Kentucky Pharmacy Owner Guilty Of Federal Charge

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A Kentucky pharmacy owner has pleaded guilty to a federal charge of distributing a prescription drug without a license.

Jeremy Delk owns Tailor Made Compounding LLC in Nicholasville. Eastern District U.S. Attorney Robert Duncan Jr. says the pharmacy distributed unapproved drugs from October 2018 through April.

The drugs included substances that mimic the effects of testosterone and anabolic steroids but are not approved by the government for distribution.

The company agreed to forfeit $1.7 million, which totals its 2019 sales of the drugs. Delk faces up to 10 years in prison.
 
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More detail in this story:
A compounding pharmacy based in Nicholasville, and its owner, admitted on Thursday in federal court to unlawful distribution of compounded prescription drugs.
Tailor Made Compounding LLC (TMC) pleaded guilty to one count of distributing unapproved new drugs throughout the U.S., from Oct. 25, 2018, through April 1, 2020, before U.S. District Judge Gregory F. Van Tatenhove.
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 U.S.
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.
Jeremy Delk, 40, 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 Oct. 23, 2018, through May 14, 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 Aug. 20, 2018, and Oct. 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.
 
More overbearing government law enforcement. Here’s a pharmacy trying to deliver quality compounded products to compete with the stuff of unknown origin for sale all over the internet, and the owner gets rewarded with the possibility of 10 years in Club Fed.
 
More overbearing government law enforcement. Here’s a pharmacy trying to deliver quality compounded products to compete with the stuff of unknown origin for sale all over the internet, and the owner gets rewarded with the possibility of 10 years in Club Fed.
It's unfortunate that the market for these substances is so far too small to give it much political clout. If only it could somehow piggyback on the movement to legalize marijuana.
 
Someone not following the rules don't help the movement. A guy on YouTube that couldn't stop talking about Tailor Made and them sending him gifts to try probably didn't help the situation. The subject matter on YouTube sure has changed. Must have seen the light or lights a flashing.
 
It would be interesting to know the details regarding the alleged "unlawful distribution of unapproved drugs". There are other compounding pharmacies that are dispensing Ipamorelin, CJC 1295, Melanotan and more and have been for some time. No sign they are in trouble, yet, I guess. Also, because they distributed the drugs in bulk violating a wholesale license law is interesting. This is one of the problems I have with government regulation is they can be so convoluted and confusing that a technicality can become a federal offense and a tool of entrapment. Often applied unequally. I remember (back in the day) doctors running weight loss clinics could order amphetamines by the truckload.
 
Someone not following the rules don't help the movement. ...
And yet over time this kind of flouting of the rules helped the marijuana legalization movement, as people began to understand the vast cost to society of locking people up for a largely victimless crime. Of course people also see the hypocrisy in allowing alcohol use in spite of its more clear-cut threat to human life. I think government should meet a high burden of proof of harm to society at large before it imposes restrictions on individual freedoms. Personally I don't care anything about marijuana—never even tried it—but there are these parallels with the peptides and such: There is the potential for abuse and harm, but generally not with responsible use. In some cases the peptides even have the potential to improve health. Marginalizing them only reduces their safety and slows our acquisition of knowledge.
 
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Delk took steps to hide records of TMC’s wholesale distributions of Methylcobalamin, as well as other records.

Sounds innocent and trustworthy.
 
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