2005P-0411 Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
FDA Comment Number : EC23
Submitter : Dr. kenneth weld Date & Time: 12/21/2005 05:12:45
Organization : Dr. kenneth weld
Category : Federal Government
Issue Areas/Comments
GENERAL
GENERAL
A recent graduate from pharmacy school and initially uneducated and critical of compounding, after 2 years of improving the lives of women on HRT, I believe to eliminate BHRT would be a disservice to our patients that we treat and take care of every day. Done under close supervision, and with exact doses compounding hormones in specific dosage forms provides the minimum strengths and side effects available for patients. Furthermore, because they can be "tailored" to each individual it is not a mass overdose to everyone as in the cases of commercial products where one size fits all. I am also very clear to my patients that compounded hormones carry the same risks (clotting/liver function/cell proliferation/cancer)as commercial products do and there is not current literature to prove otherwise, however with all HRT in "the headlights" right now at least we can provide an accurate dose based according to objective and subjective data, and treating with the lowest effective dose for the shortest amount of time is still the philosophy we stand by. Unless there is information that I am not aware of, compounding pharmacies do not mass produce large quantities of bioidentical hormones like a manufacture, this is not only illegal but immoral and would not be in the best interest of the patient, which is why we take an oath before graduating.