Are compounded bioidentical hormones FDA approved?

The label "bioidentical" sounds official, so it is fair to ask whether the FDA has signed off on the compounded kind. The answer depends on who made the hormone.

Short answer: some are, compounded ones are not

Cleveland Clinic separates the two groups. It says "The U.S. Food and Drug Administration (FDA) has approved certain types of bioidentical hormones." Those are the forms premade by drug companies.

Cleveland Clinic then describes the other group: "Other forms of bioidentical hormones are custom-made by a pharmacist based on a healthcare provider's prescription." Its verdict on that group is "The compounded forms have not been tested and approved by the FDA."

What that means in practice

The Endocrine Society says "preparation of cBHT formulations is not subject to FDA oversight, and can be inconsistent in dose and purity." Here, cBHT stands for compounded bioidentical hormone therapy.

The cause and effect is simple. When the preparation is outside FDA oversight, dose and purity can vary, so ask how yours is confirmed.

Questions to ask before you agree

Bring these to a consult in West Sacramento:

• Is the hormone you are offering FDA approved, or is it compounded?
• Who prepares it, and how is its dose and purity confirmed?
• What is the alternative if I prefer an FDA-approved product?

Primary documents on compounding

MedlinePlus has a page on hormone therapy for menopause. The U.S. Food and Drug Administration answers questions about compounding. The Endocrine Society publishes a position on compounded bioidentical hormone therapy. Cleveland Clinic explains bioidentical hormones, their uses, safety and side effects.

What to remember

"Bioidentical" describes a hormone. "FDA approved" describes a review. Ask which of the two you are being sold.