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Regulatory

The GLP-1 Compounding Crackdown: What Prescribers and Patients Need to Know

8 min · 2026-01-10 · Ercle Editorial

The FDA removed semaglutide and tirzepatide from shortage lists in 2024, triggering the end of legal compounding. Here's what happened, what the enforcement timeline looks like, and what comes next.

What Happened

From 2022 to 2024, FDA-declared drug shortages for semaglutide and tirzepatide legally allowed compounding pharmacies to prepare these drugs — even though they were FDA-approved. Federal law (21 USC 503A/503B) permits compounding of FDA-approved drugs during shortage periods.

By late 2024, FDA removed both semaglutide (October 2024) and tirzepatide (October 2024) from its official shortage list, triggering a mandatory phase-out of compounding.

The Enforcement Timeline

  • October 2024: FDA removes semaglutide from shortage list
  • October 2024: FDA removes tirzepatide from shortage list
  • November 2024 – February 2025: 503A pharmacies given wind-down period
  • February 2025: 503A compounding of semaglutide/tirzepatide prohibited
  • Ongoing: FDA enforcement letters and actions against non-compliant pharmacies

What Prescribers Need to Know

  1. Prescribing compounded semaglutide/tirzepatide is now federally non-compliant for 503A pharmacies
  2. 503B outsourcing facilities had even shorter wind-down periods and face stricter enforcement
  3. Patient transition planning to brand-name Wegovy/Ozempic/Zepbound/Mounjaro is now the clinical priority
  4. Access and cost barriers are real — Novo Nordisk and Lilly have patient assistance programs worth exploring

What Patients Need to Know

If you were receiving compounded semaglutide or tirzepatide:

  • Your pharmacy can no longer legally compound these drugs
  • The FDA considers continued compounding post-shortage a federal violation
  • Talk to your prescriber about transitioning to brand-name therapy or alternative agents
  • GoodRx, manufacturer coupons, and patient assistance programs exist

What Comes Next

The compounding ban doesn’t solve the access problem — brand-name GLP-1 agents remain expensive and often poorly covered by insurance. This is driving accelerated development of generic/biosimilar pathways and oral alternatives (orforglipron). The underlying demand is not going away.

Ercle’s Position

We follow the evidence and the regulations. As of 2025, compounded semaglutide and tirzepatide are not legally available. Prescribers recommending compounded versions of these drugs are taking on significant legal and ethical risk.

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