1. Prescribers and compounding pharmacists should restrict the use of [compounded bioidentical hormone therapy] cBHT preparations.
   
   
2. The (FDA) Pharmacy Compounding Advisory Committee should review select bioidentical hormone therapies and dosage forms as candidates for the FDA Difficult to Compound List.
   
   
3. Improve education for prescribers and pharmacists who market, prescribe, compound, and dispense cBHT preparations.
   
   
4. Additional federal and state-level oversight is needed to better address public health and clinical concerns regarding the safety and effectiveness of cBHT.
   
   
5. Collect and disclose conflicts of interest.
   
   
6. Strengthen and expand the evidence base on safety, effectiveness, and use of cBHT preparations.

RECOMMENDATION 1

Restrict the use of cBHT preparations.

Prescribers should restrict the use of cBHT preparations to the following: documented allergy to an active pharmaceutical ingredient or excipient of FDA-approved drug product, or a documented requirement for a different dosage form. Patient preference alone should not determine the use of cBHT preparations.

In general, the potency of cBHT doses should not exceed those of FDA-approved hormone therapy products because of potential safety concerns. Any use of cBHT, including therapy for gender dysphoria, should align with established clinical guidance and require documentation of shared decision making and rigorous monitoring for long-term risks.

Prescribers and compounding pharmacists should clearly explain the limited evidence-based information about the safety and effectiveness of cBHT preparations. They should inform patients that compounded preparations are not FDA-approved.

This recommendation encroaches on the physician-patient relationship and provides no substantive reason for "restricting" the use of cBHT preparations. Patients generally request cBHT preparations after trying FDA-approved products without satisfactory relief. Dosing is dependent upon the physicians' judgment and patient response and monitoring. After decades of use of hormone products, their clinical safety and effectiveness have been well-documented.

Review select bioidentical hormone therapies and dosage forms as candidates for the FDA Difficult to Compound List.

The Pharmacy Compounding Advisory Committee should review the following bioidentical hormone therapies as candidates for FDA's Difficult to Compound List: estradiol, estrone, estradiol cypionate, estriol, dehydroepiandrosterone, pregnenolone, progesterone, testosterone, testosterone cypionate, and testosterone propionate. These candidates have safety and efficacy concerns related to the lack of bioavailability data and product-to-product variability as a result of drug formulation differences, stability, and quality control.

The Pharmacy Compounding Advisory Committee should consider all cBHT preparations formulated in pellet dosage form as candidates for FDA's Difficult to Compound List.

As is quite evident, the committee approached cBHT compounding from an FDA New-Drug-Application point of view which is not applicable to compounding individual cBHT prescriptions for individual patients. These preparations have been safely and effectively compounded for over 50 years with millions of treated and satisfied patients and are not difficult to compound. The FDA Difficult to Compound list should be limited to those products with demonstrated difficulty to compound leading to documented safety issues.