# Compounded Semaglutide and Tirzepatide in 2026: Legal Status and Research Peptides

> Only in narrow cases. FDA declared the tirzepatide and semaglutide shortages over in December 2024 and February 2025. Since the 2025 grace periods ended, state-licensed pharmacies may compound these drugs only in limited situations, such as a documented clinical need for a specific patient, and outsourcing facilities cannot use bulk ingredient. FDA knows of no lawful basis for compounding salt forms, and says retatrutide cannot be compounded.

- URL: https://glpcalendar.app/blog/compounded-glp-1-and-research-peptides
- Published: 2026-09-29
- Updated: 2026-09-29
- Publisher: GLP Calendar (https://glpcalendar.app)

Compounded GLP-1s are versions of semaglutide or tirzepatide mixed by a pharmacy rather than made by Novo Nordisk or Eli Lilly. They spread widely while the brand-name drugs were in shortage. Since those shortages ended, the rules have tightened, FDA enforcement has stepped up, and a gray market of 'research peptides' has grown alongside. This guide covers US rules as of September 2026.

## Is compounded semaglutide or tirzepatide still legal in 2026?

Only in narrow cases. FDA declared the tirzepatide shortage over in December 2024 and the semaglutide shortage over in February 2025. After the grace periods ended in 2025, state-licensed pharmacies may compound these drugs only in limited situations, and outsourcing facilities cannot compound them from bulk ingredient.

| Date | What happened |
|---|---|
| Oct 2, 2024 | FDA decides the tirzepatide shortage is resolved, and reaffirms it on Dec 19, 2024 |
| Feb 18, 2025 | Grace period ends for state-licensed (503A) pharmacies compounding tirzepatide |
| Feb 21, 2025 | FDA decides the semaglutide shortage is resolved |
| Mar 19, 2025 | Grace period ends for outsourcing facilities (503B) compounding tirzepatide |
| Apr 22, 2025 | Grace period ends for 503A pharmacies compounding semaglutide |
| May 22, 2025 | Grace period ends for 503B facilities compounding semaglutide |
| Mar 3, 2026 | FDA announces warning letters to 30 telehealth companies over compounded GLP-1 marketing |
| Apr 30, 2026 | FDA proposes keeping semaglutide, tirzepatide and liraglutide off the 503B bulks list |
| Jul 30, 2026 | Extended deadline for public comments on that proposal |

### What this means for state-licensed pharmacies (503A)

A 503A pharmacy may not regularly compound drugs that are essentially copies of an approved drug. Under FDA's policy, a compounded version can be made when the prescriber documents that a change makes a significant difference for that individual patient. FDA also says it does not intend to act against a pharmacy that fills four or fewer prescriptions of an essentially copied product in a calendar month.

Either way, compounded drugs are not FDA-approved. The agency does not verify their safety, effectiveness or quality before they are sold.

### What changed for outsourcing facilities (503B)

An outsourcing facility may compound from bulk ingredient only if the ingredient is on FDA's 503B bulks list or the drug is on FDA's shortage list. FDA says semaglutide and tirzepatide are on neither. On April 30, 2026, FDA proposed formally leaving semaglutide, tirzepatide and liraglutide off the 503B list, finding no clinical need to compound them from bulk while approved drugs are available.

Comments were first due at the end of June. FDA extended the deadline to July 30, 2026, after a request for more time. As of late September 2026, we found no final decision published in the Federal Register.

## How do brand-name, 503A, 503B and 'research peptide' products differ?

Brand-name drugs are FDA-approved after review of their safety, effectiveness and quality. Compounded drugs from 503A pharmacies and 503B outsourcing facilities are not FDA-approved, but they can be legal when made under the rules. 'Research peptides' sold online for people to inject are unapproved drugs with no legal route to patients.

| Type | Who makes it | FDA review before sale | Prescription needed | Quality oversight |
|---|---|---|---|---|
| FDA-approved brand (Wegovy, Zepbound) | Licensed drug manufacturer | Yes | Yes | FDA |
| 503A compounded | State-licensed pharmacy or physician | No | Yes, for a specific patient | State board of pharmacy |
| 503B compounded | Outsourcing facility registered with FDA | No | Not always ('office use' stock) | FDA: CGMP rules, risk-based inspections |
| 'Research peptide' | Unknown seller | No | None (illegal for human use) | None |

