GLP's Shortage Designation Update: Where Things Stand in 2026
The FDA has updated shortage designations for semaglutide and tirzepatide multiple times. Here is the current status, what it means for compounding, and how practices should be thinking about supply.
GLP-1 Shortage Designation Update: Where Things Stand in 2026
The FDA's shortage designation for semaglutide and tirzepatide has been one of the most consequential — and most frequently updated — regulatory issues in the compounding space over the past two years. For practices that prescribe compounded GLP-1s, understanding the current status is not optional.
This post covers where things stand as of mid-2026, what the regulatory history looks like, and how practices should be thinking about supply planning in this environment.
Why Shortage Designation Matters for Compounding
Under Section 503A and 503B of the FDCA, compounding of a drug that is essentially a copy of a commercially available product is generally prohibited — unless that drug appears on the FDA's drug shortage list.
When semaglutide (Ozempic, Wegovy) and tirzepatide (Mounjaro, Zepbound) were added to the FDA's shortage list, it opened the door for licensed 503A and 503B compounders to prepare these compounds legally. That shortage designation has been the legal foundation for the compounded GLP-1 market.
As shortage designations are updated or removed, the legal landscape for compounding shifts. This is why practices need to work with supply partners who actively monitor these designations.
The Regulatory History: A Timeline
2022–2023: Semaglutide and tirzepatide added to FDA shortage list. Compounding of these compounds becomes legally permissible under 503A and 503B.
2024: Compounded GLP-1 market expands rapidly. FDA issues guidance clarifying that compounders must use the same active ingredient (not a salt or ester) as the branded product.
Early 2025: FDA announces it is reviewing shortage designations for semaglutide and tirzepatide as branded supply improves. Industry groups and patient advocates push back, citing continued access barriers.
Mid-2025: FDA updates shortage status for certain semaglutide formulations. 503B outsourcing facilities face new restrictions. 503A compounding for patient-specific prescriptions continues under different rules.
2026: The situation remains dynamic. Shortage designations continue to be updated, and the rules differ between 503A and 503B tracks.
Current Status: What We Know
As of mid-2026, the key points are:
503A compounding: Patient-specific compounding of semaglutide and tirzepatide continues to be permissible in most circumstances, subject to state board of pharmacy rules and the requirement for a valid patient-specific prescription.
503B outsourcing: The rules for 503B bulk compounding of GLP-1s have been more restrictive following shortage status updates. 503B facilities should be operating under current FDA guidance and should be able to document the basis for their compounding.
State variation: Some states have enacted their own rules that are more restrictive than federal requirements. California, in particular, has been active in this area.
The "essentially a copy" issue: FDA has been more active in scrutinizing whether compounded GLP-1 preparations are "essentially a copy" of branded products. Compounders need to be able to articulate why their preparation is not essentially a copy (e.g., different strength, different form, different route of administration).
What This Means for Your Practice
Work with Legally Sophisticated Suppliers
In a rapidly shifting regulatory environment, your supply partner's legal expertise is part of your compliance infrastructure. A supplier that cannot explain the current regulatory basis for their compounding is a liability.
Maintain Documentation
Document the clinical rationale for each patient's prescription. If a patient needs a compounded formulation because the branded product is unavailable, unaffordable, or clinically inappropriate, document that.
Monitor Shortage Designations
The FDA's drug shortage database is publicly accessible. Practices should monitor it — or work with a supply partner who does.
Have a Contingency Plan
If shortage designations change in a way that affects compounding permissibility, practices need a contingency plan. This might include relationships with multiple suppliers, protocols for transitioning patients to branded products, or patient communication plans.
How MedClinic Partners Navigates This
Our founding team includes mass-tort attorneys who have litigated pharmaceutical cases for 15+ years. We track FDA shortage designations in real time and advise our clients proactively when changes affect their supply.
We do not wait for clients to ask — we reach out when something changes that affects their practice.
Contact us with regulatory questions →
This content is for informational purposes only and does not constitute legal advice. FDA regulations change frequently. Consult qualified legal counsel regarding your specific compliance obligations.
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Written by
MedClinic Partners Editorial Team
B2B Medical Supply & Compounding Experts
The MedClinic Partners editorial team is composed of licensed medical operators, compounding compliance specialists, and mass-tort attorneys with direct experience running GLP-1 and peptide programs across all 50 states. Every article is reviewed for clinical accuracy, regulatory compliance, and practical applicability before publication.
Editorial standards: All content on medclinicpartners.com is reviewed by licensed medical operators and compounding compliance specialists before publication. Articles are updated when regulatory guidance changes. This content is for licensed healthcare providers only and does not constitute medical advice.
