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Testosterone Replacement, Low T, HCG, & Beyond
Testosterone Side Effect Management
The FDA and hCG: Approved NDAs for Biological Products That Were Deemed to be BLAs on March 23, 2020
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<blockquote data-quote="Nelson Vergel" data-source="post: 186641" data-attributes="member: 3"><p>Empower still has it but I don't know for how long. Your doctor has to fax a script to them. You can’t. Have your doctor’s front desk call Empower to ask how to set up an account with them.</p><p>The brand name product may be available at regular pharmacies but I hear there may be a shortage. Prices will increase for sure now that over 23 compounding pharmacies were made to stop selling it by the FDA.</p><p></p><p>I repeat this every week but it seems no one is reading.</p><p></p><p>[URL unfurl="true"]https://www.excelmale.com/forum/threads/your-access-to-more-economical-hcg-and-fsh-may-end-send-comments-to-the-fda.19942/[/URL]</p><p></p><p>From Empower Pharmacy:</p><p></p><p>Empower is still engaging with the FDA and pursuing legislative options to update the Biologics Price Competition and Innovation Act to allow compounders to continue making HCG and other biologics like we have always been able to. Just as there has never been a risk to a prescriber for prescribing a compounded biologic there will be none to further do so.</p><p></p><p>The Biologics Price Competition and Innovation Act was designed to improve access to important biologic medications including insulin. The effect on compounding pharmacies was unintentional, and to stop compounding pharmacies from producing certain transitional biologics that have been compounded for years goes against the intention of this policy.</p><p></p><p></p><p>In addition, the off-label use of HCG includes infertility and TRT protocols in men. Urologists and men’s health providers have used compounding pharmacies for years, and compounded prescription data is not reported to the government the same way commercial drugs are reported through insurances, therefore the very large patient population who uses HCG off label has not been accounted for. There isn’t enough commercial supply to meet all patients needs at this time. Until there is enough supply to meet patients needs and the discrepancy in policy has been properly addressed, several FDA registered outsourcing facilities are continuing to supply HCG until further notice.</p></blockquote><p></p>
[QUOTE="Nelson Vergel, post: 186641, member: 3"] Empower still has it but I don't know for how long. Your doctor has to fax a script to them. You can’t. Have your doctor’s front desk call Empower to ask how to set up an account with them. The brand name product may be available at regular pharmacies but I hear there may be a shortage. Prices will increase for sure now that over 23 compounding pharmacies were made to stop selling it by the FDA. I repeat this every week but it seems no one is reading. [URL unfurl="true"]https://www.excelmale.com/forum/threads/your-access-to-more-economical-hcg-and-fsh-may-end-send-comments-to-the-fda.19942/[/URL] From Empower Pharmacy: Empower is still engaging with the FDA and pursuing legislative options to update the Biologics Price Competition and Innovation Act to allow compounders to continue making HCG and other biologics like we have always been able to. Just as there has never been a risk to a prescriber for prescribing a compounded biologic there will be none to further do so. The Biologics Price Competition and Innovation Act was designed to improve access to important biologic medications including insulin. The effect on compounding pharmacies was unintentional, and to stop compounding pharmacies from producing certain transitional biologics that have been compounded for years goes against the intention of this policy. In addition, the off-label use of HCG includes infertility and TRT protocols in men. Urologists and men’s health providers have used compounding pharmacies for years, and compounded prescription data is not reported to the government the same way commercial drugs are reported through insurances, therefore the very large patient population who uses HCG off label has not been accounted for. There isn’t enough commercial supply to meet all patients needs at this time. Until there is enough supply to meet patients needs and the discrepancy in policy has been properly addressed, several FDA registered outsourcing facilities are continuing to supply HCG until further notice. [/QUOTE]
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Testosterone Replacement, Low T, HCG, & Beyond
Testosterone Side Effect Management
The FDA and hCG: Approved NDAs for Biological Products That Were Deemed to be BLAs on March 23, 2020
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