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Wyeth Urges Halt to Hormone Compounding, Questioning Its Safety

Executive Summary

Wyeth's citizen petition to the FDA urging it to stop compounding pharmacists from producing "bioidentical hormone replacement therapy" focuses on safety concerns about the practice

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Wyeth Loses Citizen Petition Battle But Wins War Over Compounded Hormones

Wyeth will probably be satisfied by FDA's response to its citizen petition appealing for regulatory action against pharmacies distributing compounded hormone replacement therapy products. Although the agency denied the bulk of Wyeth's petition, FDA took action against compounding pharmacies for several related violations

Wyeth Loses Citizen Petition Battle But Wins War Over Compounded Hormones

Wyeth will probably be satisfied by FDA's response to its citizen petition appealing for regulatory action against pharmacies distributing compounded hormone replacement therapy products. Although the agency denied the bulk of Wyeth's petition, FDA took action against compounding pharmacies for several related violations

Medco mail-order drops hormones

Medco's mail order pharmacy will cease dispensing compounded estrogen, testosterone and progestin products. In a letter to physicians acknowledging that "the practice of extemporaneous compounding remains controversial," the pharmacy benefit manager asks doctors to consider switching patients to an FDA-approved product. The firm cites claims from physician groups that compounded hormones have not been proven to be more safe or effective than marketed products. FDA is reviewing a Wyeth citizen petition requesting the agency stop pharmacists from compounding bioidentical HRTs (1"The Pink Sheet" Nov. 7, 2005, p. 11)...

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