To ensure the appropriate clinical use of cBHT, the committee recommends the following for prescribers

State medical boards, the Federation of State Medical Boards, and medical professional societies and associations (e.g., American Medical Association, Endocrine Society, and the North American Menopause Society) should advocate for a state-level certification for individuals who are seeking to begin or continue to prescribe cBHT. Formal clinical education should be offered in parallel to continuing medical education courses.

Non-profit professional societies and organizations within the medical sectors (e.g., American Medical Association) should expand and promote evidence-based guidelines and best practices for clinicians who prescribe or compound cBHT preparations. These guidelines should include not only evidence-based conclusions on the potential benefits and risks, but also practical steps of when to consider cBHT in lieu of FDA-approved products, which potential formulations should be considered, and the contraindications associated with the treatment.

To ensure the appropriate clinical use of cBHT, the committee recommends the following for prescribers and pharmacists:

State boards of pharmacies, the National Association of Boards of Pharmacy, Pharmacy Compounding Accreditation Board, local and regional schools of pharmacies, and non-profit professional societies and organizations within the medical and pharmaceutical sectors with a particular focus in epidemiology and women's health, (e.g., American Association of Colleges of Pharmacy, American Medical Association, Endocrine Society, North American Menopause Society) should develop pathways to support and incentivize the attainment of more in-depth training on complex compounding of hormone preparations.

These courses should do the following:

Be conducted by schools of pharmacies or non-profit professional societies and organizations within the medical and pharmaceutical sectors.

Include a review of the compounding process, including complexities of formulation science.

Examine the current peer-reviewed, evidence-based conclusions on the safety and effectiveness of commonly prescribed cBHT preparations.

Review the potential risks and reported adverse effects associated with the use of cBHT and FDA-approved products with the same active ingredients.

Describe potential conflicts of interest that exist within the prescribing, compounding and treatment sectors of pharmaceutics.

Additional continuing medical education courses hosted by for-profit organizations should not substitute for this training.

EDITORIAL COMMENT
Recommendation 3 seems to be outside the scope of the defined regulatory activities of the FDA. Although probably meant to supplement, this entire recommendation directly interferes with the education and practice requirements for physicians and pharmacists. The suggested material is not even under the purview/ expertise of some of the organizations listed to provide it, and it would be unwise to incorporate some of these organizations into determining the academic curriculum for medical and pharmacy schools.

The North American Menopause Society (NAMS) specifically has been "anti-compounding" for decades and is financially supported by PHARMA companies; also, NAMS financially supports research articles on cBHT with biased statements that manufactured products are superior. A number of the authors are closely affiliated with the NAMS organization, and this has been problematic for years.

The last explanatory statement regarding "for-profit" organizations is very interesting as the speakers used in these programs are generally practitioners or academicians and include both real-life practitioners and researchers that speak for both for-profit and not-for-profit organizations; this is a very petty and nonsensical recommendation. Does this also mean that all programs sponsored by PHARMA companies should not be allowed for physicians and pharmacists since all PHARMA companies are "for-profit"??