The fungal meningitis outbreak caused by contaminated injectable steroid medicine at the New England Compounding Center has caused compounding pharmacies nationwide to come under heavy scrutiny. After hundreds of cases of sickness and 32 deaths across 19 states, regulators and state pharmacy boards are promising more thorough oversight.
The Texas State Board of Pharmacy commented in 2008 that there needed to be more testing of compounded drugs. This is because government regulators don’t oversee compounding pharmacies like they do drug manufacturers, even though compounded drugs are mixed and prepared by individual compounding pharmacies.
Because of this, the Texas State Board of Pharmacy wanted to conduct tests on compounding pharmacies to verify patient safety. For the first time, legislators in Texas approved $50,000 to pay for random testing of compounding pharmacies over a 12-month period to test for sterility, potency and contamination. In 2010, the board’s administrators continued to ask for the budget to increase random testing due to the potentially life-threatening effects a pharmacy error would have on patients. However, budget cuts have decreased the number of pharmacies being tested over the last three years and the results include:
- 65 Texas pharmacies had their products tested in 2010
- 35 Texas pharmacies had their medications tested in 2011
- 21 Texas pharmacies received tests on their compounded medications by the end of fiscal year 2012
Although drug contamination, sterility and potency could potentially cause life-threatening effects to patients, Texas’s budget for testing compounded drugs has been cut. This means that patient safety is reduced. The funding for Texas’s program for testing compounding pharmacies decreased by 72 percent and many state regulators do not believe this is sufficient to protect Texans.
Because the Food and Drug Administration (FDA) does not regulate compounding pharmacies, the oversight of these pharmacies has fallen to the states. While Texas hasn’t conducted as many tests on compounded drugs due to budget cuts, it may look to increase its oversight due to the recent compounding pharmacy error that occurred in Massachusetts.
If you have been hurt by dangerous drugs or a pharmacy error because of the lack of state oversight, contact Kennedy Hodges, L.L.P. at 888-526-7616 for a free consultation with an experienced drug error lawyer, and get your FREE copy of our report, How to Make Pharmacies Pay for Injuries Caused by Medication Errors.