In the wake of the meningitis outbreak linked to contaminated drugs compounded by the New England Compounding Center (NECC), the Texas State Board of Pharmacy conducted a special survey to determine how many pharmacies in the state are engaging in sterile and nonsterile compounding. The Board surveyed approximately 6,000 pharmacies and the data obtained will help guide future inspection plans. The Board will also ask the Texas Legislature to approve the hiring of at least three new inspectors in 2013. The Texas Board inspects pharmacies engaged in compounding every two years, and the Board’s inspectors receive intensive training in sterile compounding standards along with regular updates. The Board is also considering adopting a separate inspection form for sterile compounding facilities.
The Texas Board has in place compounding regulations that include most of United States Pharmaecopia (USP) Chapter 797 standards and some more detailed requirements not included in USP 797 (such as training for pharmacists and pharmacy technicians and specific recall procedures). In addition, the Board’s inspection process includes sampling compounded products for testing. The Board has the authority to sample both sterile and nonsterile products for testing. In Texas, nonsterile products are tested for potency, and sterile products are tested for potency, sterility, and pyrogenicity. Since the NECC incident, Texas has added testing for fungi to the requirements. Product samples are processed by an outside lab and the Board tracks data from the results. When a failure is detected, the Board will take action to resolve the issue with the pharmacy. Or, if testing were to determine that a product would be an imminent danger to the public, the Board would require the pharmacy to immediately recall the product and cease all compounding of that product. Of note, the Board has never had a product prepared under sterile conditions fail the sterility testing, including samples taken from entities compounding high volumes of drug products.
The Board indicates that there are currently pharmacies in Texas that compound products for distribution to out-of-state entities. The Texas Board has instructed inspectors to place a high priority on the inspection of all pharmacies that compound sterile products, including those that are distributing products to out-of-state entities. The Board has formed a task force to assist it in a thorough review of all of the laws and rules related to compounding and to make recommendations for changes to these rules and/or laws.