A compounding pharmacy in Nicholasville, Ky., and its owner admitted in federal court to the unlawful distribution of compounded prescription drugs, the U.S. Justice Department said Oct. 29.
Tailor Made Compounding pleaded guilty to one count of distributing unapproved drugs in the U.S. between 2018 and 2020. The pharmacy distributed selective androgen receptor modulators, or SARMS, which aren't FDA approved for distribution in the U.S.
SARMS are synthetic chemicals designed to mimic the effects of testosterone and other anabolic steroids, the Justice Department said. They're often marketed and sold for body-building purposes.
According to the plea agreement, between 2018 and 2020, the pharmacy sent 112 vials of the drug to a physician in Los Angeles who operated an anti-aging/wellness clinic. Rather than sending patient-specific prescriptions to the pharmacy, the physician made bulk orders of the drug without issuing prescriptions or providing accurate patient names.
Tailor Made Compounding agreed to forfeit $1.79 million, which was its total sales for the illegal drug products in 2019.
Jeremy Delk, the pharmacy's owner and CEO, pleaded guilty to one count of unlawfully engaging in wholesale distribution of a prescription drug. The Justice Department said that when Tailor Made Compounding was investigated in 2018, Mr. Delk took steps to hide records of the pharmacy's wholesale distributions of the illegal drugs, as well as other records.
Mr. Delk is scheduled to be sentenced in February and faces up to 10 years in prison and a maximum fine of $250,000.
Read the Justice Department's full news release here.