Compounded Semaglutide and Tirzepatide: what FDA says and the risks

Key takeaways

• Compounded semaglutide and tirzepatide are not FDA approved, and the FDA does not review them for safety, effectiveness or quality before sale.^[1]
• The FDA confirmed the tirzepatide shortage resolved on December 19, 2024 and the semaglutide shortage on February 21, 2025; the grace periods for compounders ended in 2025.^[2]
• As of May 31, 2026 the FDA had 990 adverse event reports for compounded semaglutide and more than 730 for compounded tirzepatide, including dosing errors.^[1]
• Salt forms such as semaglutide sodium or acetate are different active ingredients from the approved drugs, and the FDA has no safety data on them.^[1]
• A safe online pharmacy requires a prescription, is state licensed, has a pharmacist available and a U.S. address, according to the FDA's BeSafeRx.^[8]

In short: Compounded tirzepatide and compounded semaglutide are pharmacy-made versions of the active ingredients in Zepbound, Mounjaro, Wegovy and Ozempic. They are not FDA approved, and the FDA does not review them for safety, effectiveness or quality before they are sold. Compounding of these drugs grew while the FDA listed them in shortage; both shortages are over (tirzepatide confirmed resolved on December 19, 2024, semaglutide on February 21, 2025), and the FDA has since moved against mass-marketed copies (checked on 2026-10-06).

This guide explains what compounding is, what happened during the shortages, what the FDA has reported about safety problems, how compounded products differ from counterfeit and “research” products, and how to check a pharmacy. It does not recommend any product or seller, and it is not personal medical advice: talk with your clinician about any medicine you take or plan to take.

What compounding is

Compounding means a pharmacist or a registered outsourcing facility combines, mixes or alters ingredients to make a medicine for a specific need. It has a real place in medicine, for example for a person who is allergic to an ingredient in the approved product or who cannot swallow a tablet. The FDA’s position is that compounded drugs should only be used when a patient’s medical need cannot be met by an FDA-approved drug.

Federal law has two routes. State-licensed pharmacies compound under section 503A of the Food, Drug, and Cosmetic Act, for an individual patient based on a prescription. Outsourcing facilities registered with the FDA compound under section 503B and can make larger batches. Both routes have limits on making copies of approved drugs. The FDA describes a compounded product as “essentially a copy” when it has the same active ingredient as a commercially available drug in the same, similar or easily substitutable strength and is used by the same route. Adding a vitamin does not change that: the FDA’s own example is semaglutide combined with vitamin B12.

Compounded is not the same as FDA approved

An FDA-approved medicine such as Zepbound or Wegovy has been through clinical trials reviewed by the FDA, is made in inspected facilities to an approved standard, and comes with official prescribing information that lists its approved uses, doses, warnings and side effects. A compounded version has none of that review. The FDA states plainly that compounded drugs are not FDA approved and that it does not review them for safety, effectiveness or quality before they are marketed.

That means the results from the trials behind the approved brands, such as STEP for semaglutide or SURMOUNT for tirzepatide, cannot simply be assumed for a compounded product. In warning letters in the fall of 2025, the FDA told companies they may not claim that compounded products are generic versions of approved drugs or the same as them. When we searched DailyMed on October 6, 2026, every semaglutide and tirzepatide label listed came from Novo Nordisk or Eli Lilly (or a repackager of their products): we found no FDA-approved generic of either.

The shortage years: a dated history

When an approved drug is on the FDA’s drug shortage list, the law allows compounders more room to make copies of it. Demand for GLP-1 medicines outran supply for a time, both drugs were listed in shortage, and compounded versions spread widely, often sold through telehealth websites. Here is how it ended, according to the FDA:

Date	What happened
October 2, 2024	The FDA determined the tirzepatide shortage was resolved, then re-evaluated that decision.
December 19, 2024	The FDA confirmed the tirzepatide shortage was resolved.
February 18, 2025	End of the FDA’s grace period for state-licensed (503A) pharmacies compounding tirzepatide.
February 21, 2025	The FDA determined the semaglutide shortage was resolved.
March 19, 2025	End of the grace period for outsourcing facilities (503B) compounding tirzepatide.
April 22 and May 22, 2025	End of the grace periods for semaglutide: 503A pharmacies, then 503B outsourcing facilities.
Fall 2025	FDA warning letters about misleading claims for compounded GLP-1s.
February 6, 2026	The FDA announced it intends to take action against non-FDA-approved GLP-1 drugs mass-marketed as alternatives to approved medicines.
April 1, 2026	The FDA reminded compounders of the legal conditions; neither drug was on the drug shortage list or the 503B bulks list.
April 30, 2026	The FDA proposed excluding semaglutide, tirzepatide and liraglutide from the 503B bulks list (comments closed June 29, 2026).

