Which Compounded Peptides Are Legal in 2026?
Key takeaways The rules for compounding peptides and GLP-1 weight-loss drugs keep shifting in 2026, and one big change just landed. On October 28, 2026, HHS cleared a path for pharmacies to compound six popular peptides. On the GLP-1 side, compounded semaglutide and tirzepatide are still available through licensed telehealth platforms. This guide lays out […]
By Astra Editorial Team
Medically reviewed by Dr. Michael Wasef, Medical Director, Wasef Health · Board-Certified Internal Medicine
Published:
Updated:
Key takeaways
- The FDA-approved GLP-1 and weight-loss drugs in 2026 include semaglutide (Ozempic, Wegovy, Rybelsus), tirzepatide (Mounjaro, Zepbound), liraglutide, dulaglutide, exenatide, and orforglipron (Foundayo).
- Compounded semaglutide and tirzepatide are still available through legitimate telehealth platforms. Since the shortages ended, they are made the patient-specific way (503A), after a provider reviews your case.
- On October 28, 2026, HHS said it will not take action against pharmacies that compound six peptides (BPC-157, TB-500, Epitalon, KPV, MOTS-c, and Semax) if strict rules are met.
- That policy is not the same as an FDA approval. It’s temporary, and HHS can cancel it.
- Most other “research” peptides, like CJC-1295, ipamorelin, AOD-9604, and Melanotan II, still cannot be legally compounded.
- Sermorelin is the exception and has stayed legal to compound the whole time.
- Nothing on this list that is compounded is FDA-approved. That means the FDA has not checked it for safety, quality, or how well it works.
The rules for compounding peptides and GLP-1 weight-loss drugs keep shifting in 2026, and one big change just landed. On October 28, 2026, HHS cleared a path for pharmacies to compound six popular peptides. On the GLP-1 side, compounded semaglutide and tirzepatide are still available through licensed telehealth platforms.
This guide lays out what is FDA-approved, what you can legally get from a compounding pharmacy, and what is still off-limits as of November 2026. It is a factual reference, not medical or legal advice. Compounded drugs are not FDA-approved and are not the same as brand-name drugs, even when they share the same active ingredient.
Status changes fast, so always check the date before you rely on any entry.
A note on who’s writing this: Astra (try-astra.com) sells compounded GLP-1s and peptides through licensed clinicians, so we have a stake in the topic. We’ve kept this guide factual and flagged plainly what is FDA-approved, what is only legal to compound, and what is neither.
Knowing what’s legal is step one. A licensed clinician is step two.
Astra prescribes compounded GLP-1s and the peptides covered by current rules through licensed providers and 503A pharmacies, the lane that’s actually open in 2026.
Start with GLP-1s → See peptide options →Are compounded peptides legal in 2026?
Quick answer: The FDA-approved GLP-1 and weight-loss drugs in 2026 are semaglutide, tirzepatide, liraglutide, dulaglutide, exenatide, orforglipron (Foundayo), and tesamorelin (for one narrow use). You can still get compounded semaglutide or tirzepatide, but only through a patient-specific 503A prescription rather than as a mass-market product.
On the peptide side, six peptides became legal to compound under an October 2026 HHS policy. Sermorelin was already legal, and most other research peptides are still off-limits.
Two terms come up a lot below, so here they are in plain English. Compounding is when a licensed pharmacy mixes or prepares a medication for a specific patient. 503A compounding is the rule that covers patient-specific compounding; 503B covers larger batches made by outsourcing facilities under stricter standards.
Which GLP-1 weight-loss drugs are legal to compound?
Quick answer: Semaglutide and tirzepatide are FDA-approved and still available as compounded medications through licensed telehealth providers. Since the shortages ended, they are compounded the patient-specific way (503A) rather than as mass-market copies. Liraglutide is the one GLP-1 that can still be compounded at scale, because it is still on the shortage list.
| Drug | FDA-Approved? | Can it be compounded in 2026? | Notes |
|---|---|---|---|
| Semaglutide (Ozempic, Wegovy, Rybelsus) | Yes | Limited. 503A, patient-specific only | Shortage ended Feb 2025; routine copies no longer allowed |
| Tirzepatide (Mounjaro, Zepbound) | Yes | Limited. 503A, patient-specific only | Shortage ended Dec 2024; same picture as semaglutide |
| Liraglutide (Victoza, Saxenda) | Yes | Yes. Still allowed, including 503B | Still on the shortage list; Saxenda ends Jan 2027 |
| Dulaglutide (Trulicity) | Yes | No | Off the shortage list |
| Exenatide (Byetta, Bydureon) | Yes | No | All brands discontinued |
| Orforglipron (Foundayo) | Yes | No | Oral, non-peptide; approved April 2026 |
| Tesamorelin (Egrifta WR) | Yes | No | Approved for one narrow use only |
| Retatrutide, CagriSema, cagrilintide | No (in trials) | No | Investigational; cannot be compounded |
Compounded semaglutide and tirzepatide are still available, but the path changed in 2026. Compounding a near-copy of an approved drug is mostly allowed only while that drug is in shortage. Tirzepatide left the FDA shortage list in December 2024 and semaglutide in February 2025, so the mass-market copy window closed.
