Legal permissibility depends on strict adherence to FDA guidance and Section 503A of the Federal Food, Drug, and Cosmetic Act. Safety considerations hinge on formulation quality, sourcing practices, sterile compounding standards, and appropriate clinical oversight.
During the national tirzepatide shortage, compounded formulations were used as temporary alternatives when FDA-approved products were unavailable. That context has changed. With commercial supply now stabilized, the FDA has ended its shortage-related enforcement discretion, significantly narrowing the circumstances under which compounded tirzepatide may be legally prescribed.
In 2026, compounded tirzepatide may still be prescribed in the United States only when a patient has a documented medical need that cannot be met by an FDA-approved formulation, such as a verified allergy to an inactive ingredient. Compounding for general weight loss, cost savings, convenience, or preference does not meet Section 503A criteria and is considered the creation of an “essentially a copy” of an approved drug, which is prohibited.
This article reviews current FDA guidance, sourcing requirements, and safety considerations related to compounded tirzepatide in 2026. Its purpose is to clarify regulatory expectations and support informed, compliant clinical decision-making.
FDA Compounding Policies Impacting Tirzepatide in 2026
The FDA has made its rules on drug compounding clear, with more focus on GLP-1 rules now that there is enough supply. FDA enforcement is in place to make sure people use drugs that are approved, safe, and work well. These drugs are made following current good manufacturing practice.
These rules change how and when compounded tirzepatide can be made and given. Let's go over recent steps taken by the FDA, and see the main ways approved drugs are not the same as compounded drugs.
Recent FDA Enforcement and GLP-1 Regulations
Recent actions by the FDA have changed the rules for compounded tirzepatide. The official drug is not on the shortage list anymore. Because of this, the grace period for making compounded tirzepatide has ended. Now, FDA enforcement is going after pharmacies that make copies of drugs which are already on the market, unless there is a real medical reason. The FDA is doing this to protect people from unsafe or unapproved drug substances.
The FDA has brought up some points about GLP-1 drugs and drug quality, such as:
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Adverse Events: There are growing reports about side effects like nausea, vomiting, and problems at the injection site.
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Dosing Errors: Some people ended up in the hospital because they got the wrong dose.
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Fraudulent Products: Some products are not true to their label or come from made-up pharmacies.
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Improper Storage: Drugs sometimes arrive at the wrong temperature, like being warm or not being kept cold, which can hurt drug quality.
They have been tested for safety and how well they work.
Differences Between Approved Tirzepatide and Compounded Versions
It is important to know that an approved drug is not the same as a compounded drug. Pharmaceutical manufacturers need to do a lot of testing to get FDA approval. The process for a compounded drug does not include this testing.
Here’s what makes them different. Rules for compounded tirzepatide are not as strict as those for approved drugs.
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Clinical Trials: An approved drug goes through tough clinical trials to show it is safe and works well. A compounded drug does not do this.
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Quality Review: The FDA looks at how approved drugs are made to check quality and consistency. The FDA does not look at the process for compounded drugs.
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Efficacy Data: Approved drugs have clear proof that they work for a certain condition. Compounded drugs may not have this, and their effects can change.
Legality of Compounded Tirzepatide: Current Status
The rules about the legal status of compounded tirzepatide are now very clear because of federal law. The medication is no longer on the FDA's drug shortage list. Now, doctors can only prescribe it in cases allowed by Section 503A of the Food, Drug, and Cosmetic Act.
This means compounding the medicine is only legal when someone’s needs can't be handled by the approved drug. We will talk about what it means to follow these rules and how state and federal groups both keep an eye on this.
Section 503A Compliance and Legal Prescribing Channels
Section 503A of the Food, Drug, and Cosmetic Act does let a licensed pharmacist make tirzepatide, but this can only happen in very certain cases. The law says a pharmacist can make prescription drugs just for one person, and it has to be for that person's use, based on a real prescription. The rules do not let you make copies of drugs that are already sold in stores.
When it comes to tirzepatide, a pharmacy needs to see that a patient really needs the drug. This could be when someone is allergic to something in the FDA-approved drug. It is not enough if it is just for a lower price or for an easier way to get it. Following Section 503A is not just a choice. It is the law.
State vs. Federal Oversight for Pharmacies and Telehealth Providers
The rules for compounded medications are set by both the federal and state governments. The FDA gives guidance through the federal law, like Section 503A. But state boards of pharmacy handle most of the day-to-day work. They give out licenses and check to make sure each pharmacy follows the rules.
What legal risks do they face? If a provider prescribes compounded tirzepatide and does not make sure there is a patient-specific medical need, there can be some serious problems.
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Providers can get into trouble with the state medical boards.
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They might have to deal with legal claims if a patient goes through an adverse event.
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They could end up working with pharmacies that do not follow federal law.
A licensed pharmacist has to be involved. Still, telehealth providers also have to be sure their prescriptions are right for both medical and legal reasons.
Sourcing and Verification: Bulk API, Base vs. Salt Forms, and COA StandardsWhether
Making sure a compounded medication is safe starts from the source. The quality of the bulk active ingredient is very important. Trusted compounding pharmacies need to check the active ingredient. They do this by getting a Certificate of Analysis (COA) to show it is pure and real.
