Regulatory Update on Compounded Bioidentical Hormone Therapy (cBHT)
The Food and Drug Administration (“FDA”) is currently considering placing eleven hormones used in Compounded Bioidentical Hormone Therapy (“cBHT”) on a “difficult to compound list”,effectively banning the compounding of these ingredients. The “difficult to compound list” is a list of drug products and categories of drug products that present demonstratable difficulties for compounding based on six criteria that FDA developed. Items on the list are prohibited from being compounded. Compounded injections, creams, gels, nasal, oral and pellet formulations of estradiol, estrone, estradiol cypionate, estriol, progesterone, pregnenolone, testosterone, testosterone cypionate and testosterone propionate and cBHT would be prohibited denying patient access to these often more affordable alternatives to commercially available products. FDA has already recently banned compounding of gonadotropin fertility compounds such as hCG, FSH and HMG, calling them “biologics” and requiring an FDA approved Biologics License Application (“BLA”).
The FDA tried unsuccessfully in 2008 and 2018 to ban cBHT. The most recent effort revolves around the July 2020 FDA-funded National Academies of Science, Engineering, and Medicine (“NASEM”) report that the widespread use of cBHT is a public health concern with the recommendation that prescribers restrict the use of cBHT to two circumstances: when a patient is allergic to an ingredient in an FDA-approved hormone product, and when a patient requires a specific dosage form unavailable for an FDA-approved product. Implementation of the NASEM’s recommendations coupled with the Pharmacy Compounding Advisory Committee review (“PCAC”) of cBHTs as candidates for the “difficult to compound list” would severely limit or eliminate the ability of prescribers to prescribe and pharmacists to compound cBHT for patients.
Patient harm considerations (both clinical and financial) have prompted grass roots efforts to circumvent the anticipated FDA action. Some have identified flaws/bias in the NASEM Report including: lack of prescribers or pharmacists on the study committee; committee members with pharmaceutical industry and FDA ties; reliance on a controversial and often debunked 2002 Women’s Health Initiative Study which looked at increased risk of breast cancer and cardiovascular disease from two commercially available estrogen/progestin products; and the unexplained narrow review of a small subset of the hundreds of studies demonstrating safety and efficacy for cBHT. Additionally, despite the fact that it is neither reasonable nor practical to apply standards for FDA-approved drugs to compounded preparations, which for cBHT includes thousands of possible combinations, strengths and formulations, NASEM did exactly that. They concluded there was insufficient evidence to support the clinical utility of cBHT.
Compounders and other stakeholders such as women’s health advocacy groups have called for a multi-prong approach to preserve patient access to cBHT. This approach includes legislative, regulatory and legal action, similar to that applied successfully applied to estriol back in 2008.
Frier Levitt routinely represents a wide array compounding pharmacies, and has supported the efforts of health professionals and our clients to prescribe and compound. In addition to this advocacy work, Frier Levitt can perform due diligence and analyze compounding practices for FDA, USP and state-specific regulatory compliance, including medical necessity documentation, labeling, reimbursement issues, infrastructure. We also prepare practice-specific compounding policies and procedures that provide clear guidelines, standards and training for staff. For legal and regulatory advice to address this latest effort to limit compounding, please reach out to Frier Levitt for more information.
 Created by the Drug Quality and Security Act of 2013. P.L. 113-54.
 The “Difficult to Compound List” has been in process since passage of DSCA in 2013. Currently, FDA is developing a proposed rule on this.
 National Academies of Science, Engineering, and Medicine Report. July 2020.
 Wooten A. The Panel Put Policy-Making Before Patient Need. BRG. April 2021.