Schedule III-V drugs. “DEA also charged that Generics did not keep records readily available, and that the audit showed substantial error in the accounting of the Schedule II and III drugs hydrocodone, carisoprodol, oxycodone and Meperitab,” the statement said.

Generics denied intentionally violating regulations, but said it has updated record-keeping procedures and taken other voluntary measures to comply with the law. The company “cooperated fully in the DEA audit and follow-up proceedings,” the statement said.

2 Responses

  1. Obviously the pharmacy’s new policy will be to not fill Schedule II and Schedule III, thus avoiding the financial burden in the future. Heads up Alabama, this is how Florida started!

  2. I guess the DEA gets to keep the $300K… so the company actually paid for the DEA to audit its books for 19 months. No doubt the agency was looking for criminal activity, but in the end, didn’t find any. Kinda like all those no-knock raids for the wrong address.

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