Incident 40495

A compounding pharmacy based in Nicholasville, and its owner,
were sentenced in federal court on 2/18/2021, by U.S. District Judge Gregory F. Van Tatenhove,
for unlawful distribution of compounded prescription drugs. Tailor Made Compounding (TMC)
was sentenced to three years probation and forfeited $1,788,906.82. The owner, Jeremy Delk, was
sentenced to three years probation, including four months home incarceration, 100 hours of
community service, a $20,000 fine, and a prohibition from participating in a business involving the
distribution of prescription drugs.

Delk was sentenced on his guilty plea to one count of unlawfully engaging in wholesale
distribution of a prescription drug, without licensing TMC as a wholesale distributor with the
Kentucky Board of Pharmacy. According to his plea agreement, from October 23, 2018 through
May 14, 2020, TMC sent 112 vials of Methylcobalamin, a prescription form of vitamin B12, to 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,
this physician made bulk orders of Methylcobalamin 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 the physician, knowing
that TMC had never applied for permission from the Kentucky Board of Pharmacy 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.
TMC was sentenced on its guilty plea to one count of distributing unapproved new drugs
throughout the United States, from October 25, 2018 through April 1, 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,
including BPC 157, Cerebrolysin, CJC 1295, DSIP, Epitalon, GW 501516, Ipamorelin, LGD-4033,
LL-37, Melanotan II, MK 677, PEG-MGF, Selank, and Semax. In connection with the plea, TMC
agreed to forfeit $1,788,906.82, representing its 2019 sales for these products
Tailor Made and Delk pleaded guilty in October 2020.