FDA’s Monograph Divide: Time to Fix It

Here’s one of those confounding regulatory practices that only Washington could concoct:

The U.S. Pharmacopeia publishes monographs that set the gold standard for the identity, strength, purity, and quality of substances used in medicine—monographs relied upon not only in the U.S. but in more than 140 countries.

Some of those monographs are for drugs. Some are for dietary supplements.

The law—Section 503A of the Food, Drug & Cosmetic Act—says compounders may use ingredients that meet the standard of an applicable USP or NF monograph.

And yet, FDA has decided that “applicable” doesn’t mean what it says. They’ve arbitrarily excluded dietary supplement monographs from that definition. In other words, if a substance has a dietary supplement monograph—but not a drug monograph—FDA says it’s off-limits for compounding.

That’s not in the statute. It’s not rooted in science. And it certainly doesn’t help patients.

Here’s the kicker: those very same ingredients can be legally sold—unregulated, unlabeled, and often unverified—in the supplement aisle at your local grocery store. But a licensed pharmacist, working from a valid prescription and using that same USP-grade ingredient to compound a specific dose in a precise dosage form for an individual patient? Somehow that’s not okay?

It defies logic. And it defies the intent of the law.

That’s why our Blueprint for Eliminating Redundant, Unauthorized, or Ineffective Regulation that Impedes Patient Access to Compounded Medications recommends this fix: Direct FDA to treat all USP monographs—drug or dietary supplement—as applicable.

It’s simple. It’s statutory. It’s common sense.

👉 Download the Blueprint and share it with your policymakers. This is how we fix compounding regulation that’s lost its moorings.

Scott Brunner, CAE, is chief executive officer at the Alliance for Pharmacy Compounding.