Nelson Vergel
Founder, ExcelMale.com
Scott Brunner, CEO of the Alliance for Pharmacy Compounding (www.compounding.com) speaks about the current threats to people's access to affordable and customized hormone products in the U.S. and what you can do about it. The FDA is considering banning compounded estradiol, estrone, estradiol cypionate, estriol, pregnenolone, progesterone, testosterone, testosterone cypionate, and testosterone propionate and all pellet cBHT therapies. Also, under the Biologics Price Competition and Innovation Act of 2009 (BPCIA) – Protein-based drug products like hCG, FSH, and hMG that had been approved as “drugs” over 15 years ago are now considered “Biologics” and now fall under the jurisdiction of the FDA’s Center for Biologics Evaluation and Research (CBER). These 3 compounds are gonadotropins that have been used in fertility and hormone replacement in women and men. Compounding pharmacies have been compounding urine-derived hCG, FSH, and hMG and increasing patient access to these medications for 50 years. Under the new law, compounding pharmacies are no longer allowed to make these products unless they go through a new lengthy and costly Biologic License Application (BLA). Scott also explained how proposed USP changes in "Beyond Use Dates" will increase cost and need for frequent refills for patients.
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