Bioidentical Hormone Replacement Therapy - Regulatory Status in The United States

Regulatory Status in The United States

Compounded BHRT is used almost exclusively in the United States, and many FDA-approved fomulations that are wholly or partially made of bioidentical hormones are available. Topical hormone preparations such as progesterone, estrogen and DHEA creams can be purchased in stores or over the internet and are not regulated by the FDA, as they are generally considered cosmetic.

When prescribed by a licensed practitioner, the compounding of bioidentical hormones is controlled by the state pharmacy boards rather than the FDA, and pharmacists are permitted to adjust dose and delivery method according to the prescription. However, the FDA does have authority over the compounded product. In 2001 the FDA surveyed a limited number of compounded preparations, including eight hormone compounds. All three estradiol products passed every test; however, two out of five progesterone products failed at least one test of potency, content or uniformity.

In October 2005 Wyeth Pharmaceuticals, a manufacturer of both FDA-approved bioidentical and nonbioidentical HRT preparations, filed a Citizen Petition with the FDA asking for enforcement action against compounding pharmacies which dispensed BHRT, and to investigate labeling and advertising guidelines. Soon after, the FDA took a number of enforcement actions against several (primarily Internet-based) pharmacies that were producing compounded BHRT and in 2008, banned the use of estriol in the US. The FDA stated that they did not take these regulatory actions against compounded bioidentical hormones in response to Wyeth's request, since that is not the purpose of a citizen petition. They said that they had an ongoing investigation when they received the petition. The FDA has acknowledged that they are unaware of any adverse events connected to the use of estriol, but ordered pharmacies to discontinue its use. The agency's Assistant Director of the Office of Compliance stated that use of estriol would require a permit for research and a new drug application. The FDA also stated that it has not approved any drug containing estriol and that no information had been submitted to the FDA regarding its safety and effectiveness. The FDA's concerns over the marketing and use of bioidentical hormones were supported by the American Association of Clinical Endocrinologists. In response to the FDA's actions, the International Academy of Compounding Pharmacists (IACP) enlisted thousands of women to join a letter-writing campaign to the FDA to reverse this action, citing Wyeth's attempt as a "self-serving, and at times duplicitous, campaign to restrict patients’ access to alternatives to its own products".

In November 2006, the American Medical Association adopted a policy urging the Food and Drug Administration to survey compounded BHRT products for purity and dosage; to maintain a registry and require mandatory adverse event reporting by manufacturers and compounding pharmacies related to bioidentical hormones; to mandate the inclusion of uniform patient information, including warnings and precautions regarding bioidentical products; and to prohibit use of the term "bioidentical hormones" unless the agency has approved the preparation.

On July 18, 2008, a US Appeals Court issued a ruling stating that new drug approval processes should not be applied to compounded drugs that complied with established guidelines, and also that provisions of the regulations relevant to the use of estriol were still in effect, preventing the FDA from taking action against pharmacies using estriol in compounded products.