State-licensed pharmacies that are not outsourcing facilities do not have to report adverse events to FDA, so FDA says problems with compounded GLP-1s are likely underreported. Even so, by May 31, 2026, FDA had received 990 adverse event reports for compounded semaglutide and more than 730 for compounded tirzepatide. FDA also uses a 'green list' import alert (66-80) to keep poor-quality GLP-1 ingredients out of the US supply chain.

## Semaglutide sodium vs semaglutide: why does the salt form matter?

FDA treats them as different drugs. Approved semaglutide products contain semaglutide itself, while some compounders have used salt forms such as semaglutide sodium or semaglutide acetate. FDA says these salts are different active ingredients, it lacks information that they behave the same way, and it knows of no lawful basis for compounding with them.

A salt form pairs a drug molecule with another charged particle, such as sodium. That can change chemical properties. FDA says it does not have information on whether these salts have the same chemical and pharmacologic properties as the ingredient in the approved drugs.

What to check: if your label lists 'semaglutide sodium' or 'semaglutide acetate', ask the pharmacy why, and show the label to your prescriber. Our [semaglutide guide](https://glpcalendar.app/blog/semaglutide) explains the approved products.

## How do compounded GLP-1 dosing errors happen?

Mostly through confusion between three measures: milligrams (the amount of drug), milliliters (the volume of liquid) and the 'units' printed on insulin-style syringes. FDA has documented patients drawing 5 to 20 times their intended dose from multi-dose vials, and clinicians miscalculating conversions in ways that led to overdoses of 5 to 10 times.

Brand-name pens and single-dose vials are built to deliver a set dose. Compounded products often come in multi-dose vials that you draw from with a syringe. Three things then have to line up:

1. The dose, in milligrams, chosen by your prescriber.
2. The strength of your vial, in milligrams per milliliter, which can differ between pharmacies and products.
3. The volume you draw, which syringes may mark in milliliters or in units.

Because strengths differ, the same number of units can hold very different amounts of drug. A number that was right for one vial can be wrong for the next.

FDA's July 2024 alert described both kinds of error. In one pattern, patients told to draw 5 units drew 50, ten times the intended dose. In another, a prescriber wrote 25 units when 0.25 milligrams was meant. Reported harms included nausea, vomiting, abdominal pain, fainting, headache, migraine, dehydration, acute pancreatitis and gallstones. Some people needed hospital care.

FDA has also received reports tied to compounded doses beyond the approved label, including larger doses, more frequent doses or faster increases. Custom 'microdosing' schedules have no clinical trial evidence behind them.

Storage matters too. FDA recommends discarding a multi-dose vial 28 days after first use and not using an injectable GLP-1 that arrives warm. See our guide to [injection sites and storage](https://glpcalendar.app/blog/glp-1-injection-sites-and-storage).

Get medical help right away for severe stomach pain that does not go away, repeated vomiting or signs of dehydration, or signs of an allergic reaction such as swelling of the face or trouble breathing.

## What are 'research peptides', and are they legal for weight loss?

No, they are not legal to sell for people to use. 'Research peptides' are unapproved drugs sold online with labels such as 'research use only' or 'not for human consumption'. FDA says such labels are false when products are sold for human use, and it has warned sellers of semaglutide, tirzepatide, retatrutide, survodutide and mazdutide marketed this way, often with dosing instructions.

Some ingredients cannot be compounded at all. FDA says retatrutide and cagrilintide cannot be used in compounding under federal law, are not components of any FDA-approved drug, and have not been found safe and effective for any condition. Retatrutide is Lilly's investigational triple agonist; see our [retatrutide guide](https://glpcalendar.app/blog/retatrutide) for its trial results and status.

