On July 23–24, 2026, an FDA advisory committee recommended BPC-157, KPV, TB-500, MOTS-c, Epitalon, and Semax for the federal compounding list. The vote is nonbinding, none of them is FDA-approved, and the FDA hasn't proposed a rule.
Primary-source only · FDA status tracked · Not a pharmacy
We're not a clinical or legal practice ourselves. Our background is behavioral health technology and operations. This tracker follows FDA public actions directly, and select clinical sections are reviewed by a licensed physician where noted. Confirm specifics with a licensed provider.
The short version of everything below, in case that's all you need.
Not yet. It isn't FDA-approved, and it isn't on the list that authorizes pharmacies to compound it. An FDA advisory committee recommended adding it on July 23, 2026, but that vote is nonbinding and the FDA hasn't proposed a rule. Some clinics and pharmacies still offer it, so ask any provider exactly what they're dispensing and where it comes from.
Nothing final. The committee advised the FDA to add six of the seven peptides it reviewed to the compounding list, several by narrow margins. The FDA still has to propose a rule, take public comment, and issue a final rule. FDA staff had recommended against all seven.
Through a licensed provider who evaluates you and prescribes, with the medication filled by a state-licensed pharmacy. That means an FDA-approved drug such as semaglutide or tirzepatide, or in narrow cases a compounded preparation. Products sold as "research use only" aren't a legal route to human use.
No. Retatrutide isn't FDA-approved and can't be legally compounded, so a clinical trial is the only legitimate access. Approved GLP-1s such as semaglutide and tirzepatide are the legal options today. Retatrutide isn't expected before 2027.
No. A certificate of analysis is a document the seller provides. It isn't FDA clearance and it doesn't make a product legal for human use. In August 2026 the FDA sent warning letters to five peptide sellers, saying products marketed as research use only were unapproved drugs intended for human use.
No. In April 2026 the FDA took twelve peptides off its highest-risk list, which is not the same as approving them. Compounded drugs aren't reviewed by the FDA for safety or quality, and quality can vary between pharmacies.
Not sure which route fits? See the three ways people get these →
Where you get a peptide decides what's legal. The same compound can be clearly legal, unsettled, or off limits depending on the route.
A doctor prescribes an FDA-approved drug and a regular pharmacy fills it, the way CVS or Walgreens would. This is the route for semaglutide, tirzepatide, and other approved GLP-1s, sometimes with insurance.
None of the six peptides on this tracker are FDA-approved, so this route isn't available for them.
A clinic or telehealth provider evaluates you and prescribes, and a state-licensed compounding pharmacy prepares the medication and mails it to you.
For the six peptides, this route depends on the FDA's list, and they aren't on it yet. The FDA lifted their "significant safety risk" label in April, but it didn't move them to the interim tier where it tolerates compounding. For compounded semaglutide and tirzepatide, FDA guidance allows compounding only when a clinician documents a patient-specific need, not to save money, and the agency is enforcing that.
This is where quality varies most. How to vet a provider →
Sold as lab chemicals with no prescriber and no pharmacy. The "not for human consumption" label is what lets them be sold at all. A certificate of analysis (COA) is a report the seller provides. It isn't FDA clearance, and it doesn't make a product legal for human use.
In letters dated August 24, the FDA told five online peptide sellers that products marketed this way were unapproved new drugs intended for human use. Purity, dose, and sterility are unverified. This site doesn't rank, review, or link to sellers in this channel.
| What differs | 1. Retail pharmacy | 2. Provider + compounding pharmacy | 3. Research use only |
|---|---|---|---|
| Where you'll see it | Your doctor, then a retail pharmacy such as CVS or Walgreens | Telehealth, wellness, and anti-aging clinics, with a partner compounding pharmacy that mails it to you | Online stores selling peptides as lab chemicals |
| Who prescribes | A licensed clinician | A licensed clinician, often after an online intake | No one |
| Who makes it | A drug manufacturer working to FDA standards | A state-licensed compounding pharmacy, or an FDA-registered outsourcing facility | An unregulated supplier |
| FDA review of safety and effectiveness | Yes, before approval | No. Compounded drugs aren't FDA-approved | No |
| Quality checks | FDA-regulated manufacturing and inspections | Varies by pharmacy. State pharmacy boards oversee them | Only a seller-supplied lab report (COA), which isn't a regulator's finding |
| Legal status today | Clearly legal With a prescription | Unsettled Depends on the compound | Not a legal route To human use |
The quality gap between telehealth companies is wide. Check these before you sign up with anyone.
Disclosure: We may earn a referral fee if you sign up through these links, at no cost to you. It doesn't change what we report about FDA status. We aren't affiliated with the FDA, any pharmacy, or any provider's medical practice.
A telehealth clinic. You complete an online intake, a licensed provider reviews it, and any prescription is filled by a partner pharmacy and shipped to you.
Ask before you sign up: which pharmacy fills the prescription, whether a brand-name GLP-1 is an option, and what they can prescribe in your state, since peptide rules are still changing.
