2005P-0411 Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
FDA Comment Number : EC21
Submitter : Mr. William Mixon Date & Time: 12/21/2005 05:12:31
Organization : Mr. William Mixon
Category : Health Professional
Issue Areas/Comments
GENERAL
GENERAL
FDA must reject the Wyeth petition (Docket 2005P-0411)!

Compounding Bio-Identical Hormones does not violate State or Federal Laws, nor does it endanger Public Health. I have many patients who have failed to benefit, or have been harmed by commercially available hormones. All of these patients have benefitted from compounded preparations that have been personalized to meet their individual health needs.

Compounding medications for individual patients upon the lawful order of a licensed practitioner has been the right of pharmacists licensed by State Boards of Pharmacy since their inception.

Many women who are pregnant depend on compounded progesterone to prevent miscarriage of their fetuses. This life saving medication would no longer be available if compounding of bio-identical hormones were restricted.