Enforcement continues. On August 24, 2026, FDA warned Tex Peptides, an online seller whose 'research use only' products included retatrutide, semaglutide, tirzepatide, SS-31, tesamorelin and PT-141, along with bacteriostatic water. FDA found that the company's own website showed the products were intended for human use, which made them unapproved new drugs. It added that injectable products can pose serious risks because they bypass some of the body's key defenses against toxins and microbes.

Telehealth marketing is also under scrutiny. On March 3, 2026, FDA announced warning letters to 30 telehealth companies for claims implying compounded drugs were the same as approved ones, and for branding that obscured which pharmacy actually made the drug. FDA said it had sent thousands of letters about misleading drug ads since a crackdown began the previous September.

### Where does BPC-157 stand?

BPC-157 is a peptide promoted online for healing and recovery. It is not an approved drug, and its compounding status changed in 2026 without being settled:

- **Category 2:** FDA's list of bulk substances that raise significant safety risks, updated April 22, 2026, no longer lists BPC-157 in Category 2. It now appears among nominations that were withdrawn, still with FDA's note about possible immunogenicity and peptide-related impurities.
- **FDA's review:** FDA evaluated BPC-157 on its own initiative for the 503A bulks list, for ulcerative colitis. Its briefing document for the July 2026 advisory committee proposed not adding it. FDA cited poor chemical characterization, too little safety and immunogenicity information, insufficient evidence of effectiveness, and existing approved treatments.
- **The vote:** on July 23, 2026, the Pharmacy Compounding Advisory Committee voted 8 to 6, with one abstention, to recommend adding it. The committee advises; FDA makes the final determination.
- **Now:** as of late September 2026, we found no FDA notice adding BPC-157 to the 503A bulks list. It remains an unapproved drug. The same meeting reviewed six other peptides, including TB-500, KPV and MOTS-c.

## What should a legitimate compounded prescription and label show?

It should show who prescribed it, who made it, exactly which drug and salt form it contains, how strong it is, and how much to take in both milligrams and volume. If the dose volume on the label doesn't match what you were told, call the pharmacy before injecting.

Check for these:

1. **A prescriber and a real evaluation.** FDA's red flags include companies that supply medicine without a screening and prescription by a licensed clinician, or with no clinician available for questions afterward.
2. **Who made it.** A state-licensed pharmacy's name, address and phone number, or an outsourcing facility's. By law, 503B labels must say 'This is a compounded drug' and show the facility's name, address and phone number, a lot number and an expiration date.
3. **The exact drug name.** 'Semaglutide' or 'tirzepatide'. If it adds 'sodium' or 'acetate', ask why.
4. **Strength in mg/mL.** This is the concentration of the vial.
5. **Your dose in milligrams and as a volume.** Ask the pharmacy to write both, plus the syringe markings to use. FDA encourages patients to ask their prescriber or compounder how to measure the dose, and prescribers to supply a syringe that suits it.
6. **Storage and dates.** Storage instructions and a beyond-use or expiration date. FDA's 28-day advice for opened multi-dose vials still applies.
7. **No warning signs.** FDA lists spelling errors on the label, incorrect pharmacy addresses, pharmacy names that may be fake, and packaging that looks different, is damaged or lacks instructions. It has also found fraudulent products labeled with pharmacies that do not exist.

If the dose volume on the label doesn't match what you were told, call the pharmacy before injecting. Ask the pharmacist to confirm it rather than working it out from an online chart.

## What to do next

- **Start with approved options.** FDA says compounded drugs should only be used when a patient's medical needs cannot be met by an FDA-approved drug. Ask your prescriber which applies to you; our [tirzepatide guide](https://glpcalendar.app/blog/tirzepatide) covers the brand-name options.
- **Check every refill.** Compare the label with the list above each time, especially when the pharmacy or vial strength changes.
- **Record exactly what was dispensed.** A tracker such as GLP Calendar can store the drug name, strength and prescribed dose exactly as written, without calculating anything.
- **Avoid 'research use only' products** sold for injection, whatever the website claims.
- **Report problems** to FDA's MedWatch program and to your prescriber.

## Frequently asked questions

### Is compounded semaglutide the same as Wegovy or Ozempic?

No. Compounded drugs are not FDA-approved, so FDA has not reviewed their safety, effectiveness or quality. In 2026 FDA sent warning letters to companies whose marketing implied their compounded products were the same as approved drugs.