As of October 6, 2026, the April 2026 proposal was at the stage of public comment on the FDA’s page; we will update this timeline when the FDA publishes a final decision.

What the FDA has reported about safety

The FDA’s page on unapproved GLP-1 drugs, updated October 1, 2026, lists several concerns:

• Adverse event reports. As of May 31, 2026, the FDA had received 990 reports for compounded semaglutide and more than 730 for compounded tirzepatide. Pharmacies that are not outsourcing facilities are not required to report adverse events, so the FDA notes the real numbers are likely higher.
• Dosing errors. Some reports involved people measuring the wrong dose from a vial, or clinicians miscalculating doses, and some required hospitalization. Approved pens deliver a fixed dose; compounded vials and syringes leave room for mistakes.
• Different ingredients. Salt forms such as semaglutide sodium and semaglutide acetate are different active ingredients from the one in approved products, and the FDA says it has no safety data on them.
• Storage and handling. Injectable GLP-1 medicines need refrigeration, and the FDA advises against using drugs that arrive warm. For multi-dose vials, it recommends discarding them 28 days after first use.

The side effects of the active ingredients themselves, such as nausea, vomiting and the risk of pancreatitis or gallbladder problems, apply whatever the source. Our guide to GLP-1 side effects explains them and when to call a doctor.

Counterfeit and “research peptide” products

Compounded drugs come from licensed pharmacies, even if they are not approved. Two other groups of products are worse, because nobody accountable stands behind them:

• Counterfeits. Fake pens made to look like the real brand. The FDA has warned about counterfeit Ozempic found in the U.S. drug supply chain three times: in December 2023, April 2025 and December 2025. It advises buying only from state-licensed pharmacies with a valid prescription and checking any product you receive. See Ozempic for details.
• “Research use” products. Powders or vials labeled “for research purposes” or “not for human consumption” and sold online to consumers. The FDA says illegal online products may contain the wrong ingredient, too much or too little of it, or none at all. In 2026 the FDA set up an import alert to block GLP-1 ingredients with quality concerns and sent warning letters to illegal online sellers.

How to check a pharmacy

The FDA’s BeSafeRx campaign lists the signs of a safe online pharmacy: it requires a valid prescription, it is licensed by a U.S. state, it has a pharmacist available to answer questions, and it has a U.S. address. BeSafeRx links to a tool for looking up state-licensed online pharmacies.

1. Ask what exactly you are getting. Is it an FDA-approved brand, or a compounded product? If compounded, which active ingredient and salt form, from which pharmacy, and why an approved product does not meet your need?
2. Check the pharmacy’s license with your state board of pharmacy or the BeSafeRx tool.
3. Check the dose in units you understand. Ask the pharmacist to show you how to measure it, and confirm whether the dose is in milligrams or in units on a syringe.
4. Report problems. Side effects and product problems can be reported to the FDA’s MedWatch program.

If you are using a compounded GLP-1 now

Do not stop or change a medicine suddenly on your own because of something you read online; talk with the clinician who prescribed it. Bring the vial or the label to the appointment so they can see exactly what you have: the active ingredient and its salt form, the concentration, the pharmacy and the dose you have been measuring. Ask whether an FDA-approved product would meet your need, and what switching would involve, since approved products are started according to their own labels. Keep the product refrigerated as instructed, do not share needles or vials, and discard multi-dose vials when the FDA-recommended 28 days after first use have passed. If you have severe stomach pain that does not go away, repeated vomiting, signs of dehydration or an allergic reaction, get medical help promptly. Whatever the medicine, the basics in life after a GLP-1 help protect the results.

