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Testosterone Replacement, Low T, HCG, & Beyond
Testosterone Basics & Questions
Group Tells the FDA to Restrict the Use of Compounded Hormones
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<blockquote data-quote="Nelson Vergel" data-source="post: 191985" data-attributes="member: 3"><p>That is the message this group is using to convince the FDA to make prescribing compounded products a very restricted field.</p><p></p><p>The use of compounded bioidentical hormone therapies (cBHTs) — an increasingly popular approach to relieve symptoms of menopause and male hypogonadism — should be limited to the small number of patients who cannot benefit from an FDA-approved hormone therapy product, says a <a href="http://www.nap.edu/25791" target="_blank">new report</a> from the National Academies of Sciences, Engineering, and Medicine. It recommends that prescribers restrict the use of cBHTs to two circumstances: when a patient is allergic to an ingredient in an FDA-approved hormone product, and when a patient requires a specific dosage form not available for an FDA-approved product.</p><p></p><p>“Bioidentical” hormone therapies (BHTs) contain hormones that are chemically and structurally identical to those produced by the human body. They are available as FDA-approved products or non-FDA-approved compounded preparations. Unlike FDA-approved BHT products, compounded preparations have not been subjected to regulatory oversight or rigorous safety, efficacy, and quality control testing. Further, because cBHTs are custom-blended in different doses and forms — such as pills, creams, or pellets — the lack of standardization can increase the possibility of overdosing, underdosing, or contamination, says <a href="http://www.nap.edu/25791" target="_blank"><strong><em>The Clinical Utility of Compounded Bioidentical Hormone Therapy: A Review of Safety, Effectiveness, and Use</em></strong></a>.</p><p></p><p></p><p></p><p>[URL unfurl="true"]https://www.nationalacademies.org/news/2020/07/prescribers-should-restrict-the-use-of-non-fda-approved-compounded-bioidentical-hormones-except-for-specific-medical-circumstances[/URL]</p></blockquote><p></p>
[QUOTE="Nelson Vergel, post: 191985, member: 3"] That is the message this group is using to convince the FDA to make prescribing compounded products a very restricted field. The use of compounded bioidentical hormone therapies (cBHTs) — an increasingly popular approach to relieve symptoms of menopause and male hypogonadism — should be limited to the small number of patients who cannot benefit from an FDA-approved hormone therapy product, says a [URL='http://www.nap.edu/25791']new report[/URL] from the National Academies of Sciences, Engineering, and Medicine. It recommends that prescribers restrict the use of cBHTs to two circumstances: when a patient is allergic to an ingredient in an FDA-approved hormone product, and when a patient requires a specific dosage form not available for an FDA-approved product. “Bioidentical” hormone therapies (BHTs) contain hormones that are chemically and structurally identical to those produced by the human body. They are available as FDA-approved products or non-FDA-approved compounded preparations. Unlike FDA-approved BHT products, compounded preparations have not been subjected to regulatory oversight or rigorous safety, efficacy, and quality control testing. Further, because cBHTs are custom-blended in different doses and forms — such as pills, creams, or pellets — the lack of standardization can increase the possibility of overdosing, underdosing, or contamination, says [URL='http://www.nap.edu/25791'][B][I]The Clinical Utility of Compounded Bioidentical Hormone Therapy: A Review of Safety, Effectiveness, and Use[/I][/B][/URL]. [URL unfurl="true"]https://www.nationalacademies.org/news/2020/07/prescribers-should-restrict-the-use-of-non-fda-approved-compounded-bioidentical-hormones-except-for-specific-medical-circumstances[/URL] [/QUOTE]
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Testosterone Replacement, Low T, HCG, & Beyond
Testosterone Basics & Questions
Group Tells the FDA to Restrict the Use of Compounded Hormones
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