2005P-0411 Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
FDA Comment Number : EC9
Submitter : Mr. Wayne Wallace Date & Time: 12/19/2005 12:12:39
Organization : The Medicine Shoppe
Category : Health Professional
Issue Areas/Comments
GENERAL
GENERAL
Wyeth's postion is politically and monetarily motivated and NOT in the best interest of the public.

AS well, they have a vested interest with this agenda. They would reap monetary rewards if there petition was adopted. This is a blantant conflict of interest and therefore, the petition should be thrown out!

As well, it should be noted that I have had many patients come to my office to seek an alternative to synthetic hormones which have caused a myriad of sympotms to include but not limited to:
fibroids, cysts, foggy thinking, headaches, breast tenderness, erritability, etc.

Since these patients have switched to an individualized dose of bio-identical hormones, their symptoms have improved without all the negative side affects that synthetic prescriptions cause. Many have told me that their lives have changed for the better since using bio-identical hormones.

We have taken extreme measures to ensure that we are preparing all of our compounds as safely as possible. First of all, we review them continuously.Secondly, we have invested in state of the art software (PK Software) that not only helps ensure accurate dosage amounts for each prescription but also provides extreme details for each and every prescription.

In conclusion, compounding is needed for better care of patients. Compounding is needed so patients and physicians have a choice, pharmacologically. To not allow compounding is to not allow pharmacists to do their jobs as trained.

Thank you for considering my opinion.

Wayne Wallace, RPH