Compounding issues

Confronting the threat to compounded hormone therapy

APC is the voice for pharmacy compounding — advocating for thousands of pharmacists, technicians, students, researchers, and suppliers — and the patients they care for who rely on the kinds of personalized medication only compounders can prepare.

With so much support, we’re able to tackle some big initiatives. Case in point: our upcoming nationwide media campaign. It’s 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.

You can read about the NASEM study, FDA’s threat, and our media campaign — and you can even contribute to it — below.

NEWS (March 2021): Documents provide unambiguous evidence of bias in NASEM report.

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 more about it — and give to help fund the effort — below.

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