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Are Winona’s treatments FDA-approved?
Are Winona’s treatments FDA-approved?
Jo Cullen avatar
Written by Jo Cullen
Updated this week

The FDA has approved medical treatments containing bioidentical hormones that mimic the hormones made naturally in the body. All Winona treatments are formulated using ingredients sourced from FDA-registered facilities. Our oral pills and transdermal patches are also manufactured in an FDA-registered setting, so they are able to be labeled FDA-approved.

Our hormone creams are compounded in our own pharmacies, in order to create the exact prescription your Winona physician has written for you. Compounding is a practice in which different ingredients found in FDA-approved medicines are combined to create medications that meet the needs of individual patients. Currently, once FDA-approved ingredients are combined, they can no longer be labeled FDA-approved, since the FDA does not regulate compounding. This means that while our creams are not labeled FDA-approved, they are formulated with ingredients from FDA-registered sources.

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