2005P-0411 Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
FDA Comment Number : EC11
Submitter : Mr. Kirsten Ward Date & Time: 12/19/2005 12:12:15
Organization : Mr. Kirsten Ward
Category : Drug Industry
Issue Areas/Comments
Bio-Identical Hormone Replacement Therapy means just that, identical to the hormones found in the human body. There is no public risk to health, since these hormones are merely replacing what was lost due to age, diet, or environment. These are the exact hormones that should be in the body, not synthetics, so BHRT's are much easier absorbed and assimilated by the body than other manufactured products. With the choice between synthetics and BHRT's, our patients choose BHRT as their hormone therapy. We compound these hormones in many different, versatile dosing forms for men and women that conform to the patients needs much more than manufactured products ever could. The best thing about compounded BHRT's is that we can adapt to the patients hormone levels as they improve. When our patients hormone levels change from treatment, we can adapt their therapy to reflect their new hormone levels, giving them constant proper care for their needs. BHRT's do not endanger public health, rather they improve the quality of life for those taking them. Those patients have spread, by word of mouth to their friends and doctors, the help they have received with BHRT's.