Compounding Pharmacy Allegedly Dispenses Contaminated Syringes

Case Overview

This case involves a compounding pharmacy that allegedly used insulin syringes to fill in an anti-cancer drug used off-label to treat eye conditions, including macular degeneration. The syringes were lubricated with silicone oil and not designed to be used for eye injections. However, they were allegedly sold to ophthalmologists for the treatment of macular degeneration. The silicone oil contamination resulted in silicone oil deposit in the eyes. This caused vision interference for patients who took the medication, and many required corrective laser surgery or a vitrectomy.

Questions to the Pharmacy expert and their responses

What is the role of the compounding pharmacist in selecting the type of syringe used for filling in a drug?

Compounders are responsible to ensure that containers (e.g., ampules, syringes, and vials) maintain sterility, strength, purity, and stability of compounded sterile preparations, i.e., CSPs.

Are you familiar or involved with USP regulations with compounding solutions?

I am a member of the USP Compounding Expert Committee and I served as the USP Council of Experts Sterile Compounding Committee Chair for 10 years. I have compounded many injections and a few ophthalmics as a civilian and US Army hospital pharmacist as well as a university faculty member. I have consulted on several cases of patient harm and death from pharmacy compounded CSPs, including for the US DOJ.

About the expert

This expert on Compounding Pharmacy obtained his BS and MS in Pharmacy and his PhD in Industrial Pharmaceutical Formulations and Science from the University of Florida. He completed his Internship in Pharmacy at the U.S. Veterans Administration Regional Outpatient Clinic of St. Petersburg and his Residency in Compounding Pharmacy at the Shands Teaching Hospital. He is a member of the American Pharmacists Association, the American Association, American Association of Colleges of Pharmacy and has 72 publications. He was formerly a Professor of Pharmaceutics up until August of 2017 and is now Professor Emeritus at a university in VA.