### Can a compounded GLP-1 be prescribed above brand-name doses?

FDA says it has received adverse event reports linked to compounded semaglutide or tirzepatide prescribed beyond the approved label, such as larger doses, more frequent doses or faster increases. Ask your prescriber how your dose compares with the FDA-approved label.

### How long can I use a multi-dose vial of a compounded GLP-1?

FDA generally recommends throwing away a multi-dose vial 28 days after first use, even if medicine remains and even if the compounder's instructions allow longer. It also advises a new sterile needle and syringe for every dose.

### What if my compounded GLP-1 arrives warm?

FDA recommends not using any injectable GLP-1 that arrives warm or without enough refrigeration, because heat can affect its quality. Contact the pharmacy before using it.

### Is BPC-157 legal?

BPC-157 is not FDA-approved for any use. As of September 2026 it is not on the list of substances pharmacies may compound under section 503A, although an FDA advisory committee voted narrowly in July 2026 to recommend adding it.

### How do I report a problem with a compounded medicine?

Report side effects or quality problems to FDA's MedWatch program, and tell your prescriber and the pharmacy. State-licensed pharmacies are not required to send adverse event reports to FDA, so patient reports matter.

## Sources

- [FDA. FDA clarifies policies for compounders as national GLP-1 supply begins to stabilize (updated April 1, 2026)](https://www.fda.gov/drugs/drug-alerts-and-statements/fda-clarifies-policies-compounders-national-glp-1-supply-begins-stabilize)
- [FDA. FDA proposes to exclude semaglutide, tirzepatide and liraglutide from the 503B bulks list, April 30, 2026](https://www.fda.gov/news-events/press-announcements/fda-proposes-exclude-semaglutide-tirzepatide-and-liraglutide-503b-bulks-list)
- [Federal Register. 503B bulks list notice on semaglutide, tirzepatide and liraglutide: extension of comment period to July 30, 2026](https://www.federalregister.gov/documents/2026/06/26/2026-12937/list-of-bulk-drug-substances-for-which-there-is-a-clinical-need-under-section-503b-of-the-federal)
- [FDA. FDA's concerns with unapproved GLP-1 drugs used for weight loss (updated September 1, 2026)](https://www.fda.gov/drugs/drug-alerts-and-statements/fdas-concerns-unapproved-glp-1-drugs-used-weight-loss)
- [FDA. FDA alerts health care providers, compounders and patients of dosing errors associated with compounded injectable semaglutide, July 26, 2024](https://www.fda.gov/drugs/human-drug-compounding/fda-alerts-health-care-providers-compounders-and-patients-dosing-errors-associated-compounded)
- [FDA. FDA warns 30 telehealth companies against illegal marketing of compounded GLP-1s, March 3, 2026](https://www.fda.gov/news-events/press-announcements/fda-warns-30-telehealth-companies-against-illegal-marketing-compounded-glp-1s)
- [FDA. Warning letter to TXP Innovations LLC dba Tex Peptides, August 24, 2026](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/txp-innovations-llc-dba-tex-peptides-735067-08242026)
- [FDA. Certain bulk drug substances for use in compounding that may present significant safety risks (updated April 22, 2026)](https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks)
- [FDA. Briefing document on BPC-157, Pharmacy Compounding Advisory Committee meeting, July 23-24, 2026](https://www.fda.gov/media/193343/download)
- [RAPS. FDA advisory committee backs two controversial peptides, July 2026](https://www.raps.org/resource/fda-advisory-committee-backs-two-controversial-peptides.html)
- [FDA. Compounding and the FDA: questions and answers](https://www.fda.gov/drugs/human-drug-compounding/compounding-and-fda-questions-and-answers)
- [21 U.S.C. 353b, outsourcing facilities, including label requirements (Cornell Legal Information Institute)](https://www.law.cornell.edu/uscode/text/21/353b)

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Educational content, not medical advice. GLP Calendar is a tracking app; it does not recommend or calculate doses.