Visit Peter MD →A telehealth program that offers brand-name Wegovy, Zepbound, Ozempic, and Mounjaro as well as compounded semaglutide and tirzepatide. Care is delivered through an independent medical group, and it names its dispensing pharmacies.
Ask before you sign up: how the clinician decides between brand-name and compounded, and what the cancellation terms are. It's a newer program, launched in 2026.
Visit Pallas Health →A telehealth program built around compounded semaglutide and tirzepatide, prescribed after an online medical evaluation.
Ask before you sign up: what the clinical basis for compounding is in your case, which pharmacy fills it, and the billing and cancellation terms. Compounded medications aren't FDA-approved.
Visit TrimRx →Six were recommended and one wasn't. Vote counts are from the July 23–24 meeting.
Recommended by the committee (6) Not recommended (1)
| Compound | What it is, and what it's studied for | July vote | Status |
|---|---|---|---|
| BPC-157 | Synthetic peptide modeled on a protein found in gastric juice. FDA reviewed it for ulcerative colitis. Most research is in animals, and FDA reviewers cited limited, underpowered human data. | Recommended 8–6 | Under review |
| KPV | Short fragment of the hormone alpha-MSH. FDA reviewed it for wound healing and inflammatory conditions. Human data is limited. | Recommended 8–6 | Under review |
| TB-500 | Synthetic peptide related to thymosin beta-4. FDA reviewed it for wound healing. Most research is in animals. | Recommended 8–6 | Under review |
| MOTS-c | Peptide encoded in mitochondrial DNA. FDA reviewed it for obesity and osteoporosis. Research is early, mostly in cells and animals. | Recommended 7–5 | Under review |
| Epitalon | Short synthetic peptide studied for aging-related and sleep effects, mostly in small, older studies. | Recommended | Under review |
| Semax | Synthetic peptide developed in Russia and used there for certain neurological conditions. Not approved in the US. | Recommended | Under review |
| Emideltide (DSIP) | Peptide studied for sleep, with weak and inconsistent evidence. | Not recommended 7–6 | Not recommended |
Every step that got us here, in order. We update this whenever something changes.
The most-searched corner of the category, and the one where the rules have moved the most in the last two years.
Medically reviewed by Hara Rosen Berger, DO — double board-certified endocrinologist and Voluntary Assistant Professor of Clinical Medicine, University of Miami Miller School of Medicine. Review covers this GLP-1 section.
| Drug | Approval | Where it stands | Status |
|---|---|---|---|
| Semaglutide Wegovy, Ozempic | FDA-approved | Prescribable today through a licensed provider, with brand-name versions filled at pharmacies. | Approved |
| Tirzepatide Zepbound, Mounjaro | FDA-approved | Prescribable today through a licensed provider, with brand-name versions filled at pharmacies. | Approved |
| Compounded semaglutide and tirzepatide | Not FDA-approved | The shortages that allowed broad compounding have ended. Compounding is now limited to a documented patient-specific need, and the FDA is enforcing against mass-marketed copies. | Narrow exception |
| Retatrutide investigational triple agonist | Not approved | No legal channel. It was never approved, so it can't be compounded, and the only legitimate access is an enrolling clinical trial. | No legal route |
What changed for compounded GLP-1s. The FDA declared the tirzepatide shortage over in December 2024 and the semaglutide shortage over in February 2025, which ended the broad exception for compounding copies. In March 2026 it sent warning letters to 30 telehealth companies over how they market compounded GLP-1s. On August 27, a federal appeals court upheld the FDA's shortage decisions. On September 18, the FDA sent a warning letter to Empower Pharmacy over semaglutide and tirzepatide combinations with B12 or niacinamide, calling them essentially copies of approved drugs. A warning letter states the agency's allegations and isn't a final finding.
What that means for you. A compounded GLP-1 can still be prescribed legally when a clinician documents a specific medical reason you can't use the approved product. Lower price alone isn't a reason under FDA guidance. If a provider only offers compounded versions, ask what the clinical basis is, which pharmacy fills it, and whether a brand-name option is available.
Why retatrutide is different. The FDA states that retatrutide can't be compounded under federal law, and it has issued warning letters to sellers marketing it. Anything sold online as retatrutide comes from an unregulated source. Approval isn't expected before 2027.
Semaglutide and tirzepatide aren't the only approved GLP-1 receptor agonists. Exenatide (Byetta, Bydureon), liraglutide (Victoza, Saxenda), lixisenatide (available as Soliqua), and dulaglutide (Trulicity) are also FDA-approved and legally prescribable. None is part of a live regulatory dispute, so the spotlight here stays on the three above.
Thinking about an approved option? Here's how to vet a provider →
The committee votes, but the FDA decides. Here's the path from here.
On timing, estimates vary a lot. Some industry analysts say FDA action could come this fall, with compliant pharmacy production starting late 2026 or early 2027. Law firms following the process say notice-and-comment rulemaking commonly takes 8 to 12 months and can run past a year. Treat any specific date as a guess.
One short email when the FDA proposes or finalizes anything on peptide compounding, or when the GLP-1 rules change. Nothing else.
Primary sources first. Where we cite law-firm or press coverage, it's linked so you can read it yourself.