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Testosterone Replacement, Low T, HCG, & Beyond
Testosterone Basics & Questions
CALL TO ACTION: Stop the FDA from restricting compounded hormone therapy!
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<blockquote data-quote="Blackhawk" data-source="post: 188561" data-attributes="member: 16042"><p>The narrative of the message is not my style. I wrote:</p><p></p><p>I'm a constituent of yours from CITY, STATE. I'm writing to request you sign on to the bipartisan joint congressional letter to FDA Commissioner Stephen Hahn regarding Compounded Bioidentical Hormone Therapy (cHBT). The letter is penned by Reps. Pocan, Roe, Cuellar, and Herrera-Beutler. Please vote against this attempt to restrict and eliminate compounded hormone therapy to patients like me, AS PRESCRIBED BY MY DOCTOR!</p><p></p><p>The FDA commissioned the National Academies of Science, Engineering & Medicine to do a study of compounded bioidentical hormone therapy (cHBT). The study and the resulting recommendations drawn from it are deeply flawed. The NASEM study committee involved no physicians or academicians with pharmacy compounding expertise, nor expertise in compounded hormone therapy.</p><p></p><p>The study concluded that there isn't much clinical evidence for or against its use. However, the resulting recommendation is to enact restrictions on compounded hormone therapy. This is non-sensical and negatively affects those of us who have used this therapy successfully for years. Many thousands or more Americans like me benefit from this therapy and patient outcome data show that cBHT is safe and effective. </p><p></p><p>I source my compounded medications from a PCAB Accredited, FDA Registered 503B pharmacy.</p><p></p><p>About 503B certification: <a href="https://www.thefdagroup.com/blog/503a-vs-503b-compounding-pharmacies" target="_blank">503A vs. 503B: A Quick-Guide to Compounding Pharmacy Designations & Regulations</a> </p><p></p><p>These standards for this level of compounding pharmacy are designated by the FDA, and are stringent. It is hypocritical for the FDA to grant such licensure while simultaneously trying to limit the ability of these companies based on a flawed recommendation based on a flawed study that did not even gather evidence to show that a problem exists.</p><p></p><p>Compounded hormone therapies are customized to the needs of specific patients like me and essential to my healthcare. The FDA's attempt to discontinue the availability of this therapy is unfounded.</p><p></p><p>Thank you for your action on this request. I have contacted you before on federal land management issues and appreciate your like minded support.</p></blockquote><p></p>
[QUOTE="Blackhawk, post: 188561, member: 16042"] The narrative of the message is not my style. I wrote: I'm a constituent of yours from CITY, STATE. I'm writing to request you sign on to the bipartisan joint congressional letter to FDA Commissioner Stephen Hahn regarding Compounded Bioidentical Hormone Therapy (cHBT). The letter is penned by Reps. Pocan, Roe, Cuellar, and Herrera-Beutler. Please vote against this attempt to restrict and eliminate compounded hormone therapy to patients like me, AS PRESCRIBED BY MY DOCTOR! The FDA commissioned the National Academies of Science, Engineering & Medicine to do a study of compounded bioidentical hormone therapy (cHBT). The study and the resulting recommendations drawn from it are deeply flawed. The NASEM study committee involved no physicians or academicians with pharmacy compounding expertise, nor expertise in compounded hormone therapy. The study concluded that there isn't much clinical evidence for or against its use. However, the resulting recommendation is to enact restrictions on compounded hormone therapy. This is non-sensical and negatively affects those of us who have used this therapy successfully for years. Many thousands or more Americans like me benefit from this therapy and patient outcome data show that cBHT is safe and effective. I source my compounded medications from a PCAB Accredited, FDA Registered 503B pharmacy. About 503B certification: [URL='https://www.thefdagroup.com/blog/503a-vs-503b-compounding-pharmacies']503A vs. 503B: A Quick-Guide to Compounding Pharmacy Designations & Regulations[/URL] These standards for this level of compounding pharmacy are designated by the FDA, and are stringent. It is hypocritical for the FDA to grant such licensure while simultaneously trying to limit the ability of these companies based on a flawed recommendation based on a flawed study that did not even gather evidence to show that a problem exists. Compounded hormone therapies are customized to the needs of specific patients like me and essential to my healthcare. The FDA's attempt to discontinue the availability of this therapy is unfounded. Thank you for your action on this request. I have contacted you before on federal land management issues and appreciate your like minded support. [/QUOTE]
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Testosterone Replacement, Low T, HCG, & Beyond
Testosterone Basics & Questions
CALL TO ACTION: Stop the FDA from restricting compounded hormone therapy!
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