A 2020 FDA-funded report on compounded hormones from the National Academies of Science, Engineering and Medicine recommends across-the-board restrictions on compounded hormones – restrictions that would undermine physicians and interfere with the practice of medicine. These restrictions could also prove catastrophic for millions of patients who benefit from those therapies. Unfortunately, the NASEM report is compromised by potential bias, conflicts of interest, and bad science.
The Food & Drug Administration may consider restricting compounded hormones, a move that could deprive millions of patients of therapies that work — that help them feel normal again and elevate their quality of life.
The Alliance for Pharmacy Compounding is working to make sure policy decisions about compounded hormones are based on good science, not FDA bias.Join APC and help protect compounded hormones
While limited in scope, a new meta-analysis of patient outcomes reveals that compounded hormones provide real benefits to patients and also find that compounded hormones pose no increased risk compared to FDA-approved products.
As part of its commission, NASEM was to review the body of patient-outcome studies for compounded hormones. NASEM chose to ignore that data, instead selecting only 13 studies to include in its report, mostly featuring hormones that are not among the most commonly prescribed. (Studies that matched their predetermined outcome?)
This report, published in Menopause, the journal of the North American Menopause Society, is exactly the kind of unbiased research that NASEM should have done but didn't.
Compounding exists for patients and animals who are not served by traditional pharmaceutical manufacturers. Every day, APC members play a critical, often life-or-death role in patients’ lives, creating essential medications unavailable elsewhere for a range of health conditions, including autism, oncology, dermatology, ophthalmology, pediatrics, women’s health, animal health, and others.
Today, we are fighting for the continued access to compounded hormones. But there are a host of other threats to compounding on the horizon.
Our commitment is not only to our dues-paying members, but to the entire scope of the pharmacy compounding profession — pharmacists, patients, prescribers, and others. We're working to ensure that the practice of pharmacy compounding is not merely preserved, but is elevated as a key component of health care delivery for millions of patients across America.
When the FDA signaled that it might severely restrict access to compounded hormones, we launched a campaign to raise awareness among patients, doctors and, especially, members of Congress.
When you contribute to this campaign — you are protecting access to this life-changing therapy for millions of patients.
Millions of women (and men) depend on compounded hormones to live normal lives. Choose your state and read the firsthand stories of people whose lives have been transformed by compounded hormones. In the debate over access to this vital therapy, their voices must be heard.
Our campaign to protect access to compounded hormones needs your support. We need your involvement. We need your voice. And, yes, we need your financial support as well.