Legislation has been introduced to protect patient access to customized natural medicines. It needs our support. Action Alert!
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THE TOPLINE
- The Drug Shortage Compounding Patient Access Act of 2025 would protect access to customized natural medicines made at compounding pharmacies.
- The bill requires the FDA to accept USP monographs for dietary supplements, reversing a 2016 decision that unjustly restricted natural substances like curcumin and aloe vera from compounding.
- While access to certain compounded hormones and peptides remains at risk, this legislation marks meaningful progress in defending patient access to safe, customized natural treatments.
Representatives Diana Harshbarger (R-TN) and Buddy Carter (R-GA) have introduced a bill to ensure continued consumer access to customized natural medicines made at specialized pharmacies (known as compounding pharmacies).
While other challenges remain, the Drug Shortage Compounding Patient Access Act of 2025 is an important step toward curbing the attack on these important natural medicines. The Act does several important things, mostly targeted at expanding compounding pharmacists’ ability to compound products during a drug shortage.
Crucially, the bill forces the FDA to accept USP monographs for dietary supplements. This is a pivotal issue. In order to be made into a customized medicine, a substance has to meet one of three criteria. It must either:
- appear on an FDA pre-approved list (the Bulk Drug list);
- have a USP monograph; or
- be a component of an approved drug.
In 2016, the FDA, with no explanation or justification, stated that it would not accept supplement USP monographs. This meant that in order to be used in customized, natural medicines, supplements had to be nominated for the FDA’s pre-approved list. Many supplements were nominated, but, no surprise, the FDA rejected them: even supplements like curcumin, Boswellia, aloe vera, acetyl-l-carnitine, and more, with very important medical uses.
This bill doesn’t fix every misguided action of the FDA since they began their attack on compounded medicine. Patient access to bioidentical hormones like progesterone and estriol is still threatened, as is access to life-enhancing peptides.
Still, this bill is a major first step forward in saving important natural medications from the FDA’s chopping block, and it needs our support.
Action Alert!