Why people look at compounded versions, and the approved alternatives

The main reason is cost, and sometimes the hope of avoiding needles or insurance paperwork. The manufacturers now sell the approved products directly at self-pay prices well below list price. As of October 6, 2026, Wegovy pens were $349 a month through NovoCare Pharmacy and Wegovy pills $149 to $299; Zepbound KwikPens were $299 to $449 a month through Lilly; and Medicare’s temporary GLP-1 Bridge charges a $50 copay for people who meet its criteria. Details are on Wegovy cost, Zepbound cost and our GLP-1 cost comparison tool.

There are also FDA-approved pills now: the Wegovy pill (oral semaglutide) and Foundayo (orforglipron). Our weight-loss injections hub and the GLP-1 guide list every approved option with its status badge.

Questions to ask a professional

• Is the product you are prescribing FDA approved, or compounded? If compounded, why does an approved product not meet my need?
• Which pharmacy makes it, is it state licensed or an FDA-registered outsourcing facility, and what exact salt form is it?
• How do I measure my dose, and what should I do if I am unsure?
• What side effects should make me call you right away?
• Could I afford an approved product through insurance, a savings card or the manufacturer's self-pay pharmacy?

Frequently asked questions

Is compounded tirzepatide the same as Zepbound?

No. It may contain the same active ingredient, but it is not FDA approved, it was not studied in the trials behind Zepbound and Mounjaro, and the FDA does not check its quality before sale. The FDA has told companies not to claim compounded products are generic versions of approved drugs.

Is compounded semaglutide still legal?

Compounding itself is legal within limits. Since the semaglutide shortage ended (grace periods through April and May 2025), pharmacies may not regularly make essentially copies of the approved product. Making a product for a documented individual medical need can still be allowed. Ask your prescriber why a compounded product is being used.

Are "research peptides" a safe shortcut?

No. Products labeled for research or not for human consumption are not legal medicines for people, and the FDA warns they may contain the wrong ingredient, the wrong amount or none at all.

How can I tell if my Ozempic or Wegovy pen is real?

Buy only with a prescription from a state-licensed pharmacy. The FDA has published counterfeit Ozempic alerts with lot numbers and visual differences; check them, and contact the manufacturer or your pharmacist if anything looks different.

Are there cheaper approved options?

Manufacturers sell approved products at self-pay prices that were $149 to $449 a month depending on product and strength on 2026-10-06, and Medicare has a temporary $50 Bridge for eligible people. Our cost pages list the dated prices.

References

1. FDA’s concerns with unapproved GLP-1 drugs used for weight loss. U.S. Food and Drug Administration, 2026. (accessed October 7, 2026) Government page
2. FDA clarifies policies for compounders as national GLP-1 supply begins to stabilize (content current as of 2026-04-01). U.S. Food and Drug Administration. (accessed October 6, 2026) Government page
3. FDA intends to take action against non-FDA-approved GLP-1 drugs. U.S. Food and Drug Administration, 2026. (accessed October 6, 2026) Government page
4. FDA proposes to exclude semaglutide, tirzepatide and liraglutide from 503B bulks list. U.S. Food and Drug Administration, 2026. (accessed October 6, 2026) Government page
5. Resolution of shortages of semaglutide injection products (declaratory order). U.S. Food and Drug Administration, 2025. (accessed October 6, 2026) Government page
6. Resolution of tirzepatide injection product shortage (decision memorandum). U.S. Food and Drug Administration, 2024. (accessed October 6, 2026) Government page
7. FDA warns consumers not to use counterfeit Ozempic found in U.S. drug supply chain. U.S. Food and Drug Administration, 2025. (accessed October 7, 2026) Government page
8. BeSafeRx: your source for online pharmacy information. U.S. Food and Drug Administration. (accessed October 6, 2026) Government page
9. WEGOVY (semaglutide) injection and tablets: prescribing information. Novo Nordisk, via DailyMed, 2026. (accessed October 7, 2026) Drug label
10. Wegovy at NovoCare Pharmacy: self-pay prices. Novo Nordisk (NovoCare Pharmacy). (accessed October 7, 2026) Other
11. Zepbound coverage and savings. Eli Lilly and Company. (accessed October 6, 2026) Other
12. Medicare GLP-1 Bridge: information for providers. Centers for Medicare and Medicaid Services. (accessed October 7, 2026) Government page

Facts checked on October 6, 2026

Educational information, not medical advice. Talk with a qualified healthcare professional about your own situation. In an emergency call 911.