Regulatory Updates

GLP-1 FDA Tracker

Stay informed about FDA regulatory updates, warning letters, drug shortages, and 503B compounding status for semaglutide and tirzepatide medications.

Last updated: May 13, 2026

Semaglutide

Shortage Active

Tirzepatide

Shortage Active

503B Status

Compounding Allowed

Active Warnings

1 Warning Letter

Drug Shortage

FDA Extends Semaglutide Shortage Designation

The FDA has extended the shortage designation for semaglutide injection products (Ozempic, Wegovy), allowing continued 503B compounding.

May 10, 2026

Warning Letter

Warning Letter to XYZ Compounding Pharmacy

FDA issued a warning letter to XYZ Compounding for quality control violations in semaglutide compounding processes.

May 5, 2026

Drug Shortage

Tirzepatide Added to FDA Shortage List

Tirzepatide (Mounjaro, Zepbound) has been added to the FDA drug shortage list due to increased demand.

April 28, 2026

503B UpdateResolved

503B Bulk Drug List Update

FDA issued updated guidance on 503B bulk drug substances list, maintaining current status for GLP-1 active ingredients.

April 15, 2026

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