Pursuant to Section 105 of the Drug Quality and Security Act (P.L. 113-54), Food and Drug Administration recently shared actions taken by the State of Texas against three local compounding pharmacies for operating in violation of the Texas State Board of Pharmacy Rules.

Their cases are described below:

  • Boudreaux’s New Drug Store in Lake Charles, LA, allegedly dispensed 3,650 prescriptions from September 11, 2020, to March 2, 2022, that were believed to be “sterile products compounded in the non-hazardous drug buffer room in a biological safety cabinet,” which last passed its certification status in June 2020. The Louisiana Board of Pharmacy entered a Consent Order against the pharmacy, and the pharmacy was ordered to pay a $25,000 fine.
  • Hallandale Pharmacy in Fort Lauderdale, FL, operated without disclosing a disciplinary action issued by the Kentucky Board of Pharmacy on its application for licensure in Texas. The pharmacy allegedly dispensed, shipped, and sold 312 prescription drugs for a 23-month period to patients residing in Texas without having a Texas pharmacy license and shipped compounded medications to Mississippi patients without having a compounding certificate from the Mississippi Board of Pharmacy to engage in such practice there. The Texas Board ordered that the respondent’s license be reprimanded.
  • Sitlausdeo Pharmacy, LLC, in Houston, TX, has failed to comply with the Remedial Plan #2020-06870. Additionally, according to the Agreed Board Order, the pharmacist-in-charge “failed to engage in the business of pharmacy within six months” of the license being issued, did not complete an initial gloved fingertip/thumb sampling procedure prior to compounding sterile preparations, did not properly supervise pharmacy personnel, and neglected to report dispensing controlled substance prescriptions to the Texas Prescription Monitoring Program. The pharmacy personnel did not complete appropriate training prior to engaging in sterile compounding duties.

For more information on these Board orders, please contact the Texas State Board of Pharmacy.