Regulatory status · Updated 2026-06-25

2026 GLP-1 compounding: where the rules actually stand

The shortage that made mass-market compounded GLP-1 possible is over. This page tracks what the FDA has done, what remains legal, and what that means before you pay for a compounded program.

The short version

What changed

Compounding semaglutide and tirzepatide became widespread in 2022–2024 only because both drugs were on the FDA shortage list. That window has closed.

Dec 2024
tirzepatide FDA resolved the tirzepatide shortage; the drug is then treated as commercially available again.
Feb 2025
semaglutide FDA resolved the semaglutide shortage and set phased wind-down deadlines.
Feb–May 2025
deadlines passed tirzepatide 503A by Feb 19 / 503B by Mar 19; semaglutide 503A by Apr 22 / 503B by May 22. Court challenges did not secure injunctions.
2025
enforcement FDA issued 50+ warning letters to compounders and telehealth distributors.
Apr 30, 2026
proposed rule FDA proposed excluding semaglutide, tirzepatide, and liraglutide from the 503B bulks list; comment closed Jun 29, 2026.
What’s still legal

The narrow 503A pathway

Conditions, in plain terms

• A valid prescription written for you specifically after an individual clinical evaluation.
• A product that is not “essentially a copy” of the commercially available branded drug.
• A documented clinical reason the FDA-approved product can’t be used.
• Compounding not done “regularly or in inordinate amounts.”

The part that matters most

The FDA has been explicit that affordability and access do not, by themselves, count as a clinical need.

Sources

Primary references