Why Semaglutide Compounding Is Allowed At All

Under Section 503A and 503B of the Federal Food, Drug, and Cosmetic Act, compounding pharmacies can prepare drugs that appear on the FDA's drug shortage list. Semaglutide (brand name Ozempic, Wegovy) was added to the shortage list due to unprecedented demand for GLP-1 medications. This shortage designation gave compounding pharmacies a legal pathway to prepare semaglutide — but that pathway comes with strict conditions.

What Your Pharmacy Needs Before Compounding Semaglutide

Before your first batch, ensure you have: - A current FDA drug shortage verification on file - Bulk semaglutide API sourced from an FDA-registered supplier

Semaglutide Compounding: What Pharmacies Can (and Can't) Do in 2026

By SlimionRX Clinical Team, Pharmacy Compliance Specialists — Published March 22, 2026

Semaglutide rules changed again in 2026. Here's exactly what your pharmacy needs to know: 503A vs 503B requirements, current FDA shortage status, BUD limits, and the compliance steps that protect your license. Plain-English breakdown →

Frequently Asked Questions

Why Semaglutide Compounding Is Allowed At All: Under Section 503A and 503B of the Federal Food, Drug, and Cosmetic Act, compounding pharmacies can prepare drugs that appear on the FDA's drug shortage list. Semaglutide (brand name Ozempic, Wegovy) was added to the shortage list due to unprecedented demand for GLP-1 medications. This shortage designation gave compounding pharmacies a legal pathway to prepare semaglutide — but that pathway comes with strict conditions.
What Your Pharmacy Needs Before Compounding Semaglutide: Before your first batch, ensure you have: - A current FDA drug shortage verification on file - Bulk semaglutide API sourced from an FDA-registered supplier