Compounding pharmacies are allowed to mix or combine several drugs under sterile conditions for the purpose of treating specific patients’ needs; however, recently the sterility of compounding pharmacies has been questioned.
Because these pharmacies are not closely regulated by the FDA, individual states are responsible for regulations. But due to budget cuts, states like Texas have decreased the overall number of inspections of pharmacies while the number of Texas pharmacies has increased to an estimated 6,300. However, not all of these pharmacies are compounding pharmacies.
Texas, like most states, does not require pharmacies to have a separate registration if they compound medicine. The state pharmacy board doesn’t exactly know the number of facilities that mix medicine, which is concerning to officials in Texas and may bring about a better tracking system in the future.
Because the number of pharmacies in Texas has increased by 1,200 over the last ten years, it would make sense that the number of Texas State Board of Pharmacy inspectors would increase as well. However, the number of inspectors has remained at six, which means that even if each inspector inspected two pharmacies per day, they still wouldn’t be able to meet their goal of inspecting every pharmacy every two years.
Source found here
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At the Florida Board of Pharmacy meeting this week, a similar concern, the lack of qualified pharmacists to become inspectors, and the lack of funding to hire them to do the inspections, was discussed. Just like Texas, Florida has to figure out how to get control of pharmacies that engage in manufacturing without manufacturer's permits. At this time, the Board has REQUIRED pharmacies to complete a survey regarding their compounding practices. The Board has also established a 3-person "compounding committee" to REVISE THE RULES of the Board of Pharmacy that pharmacies will have to comply with. The Board is also looking to raise fees pharmacies (especially non-resident pharmacies) pay, so there can be funding to hire more inspectors. In addition, the Department of Health is going to do more training of the inspectors, as previous inspections failed to reveal obvious (in retrospect) violations that impair patient safety.
An ironic thing is that "enforcement and inspections" of pharmacies and dispensing practitioners is "self-funded through licensure fees", but the trust funds get raided by cash strapped Governors/State Legislatures, who don't want to raise taxes on the general population to pay for other services (education, incarceration, medication [Medicaid]).
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