Confronting the threat to compounded hormone therapy

One of APC’s biggest initiatives is our upcoming nationwide media campaign aimed at stopping the FDA’s threat to restrict compounded bioidentical hormone therapy — treatment that has done wonders for millions of women and men for decades.

That threat to cBHT is not only a threat to patients, but to pharmacies as well, with cBHT one of the most frequently compounded medications. APC and the coalition we’re building are stepping up to counter this threat — and whatever comes next.

The issue

The FDA, no fan of compounding, commissioned a study from the National Academies of Sciences, Engineering, and Medicine on “the safety, effectiveness, and use” of compounded bioidentical hormone [replacement] therapy (cBHT or cBHRT). The study concluded that there isn’t much clinical evidence for or against cBHT. Strangely, though, the study recommended that cBHT be restricted.

Now, despite the undisputed fact that millions of Americans use cBHT every day and rely on it, the FDA is using that study — yes, the one it paid for — as an excuse to consider limiting or even outright banning compounded hormone therapy.

This cannot be allowed to happen. The lives and health of too many people are at risk.

The plan

APC is leading a coalition of cBHT compounders, prescribers, and patients to mount a digital media campaign aimed at confronting the threat to compounding hormone therapy. It’s a $1.5 million effort that launches Q2 2021.

Read an overview of that media campaign.

Important information

April 2021: Berkeley Research Group’s whitepaper analyzing the NASEM report (27-page PDF)


March 2021: FOIA-requested documents provide unambiguous evidence of bias in NASEM report.

Tools you can use

Share your story here: APC’s cBHT Testimonial Portal — for cBHT patients, prescribers, and compounders. Share the link, too:

Join the Cause: a four-page (PDF) brochure explaining the issue and urging people to contribute to the media campaign

Recruit your vendors: Here’s a sample letter (.docx format) you can customize and send your vendors, asking them to support the campaign to save cBHT.

Add prescribers’ voices: Here’s a sample letter for prescribers they can use to inform patients of the threat to cBHT.

Present the facts: a PowerPoint slide deck you can use in presentations for legislators, physicians, and even patients to explain the threat to cBHT

Inform your patients: a one-page patient-focused brief on the threat to cBHT, customizable by pharmacies. Available as a PDF or as a Word .docx file).

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