Endocrine Insider
Februrary 21, 2007

Following the adoption by the American Medical Association (AMA) of the Society’s bioidentical hormone position statement, the U.S. Food and Drug Administration (FDA) issued warning letters to three independent compounding pharmacies in December of last year. The letters warn the pharmacies to disengage from one or more of a number of violations, including producing hormone medications that are copies or essentially copies of FDA-approved versions, producing compounded hormones for mass sale rather than for individuals by prescription, or engaging in illegal interstate commerce by shipping products across state lines. The letters required that the pharmacies respond in writing within 15 days; only one pharmacy has issued a response to FDA.

The warning letters underscore the importance of Society’s recent position statement on the use and regulation of bioidentical hormones. The position statement, which can be viewed in its entirety here, (Bioidentical Hormones Position Statement), was published by the Society last October and adopted by the AMA last November and was recently endorsed by the North American Menopause Society.

The Society’s position statement highlights the need for uniform patient safety information and surveys for safety and efficacy of all hormone preparations, regardless of the source of the formulation. This position asks that FDA exert more regulatory control than it has previously, even beyond the action recently taken with the warning letters. The recent FDA warning letters and the single response may be viewed at:

http://www.accessdata.fda.gov/scripts/wlcfm/resultswl.cfm http://www.accessdata.fda.gov/scripts/wlcfm/resultswl.cfm http://www.accessdata.fda.gov/scripts/wlcfm/resultswl.cfm