The rise of GLP-1’s

You’ve probably heard a lot about the rise of GLP-1 receptor agonists, specifically tirzepatide (Mounjaro®, Zepbound®) and semaglutide (Ozempic®, Wegovy®) over the last few years. GLP-1s marked a major shift in treating type 2 diabetes and weight management. Although originally developed for blood glucose control, they have quickly gained attention for their remarkable weight-loss effects.

Regulatory changes have affected the compounded versions of tirzepatide and semaglutide

While they have officially been removed from the shortage list, certain compounding pharmacies are no longer able to make copies of semaglutide and tirzepatide without demonstrating a clinical difference in the drug that addresses specific patient needs, in compliance with Section 503A of the Federal Food, Drug, and Cosmetic Act.

So what does this mean for you and other patients? Well, compounding pharmacies are facing harsh scrutiny from regulatory agencies, and the medications must meet rigorous quality standards. However, as long as there are differences, such as allergens being removed, vitamins being added, or dosages being personalized, compounding pharmacies can still produce semaglutide and tirzepatide as long as a licensed provider determines it’s a medical necessity for their patients. Meaning, not all patients will be eligible for compounded versions of these medications. 

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The rise and fall of compounded tirzepatide

A little background on compounding

As you know, no two people are the same, and as such, sometimes what works for one patient might not work for another. Enter compounding. Compounded medications are custom-made drugs prepared to meet the specific needs of an individual patient. These are not mass-produced medications like those you find on pharmacy shelves. Instead, they are mixed, altered, or combined from scratch to meet an individual’s needs as deemed appropriate and clinically necessary by a licensed medical provider.

Tirzepatide started running low in December of 2022 because of high demand, which opened the door for compounding pharmacies and outsourcing facilities to produce compounded formulations to help meet higher demand.

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The FDA temporarily allowed compounding tirzepatide

Because of the tirzepatide shortage, the FDA permitted compounding pharmacies to produce versions of the medication under specific conditions outlined in Sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act.

Section 503A allows for state-licensed pharmacies and physicians to compound tirzepatide for individual patients based on valid prescriptions for clinically necessary reasons as determined by a licensed medical provider.

Section 503B gave permission for registered outsourcing facilities to compound tirzepatide in bulk without patient-specific prescriptions as long as the drug was on the FDA's shortage list.

The end of the tirzepatide shortage 

Though it is still up for debate, the FDA announced that by December 2024, manufacturers should be able to keep up with the national demand for tirzepatide and will be taken off the shortage list. This means that 503B outsourcing facilities can no longer produce tirzepatide. 503A compounding pharmacies can only continue production if there is a clear, documented clinical difference and a licensed medical provider determines necessity for a specific patient’s treatment.

Semaglutide: A different regulatory timeline

Similar to tirzepatide, the FDA has declared the semaglutide shortage resolved. Though many still feel that this medication is not easily accessible, as of February 21, 2025, semaglutide has been removed from the shortage list with the FDA stating that the demand was now manageable for manufacturers.

Legal challenges: OFA vs. FDA

Currently, there is a pending court case between the Outsourcing Facilities Association et al. v. United States Food and Drug Administration et al. (Case No. 4:24-cv-0953), which involves a dispute over the FDA's removal of tirzepatide and semaglutide from its drug shortage list.

According to FDA.gov, on April 24, 2025, a federal judge denied the Outsourcing Facilities Association’s (OFA) motion for a preliminary injunction in its lawsuit against the FDA. This legal action challenges the FDA’s March 2025 guidance concerning compounded semaglutide and tirzepatide.

So what does all this mean? 

• For traditional compounders (503A): Production of semaglutide or tirzepatide may continue so long as the compounding pharmacy produces a product with unique characteristics and a licensed medical provider determines that a given formulation is clinically necessary for a specific patient’s treatment.
• For outsourcing facilities (503B): The FDA is pausing enforcement only related to the drug shortage status of semaglutide, but just until May 22, 2025.

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So what does all this mean for compounding pharmacies?

Compounding pharmacies must now adapt

With GLP-1 drug shortages coming to an end, compounded versions are only available when a prescribing physician determines and documents a legitimate clinical difference and in strict compliance with 503A provisions.* 

Looking ahead, many compounding pharmacies may focus on other medications where individual dosing or formulation makes a difference, beyond just semaglutide and tirzepatide.

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How will all of this affect patients’ ability to access these medications?

Some patients feel like they’re back at square one, struggling to afford the brand-name versions, which can cost around $1,000 a month. Drugmakers like Novo Nordisk and Eli Lilly have started offering lower-priced options, ranging from about $350 to $700 a month. But even with those discounts, the cost is still out of reach for a lot of people who had been paying closer to $200 a month for compounded alternatives. Additionally, the higher-dose vials are still unavailable for Eli Lilly’s tirzepatide products.

With all this in mind, Shed continues to work on creating personalized solutions for its members, along with making insurance acceptance a priority in the coming months. 

While the landscape is shifting, personalized compounding isn’t going away. It’s just evolving to meet both regulatory requirements and patient-specific needs.

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*Shed complies with all applicable federal and state regulations related to the compounding of medications. Any references to compounded GLP-1 medications are for informational purposes only and do not constitute an offer or guarantee of availability. Shed does not prescribe or produce medication. We connect patients with licensed medical providers who evaluate each person’s individual needs to determine personalized treatment plans. If a provider determines that a compounded GLP-1 medication is medically necessary, then our partner pharmacies may fulfill the prescription as written by the provider. Compounded medications are only prepared when prescribed by a licensed practitioner based on a documented clinical difference, as required by Section 503A of the Federal Food, Drug, and Cosmetic Act.

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