Saturday, November 28, 2015

San Diego Pharmacy Owners Pay $750,000 to Resolve Civil Drug Diversion, Record Keeping and Logbook Allegations After DEA Audit

On November 17, 2015, a group of San Diego pharmacies and their owners paid $750,000 to the federal government to resolve allegations that they mishandled significant amounts of highly addictive and frequently abused prescription narcotics, as well as ephedrine or pseudoephedrine products. This was a civil settlement with the DEA and any true wrongdoing of a criminal nature appeared to be done by pharmacy technicians.

In addition to paying $750,000 in settlement to the government, Medical Center Pharmacy has committed to implementing new inventory control procedures to assure full accountability of all controlled substances.

The settlement is with Park Medical Pharmacy, Inc., and owners Joseph Grasela and John Grasela.  The Graselas and Park Medical Pharmacy, Inc. do business as Medical Center Pharmacy.  They operate a dozen storefront pharmacies under various names such as Galloway Medical Center Pharmacy, Community Medical Center Pharmacy, and Medical Center Pharmacy. 

The United States asserts that Medical Center Pharmacy was unable to account for roughly 21,000 pills at four locations over a two-year span.  In some instances, two pharmacy technicians allegedly diverted thousands of pills.  

In others, Medical Center Pharmacy allegedly delivered drugs to a residence that pill seekers used in conjunction with their sham identities.  The unaccounted-for pills were the powerful and highly addictive drugs oxycodone and hydrocodone, commonly known by their brand names OxyContin, Roxicodone, and Percocet. 

The United States asserts that Medical Center Pharmacy unlawfully sold listed chemical products without DEA authorization, did not properly maintain logbooks, and did not train employees.

The settlement arises from a U.S. Drug Enforcement Agency (“DEA”) investigation into suspected illegal activity at one of the pharmacies, Medical Center Pharmacy. Based on DEA’s inventory audits, inspections, and other investigative activities, the United States alleged that Medical Center Pharmacy committed multiple violations of the Controlled Substances Act (“CSA”).   

The alleged violations include diversion of a significant amount of controlled substances, failure to control the pharmacies’ inventory of controlled substances, and failure to maintain required records of the pharmacies’ distribution of controlled substances. The rules governing this are set forth in the Combat Methamphetamine Epidemic Act (“CMEA”) portion of the CSA. The alleged violations also include failure to obtain the proper authorization required for the sale of ephedrine and pseudoephedrine products, which can be used to produce methamphetamine.

The CMEA was enacted to curtail the illicit production and use of methamphetamine by requiring pharmacies to certify that they have met CMEA requirements such as properly training their employees in the proper sale of ephedrine, pseudoephedrine, and other listed chemical products.

The CMEA also requires pharmacies to keep a logbook of certain listed chemical products sold, and the logbook must contain the identity of the purchaser and the product that was purchased.  This requirement, along with a cap on the amount of listed chemical products an individual may purchase, helps prevent “meth smurfing” – the purchasing of legal amounts of ephedrine products but in many separate purchases.  

DEA audits are on the increase and it is critical that pharmacies perform self-audits since when an audit occurs it is frequently the case that recordkeeping issues, logbook maintenance and training issues arise. 

Posted by Tracy Green, Esq.
Green and Associates


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