The FDA’s New Tirzepatide Ruling: What It Means for Your Weight Loss Treatment

In October 2024, the FDA made a significant announcement that affects how tirzepatide, a popular weight loss medication, is produced and accessed. If you’ve been using or considering compounded tirzepatide injections, here’s what you need to know about this change.

What Is Compounded Tirzepatide?

Compounded tirzepatide is a version of the drug made by specialized pharmacies, known as compounding pharmacies, rather than the original drug manufacturer. These pharmacies created their own versions of tirzepatide injections when there was a shortage of the brand-name versions, Mounjaro® and Zepbound®.

The FDA allows compounding when a drug is in short supply, but now that the shortage has ended, pharmacies are no longer allowed to produce compounded tirzepatide unless it’s medically necessary for a specific patient. This means that compounded tirzepatide injections are no longer widely available, and patients need to look for alternative, FDA-approved options

Why Did the FDA Make This Change?

The FDA regulates compounded medications to ensure patients are getting safe, effective treatments. During the tirzepatide shortage, compounding pharmacies were allowed to produce injectable forms of the medication. Now that the shortage is over and the original tirzepatide products are back in stock, the FDA wants patients to use the FDA-approved iversions, which have undergone thorough testing for safety and quality​, unless they meet specific exemptions under sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act.

This means that any new orders for compounded tirzepatide injections are restricted, and compounding facilities only have a 60-day window to dispense any orders placed before the FDA shortage status was lifted​

This move by the FDA aims to ensure that patients receive medications that have undergone rigorous testing for safety, efficacy, and quality. While this is a positive step toward ensuring consistent access to FDA-approved products, it limits the options for those who had relied on compounded tirzepatide injections during the shortage.

What Are Your Options Now?

At premd.RX, we understand the importance of having access to effective weight loss solutions that meet FDA standards. That’s why we are excited to continue offering FDA-approved sublingual tirzepatide drops as a safe and compliant alternative for our patients.

Sublingual formulations are an innovative option that allows the medication to be absorbed through the tissue under the tongue, offering convenience and effectiveness without the need for injections.

This alternative remains fully compliant with FDA regulations and provides a seamless transition for patients who may no longer be able to access compounded injectable tirzepatide. Additionally, sublingual tirzepatide offers unique benefits, such as ease of administration and a less invasive experience, while delivering similar weight loss and metabolic benefits.

What Is Sublingual Tirzepatide?

Sublingual tirzepatide is taken by placing the medication under your tongue, where it’s absorbed into the body without the need for injections. It’s a great alternative for those looking for a more convenient method, and it provides the same benefits as injectable tirzepatide.

Why Choose Sublingual Tirzepatide?

• No Need for Injections: Skip the needles with this easy, under-the-tongue medication.

• FDA-Approved: Unlike compounded versions, our sublingual tirzepatide has been thoroughly tested and approved by the FDA, ensuring it meets the highest safety and efficacy standards.

• Effective Weight Loss: Sublingual tirzepatide offers the same weight loss benefits as injectable forms, helping you achieve your goals without compromising on treatment quality.

How We Can Help You

As a trusted provider of GLP-1 medications like tirzepatide we're committed to staying ahead of regulatory changes while continuing to offer top-tier weight loss solutions. Our licensed physicians and expert team are here to guide you through your treatment options, ensuring you receive the most effective and legally compliant care available.

Book a consultation today to explore how sublingual tirzepatide can be part of your weight loss journey, and let premd.RX help you achieve your health goals with confidence and compliance.