The Board of Pharmacy's Shortcomings in Monitoring Compounding Pharmacies
September 21, 2015
The Board of Pharmacy is tasked with inspecting Texas compounding pharmacies and ensuring their compliance with laws and regulations. Compounding is a process where licensed pharmacists or physicians (or someone who falls under their supervision) combines, mixes, or changes a drug's ingredients to customize it to an individual patient's needs. Furthermore, compounding pharmacies may compound preparations that require sterility, such as eyedrops, or they may only compound preparations that do not require sterility.
However, the State Auditor's Office (SAO) found problems with the Board's operating procedures.
- Specifically, SAO found that the Board ought to document how it guarantees that pharmacies that perform sterile preparations are inspected within their licensing or license renewal periods.
- Also, the Board has not established formal goals for the frequency of inspecting non-sterile compounding pharmacies, nor does it have a sufficient way of determining whether it has achieved those goals.
- The SAO also found that the Board has not completely implemented processes that ensure that inspections adhere to all major federal and state standards.
Finally, the SAO recommended that, after the U.S. Department of Health and Human Services establishes a reporting process, the Board should report any violations that they find during inspections of compounding pharmacies. The SAO also encouraged the Board to bolster its monitoring of vendors who inspect out-of-state compounding pharmacies (specifically by consistently adhering to the monthly reporting process that it detailed in its contracts with said vendors). The SAO further advised the Board to formalize and document the input of data into its database, and to individualize database user accounts, or to limit generic user accounts to read-only status.
Source: "An Audit Report on Inspections of Compounding Pharmacies at the Board of Pharmacy," State of Texas Auditor's Office, August 2015.
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