Compounded Tirzepatide: Is It Legal & Safe in 2025?

December 15, 2025
Blog
Journal

Authors

Reviewed by Dr. Rasoul Montazeri

Triple Board Certified Physician and The Founder

Niayesh Najafi

Medical student and researcher in Health Sciences

Table of contents

Overview of Compounded Tirzepatide in 2025
FDA Guidance on Tirzepatide and Compounded Medications
Legality of Compounded Tirzepatide in 2025
Sourcing: API vs. Finished Tirzepatide Products
Have Questions? Healthon Is Here to Help
Frequently Asked Questions

Key takeaways

Compounded tirzepatide is now restricted and allowed only for patients with a documented medical need (e.g., excipient allergy).
Cost, preference, or convenience are not valid reasons for compounding.
Safety varies with compounded versions because they are not FDA-approved and may differ in purity or potency.
FDA enforcement has increased, limiting access and requiring most patients to use FDA-approved tirzepatide instead.

Multi-dose tirzepatide autoinjection pen representing dual GLP-1 and GIP agonist therapy used for diabetes and weight loss treatment

During the national shortage, compounded tirzepatide served as a temporary alternative for patients who could not access FDA-approved products. With commercial supply now restored, the FDA has implemented strict limits on when compounded versions may be used. Only patients with a medically necessary requirement, such as a documented allergy to an excipient in the approved drug, may qualify for compounded tirzepatide.

Cost, convenience, or personal preference are not valid reasons for compounding. The FDA’s announcement that tirzepatide is no longer in shortage means compounding is now tightly restricted, and pharmacies may only prepare the medication for patients with verifiable clinical need that cannot be met by the FDA-approved formulation. As a result, general access to compounded tirzepatide has been significantly reduced.

Overview of Compounded Tirzepatide in 2025

Compounded tirzepatide, as well as oral semaglutide, is made by a pharmacy using the active ingredient found in the main brand medicine. People started using it for weight management when there was a drug shortage. FDA-approved tirzepatide and injectable semaglutide products were on the shortage list. This helped patients get the treatment they needed without stopping, although it’s not known how well oral tirzepatide works.

Now, the supply of these GLP-1 medicines is back to normal. The FDA has taken tirzepatide off the drug shortage list. Because of this, the laws around compounding have changed. Pharmacies are not allowed to make copies of a commercially available drug or a commercially available drug product just to offer a more accessible option, and making small changes without a documented medical need isn’t permitted. The rules now say pharmacies can only compound in a few special situations.

FDA Guidance on Tirzepatide and Compounded Medications

FDA White Oak Campus symbolizing federal oversight, regulation, and 2025 policy changes affecting compounded tirzepatide legality

The FDA has not banned compounded tirzepatide made by Eli Lilly. But it has put strong limits on how compounding pharmacies can use it. The Federal Food, Drug, and Cosmetic Act says these pharmacies can’t make copies of drug products that are already on the market. For a time, there was an exception when a drug was on the FDA’s drug shortage list. But tirzepatide is no longer on that shortage list.

Now, the grace period for removing these products is over. The FDA will enforce these rules more. So, compounding pharmacies are not allowed to give people compounded versions of standard doses or lower doses just for general use. The aim is to make sure people use FDA-approved drug products, which are reviewed for their safety and how well they work as they move through the supply chain.

Legality of Compounded Tirzepatide in 2025

Illustration explaining 2025 legality of compounded tirzepatide and FDA restrictions following the end of the drug shortage list

Is compounded tirzepatide still legal? The answer is not so simple. It is only legal in certain cases. According to FDA guidelines, a pharmacy can make a compounded medication if someone has a specific medical need that the FDA-approved prefilled pens product cannot fill, especially a real medical need. For example, maybe a person is allergic to an added ingredient in the regular, approved product.

But, you cannot compound just to save money or because it seems easier. Doctors who give, and pharmacies that sell, compounded tirzepatide outside these strict rules could face legal action from the FDA. For people using it, a good idea regarding the main risk has to do with safety. These drugs do not get checked by the FDA, and if you have commercial insurance, manufacturer copay cards can help reduce costs.

Sourcing: API vs. Finished Tirzepatide Products

Understanding where your medication comes from is key to ensuring its safety. There is a major difference between sourcing the Active Pharmaceutical Ingredient (API) and using finished tirzepatide products. Compounding pharmacies create their medications by obtaining tirzepatide API, the raw chemical, and mixing it into a single dose final formulation.

In contrast, FDA-approved products like Zepbound vials are finished drug products manufactured and tested under strict regulatory oversight. Ozempic’s manufacturer’s process ensures dose-to-dose consistency and minimizes the risk of contamination or incorrect potency, which can lead to unexpected side effects.

Aspect	Compounded from API	Finished Tirzepatide Product
Source	Raw active ingredient (API)	FDA-approved manufacturing facility
FDA Approval	Not approved for safety or efficacy	Approved after rigorous clinical trials
Varies by pharmacy; state-level regulation; it’s important to consider the route of administration in these processes.	Varies by pharmacy; state-level regulation; it’s essential to consider the route of administration in these processes.	Federally regulated by the FDA
Consistency	Can vary between batches and pharmacies	Standardized and consistent dosage

Have Questions? Healthon Is Here to Help

With compounded tirzepatide now subject to strict FDA limitations, choosing the safest and most appropriate GLP-1 treatment requires expert guidance. Healthon clinicians assess each patient’s medical history, treatment objectives, and regulatory constraints to determine whether a compounded option is medically necessary or if an FDA-approved medication is the better choice. Through individualized evaluations and clear, evidence-based recommendations, Healthon helps patients navigate evolving regulations and select weight-management therapies that align with their health needs and current FDA standards.

Frequently Asked Questions

Can patients still access compounded tirzepatide in 2025?

Yes, but the use of compounded tirzepatide is now very strict. Under normal circumstances, the drug shortage is over, so it can be used only if a person has a specific medical need. That medical need must be clear, and it must be something that the approved product cannot help with. Compounded tirzepatide is not for everyone any more. It is only for those with a real, documented medical need.

What are the main tirzepatide safety concerns to discuss with your provider?

The biggest safety worry is that these compounded versions of small amounts of medication are not FDA-approved. So, you cannot be sure about their purity, how strong they are, or if they are clean. Talk with your provider about the risks. You should talk about using an active ingredient that is not regulated, how there could be mistakes in the dose, and all the possible side effects. You and your provider should decide together what is good for your specific situation.

Where to find reliable updates about compounded tirzepatide laws?

For the best and up-to-date information, check the U.S. Food and Drug Administration (FDA) website. You can also talk to your healthcare provider for help, as there are important factors related to human services to consider. Trusted websites like Healthon are good places to stay updated on the latest drug administration news and FDA regulations for compounded medications.