Are compounded bioidentical hormones FDA-approved and standardized in dosing?

• A. Fully FDA-approved with standardized dosing
• B. FDA-approved for men only
• C. Not FDA-approved and dosing is variable.
• D. They are illegal in the United States

Answer: (C)

Compounded bioidentical hormones are not FDA-approved and dosing is not standardized. They’re prepared by pharmacists to a specific prescription rather than manufactured as an approved drug with a fixed dose and established potency. Because they bypass the FDA’s premarket evaluation for that product, there’s no uniform strength or dosing across batches, which can lead to variability in potency and quality. This stands in contrast to FDA-approved hormone therapies that come with defined dosing guidelines and quality controls. They’re not illegal in the United States, and their use isn’t restricted to men, but the key point is that compounded products lack standardized dosing and carry variability in potency and safety profiles.