Austin pharmacy to pay $200K for alleged Controlled Substances Act violation
AUSTIN, Texas - An Austin pharmacy has agreed to pay $200,000 in civil penalties related to allegations it violated provisions of the Controlled Substances Act (CSA).
People’s Pharmacy Inc., doing business as Peoples Rx, operates five retail pharmacies and one compounding laboratory in the Austin area.
During a routine inspection of one location in June 2022, DEA diversion investigators determined that the pharmacy had violated certain regulatory recordkeeping provisions, improperly dispensed controlled substances to practitioners for office use, and issued prescriptions without authorization.
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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 CMEA regulates over-the-counter sales of cough, cold, and allergy products containing ephedrine, pseudoephedrine, and phenylpropanolamine, ingredients that can be used to produce illegal methamphetamines.
Retail provisions include daily sales limits and 30-day purchase limits, placement of product out of direct customer access, sales logbooks, customer ID verification, employee training, and self-certification of regulated sellers.
Peoples Pharmacy later released a statement to FOX 7 Austin, saying:
"Peoples Pharmacy points out that 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."