An Audit Report on Inspections of Compounding Pharmacies at the Board of Pharmacy
Report Number 15-039
The Board of Pharmacy (Board) has designed and implemented inspection processes to help ensure that it conducts inspections of compounding pharmacies in accordance with applicable statutes and administrative rules. In addition, the Board ensures that its inspectors substantially follow those processes.
However, the Board should fully implement and document those processes and improve its monitoring of contractors that conduct inspections of out-of-state compounding pharmacies.
As of February 28, 2015, 7,899 pharmacy facilities were licensed by the state of Texas, and 934 of those were licensed as pharmacies that compound sterile preparations. While there is no separate license designation for pharmacies that compound only preparations that do not require sterility, 2,925 pharmacies self-reported that they were that type of pharmacy.
The Board has an adequate process for inspecting pharmacies that compound sterile preparations within required time frames; however, it should document that process.
As of December 10, 2013, the Texas Occupations Code and the Texas Administrative Code required the Board to inspect pharmacies that compound sterile preparations prior to initial licensure and upon license renewal if an inspection had not been conducted within the renewal period, which is usually two years. The Board has developed adequate processes to monitor the timeliness of inspections for new licenses and license renewals for pharmacies that compound sterile preparations, and it has generally inspected pharmacies that compound sterile preparations within the required time frames. However, the Board has not documented its processes for ensuring that pharmacies that compound sterile preparations are inspected within the required time frames.
The Board has not established formal goals for the frequency of inspections of pharmacies that compound only preparations not requiring sterility, and it has not developed an adequate process to ensure that it meets its goals for inspecting those pharmacies.
In addition to inspecting sterile compounding pharmacies, the Board also conducts inspections of pharmacies that compound only preparations not requiring sterility. Unlike for pharmacies that have a license for compounding sterile components, there are no statutory requirements, administrative rules, or formal Board policies that specify how often other compounding pharmacies must be inspected. The Board has set an informal, internal goal of inspecting pharmacies that compound preparations not requiring sterility once every three years; however, it has not met that goal. As of March 6, 2015, the Board had inspected 1,864 (64 percent) of the 2,925 reported pharmacies that compound preparations not requiring sterility within the previous three years, and it had inspected 2,265 (77 percent) within the previous 5 years.
The Board has documented processes and forms to help ensure that inspections address all significant federal and state standards; however, the Board has not fully implemented those processes.
The Board's documented policies and procedures for inspections of compounding pharmacies address all significant requirements in federal standards, state statutes, and the Texas Administrative Code. Inspectors consistently used standard forms the Board developed while conducting inspections of compounding pharmacies. However, the Board does not require inspectors to complete and submit a separate inspection form that it developed that is specific to inspections of pharmacies that compound sterile preparations. Without requiring inspectors to document inspections on that form, the Board lacks assurance that its inspectors address all required areas during inspections of pharmacies that compound sterile preparations.
The Board has a documented process to monitor violations and track corrective action plans, and it should report violations to the U.S. Department of Health and Human Services after a reporting mechanism is established.
The Board has a documented process to monitor violations identified during inspections of compounding pharmacies. The inspector initially classifies violations using three categories: needs improvement, warning notice, and refer to legal. The Board is also required to report violations identified during those inspections to the U.S. Secretary of Health and Human Services. However, the U.S. Department of Health and Human Services has not yet implemented a reporting process.
The Board has a process to help ensure that inspections of out-of-state pharmacies that compound sterile preparations are completed within required time frames; however, it should improve its monitoring of the vendors that conduct those inspections.
The Board contracts with three vendors to inspect pharmacies that compound sterile preparations outside of Texas. As of February 28, 2015, 164 pharmacies compounded sterile preparations outside of Texas and were licensed through the Board. The Board implemented a monthly reporting process outlined in the contracts with its vendors to monitor the vendors' inspection performance, but it did not consistently follow that process.
The Board has controls to help ensure that its inspection data is reliable; however, it should strengthen its data entry reviews and restrict the use of generic user accounts.
The Board has information technology controls to help ensure that inspection data in its licensing and inspection system, Versa, is reliable. However, its reviews of inspection data entered into Versa are informal and not documented. The Board also should restrict the use of generic user accounts and either assign each user an individual account or limit the access of all generic user accounts to read-only.
Auditors communicated other, less significant issues related to the Board's inspection processes to Board management separately in writing.
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