MADISON, WI. – Timothy M. O’Shea, US Attorney for the Western District of Wisconsin, announced today that Cadott Miller Pharmacy, Ltd. based in Cadott, Wisconsin, has entered into a $20,000 settlement agreement to resolve civil allegations that it violated the Controlled Substances Act (CSA) by dispensing controlled substances outside of the usual flow of professional pharmacy practice, alongside other CSA violations.
As a registrant with the US Drug Enforcement Administration (DEA), the CSA required the pharmacy to control federal and state laws and regulations relating to the receipt, storage, record-keeping, distribution, dispensing, and disposal of both knows and observes substances .
Between 2017 and 2019, the DEA executed several regulatory inspection orders to review the pharmacy’s operations. As part of the inspections, the DEA examined the pharmacy’s practices related to the receipt, dispensing, and storage of controlled substances. On December 17, 2019, after determining that the pharmacy’s compliance actions were unsuccessful, DEA served an immediate suspension order of the pharmacy’s DEA registration certificate, and Cadott Miller Pharmacy issued its DEA registration on January 7, 2020 on important notice reason voluntarily. As a result, the pharmacy was unable to dispense controlled substances.
Pursuant to Government allegations set forth in the Settlement Agreement, Cadott Miller Pharmacy dispensed controlled substances outside of the normal flow of professional pharmacy practice by dispensing combinations of controlled substances and drugs that have no legitimate medical purpose, are highly addictive, and were specifically combined for abusive purposes and produce or enhance euphoric effects. In addition, the government alleged that the pharmacy dispensed controlled substances without a valid prescription, provided unauthorized early refills, and dispensed Schedule II controlled substances for opioid addiction, which are prohibited under federal law.
With the passage of the CSA, Congress recognized the importance of preventing the diversion of drugs from legal to illicit use. The CSA effectively prevents the illegal distribution, possession, dispensing and misuse of controlled substances, all of which have contributed significantly to the opioid epidemic over the past two decades. The CSA therefore regulates all entities in the distribution chain, including pharmacies and pharmacists.
“Pharmacies that dispense controlled substances outside of professional pharmacy practice endanger the public, abuse their DEA registration, and violate federal laws,” said United States Attorney O’Shea. “Pharmacies have a public trust and a great responsibility. The overwhelming majority of pharmacies strictly adhere to federal and state laws and deserve the trust of the public. However, the U.S. Attorney’s Office will be happy to work with the DEA to protect the public when pharmacies violate federal laws.”
“The men and women of the DEA, alongside our state and local partners, will continue to protect the citizens of Wisconsin from the reckless and unscrupulous practices of dispensaries that do not comply with the Controlled Substances Act,” said John G. McGarry, Assistant Special Agent in Charge the US Drug Enforcement Administration-Wisconsin.
Under the settlement agreement, the amount of the civil penalty was based on inability to pay a significant penalty and was determined after analysis and review of the pharmacy’s financial circumstances.
United States Assistant Attorney Leslie Herje represented the government in the matter. The DEA Milwaukee District Office conducted the investigation primarily in conjunction with the United States Attorney’s Office Affirmative Civil Enforcement Team. The Settlement Agreement contains only CSA allegations; Cadott Miller Pharmacy denies the allegations.