Compounded GLP-1 Drugs: What FDA Says

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Compounded semaglutide and tirzepatide are sold under many names, and the claims around them run ahead of what FDA says. This guide lays out what FDA has said, with dates. It is not legal advice, and it does not recommend any pharmacy, telehealth service or seller.

The short answer

Compounded semaglutide and tirzepatide are not FDA-approved. FDA says it does not review compounded drugs to evaluate their safety, effectiveness or quality before they reach patients (FDA). In FDA’s words, compounded drugs “should only be used in patients whose medical needs cannot be met by an FDA-approved drug” (FDA, Oct. 1, 2026).

What else FDA has said, in brief:

• The shortage-based latitude has ended. Neither drug currently appears on FDA’s drug shortage list or its 503B bulks list.
• Copies of approved drugs are restricted. FDA says a compounded product with the same ingredient in a similar strength, by the same route, can be treated as “essentially a copy” of an approved drug, with some exceptions.
• Adding an ingredient does not by itself change that. FDA’s example is semaglutide with vitamin B12.
• Salt forms of semaglutide are different active ingredients, and FDA says it is “not aware of any lawful basis” for using them in compounding.
• Retatrutide and cagrilintide cannot be used in compounding under federal law, according to FDA.
• FDA has listed quality and dosing concerns: multi-dose vials, shipping temperature, fraudulent labels and dosing errors.

We do not call compounded GLP-1 drugs legal or illegal in general. FDA’s pages describe conditions and enforcement positions, and state rules are separate. For a specific situation, ask a licensed clinician or pharmacist.

How this guide is built

This is a regulatory explainer, not a ranking of products. Every statement about FDA’s position links to FDA’s own page, and we say when a source is a warning letter (an agency position, not a court ruling). Nothing here is a recommendation of a product or a provider. For the evidence on the approved drugs, see our semaglutide guide, tirzepatide guide and weight loss guide.

What is a compounded drug?

A compounded drug is made when a licensed pharmacist or physician, or a person supervised by a licensed pharmacist at an outsourcing facility, combines, mixes or alters ingredients. FDA describes two sets of rules (FDA):

• Section 503A describes the conditions under which compounded products are exempt from FDA approval before marketing, from current good manufacturing practice (CGMP) requirements and from labeling with adequate directions for use. One condition is a valid patient-specific prescription.
• Section 503B created a voluntary category of compounders called outsourcing facilities. They are subject to CGMP requirements and may distribute compounded drugs either under a patient-specific prescription or in response to an order from a health care provider.

Compounded drugs are not FDA-approved. FDA says a compounded drug “might be appropriate if a patient’s medical need cannot be met by an FDA-approved drug, or the FDA-approved drug is not commercially available” (FDA).

Are these drugs still in shortage?

FDA’s April 1, 2026 statement says tirzepatide and semaglutide “do not currently appear on the 503B bulks list or on FDA’s drug shortage list.” When we checked FDA’s drug shortage database on Nov. 3, 2026, neither was listed as in shortage; it listed three strengths of Rybelsus (semaglutide tablets) as “To Be Discontinued,” which is a discontinuation notice, not a shortage.

The same page records how the shortage-based enforcement latitude ended:

These dates concern conditions that depended on the shortage listing. FDA noted it can still act on other requirements, for example if a product may be of substandard quality or otherwise unsafe.

What does FDA say about “essentially a copy”?

Under section 503A, FDA’s April 1, 2026 statement says a compounder may not compound, “regularly or in inordinate amounts,” drugs that are essentially copies of a commercially available drug. FDA says it intends to consider a compounded product essentially a copy if:

• it has the same active ingredient as the commercially available drug, in the same, similar or easily substitutable strength; and
• the commercially available drug can be used by the same route of administration (regardless of how it is labeled) prescribed for the compounded drug;
• unless a prescriber determines and documents that the compounded product contains a change that produces a significant difference for an identified individual patient.

Adding a second ingredient. FDA’s example: a compounded product combining semaglutide and vitamin B12 (cyanocobalamin) may be considered essentially a copy when it is given the same way as the approved product and the amounts of both ingredients are within 10% of the strengths of the approved products. FDA says that, at this time, it does not intend to take action against a compounder for essentially copies made regularly or in inordinate amounts if the compounder fills four or fewer prescriptions of that compounded drug in a calendar month.

