3 Label Questions About Compounded Menopause Hormones

Bring the packaging, prescription and any testing report to a hormone review. The name used in an advertisement may not tell you how the product was made or evaluated.

Three questions about the label

1. Is this specific product FDA¹-approved? Compounded preparations do not undergo FDA premarketing review for safety, effectiveness and quality. Ask the prescriber to identify the product’s status, separate from the ingredients’ names.²
2. Why is a compounded preparation needed? A custom product may meet a particular need, such as an allergy to an ingredient or an unavailable formulation. Ask which need applies to you and whether an approved alternative can meet it. Record the ingredients and strength you are prescribed.²
3. What supports the personalization claim? ACOG² does not recommend using adjunct hormone tests, such as saliva testing, to prescribe or dose compounded menopausal hormones. Ask what evidence supports the proposed testing and plan.²

Keep the explanation with the prescription

The FDA¹ has not found evidence that compounded “bioidentical” hormones are safer or more effective than approved hormone therapies. Ask for the expected benefits, risks and review date for your particular prescription.¹

Write down the reason for the choice in your own words. If you cannot explain what a label term means, add it to your next appointment questions.

My Body Changed. Now What? includes a Visit Brief. Use it to collect the product details and questions for the prescribing discussion. See the book.