What remains, and what legitimate telehealth platforms use, is 503A compounding for a specific patient with a documented need. A separate FDA proposal from 2026 could also close the 503B route for these drugs.
This is the route that stays open, and it’s where Astra works. We offer compounded semaglutide and compounded tirzepatide through licensed clinicians under the 503A patient-specific pathway. A provider reviews your health history first and decides whether it is appropriate for you.
Which compounded peptides are legal in 2026?
Quick answer: On October 28, 2026, HHS said it will not take action against pharmacies that compound six peptides under 503A rules: BPC-157, TB-500, Epitalon, KPV, MOTS-c, and Semax. That made them legal to compound for the first time in years. It is not FDA approval, and it can be undone.
These are the same six peptides an FDA advisory panel recommended back in July 2026. The policy limits each one to specific forms and routes:
| Peptide | Commonly marketed for | Allowed forms and routes |
|---|---|---|
| BPC-157 | Healing and recovery | Injection (under the skin or into muscle), a pill, or on the skin |
| TB-500 | Recovery | Injection under the skin or into muscle |
| Epitalon | Anti-aging | Injection, in short on-and-off courses |
| MOTS-c | Metabolism | Injection |
| Semax | Focus and brain support | Nasal spray only |
| KPV | Inflammation | On the skin or as a pill |
Pharmacies only get this protection if they follow the policy’s conditions, including:
- Single-ingredient only. A product can hold just one of the six. Combination products, like BPC-157 plus TB-500, fall outside the policy.
- Prescription and tested source required. It still takes a patient-specific prescription, and the raw peptide must come from an FDA-registered supplier with lab testing.
- Labeling and reporting rules apply. Pharmacies must label products as compounded, use a cleared syringe, and report safety problems to the FDA.
These six are legal to compound today, but they are not FDA-approved, not on the 503A bulks list, and the policy is temporary and already facing legal challenges. For the full breakdown of the 10 conditions and what enforcement discretion does and does not mean, see our dedicated guide to the 2026 HHS peptide policy. Astra offers compounded peptides covered by the current rules through licensed providers, who decide case by case whether one fits your situation.
The HHS policy is new. Sermorelin has been legal to compound the whole time.
Of every peptide in this guide, sermorelin has the strongest legal footing, staying at Category 1 through every policy shift. Astra’s licensed providers prescribe it through 503A pharmacies.
Explore peptide options →Which peptides are still illegal to compound?
Quick answer: The October 2026 policy only covers six peptides. Many popular “research” peptides are still not legal to compound, including CJC-1295, ipamorelin, AOD-9604, injectable GHK-Cu, and Melanotan II.
| Peptide | Can it be compounded now? | Notes |
|---|---|---|
| CJC-1295 | No | May be reviewed later (around early 2027); not in the Oct 2026 policy |
| Ipamorelin | No | Same track as CJC-1295 |
| AOD-9604 | No | Growth-hormone fragment; review still pending |
| GHK-Cu (injectable) | No | Review pending; topical copper-peptide is a separate cosmetic lane |
| Melanotan II | No | Specifically left out of the 2026 reclassification |
Sermorelin has stayed legal to compound the whole time. It kept its “Category 1” status through the 2023 peptide crackdown, so pharmacies could always make it under 503A and 503B. Of every peptide on this page, sermorelin has the strongest legal footing. It is not a currently marketed brand-name drug, but it was FDA-approved in the past (as Geref) and pulled in 2008 for business reasons.
FDA-approved vs compounded vs gray-market peptides: what’s the difference?
Quick answer: Regulators do not treat all peptides the same, and you shouldn’t either. There are three groups: FDA-approved drugs, compounded drugs that are legal but not approved, and gray-market “research only” products.
| Group | Did the FDA review it? | Legal to compound? | Example |
|---|---|---|---|
| FDA-approved drug | Yes | Depends on shortage rules | Semaglutide |
| Compounded, not approved | No | Yes, under pharmacy rules | Sermorelin; BPC-157 under the new policy |
| Gray-market “research only” | No | No | Most peptides sold online |
FDA-approved drugs like semaglutide, tirzepatide, orforglipron, and tesamorelin have passed the FDA’s safety and effectiveness review. The only compounding question here is narrow and turns on shortage status.
Compounded but not approved covers sermorelin today and the six peptides under the new HHS policy. “Legal to prepare” under pharmacy law is not the same as “approved” or “proven to work.”
