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Testosterone Replacement, Low T, HCG, & Beyond
Testosterone Side Effect Management
Gonadorelin alternative to hCG - Kisspeptin a peptide that is not approved for compounding
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<blockquote data-quote="Cataceous" data-source="post: 188151" data-attributes="member: 38109"><p>I would like to understand how Hallandale is lying. <a href="https://www.fda.gov/drugs/human-drug-compounding/bulk-drug-substances-used-compounding-under-section-503a-fdc-act" target="_blank">According to FDA</a>:</p><p></p><p><em>State-licensed physicians and pharmacists that compound under section 503A of the Federal Food, Drug, and Cosmetic Act (FD&C Act) may only compound drug products using bulk drug substances that:</em></p><ol> <li data-xf-list-type="ol"><em><strong>comply with an applicable United States Pharmacopeia (USP) or National Formulary (NF) monograph if one exists, and the USP chapter on pharmacy compounding;</strong></em></li> <li data-xf-list-type="ol"><em><strong>are components of FDA-approved drug products if an applicable USP or NF monograph does not exist; <u>or</u></strong></em></li> <li data-xf-list-type="ol"><em>appear on FDA’s list of bulk drug substances that can be used in compounding (the 503A bulks list) if such a monograph does not exist and the substance is not a component of an FDA-approved drug product.</em></li> </ol><p><em>In addition, bulk drug substances must be accompanied by a valid certificate of analysis and must have been manufactured by an establishment registered with FDA under section 510 of the FD&C Act. The agency urges compounders to <a href="https://www.fda.gov/drugs/human-drug-compounding/fda-compounders-know-your-bulks-supplier" target="_blank">know your bulks supplier</a>.</em></p><p></p><p>I would interpret this as not requiring that a bulk drug substance be on the FDA's list of bulk drug substances for compounding if there is an applicable USP-NF monograph or if the substance is a component of an FDA-approved drug product. It appears that both of these conditions are met with gonadorelin.</p><p></p><p>I don't disagree that the TRT community at large should have a stronger focus on access to hCG. But I think it's beneficial to have gonadorelin as an option for those who want or need it.</p></blockquote><p></p>
[QUOTE="Cataceous, post: 188151, member: 38109"] I would like to understand how Hallandale is lying. [URL='https://www.fda.gov/drugs/human-drug-compounding/bulk-drug-substances-used-compounding-under-section-503a-fdc-act']According to FDA[/URL]: [I]State-licensed physicians and pharmacists that compound under section 503A of the Federal Food, Drug, and Cosmetic Act (FD&C Act) may only compound drug products using bulk drug substances that:[/I] [LIST=1] [*][I][B]comply with an applicable United States Pharmacopeia (USP) or National Formulary (NF) monograph if one exists, and the USP chapter on pharmacy compounding;[/B][/I] [*][I][B]are components of FDA-approved drug products if an applicable USP or NF monograph does not exist; [U]or[/U][/B][/I] [*][I]appear on FDA’s list of bulk drug substances that can be used in compounding (the 503A bulks list) if such a monograph does not exist and the substance is not a component of an FDA-approved drug product.[/I] [/LIST] [I]In addition, bulk drug substances must be accompanied by a valid certificate of analysis and must have been manufactured by an establishment registered with FDA under section 510 of the FD&C Act. The agency urges compounders to [URL='https://www.fda.gov/drugs/human-drug-compounding/fda-compounders-know-your-bulks-supplier']know your bulks supplier[/URL].[/I] I would interpret this as not requiring that a bulk drug substance be on the FDA's list of bulk drug substances for compounding if there is an applicable USP-NF monograph or if the substance is a component of an FDA-approved drug product. It appears that both of these conditions are met with gonadorelin. I don't disagree that the TRT community at large should have a stronger focus on access to hCG. But I think it's beneficial to have gonadorelin as an option for those who want or need it. [/QUOTE]
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Testosterone Replacement, Low T, HCG, & Beyond
Testosterone Side Effect Management
Gonadorelin alternative to hCG - Kisspeptin a peptide that is not approved for compounding
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