Pharmacist pleads guilty to 'adulterating' radiopharmaceuticals
A South Carolina pharmacist has pleaded guilty to adulterating radiopharmaceutical drugs prior to distributing them to medical facilities in the Greenville area, according to a news release from the Department of Justice.
Richard A. Sheriff, 73, is a pharmacist and owner of Shertech—a pharmacy that specializes in radiopharmaceuticals. An investigation into the company revealed that Sheriff and his staff had been diluting the active ingredient of Technescan MAG3, or TC-99m MAG3, prior to distributing it to medical facilities between January 2018 and June 2019.
According to the DOJ, Sherriff and those working under him “would ‘fractionate’ or ‘split’ the active ingredient of Technescan MAG3, without ensuring the pieces were equal in size, purity or strength.”
“This compounding was done without proper protective gear, testing or quality assurance. The resulting diluted product was used in procedures such as renal scans to diagnose various illnesses, such as kidney disease,” the release reads.
What’s more the facilities purchasing these products from Shertech were not made aware that they had been diluted. This could have resulted in suboptimal image quality and the potential need for additional scans, the DOJ notes.
“Adulterating a drug under insanitary conditions threatens the health and safety of U.S. consumers. In this case, the adulterated product potentially contained only a portion of the full dosage needed for renal imaging, causing a direct risk to adult and pediatric patients of poor-quality and potential repeat scans with additional radiation exposure,” Special Agent in Charge Justin Fielder, with the FDA Office of Criminal Investigations, said in a release.
As part of his plea agreement, Sheriff will have to pay back $166,000 in revenues made from the diluted products, in addition to a $2,000 fine. He has also been sentenced to two years of probation.