---
title: "What Is the FDA Drug Shortage List? Compounding Rules"
description: "The FDA drug shortage list changes what pharmacies may compound. The GLP-1 timeline from FDA's own statements, and how Cuvo Health tracks current rules."
canonical: "https://cuvo.co/glossary/fda-drug-shortage-list"
last-updated: "Oct 26, 2026"
---
**Definition:** The FDA drug shortage list is the public, up-to-date list of drugs FDA has determined to be in shortage in the United States, kept under section 506E of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356e) and published as FDA's Drug Shortages Database.

# What is the FDA drug shortage list?

A drug's place on FDA's shortage list decides whether compounders may make copies of it, which is why FDA set dated wind-down periods for compounders when the semaglutide and tirzepatide shortages ended. A telehealth brand needs to know where each molecule it sells stands today. Cuvo Health tracks what current rules permit and routes each prescription only to a licensed pharmacy operating inside them.

Published Oct 26, 2026. Facts reviewed Oct 26, 2026.

The FDA drug shortage list is the public list of drugs FDA has determined to be in shortage in the United States, kept under section 506E of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356e) and published as FDA's Drug Shortages Database. For compounding it works as a switch. While an approved drug is on the list, FDA does not treat it as commercially available under section 503A, and an outsourcing facility may compound copies of it and use its bulk ingredient under section 503B. When FDA resolves the shortage, those allowances end. On Cuvo Health, what current rules permit for each molecule is tracked for the brand, and every prescription routes to a licensed partner pharmacy operating inside those rules.

**At a glance**
- The law: Section 506E of the FD&C Act, 21 U.S.C. 356e
- What each entry shows: Drug name and NDC, each manufacturer, the reason and the estimated duration
- Resolved: When supply from at least one manufacturer covers total market demand
- 503A effect: A listed drug is not commercially available, so the copy limit does not apply
- 503B effect: Copies and bulk-ingredient compounding of a listed drug are allowed
- On Cuvo: Current rules tracked per molecule; prescriptions routed only inside them

**The GLP-1 shortage timeline, from FDA's own statements**

| Date | FDA action | Effect on compounders |
| --- | --- | --- |
| **Oct 2 and Dec 19, 2024** | Tirzepatide injection shortage resolved, then reaffirmed on reevaluation | 503A discretion to Feb 18, 2025; 503B to Mar 19, 2025 |
| **Feb 21, 2025** | Semaglutide injection shortage resolved | 503A discretion to Apr 22, 2025; 503B to May 22, 2025, or a later court ruling |
| **Mar 5 and Apr 24, 2025** | District court denied injunctions on tirzepatide, then semaglutide | 503A discretion ended; 503B ran to Mar 19 and May 22, 2025 |
| **Apr 1, 2026** | FDA: neither drug on the shortage list or the 503B bulks list | The copy limits of 503A and 503B apply |
| **May 1, 2026** | Proposed not to include either on the 503B bulks list (91 FR 23431) | Comments closed July 30, 2026; no final notice as of Oct 26, 2026 |

## 01. Why does the shortage list matter for compounding?

Because both compounding exemptions turn on it. Section 503A bars regularly compounding essentially copies of a commercially available drug, and FDA states that a drug on its shortage list is not commercially available. Section 503B bars essentially copies of approved drugs unless the drug is on the list at the time of compounding, distribution and dispensing, and lets an outsourcing facility use a bulk ingredient for a listed drug. Every other condition still applies, including a valid prescription for an identified patient under 503A.

## 02. What happens when a drug shortage is resolved?

FDA generally considers the drug commercially available again, so the copy limits return. For 503A, FDA has said it does not intend to act against a compounder that fills four or fewer prescriptions of an essentially-copy product in a calendar month, and a prescriber-documented change that makes a significant difference for an identified patient is not a copy. For 503B, FDA may act if a facility fills new orders after removal, or existing orders more than 60 days after it. For both GLP-1 drugs, FDA first announced dated wind-down periods.

## 03. Where do semaglutide and tirzepatide stand today?

As of October 26, 2026, FDA's Drug Shortages Database lists neither semaglutide injection nor tirzepatide injection as a current shortage, consistent with FDA's April 1, 2026 statement. On Cuvo, semaglutide and tirzepatide programs, including compounded options where clinically appropriate, run on a provider's prescription and a partner pharmacy operating within the current rules for each molecule. This is general information, not legal advice.

## Frequently asked questions

**Q: What is the FDA drug shortage list?**

A: It is FDA's public list of drugs determined to be in shortage in the United States, kept under 21 U.S.C. 356e and published as the Drug Shortages Database. On Cuvo, shortage status is part of the current rules tracked for each molecule a brand sells.

**Q: Is semaglutide still on the FDA shortage list?**

A: No. FDA declared the semaglutide injection shortage resolved on February 21, 2025, and its Drug Shortages Database did not list it as a current shortage on October 26, 2026. On Cuvo, semaglutide programs run on a licensed provider's prescription and a partner pharmacy operating within current rules.

**Q: Is tirzepatide on the FDA drug shortage list?**

A: No. FDA declared the tirzepatide injection shortage resolved on October 2, 2024 and again, after reevaluation, on December 19, 2024, and the database did not list it as a current shortage on October 26, 2026. On Cuvo, tirzepatide programs likewise run on a licensed provider's prescription and a partner pharmacy operating within current rules.

**Q: Can pharmacies compound drugs that are not in shortage?**

A: Yes, within limits: a 503A pharmacy may not regularly compound essentially copies of a commercially available drug, and a 503B facility may not compound essentially copies of an approved drug. On Cuvo, compounded orders run only where a licensed provider finds them clinically appropriate, through a licensed pharmacy operating within current rules.

**Q: Does a telehealth brand need to track FDA drug shortages?**

A: Yes, if it sells compounded versions of approved drugs, because a resolved shortage changes what may be filled. Cuvo Health tracks what current rules permit for each molecule and routes prescriptions only to licensed pharmacies operating inside them, so the brand does not watch the database itself.

**Related pages**

- [503A vs 503B compounding](/blog/compounding-503a-vs-503b): How the shortage list affects each compounder
- [503A compounding pharmacy](/glossary/503a-pharmacy): The essentially-a-copy limit
- [503B outsourcing facility](/glossary/503b-outsourcing-facility): The shortage pathway for bulk ingredients
- [Compounded medication](/glossary/compounded-medication): Why compounded drugs are not FDA-approved
- [GLP-1 weight loss programs](/solutions/glp-1-weight-loss): Semaglutide and tirzepatide on Cuvo
- [GLP-1 pharmacy fulfillment](/blog/glp1-fulfillment-pipeline): Prescription to doorstep

Canonical page: https://cuvo.co/glossary/fda-drug-shortage-list