State Officials Connect Specialty Compounding to Bacterial Outbreak
Texas Department of State Health Services told the Associated Press Tuesday that while state testing had identified the bacterium Rhodococcus equi in the products before, the most recent results showed a “genetic match” between the product and the blood samples of 15 of the 17 patients that had been sickened surrouding the August recall.
To date, Specialty Compounding's own testing and testing by the FDA have not found this particular bacterium.
In a recent company statement, Specialty Compounding said, “The pharmacy’s own testing similarly detected no Rhodococcus equi in its facility, in its products, or on its personnel.” “For this reason, it seems clear that Specialty Compounding was not the source of the infections.”
The FDA did find other types of bacteria, and stated in a November 15 release, "Based on our inspectional findings and the sample results, we do not believe Specialty Compounding should perform any sterile drug production at this time."
Recent recalls have brought attention to the regulation of Compounding pharmacies and launched debate surrounding the Drug Quality and Security Act as it awaits presidential approval.