Oversight of hormone compounding

Executive Summary

American Medical Association House of Delegates requests Nov. 14 that FDA review the formulations of all compounded bioidentical hormone formulations. "Since the final hormone formulations of most compounding pharmacies are not subject to FDA monitoring for dose, purity, safety, or efficacy, there may be additional, and at this point unknown, risks associated with them," AMA says. Association is also asking FDA to require adverse event monitoring and patient information for bioidentical formulations. Medco recently stopped dispensing compounded estrogen, and Wyeth is pressing FDA to block pharmacists from producing the products (1"The Pink Sheet" Oct. 9, 2006, In Brief)...