Outsourcing facilities (503B) are restricted from compounding with bulk substances unless the substance is on the 503B bulks list or the drug is on FDA’s shortage list at the time of compounding.

What did FDA’s Sept. 18, 2026 warning letter say?

In a warning letter to a compounding pharmacy, FDA said products combining tirzepatide with niacinamide and semaglutide with cyanocobalamin appear to be essentially copies of approved drugs. FDA wrote that the volume of products suggested that the differences were “pretextual.” The monthly figures are redacted in the published letter. FDA also cited violations of current good manufacturing practice, and said the products were unapproved new drugs and misbranded.

Two cautions. A warning letter states FDA’s position about one company and its facts; it is not a court ruling. And we did not check the company’s response or any later action.

What about the proposed 503B list?

On May 1, 2026, FDA proposed not adding semaglutide, tirzepatide or liraglutide to the 503B bulks list, and it extended the comment period to July 30, 2026. We found no final notice as of Nov. 3, 2026.

Does the HHS peptide policy cover them?

No. HHS’s interim policy of Oct. 30, 2026 names six other peptides; semaglutide and tirzepatide are not among them. It is not FDA approval of anything.

What are the salt forms and the “research use only” products?

• Salt forms. FDA says it is aware that some semaglutide products sold by compounders may be salt forms, such as semaglutide sodium and semaglutide acetate. These are “different active ingredients than are used in the approved drugs,” FDA does not have information on whether they have the same chemical and pharmacologic properties, and it is “not aware of any lawful basis for their use in compounding” (FDA).
• Retatrutide and cagrilintide. FDA says they cannot be used in compounding under federal law, and are not components of FDA-approved drugs. It has warned telehealth companies, active-ingredient distributors and outsourcing facilities over retatrutide (same page). See our retatrutide guide.
• Products labeled “for research purposes.” FDA says it has warned companies that sold unapproved drugs containing semaglutide, tirzepatide, retatrutide, survodutide or mazdutide that were falsely labeled “for research purposes” or “not for human consumption,” and that were sold directly to consumers for human use with dosing instructions. FDA urges consumers not to purchase these products, which are of unknown quality and may be harmful (same page).
• Counterfeit Ozempic. FDA says it is aware of counterfeit Ozempic marketed in the U.S.

What quality and dosing concerns has FDA described?

All of this is from FDA’s page unless noted.

• Multi-dose vials. FDA generally recommends that vials containing multiple doses of sterile medication be used within 28 days after first use, because contamination risk rises after that, and that the vial be discarded after 28 days even if medication remains.
• Shipping and storage. FDA has received complaints that certain compounded GLP-1 drugs arrived warm or with too few ice packs, and it recommends not using an injectable GLP-1 drug that arrives warm or without enough refrigeration.
• Fraudulent products. FDA is aware of fraudulent compounded semaglutide and tirzepatide with false information on the label, including cases where the pharmacy named on the label does not exist, or is a licensed pharmacy that did not compound the product.
• Dosing errors. FDA received multiple reports of adverse events, some requiring hospitalization, that may be related to dosing errors with compounded injectable semaglutide. FDA’s separate alert says the majority described patients drawing up more than the prescribed dose from a multi-dose vial, and that in these cases patients took five to 20 times the intended amount. FDA also received reports that may be related to doses beyond what the approved label provides.
• Adverse event reports. As of May 31, 2026, FDA had received 990 reports of adverse events associated with compounded semaglutide and more than 730 associated with compounded tirzepatide. FDA says federal law does not require state-licensed pharmacies that are not outsourcing facilities to submit adverse events to FDA, so these are likely underreported; many of the events appear consistent with those of the approved versions; and it is not always possible to tell whether an event directly resulted from the drug.

What are FDA’s telehealth red flags?

FDA’s list of warning signs for consumers includes a company that:

• claims the compounded drug is the same as an FDA-approved drug;
• offers medicine at deep discounts or prices that seem too good to be true;
• sends medicine that looks different from what you’ve received before, or arrives in broken packaging or without instructions for use;
• does not require a screening and prescription by a licensed doctor, or has no licensed doctor available to answer questions;
• has spelling errors on the label or incorrect pharmacy addresses, or names a pharmacy that might be fraudulent.

