Tag: Compounding pharmacies

Following the U.S. Food and Drug Administration's (FDA) declaration in late 2024 that the national tirzepatide shortage was resolved, a wave of confusion and misinformation has circulated regarding the medication's status. It is crucial to clarify that the FDA is **not removing tirzepatide** from the market; instead, it has ceased the temporary allowance for compounding pharmacies to produce non-FDA-approved versions of the drug. This regulatory shift impacts patients using compounded products, requiring them to transition to the brand-name alternatives, Mounjaro and Zepbound.

Following months of widespread scarcity, the U.S. Food and Drug Administration (FDA) officially declared the Zepbound shortage resolved in December 2024, although temporary, local supply chain disruptions may still occur. Here's a look at how bad is the Zepbound shortage in 2025 and what patients need to know.

As of March 19, 2025, the landscape for tirzepatide users has fundamentally changed [1.2.1, 1.2.3]. The question on many minds is: **is compounded tirzepatide really going away?** The short answer is yes, due to decisive action from the U.S. Food and Drug Administration (FDA).

While compounded semaglutide contains the same active ingredient as FDA-approved versions, it is not an identical or equivalent product. Its quality, safety, and effectiveness are not subject to the rigorous testing and review mandated by the FDA for branded medications like Ozempic and Wegovy.

In a study of the FDA-approved drug Wegovy, participants lost up to 20% of their body weight over 68 weeks. This raises a critical question for many: is compounded semaglutide as effective as regular semaglutide, and is it a safe alternative?

An estimated 1 billion people globally are affected by obesity [1.3.1]. For those exploring medical weight loss, a key question is: **what is compounded semaglutide with glycine?** This custom-made medication combines a GLP-1 agonist with an amino acid to support weight management goals [1.2.2, 1.2.6].

As of September 2025, the manufacturer Eli Lilly has made all FDA-approved doses of Zepbound (tirzepatide) available in both single-dose pens and single-dose vials. For patients wondering, 'Is Zepbound available in vials yet?', the answer is yes, offering a new, lower-cost self-pay option.

As of September 2025, the question 'is compounded tirzepatide off shortage' has a definitive answer: its widespread availability has ended [1.2.6]. The FDA declared the shortage of brand-name tirzepatide (Mounjaro and Zepbound) resolved, leading to a halt in production for most compounding pharmacies by March 19, 2025 [1.2.1, 1.2.4].

The U.S. Food and Drug Administration (FDA) first listed Zepbound on its drug shortage list in April 2024, citing immense demand that outpaced the manufacturer's production. The question, **Why is Zepbound out of stock everywhere?**, can be answered by examining the perfect storm of surging demand, manufacturing complexities, and regulatory changes affecting compounded alternatives.

In a 72-week clinical trial, the highest dose of tirzepatide resulted in an average body weight reduction of 20.9% [1.7.3]. This success has led to questions about drug sourcing, such as: **which is better, compounded tirzepatide or tirzepatide** from the manufacturer?