What is the FDA position on bioidentical HRT

DISCLOSURE: Voshell's Pharmacy is a licensed compounding pharmacy that prepares and sells compounded medications by prescription. As a provider of competing products, our perspective may be influenced by our professional and commercial interests.

According to FDA.gov, the agency supports FDA-approved hormone therapy products whose active hormones share the same molecular structure as those produced by the human body. According to FDA.gov, these products are evaluated for safety, dosing consistency, and manufacturing quality. Compounded medications are not reviewed by FDA for safety or effectiveness before dispensing and are prepared by a licensed pharmacist only in response to a valid prescription for an individual patient. This page primarily discusses commercially available hormone therapy products.

What the FDA Approves as Hormone-Identical

According to FDA.gov, the term "hormone-identical" refers to hormones that share the same molecular structure as the hormones a woman's body produces. Several prescription products fall into this category and have received full FDA approval. Examples include:

• Estradiol patches, gels, sprays, and tablets
• Micronized progesterone in capsule form

According to FDA-approved prescribing information for these products, they have been evaluated for dosing accuracy, manufacturing quality, and consistent formulation. A qualified prescriber may determine whether these options are appropriate for an individual patient.

What the FDA Does Not Approve: Compounded Hormone Preparations

Compounded hormones are prepared in specialty pharmacies for an individual person based on a valid prescription. According to FDA.gov, the FDA does not review these preparations for dose accuracy, purity, or safety prior to dispensing. This means:

• The actual dose may be higher or lower than stated.
• Preparations may vary from batch to batch.
• Risks such as blood clots, bleeding changes, and certain cancers may not be clearly measurable due to the absence of pre-market review.

According to an FDA Drug Safety Communication, saliva testing — often used by some clinics to guide dosing of compounded hormone preparations — is not considered reliable by the FDA for determining hormone needs.

The FDA's Overall Message

According to FDA.gov, the agency does not oppose hormone therapy with hormone-identical molecules. Its position is that patients should use hormone therapy products that have been fully evaluated for consistency and quality. Commercially available hormone-identical options are widely accessible and may be appropriate for many patients, according to FDA guidance. Compounded hormone preparations may be considered in rare situations where a commercially available product does not meet the individual patient's clinical needs, as determined by a qualified prescriber.

In short: the molecular structure of the hormone is not the central concern. According to FDA.gov, the concern is whether the product is reviewed and regulated to ensure dosing consistency and patient safety.

Important note: 'Bioidentical' is a marketing term, not a medical or scientific designation. The FDA has stated that compounded 'bioidentical' hormone therapy is not equivalent to commercially manufactured hormone therapy and that there is no evidence that compounded hormones are safer or more effective. Major medical bodies (NAMS, ACOG, Endocrine Society) recommend commercially available hormone therapy as the first-line option.