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AUSTIN (KXAN) — An Austin pharmacy agreed to pay $200,000 in civil penalties to resolve allegations that it violated the Controlled Substances Act (CSA), according to the Department of Justice.
The DOJ said a routine inspection was conducted at People’s Pharmacy Inc., or Peoples Rx, in June 2022. Peoples Rx operates five retail pharmacies and one compounding laboratory in the Austin area, according to the DOJ.
A release said investigators with the Drug Enforcement Administration determined the pharmacy violated certain regulatory recordkeeping provisions, improperly dispensed controlled substances to practitioners for office use and issued prescriptions without authorization.
According to the DOJ, the claims resolved by the settlement were allegations only, and there had been no determination of liability.
Peoples Pharmacy provided a statement, writing “the DEA found no evidence of diversion of controlled substances.”
Peoples was deficient on some recordkeeping practices, which has been remedied through additional training of pharmacists and pharmacy staff. Some of the deficiencies, for example, had to do with missing dates on DEA-required forms, often due to time-crunched pharmacists and staff. Numerous articles have been published about the stress placed on pharmacies since the beginning of the Covid pandemic.
While the failure to complete the annual self-certification that is required to sell over-the-counter ephedrine, pseudoephedrine, and phenylpropanolamine products (common ingredients in cough, cold and allergy products) was an oversight, Peoples uses a secondary screening tool in its Point-of-Sale system that is used to show that there were no irregular or questionable purchases of those products during the time period at issue, which indicates that no sales were made to customers who could use those products for illegal purposes.
Peoples Pharmacy has, and will continue to, improve its recordkeeping and compliance program through additional training of staff and by adding an inspection role to ensure the proper paperwork is being completed fully and accurately in compliance with the protocols required by the DEA.Peoples Pharmacy statement
“During their inspection, DEA diversion investigators also learned that Peoples Rx had sold pseudoephedrine products without self-certifying as required by the Combat Methamphetamine Epidemic Act of 2005 (CMEA),” the DOJ said.
According to the release, the Diversion Control Unit in DEA’s San Antonio District Office led the investigation.
“The primary goal of the DEA’s diversion control program is to prevent, detect, and investigate the diversion of controlled substances from their lawful purpose into illicit drug traffic. In furtherance of this goal, DEA conducts inspections of pharmacies and other DEA registrants to ensure compliance with regulatory requirements relating to drug security and recordkeeping,” the DOJ said.