Conclusion 3-1
The production, labeling, distribution, and marketing of compounded preparations are regulated at the federal and state levels. However, the widely variable capacities and inconsistencies in oversight, particularly for 503A compounding pharmacies, are a matter of concern.

Conclusion 4-1
Use of the term bioidentical is a source of confusion. Bioidentical means that the hormone's chemical structure is identical to that of a hormone occurring naturally in the body, and, consequently, implies its biologic activity is identical to that of a hormone occurring naturally in the body. Many patients believe that bioidentical means that plants are the source of the hormones; however, it is the chemical structure and not the source that determines whether a hormone is bioidentical. Furthermore, bioidentical hormone medications that have plant sources and are called natural are, in fact, chemically modified in the laboratory before they are provided to a patient.

Conclusion 4-2
Circulating hormone levels are not necessarily predictive of biological activity because steroid hormones, including those used in compounded bioidentical hormone therapy preparations, produce highly variable responses that are dependent on a number of factors, including genetic background, prior exposure to steroid hormones, and environmental and lifestyle factors.

Conclusion 5-3
In contrast to FDA-approved drug products, cBHT preparations lack standardized production methods, potentially leading to state-by-state and even pharmacy-by-pharmacy variability in the medications dispensed to patients. In addition, cBHT active dose ranges are wider, both lower and higher, than corresponding bioidentical FDA-approved drug products, and inactive ingredients (e.g., excipients) can be difficult to identify, creating concerns about cBHT safety and efficacy.

Conclusion 6-1
The immense number of potential combinations of different hormones, excipients, dosage forms, and strengths, as well as the lack of uniformity of cBHT preparations, make determining definitive bioavailability of those preparations difficult. Without reliable bioavailability data, an accurate characterization of the safety and effectiveness of cBHT preparations is not possible.

Conclusion 6-2
There is no established evidence base to support the routine clinical use of steroid sex hormone levels for guiding the dosing in the treatment of menopausal symptoms.

Conclusion 7-1
There is limited and mixed quality evidence to suggest that estriol may be effective in treating certain menopausal symptoms; however, there is insufficient evidence to inform conclusions regarding the safety of estriol. Well-designed and properly controlled clinical trials are needed to clarify the potential clinical utility of estriol.

Conclusion 7-2
There is insufficient evidence to determine the safety and effectiveness of compounded estriol in comparison to bioidentical hormone therapy products approved by the FDA or similar international bodies.

Conclusion 9-1
There is insufficient evidence to support the overall clinical utility of cBHT as treatment for menopause and male hypogonadism symptoms.

As is quite evident, the committee looked at cBHT compounding from an FDA New Drug-approval point of view, which is not applicable to compounding individual cBHT prescriptions for individual patients. The value of the Report is severely compromised by this approach as compounded medications are exempt from the NDA requirements as they are impractical for individual prescriptions.

Next week, we will again look at the "Recommendations" of the Report.