The FDA has announced a major assault on compounding medicine and bio-identical hormones. They are continuing to ban estriol, denying the term “bio-identical” to characterize compounded hormone therapies, and encouraging consumers to use drugs instead.

The FDA has sent a series of warning letters to compounding pharmacies across the country, asserting a policy that would deny hundreds of thousands of women access to many compounded bio-identical hormones. Banning estriol would effectively end the use of compounded hormones for women, since 80 percent of all bio-identical hormone therapy uses estriol.

Since estriol is an unpatentable, natural ingredient, no company has submitted it to the expensive approval pipeline at the FDA.

Before Premarin, work on hormone replacement therapy entirely used "bio-identical" hormones, and there are several European studies regarding estriol.