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# Reps Urge FDA Relief on Compounded Hormones
- URL: https://www.fdaweb.com/reps-urge-fda-relief-on-compounded-hormones/
- Published: 2023-06-21T12:00:00.000Z
- Updated: 2026-09-14T18:40:04.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5154739

Twenty-five bipartisan House representatives are urging FDA to create patient-centered policies on compounded hormones that maintain patients’ access to care and treatment options. In a 6/20 [letter](https://iqconnect.house.gov/iqextranet/iqClickTrk.aspx?&cid=VA10JW&crop=0000.0000.0000.0000&report%5Fid=&redirect=https%3a%2f%2fwexton.house.gov%2fUploadedFiles%2fCongressional%5FLetter%5Fon%5FCompound%5FHormone%5FTherapy.pdf&redir%5Flog=143225411818651&ref=fdaweb.com) to FDA commissioner **Robert Califf**, the lawmakers said they were concerned that recommendations in a 2020 National Academies of Sciences, Engineering, and Medicine (NASEM) report entitled *The Clinical Utility of Compounded Bioidentical Hormone Therapy: A Review of Safety, Effectiveness, and Use* could “severely reduce or eliminate access to these critical medications.” The report was undertaken pursuant to an FDA request to evaluate the safety, effectiveness, use, and overall clinical utility of such therapies.

The NASEM report included several recommendations to restrict the use of compounded bioidentical hormone therapies (cBHT), such as restricting their use to patients having documented allergies to active pharmaceutical ingredients or excipients of FDA-approved drug products, or a documented requirement for a different dosage form. “Patient preference alone should not determine the use of cBHT preparations,” it said.

“Given the number of patients who rely on these treatments, and that the FDA-approved bioidentical hormone drug products that are commercially available are not appropriate for all individuals, we continue to urge FDA to cautiously approach this issue and strive to avoid disruption to care,” the lawmakers said in the letter. “Finally, we are concerned by reports from stakeholders that the NASEM committee that produced the report may not have included all relevant perspectives, including prescribers or compounders of hormone products.… We urge you to consider the perspective of all stakeholders, including prescribers, compounders, and patients, to ensure FDA policies related to compounded hormones are patient-centered and do not limit access to care and treatment options.”