Gray-market “research only” peptides are sold online with no FDA review, no medical oversight, and purity that can vary from batch to batch. This is where most peptides sold online actually sit, and it is the riskiest group by far.
The safer path is a licensed provider and a compounding pharmacy that follows the rules. Astra, for example, prescribes compounded GLP-1s and peptides only after a licensed clinician reviews your health history, so you are not sourcing an unregulated “research only” product on your own.
What changed for peptide and GLP-1 compounding in 2026?
Quick answer: Three things tightened compounded GLP-1 access in 2026, and one thing opened up peptide access. Here is the short timeline.
- Dec 2024 to Feb 2025: The FDA declared the tirzepatide and semaglutide shortages over. That removed the main legal reason to compound near-copies of them.
- 2025 into 2026: The FDA sent warning letters to telehealth companies over how they marketed compounded GLP-1s. One wave in early 2026 hit about 30 companies, with more letters in June 2026.
- April 2026 to May 2026: The FDA proposed closing the 503B route for semaglutide, tirzepatide, and liraglutide, saying outsourcing facilities had no clear need to make them. This was still pending a final decision as of late 2026.
- Oct 28, 2026: HHS issued its enforcement discretion policy, letting pharmacies compound six peptides under strict rules.
How we check compounding status
Quick answer: We check each drug against four questions and cite primary sources. The sources are the FDA drug shortage database, Federal Register notices, and the FDA’s bulk drug substance lists.
- Is there an FDA-approved version? Approval means the drug passed the FDA’s safety and effectiveness review. A compounded version has not, even if it shares the same active ingredient.
- Which compounding rule applies, if any? 503A covers patient-specific prescriptions. 503B covers larger batches from outsourcing facilities. A drug can be legal under one, both, or neither.
- Does it depend on a shortage? Compounding room grows during an official FDA shortage and shrinks when it ends. Only the FDA’s shortage list counts as the legal trigger, not supply bulletins from other groups.
- Is the ingredient on a restricted list? A “Category 2” substance is off-limits for compounding. A “Category 1” drug may be compounded while the FDA keeps reviewing it. Neither is the same as approval of a finished drug.
A prescription, a licensed pharmacy, and a clinician who reviews your case.
That’s what “legal to compound” actually looks like in 2026. Astra runs it that way for GLP-1s and peptides covered by current rules.
Get started with Astra About 5 minutes. Compounded medications are not FDA-approved.📖 What to Read Next
Frequently Asked Questions
Narrowly, yes. The easy “just a copy” version ended when the FDA called the semaglutide shortage over in February 2025. What is left is 503A compounding for a specific patient with a documented medical need. A pending FDA proposal could tighten this even more.
No. They are not FDA-approved and are not proven equal to the brand-name drugs, even with the same active ingredient. The FDA does not check compounded drugs for safety, quality, or how well they work before they are sold. That is why the FDA has warned hundreds of telehealth companies that implied otherwise.
As of October 28, 2026, yes, within limits. HHS said it will not act against pharmacies that compound BPC-157 under 503A if they follow strict rules. But it is not FDA-approved, it is not on the official bulks list, and the policy is temporary and can be reversed
BPC-157, TB-500, Epitalon, KPV, MOTS-c, and Semax. Other peptides like CJC-1295, ipamorelin, AOD-9604, and Melanotan II are not covered and still cannot be legally compounded.
No. The policy only means the FDA will not take action against pharmacies that compound them under the rules. The FDA has not approved them or confirmed they are safe and effective.
Not as a currently sold product. It was approved in the past (as Geref) and pulled in 2008 for business reasons, not safety. It has stayed legal to compound ever since, which makes it the cleanest-standing peptide here.
Through a licensed prescriber and a compounding pharmacy that follows the rules, not an online “research only” seller. A provider reviews your health history and decides whether a compounded medication is appropriate. Astra offers compounded GLP-1s and peptides this way, through licensed clinicians and 503A pharmacies. Remember that these products are still not FDA-approved.
References
- HHS, Enforcement Discretion Policy Regarding 503A Compounding Using Certain Peptide Bulk Drug Substances (Oct 28, 2026; Federal Register Doc. 2026-22192) — the new peptide policy.
- FDA Drug Shortages database.
- FDA, Proposes to Exclude Semaglutide, Tirzepatide, and Liraglutide on 503B Bulks List (April 30, 2026).
- Federal Register, List of Bulk Drug Substances for 503B (91 Fed. Reg. 23431, May 1, 2026).
- FDA, Warns 30 Telehealth Companies Against Illegal Marketing of Compounded GLP-1s (March 3, 2026).
- FDA, July 23-24, 2026 Pharmacy Compounding Advisory Committee meeting.
- FDA, Bulk Drug Substances Used in Compounding Under Section 503A (Category 1 / Category 2 lists).
Related Astra programs
This article is for educational purposes only and does not constitute medical advice. Consult a licensed physician regarding any medical condition or treatment.