FDA recommends getting a prescription from your doctor and filling it at a state-licensed pharmacy (FDA). FDA’s reminders to telehealth companies include not describing a compounded drug as “clinically proven to produce the same result as the FDA-approved drug,” and not claiming it is sourced from an “FDA-approved” or “FDA-licensed” pharmacy or outsourcing facility, because FDA does not approve or license any facility.

FDA has also said that its import alert on GLP-1 active ingredients does not stop importation of those ingredients from manufacturers that appear to comply with FDA’s standards, and does not “create any new limits on the legal compounding of GLP-1 drugs.”

Is a compounded version the same as Wegovy, Ozempic, Zepbound or Mounjaro?

No. FDA says compounded drugs are not FDA-approved, so it does not review them for safety, effectiveness or quality before they are marketed. Our comparisons of Wegovy and Ozempic and Zepbound and Mounjaro explain what each approved label covers. Brand names are used here only to identify the FDA labels.

What should you ask your doctor or pharmacist?

• Is there an FDA-approved product that fits my situation, and what stops me from using it?
• If a compounded product is suggested, why can’t the approved product meet my medical need?
• Who compounds it: a state-licensed pharmacy or an outsourcing facility, and how can I confirm?
• What ingredients does it contain, and is it semaglutide or tirzepatide itself rather than a salt form?
• How will I measure and take each dose, and who can I call with questions?

We do not give doses, and we do not recommend pharmacies, telehealth services or sellers.

Frequently asked questions

Is compounded semaglutide FDA-approved?

No. FDA says compounded drugs are not FDA-approved and are not reviewed for safety, effectiveness or quality before they are marketed.

Is compounded semaglutide the same as Ozempic or Wegovy?

FDA says a compounded drug should not be described as the same as an FDA-approved drug.

Does adding vitamin B12 make it a different drug?

Not by itself, according to FDA. It says it may consider a product combining semaglutide and vitamin B12 to be essentially a copy of an approved drug when the route is the same and the amounts are within 10% of the approved strengths.

Is semaglutide or tirzepatide still in shortage?

Neither currently appears on FDA’s drug shortage list, according to FDA’s April 1, 2026 statement and our Nov. 3 check.

Can compounded semaglutide or tirzepatide be called illegal?

We don’t give legal conclusions. FDA has set conditions and taken enforcement positions, described above, and state rules are separate.

Can you use “research use only” semaglutide or tirzepatide?

FDA says products falsely labeled for research purposes were sold directly to consumers for human use, urges consumers not to purchase them, and says they are of unknown quality.

From Best Peptides Today

1. FDA Warning Letter Says Empower Pharmacy's Compounded Semaglutide and Tirzepatide Appear to Be CopiesOct. 31, 2026
2. FDA Warning Letters on Peptides: A Running TrackerNov. 3, 2026

Sources we checked

1. FDA: compounding laws and policiesFDA. Accessed November 3, 2026.
2. FDA clarifies policies for compounders as national GLP-1 supply stabilizes (April 1, 2026)FDA. Accessed November 3, 2026.
3. FDA's concerns with unapproved GLP-1 drugs used for weight loss (Oct. 1, 2026)FDA. Accessed November 3, 2026.
4. FDA: telehealth companies and promoting compounded drugs (June 15, 2026)FDA. Accessed November 3, 2026.
5. FDA alert: dosing errors with compounded semaglutideFDA. Accessed November 3, 2026.
6. FDA warning letter to a compounding pharmacy, Sept. 18, 2026FDA. Accessed November 3, 2026.
7. Federal Register: proposed 503B bulk drug substances list (May 1, 2026)Other. Accessed November 3, 2026.
8. Federal Register: extension of comment period on 503B list (June 26, 2026)Other. Accessed November 3, 2026.
9. FDA drug shortage listFDA. Accessed November 3, 2026.
10. Federal Register: HHS enforcement discretion policy on 503A peptide compounding (Oct. 30, 2026)Other. Accessed November 3, 2026.
11. HHS: Enforcement Discretion Policy, with Appendices A and BOther. Accessed November 3, 2026.
12. Wegovy prescribing information (DailyMed, rev. 06/2026)FDA. Accessed November 3, 2026.
13. Zepbound prescribing information (DailyMed, rev. 08/2026)FDA. Accessed November 3, 2026.

Written and maintained by the Best Peptides For Editorial Team. How we rate evidence.