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What the FDA’s Guidance on Compounded GLP-1 Medications Means for You

Reading time:

3 min

Author

Sydney Wexler, RDN

Published on

Aug 13, 2025

Updated on

Jul 10, 2026

Mochi Bites

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Introduction

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If you're using compounded GLP-1 medications like semaglutide or tirzepatide for weight management, recent FDA updates may have raised questions about your treatment's future. Let's break down what these changes mean and how Mochi is here to support you.

What Did the FDA Announce?

The FDA has determined that the national shortages of GLP-1 medications, specifically semaglutide and tirzepatide, have been resolved. As a result, the agency is ending its temporary allowance for compounding pharmacies to produce versions of these drugs that are essential copies of the FDA-approved products (1).

To facilitate a smooth transition, the FDA provided a grace period:

For state-licensed pharmacies (Section 503A): The enforcement discretion ended on April 22, 2025.
For FDA-registered outsourcing facilities (Section 503B): The enforcement discretion ended on May 22, 2025.

After these dates, compounding pharmacies are expected to stop producing compounded versions that are essential copies of the approved medications.

What Did the FDA Announce?

To facilitate a smooth transition, the FDA provided a grace period:

For state-licensed pharmacies (Section 503A): The enforcement discretion ended on April 22, 2025.
For FDA-registered outsourcing facilities (Section 503B): The enforcement discretion ended on May 22, 2025.

After these dates, compounding pharmacies are expected to stop producing compounded versions that are essential copies of the approved medications.

Is Compounding Still Legal?

Yes, compounding remains a legal and vital part of personalized medicine (2). Compounded medications are custom-prepared to meet an individual patient's specific needs (3). For example, they may include a specific dosage strength not available commercially or additional active ingredients clinically indicated for the patient.

These medications are created by licensed pharmacies, based on a valid prescription from a licensed provider. While they are not FDA-approved (meaning they haven’t gone through the FDA drug approval process), they are still regulated at the state and/or federal level, and must meet important safety and quality standards.

Interested in a personalized treatment plan that meets your unique needs? Start your care journey with Mochi today.

Is Compounding Still Legal?

Interested in a personalized treatment plan that meets your unique needs? Start your care journey with Mochi today.

Is Compounding Going Away?

No, compounding is not going away. The FDA's recent guidance specifically targets compounded medications that are copies of FDA-approved drugs now readily available on the market. Personalized compounded medications that differ from commercial products and are prescribed based on individual patient needs can still be legally prepared and dispensed (2).

Is Compounding Going Away?

Will Mochi Continue Offering Compounded Medications?

Absolutely. At Mochi, our mission is to provide personalized, accessible obesity care. Our network of healthcare providers will assess each patient's unique medical history and needs to determine the most appropriate treatment plan. This may include:

FDA-approved GLP-1 medications
Personalized compounded medications when clinically appropriate

If the prescription includes a compounded medication, we’ll send it to a trusted, licensed compounding pharmacy that adheres to strict regulatory and safety standards.

Want to explore which medication might be right for you? Connect with a Mochi provider for a personalized consultation with a medical professional.

Our Commitment to Personalized Obesity Care

Mochi is dedicated to bridging the gap in access to effective obesity treatments. We believe that:

Personalization for better care: Tailoring treatments to individual needs in an effort to improve outcomes and patient satisfaction.

Provider autonomy is essential: Healthcare providers are educated and trained to make clinical decisions in the best interest of their patients and have the flexibility to prescribe the most suitable treatments.

Access should be equitable: All patients deserve access to effective obesity care, regardless of insurance coverage or other barriers.

We are continuously working to enhance our platform, making it easier for patients to connect with knowledgeable providers and access the medications they need.

Whether you're exploring GLP-1 medications for the first time or looking for clarity on your current treatment, we’re here to help. Get started with Mochi Health today.

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Mochi Bites

Sydney Wexler, RDN

Aug 13, 2025

All professional medical services are provided by licensed physicians and clinicians affiliated with independently owned and operated professional practices. Mochi Health Corp. provides administrative and technology services to affiliated medical practices it supports, and does not provide any professional medical services itself.

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