Texas pharmacy board under scrutiny over compounding-inspection procedures

Problems with the Texas State Board of Pharmacy's operating procedures were uncovered recently by the State Auditor's Office (SAO).

The Board of Pharmacy is charged with the inspection of all compounding pharmacies in the state to be sure they are complying with all laws and regulations.

Compounding is a process by which licensed pharmacists, physicians or anyone who falls under their supervision mixes, combines or alters a drug's ingredients to tailor it to individual patient needs. These procedures often require special sterility precautions.

The SAO determined that the Texas State Board of Pharmacy was not adequately documenting how sterile compounding preparations were inspected to guarantee pharmacies that perform sterile preparations were inspected within their licensing or license-renewal periods.

Furthermore, it was discovered that the board had not set formal goals for the frequency with which the inspections of nonsterile compounding pharmacies took place; there was also no protocol in place to determine whether those goals had been met.

Processes to ensure that inspections adhere to all major federal and state standards were also not set.

The SAO gave the Texas State Board of Pharmacy the following recommendations:

- That after the U.S. Department of Health and Human Services establishes a reporting process, the board should report any violations found during inspections of compounding pharmacies

- That the board increase monitoring of vendors that inspect out-of-state compounding pharmacies

- That the board formalize and document the input of data into its database, individualize database user accounts or limit generic user accounts to read-only status