DEA recently revoked the registration of the Medicine Shoppe, a San Antonio, Texas, pharmacy, based on a finding that the pharmacy violated the Controlled Substances Act in all of the following ways:
- dispensed controlled substances without a prescription;
- dispensed controlled substances when the prescription was “signed” using a signature stamp;
- allowed some customers to retain original controlled substances prescriptions;
- dispensed controlled substances when the prescription contained irregular dosing instructions;
- dispensed controlled substances when the prescriptions revealed pattern prescribing by physicians;
- dispensed controlled substances when the prescription lacked a patient’s address and the physician’s DEA registration number;
- placed a prescription label on the back of the prescription with a physician’s name that was not consistent with the name on the front of the prescription;
- accepted prescriptions where the refill line was blank; and
- allowed patients with prescriptions containing both controlled and non-controlled substances to fill only the controlled substances’ portion of the prescription.
Deputy Administrator Thomas M. Harrigan affirmed the conclusion of the administrative law judge (“ALJ”) that the pharmacy’s continued registration was inconsistent with the public interest. Specifically, the Deputy Administrator found that the pharmacy, through its pharmacists, violated its corresponding responsibility by dispensing prescriptions that lacked a legitimate medical purpose and that did not comply with DEA’s regulations.
In addition to dispensing prescriptions without resolving “red flags” of diversion, the pharmacy also employed as a delivery person a man who had been convicted previously of distributing crack cocaine, in violation of DEA regulations.
The pharmacy also failed to maintain accurate records. When DEA attempted to conduct an audit, it found what Deputy Administrator Harrigan called “massive shortages” of multiple controlled substances, including: promethazine with codeine; hydrocodone 10 mg, and alprazolam 1 mg and 2 mg. The audit results, alone, could have justified revoking The Medicine Shoppe’s registration, according to Deputy Administrator Harrigan.
It is interesting to note that the Deputy Administrator and the ALJ both concluded that the owner and pharmacist-in-charge (“PIC”), Nate Lekwa, had not truly accepted responsibility for the violations proven by the Government, which is a factor that can weigh in favor of continued registration.
Though the PIC made general statements about accepting responsibility, under questioning by the Government about specific instances of violations, he refused to admit wrong-doing. For instance, when asked about numerous prescriptions that the Government’s expert witness testified should not have been filled, the PIC maintained that none of the dispensings were improper. As such, Deputy Administrator Harrigan called the PIC’s acceptance of responsibility “double talk.”
The revocation is effective November 4, 2014.