Tailor Made Compounding (“The Peptide People”) and its owner were both charged by federal prosecutors in Kentucky.
Carlton S. Shier, IV., the Acting United States Attorney for the Eastern District of Kentucky, charged Tailor Made Compounding (as a corporation) with one felony count of distributing unapproved new drugs in connection with its distribution of selective androgen receptor modulators (SARMs).
Federal prosecutors also charged TMC’s owner, Jeremy Delk (as an individual) with one felony count of unlawfully engaging in wholesale distribution of a prescription drug in connection with selling wholesale quantities of injectable Vitamin B12 without licensing.
TMC and Delk pleaded guilty to the respective charges in October 2020.
U.S. District Judge Gregory F. Van Tatenhove sentenced TMC to three years probation and ordered the forfeiture of $1,788,906.82. The forfeiture represented the proceeds from the sale of SARMs and peptides between October 25, 2018 through April 1, 2020.
Judge Van Tatenhove sentenced Jeremy Delk to four months of home incarceration and three years probation. Delk was also ordered to serve 100 hours of community service and pay a $20,000 fine. He was further prohibited from starting or participating in any type of business involving the distribution of prescription drugs.
SARMs have often been advertised (falsely) as a safe and legal alternative to anabolic steroids.
SARMs have always been illegal to sell as dietary supplements. SARMs never met the criteria under federal law. They were always considered “unapproved new drugs” by the U.S. Food and Drug Administration (FDA).
The fact that SARMs were considered unapproved new drugs also meant that physicians and pharmacies were never legally allowed to prescribe and sell them either.
For several years, SARMs were falsely sold as safe alternatives to anabolic steroids. They were marketed to bodybuilders for their muscle-building effects.
While SARMs differ from steroids in their chemical structure, both SARMs and anabolic steroids exert their effects by acting on the Androgen Receptor. This means that many of the SARM side effects are similar to traditional steroid compounds.
In addition to SARMs, TMC sold a wide variety of peptides and other compounds frequently used by bodybuilders. These included BPC 157, Cerebrolysin, CJC 1295, DSIP, Epitalon, GW 501516, Ipamorelin, LGD-4033, LL-37, Melanotan II, MK 677, PEG-MGF, Selank, and Semax.
Delk was not individually charged for distributing SARMs.
However, Delk was charged with unlawfully distributing wholesale quantities of injectable Vitamin B-12. TMC was only licensed to fulfill individualized, patient-specific prescriptions for legal compounded drugs. TMC did not have a wholesale license.
Delk caused TMC to send 112 vials of Methylcobalamn 10mg/ml to a licensed anti-aging doctor at a Los Angeles area wellness clinic between October 23, 2018 through May 14, 2020. To make matters worse, Delk tried to hide wholesale distribution records from the FDA and the Kentucky Board of Pharmacy.
The FDA insisted that it is not choosing to single out compounding pharmacies. It just wants to make sure that compounding pharmacies follow the laws.
“Compounded drugs can serve an important role for patients whose medical needs cannot be met by an FDA-approved drug product. But pharmacies will be held responsible for failing to follow the laws intended to protect patients, including requirements for licensure and limitations on what drugs can be appropriately compounded,” said Special Agent in Charge Mark S. McCormack, FDA Office of Criminal Investigations Metro Washington Field Office. “We will continue to investigate and bring to justice those who put profits above a patient’s health.”
DOJ. (February 24, 2021). Nicholasville Compounding Pharmacy and Its Owner Sentenced for Unlawful Distribution of Prescription Drugs Unlawful Distribution of Prescription Drugs. Retrieved from justice.gov/usao-edky/pr/nicholasville-compounding-pharmacy-and-its-owner-sentenced-unlawful-distribution