Sunday, September 9, 2018

Texas Compounder Approved in Tennessee


By Walter F. Roche Jr.

The Tennessee Pharmacy Board has licensed a Texas pharmacy to issue sterile compounded and other prescription drugs in the state even though the company says it has suspended the production of sterile drugs while its facilities are upgraded.
Records from the state board show Surecare Specialty Pharmacy of El Paso, Texas was issued a pharmacy license in early July. But you won't find Surecare listed among the licensed pharmacies on the board's website. It was removed from the automated listing shortly after a request was submitted for a copy of the application.
Asked why the listing was removed, Shelley Walker, a spokeswoman for the state Health Department, said the action was taken under the state law creating the pharmacy panel. She declined to be more specific.
The unusual handling of the Texas drug compounding firm comes in a state where drug compounding has become controversial. It was a Massachusetts drug firm that compounded fungus laden steroids that took the lives of 15 Tennessee patients in a 2012 outbreak. Dozens more were sickened.
More recently an unnamed out-of-state drug compounder provided the Tennessee Corrections Department with the drug, Midazolam, needed to execute Billy Ray Irick on Aug. 9. Under state law the identity of that compounder has been kept secret.
Repeated calls and emails to Surecare and its majority owner Paul Galbiati went unanswered.
The Surecare web site lists sterile compounding as one of its services, but also states, "We
are currently updating our clean room facilities to meet changes in standards and regulations – at which time we will continue to offer sterile compounding for our patients."
According to the company's application, a predecessor firm, Sun City Compounding, was cited by the Texas Pharmacy Board for failing to disclose the fact that an officer had been convicted of a misdemeanor.
Surecare's Tennessee application lists Alexandra Abbas as the pharmacist in charge.
Abbas was also cited by the Texas board in 2017 for allowing an unlicensed technician to perform technician's duties. She was employed in a different pharmacy at the time.
Though Abbas was listed as the pharmacist-in-charge in the Tennessee application the company web site lists a different pharmacist in that position.
The application lists Galbiati as a 60 percent owner, 4AM Consulting with 30 percent, James A. Lyle at 5 percent and Ed Anderson with 5 percent. Neither Lyle or Anderson responded to requests for comment.
Contact: wfrochejr999@gmail.com

No comments:

Post a Comment