FDA WARNING_LETTER - American Hormones, Inc. - December 29, 2006

An FDA inspection of American Hormones Inc. from December 14-29, 2006, revealed serious violations of the Federal Food, Drug, and Cosmetic Act (FDCA). The firm, purporting to be a compounding pharmacy, was found to operate more like a pharmaceutical manufacturer, mass-producing copies of FDA-approved drugs and products with active ingredients not found in approved drugs (e.g., Pregnenolone, DHEA, Estriol). These activities fall outside traditional pharmacy compounding.

The firm's products, including testosterone gel, thyroid capsules, pregnenolone capsules, DHEA capsules, and Estriol-containing hormone therapy products, are considered unapproved new drugs under FDCA Section 505(a) and misbranded under Section 502(f)(1) for lacking adequate directions for use. Furthermore, the drugs are adulterated under Section 501(a)(2)(B) due to numerous Current Good Manufacturing Practice (cGMP) violations (21 CFR Parts 210 and 211), including failures in stability testing, batch uniformity, equipment cleaning procedures, final product testing, process controls, component testing, and complaint handling. Additionally, hormone therapy products containing Estriol are misbranded under Section 502(a) due to unsubstantiated efficacy, superiority, and "bio-identical" claims on the firm's website. The firm also failed to register as a manufacturer and list its drug products, leading to further misbranding under Sections 502(o) and 510(j).

American Hormones Inc. must promptly correct all cited violations and provide a written response within fifteen working days detailing corrective actions and prevention measures. Failure to comply may result in legal action, including seizure and injunction. The FDA also warned against compounding human growth hormone for unapproved uses.