Owner of Nicholasville compounding pharmacy pleads guilty in prescription drugs case

The decision by U.S. District Court Judge Joshua Kindred, released late Thursday, comes in a...
The decision by U.S. District Court Judge Joshua Kindred, released late Thursday, comes in a case that challenged the state’s decision to mail, unprompted, absentee ballot applications to registered voters who are 65 and older ahead of the August primary amid coronavirus concerns.(MGN)
Published: Oct. 29, 2020 at 4:01 PM EDT
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NICHOLASVILLE, Ky. (WKYT) - A Nicholasville-based compounding pharmacy, and its owner, admitted in federal court on Thursday to the unlawful distribution of compounded prescription drugs.

The U.S. Attorney’s Office says Tailor Made Compounding pleaded guilty to one count of distributing unapproved new drugs throughout the United States, from October 2018 through April 2020.

Specifically, TMC pleaded guilty to unlawful distribution of selective androgen receptor modulators (“SARMS”) and other substances that the FDA had not approved for distribution in the United States. 

SARMS are synthetic chemicals designed to mimic the effects of testosterone and other anabolic steroids.  Products containing SARMS were often marketed and sold for body-building purposes. 

According to the plea agreement, TMC also unlawfully distributed other unapproved new drugs. In connection with the plea, TMC agreed to forfeit more than $1.7 million representing its 2019 sales for the products.

The U.S. Attorney’s Office says the company’s owner, 40-year-old Jeremy Delk, pleaded guilty to one count of unlawfully engaging in wholesale distribution of a prescription drug, without licensing TMC as a wholesale distributor with the Board of Pharmacy for the Commonwealth of Kentucky. 

According to the plea agreement, from October 2018 through May 2020, TMC sent 112 vials of Methylcobalamin 10mg/ml 10mL, a prescription form of vitamin B12, to Doctor 1, a licensed physician who operated an anti-aging/wellness clinic in the Greater Los Angeles area.

Rather than sending individualized, patient-specific prescriptions to TMC, as is required by law, Doctor 1 made bulk orders of Methylcobalamin 10mg/ml 10mL without issuing prescriptions or providing accurate patient names. 

Delk, as owner and chief executive officer of TMC, knowingly caused TMC to fill and ship bulk, wholesale distributions of Methylcobalamin to Doctor 1, knowing that TMC had never applied for permission from the Kentucky Board of Pharmacy for TMC to act as a wholesale distributor of prescription drugs. 

When authorities from the FDA and the Kentucky Board of Pharmacy inspected TMC between August 20 and October 24, 2018, Delk took steps to hide records of TMC’s wholesale distributions of Methylcobalamin, as well as other records.

Tailor Made and Delk were charged by way of information, waiving their right to indictment by a federal grand jury.

Delk and Tailor Made Compounding are scheduled to be sentenced on February 24, 2021.  Delk faces up to 10 years in prison and a maximum fine of $250,000. 

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