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Compounding Pharmacy Product Reviews
Kentucky Pharmacy Owner Guilty Of Federal Charge
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<blockquote data-quote="Cataceous" data-source="post: 189988" data-attributes="member: 38109"><p>More detail in this story:</p><p>[URL unfurl="true"]https://www.jessaminejournal.com/2020/10/30/nicholasville-compounding-pharmacy-and-its-owner-plead-guilty-to-unlawful-distribution-of-prescription-drugs/[/URL]</p><p style="margin-left: 20px"><em>A compounding pharmacy based in Nicholasville, and its owner, admitted on Thursday in federal court to unlawful distribution of compounded prescription drugs.</em></p> <p style="margin-left: 20px"></p> <p style="margin-left: 20px"><em>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.</em></p> <p style="margin-left: 20px"></p> <p style="margin-left: 20px"><em><strong>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.</strong></em></p> <p style="margin-left: 20px"></p> <p style="margin-left: 20px"><em>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.</em></p> <p style="margin-left: 20px"></p> <p style="margin-left: 20px"><em><strong>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.</strong></em></p> <p style="margin-left: 20px"></p> <p style="margin-left: 20px"><em>In connection with the plea, TMC agreed to forfeit $1,788,906.82, representing its 2019 sales for these products.</em></p> <p style="margin-left: 20px"></p> <p style="margin-left: 20px"><em>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.</em></p> <p style="margin-left: 20px"></p> <p style="margin-left: 20px"><em>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.</em></p> <p style="margin-left: 20px"></p> <p style="margin-left: 20px"><em>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.</em></p> <p style="margin-left: 20px"></p> <p style="margin-left: 20px"><em>Tailor Made and Delk were charged by way of information, waiving their right to indictment by a federal grand jury.</em></p></blockquote><p></p>
[QUOTE="Cataceous, post: 189988, member: 38109"] More detail in this story: [URL unfurl="true"]https://www.jessaminejournal.com/2020/10/30/nicholasville-compounding-pharmacy-and-its-owner-plead-guilty-to-unlawful-distribution-of-prescription-drugs/[/URL] [INDENT][I]A compounding pharmacy based in Nicholasville, and its owner, admitted on Thursday in federal court to unlawful distribution of compounded prescription drugs.[/I][/INDENT] [INDENT][I][/I][/INDENT] [INDENT][I]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.[/I][/INDENT] [INDENT][I][/I][/INDENT] [INDENT][I][B]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.[/B][/I][/INDENT] [INDENT][I][/I][/INDENT] [INDENT][I]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.[/I][/INDENT] [INDENT][I][/I][/INDENT] [INDENT][I][B]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.[/B][/I][/INDENT] [INDENT][I][/I][/INDENT] [INDENT][I]In connection with the plea, TMC agreed to forfeit $1,788,906.82, representing its 2019 sales for these products.[/I][/INDENT] [INDENT][I][/I][/INDENT] [INDENT][I]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.[/I][/INDENT] [INDENT][I][/I][/INDENT] [INDENT][I]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.[/I][/INDENT] [INDENT][I][/I][/INDENT] [INDENT][I]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.[/I][/INDENT] [INDENT][I][/I][/INDENT] [INDENT][I]Tailor Made and Delk were charged by way of information, waiving their right to indictment by a federal grand jury.[/I][/INDENT] [/QUOTE]
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Compounding Pharmacy Product Reviews
Kentucky Pharmacy Owner Guilty Of Federal Charge
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