Texas State Auditor finds problems with Board of Pharmacy's inspection protocols

The Texas State Auditor's Office (SAO) recently said it found problems with the Texas State Board of Pharmacy's operating procedures.

It is the responsibility of the Board of Pharmacy to inspect 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 an individual patient's 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 ensure 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 non-sterile compounding pharmacies took place; there was also no protocol in place to determine whether those goals had been met.

Processes to ensure that inspections adhered to all major federal and state standards also were not established.

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