That is, the content and quality of the final preparation depends completely on what is described in the Master Formulation Record (MFR) as chosen or described by the compounder. Unlike with FDA-approved hormone products, the process of formulating a compounded prescription is entirely compounder specific. 2 However, certain cBHT preparations contain hormones not available in FDA-approved drug products. For the purposes of this chapter, the committee will focus its discussion on bioidentical compounded formulations and, where relevant, bioidentical FDA-approved products. These hormones include estrone (E1), estradiol (E2), estradiol cypionate (Ec), estriol (E3), dehydroepiandrosterone (DHEA), pregnenolone (P5), progesterone (P4), testosterone (T), testosterone cypionate (Tc), and testosterone propionate (Tp). 1įor the purposes of this report, the committee maintained a focus prioritized on 10 hormones (7 unique hormone substances and 3 salt forms) that were of interest to the U.S. Where relevant, this chapter will discuss FDA-approved hormone products and commercial drug manufacturing facilities to provide relevant comparisons and contrasts between formulation procedures and quality testing. This chapter will also describe features that may affect the quality of the cBHT preparations and highlight important variations between compounding settings (i.e., 503A compounding pharmacies and 503B outsourcing facilities).

This chapter will provide an overview of compounded bioidentical hormone therapy (cBHT) preparations, including a description of their common formulations (e.g., common active and inactive ingredients), formulation methods, quality testing, and labeling. Medications containing steroid hormones are prescribed frequently to treat symptoms associated with the normal age-related decline in circulating hormone levels.

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