South Carolina Pharmacist Sentenced for Illegally Compounding Radioactive Drugs

The United States Attorney’s Office for the District of South Carolina has announced that a pharmacist pleaded guilty to adulteration of a radioactive drug and has been sentenced.

Just the Facts

Richard A. Sheriff was the 73-year-old owner and pharmacist-in-charge of Shertech Pharmacy. The pharmacy provided radiopharmaceutical and nuclear medications to medical facilities in the Greenville, South Carolina area who would then use them for procedures such as renal scans. Federal investigators determined that from January 2018 through June 2019, Sheriff and the pharmacists he supervised would fractionate (also known as “splitting”) the active ingredient of Technescan MAG3 without ensuring that the resulting pieces were of equal size, purity, or strength. This resulted in diluted medications, creating a risk of low-quality patient scans, which might not reveal abnormalities, or repeated scans, which would expose patients to additional radiation.

In addition, investigators found that the compounding was being done without proper protective equipment, testing, or quality assurance. Sheriff failed to notify patients when dispensing the radioactive medication that the amount of active ingredient might be diluted, resulting in patients needing extra scans or having poor quality results.

The Plea

Sheriff eventually pleaded guilty to adulterating a medication, and was sentenced to 2 years of probation and a $2000 fine. In addition, Sheriff agreed to forfeit over $166 000 in revenues.

“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,” said Special Agent in Charge Justin Fielder, FDA Office of Criminal Investigations, Miami Field Office, in a statement.

“Patients and health care facilities must be able to trust the quality of the pharmaceuticals they receive from providers like Shertech,” said Adair F. Boroughs, US Attorney for the District of South Carolina, in a statement. “Adhering to sanitary standards when formulating these drugs is not only the lawful thing to do, but also the ethical thing to do.”

The takeaway: This case was investigated by the Food and Drug Administration’s Office of Criminal Investigations. The FDA is very serious about its compounding requirements, particularly in light of a few disturbing and noteworthy compounding cases that have taken place over the last decade. If your pharmacy compounds, it is essential to comply with FDA regulations.

References

United States Attorney’s Office, District of South Carolina. Upstate Pharmacist Sentenced for Unlawfully Compounding Radioactive Drugs. July 25, 2024. Accessed September 12, 2024. https://www.justice.gov/usao-sc/pr/upstate-pharmacist-sentenced-unlawfully-compounding-radioactive-drugs

US Food and Dry Administration. Department of Health and Human Services. Inspectional Observations. Accessed September 12, 2024. https://www.fda.gov/media/130254/download