2005P-0411 Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
FDA Comment Number : EC2630
Submitter : Mr. Kenton Quick Date & Time: 02/16/2006 12:02:18
Organization : Mr. Kenton Quick
Category : Individual Consumer
Issue Areas/Comments
GENERAL
GENERAL
I am writing to protest Wyeth Pharmaceuticals Citizen's Peitition with the FDA against compounding pharmacies that provide bio-identical hormones.

I am protesting Wyeth's Petition because:
1) Wyeth mischaracterizes pharmacy compounding by deliberately ignoring the crucial role of the physician.
2) Wyeth equates compounding with manufacturing.
3) Wyeth accuses pharmacists that compound BHRT of copying Wyeth's drugs.
4) Wyeth tries to use advertising as something that distinguishes pharmacist from manufacturer.
5) Compounded medications are not unapproved new drugs and do not require new drug approval.

These are erroneous arguments. We need access to BHRT.

Thank you.

Kenton J. Quick