FDA Shifts Approach on GLP-1 Compounding: Announces Consumer Green List Instead of Immediate Crackdown

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The FDA recently resolved the national shortages of GLP-1 medications, specifically semaglutide and tirzepatide, and removed them from its official drug shortage list as of spring 20252345.

Following the end of these shortages, compounding pharmacies are generally no longer allowed to compound GLP-1 drugs unless there is a documented patient-specific medical need; bulk compounding as 'essentially copies' is no longer permitted2345.

Instead of an immediate crackdown on compounding, the FDA introduced a 'green list' import alert to prevent unverified GLP-1 active ingredients, especially from foreign sources, from entering the U.S. market1.

The green list allows only those GLP-1 active pharmaceutical ingredients (APIs) from facilities approved or inspected by the FDA to enter the U.S.; other imports are detained without physical inspection1.

This green list strategy is intended to secure the GLP-1 drug supply chain and protect consumers from illegal or potentially unsafe compounded versions, but it does not explicitly end all compounding activity if regulatory hurdles are cleared1.

The FDA's new approach reflects ongoing concerns about consumer safety with unapproved compounded GLP-1 drugs, which have not been individually evaluated by the agency for safety or efficacy and may pose risks of adverse events5.

State regulators have issued additional guidance, and litigation continues around the legality of continued GLP-1 compounding post-shortage, causing some uncertainty and variability in enforcement and practice at the state level25.

Sources:

1. https://www.techtarget.com/pharmalifesciences/feature/Will-the-FDAs-green-list-end-illegal-GLP-1-compounding

2. https://natlawreview.com/article/glp-1-drugs-ohio-board-pharmacy-issues-faqs-compounders

3. https://www.goodrx.com/classes/glp-1-agonists/compounded-glp-1-going-away

4. https://www.drugtopics.com/view/glp-1-no-longer-on-fda-s-drug-shortage-list

5. https://www.bipc.com/major-update-on-glp-1-litigation-involving-compounding-pharmacies