It is important to know if tirzepatide is the base or salt form. This matters for the safety and following rules in health care. We will talk about why these things are so important for your health care. We also look at how to meet good quality standards.
Choosing Safe Bulk API Sources with Valid Certificates of Analysis (COA)
It is important for every compounding pharmacy to choose a safe source for bulk API. This is something you cannot skip. Having a real Certificate of Analysis (COA) is the best way to show that the raw ingredient meets quality standards. A COA proves the API’s identity, how pure it is, and how strong it is. This helps stop bad or weak drugs from getting to patients.
There are rules right now that have a big effect on how pharmacies do their work. Pharmacies need to get their API from a good manufacturer. The manufacturer should not be on the FDA import alert list.
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Pharmacies have to get a COA for every batch of bulk API.
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Pharmacies can only use ingredients that meet the official standards.
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The FDA can take action if someone uses low-quality or unauthorized APIs.
Why Only Base Form Tirzepatide Meets FDA 503A COA Standards
The difference between the "base" and "salt" forms of tirzepatide is important to know for legal and safe compounding. The FDA-approved drug has the tirzepatide base as the active ingredient. So, only this form should be used when you make a compounded drug under Section 503A.
Some people use salt forms like tirzepatide sodium or tirzepatide acetate for compounding. These are seen as different active ingredients. They have not been shown to be safe or work well.
How do the FDA 503A COA standards help keep people safe?
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They make sure the compounded drug has the right, approved active ingredient.
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They stop people from using salt forms that have not been studied and could have effects no one knows about.
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They check how pure the ingredient is, so people have less chance of problems after taking it.
Your Path to Better Health Begins with Healthon
Managing weight-loss therapies in 2026 requires careful attention to regulatory standards and patient safety. Healthon clinicians assess medical history, treatment goals, and clinical necessity before recommending any therapy. FDA-approved medications remain the first-line option, and compounded treatments are considered only when clearly justified under federal and state regulations.
Recent FDA enforcement changes have significantly limited the use of compounded tirzepatide. In most cases, it is appropriate only when a documented medical need prevents use of an FDA-approved formulation. Clinical oversight is essential to confirm eligibility, evaluate sourcing and formulation quality, and ensure patient protection.
Patients receive clear guidance on available options, current FDA requirements, and safe treatment pathways tailored to individual needs.
For professional evaluation and personalized guidance, contact Healthon to discuss weight-management options that align with both clinical goals and regulatory standards.
Frequently Asked Questions
Is compounded tirzepatide expected to remain legal in 2026 under updated regulations?
Yes, it may still be used, but the rules are very strict. Under federal law and updated FDA enforcement, compounded tirzepatide is permitted only with a valid prescription for a documented medical need that cannot be met by an FDA-approved product. This limited use is allowed solely under the requirements of Section 503A.
What are the latest FDA safety concerns about compounded tirzepatide?
The FDA is worried about a few things. First, nobody is checking the quality or purity of the drug. There are also reports of bad things happening when people take the wrong dose. Another problem is that some places use the wrong salt instead of the right active ingredient. All of this shows that using a compounded drug can be risky.
How do FDA 503A COA standards protect patient safety with compounded tirzepatide?
Section 503A and Certificate of Analysis (COA) rules help keep patients safe. These rules make sure that compounded tirzepatide is made with the right active ingredient, using its base form. They also check that it meets set standards for being pure and strong. This lowers the risk of using things that are not approved or are dirty.
Reference List
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Food and Drug Administration. (2024). FDA clarifies policies as national GLP-1 supply begins to stabilize.
https://www.fda.gov/drugs/drug-safety-and-availability/fda-clarifies-policies-compounders-national-glp-1-supply-begins-stabilize -
Hogan Lovells. (2025). FDA and HHS taking action against telehealth’s compounded drug advertising.
https://www.hklaw.com/en/insights/publications/2025/09/fda-hhs-taking-action-against-telehealths-compounded-drug-advertising -
McDermott Will & Emery. (2025). Court backs FDA in tirzepatide compounding case.
https://www.mwe.com/insights/court-backs-fda-in-tirzepatide-compounding-case/ -
National Center for Biotechnology Information. (2023). Compounding quality, contamination, and dosing risk.
https://www.ncbi.nlm.nih.gov/books/NBK562888/ -
USP <795>/<797>. (2024). Pharmaceutical Compounding Standards. https://www.usp.org/compounding/general-chapter-795
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LegitScript. (2025). Pharmacy Compliance Best Practices. https://www.legitscript.com/healthcare/pharmaceutical-manufacturing-compliance/
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Pharmacy Times. (2024). FDA affirms tirzepatide shortage resolved and sets transition period.
https://www.pharmacytimes.com/view/fda-affirms-tirzepatide-shortage-resolved-sets-transition-period-for-compounding -
FDA. (2026). Compounded GLP-1 Products: Tirzepatide Enforcement Update https://www.fda.gov/drugs/drug-safety-and-availability/fda-clarifies-policies-compounders-national-glp-1-supply-begins-stabilize
- Healthon. (2025). Compounded tirzepatide: Is it legal & safe in 2025?
https://healthon.com/blogs/journal/compounded-tirzepatide-is-it-legal-safe-in-2025
