On Oct 28, 2026, HHS released an interim policy saying it generally won't take enforcement action against state-licensed pharmacies, federal facilities, or licensed physicians that compound BPC-157, KPV, TB-500, MOTS-c, Epitalon, or Semax under set conditions, including a patient-specific prescription. It isn't an approval, none of the six is on the FDA's compounding list, and HHS can change course. The FDA's own reviewers had recommended against all seven peptides its advisory committee considered.
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.
It's an enforcement-discretion policy, not a change in the law and not an FDA approval. HHS says it generally won't take action against state-licensed pharmacies, federal facilities, or licensed physicians that compound BPC-157, KPV, TB-500, MOTS-c, Epitalon, or Semax, as long as conditions are met. They include a valid patient-specific prescription, single-ingredient products with no blends, bulk ingredient from an FDA-registered manufacturer with a certificate of analysis, adverse-event reporting, and limits on the forms each peptide can take. HHS says it can revisit the policy, and state rules still apply. It covers pharmacy compounding, not products sold as research use only.
Not formally, but the picture just shifted. BPC-157 isn't FDA-approved and isn't on the list that authorizes pharmacies to compound it. Since Oct 28, HHS says it generally won't take enforcement action against pharmacies and physicians that compound it under set conditions, including a patient-specific prescription. FDA reviewers said the human safety data is limited. Ask any provider exactly what they're dispensing, which pharmacy fills it, and where the ingredient comes from.
Nothing final on its own. The committee advised the FDA to add six of the seven peptides it reviewed to the compounding list, several by narrow margins, and FDA staff had recommended against all seven. The FDA still has to propose a rule, take public comment, and issue a final rule. In October, HHS issued an interim policy covering the same six peptides while that process plays out.
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 a compounded preparation where the rules allow it, which now includes the six peptides under HHS's interim policy, subject to its conditions and your state's rules. 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. Eli Lilly says it plans to submit an application in the first quarter of 2027, and a standard FDA review usually takes 10 to 12 months, so approval is unlikely before late 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. HHS's October policy covers pharmacy compounding under a prescription, not these sellers.
No. In April 2026 the FDA took twelve peptides off its highest-risk list, and in October HHS said it won't penalize pharmacies for compounding six peptides. Neither is an approval or a safety finding. FDA reviewers said human safety data on these peptides is limited, and compounded drugs aren't reviewed by the FDA for safety or quality, which 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 changed on Oct 28. They still aren't FDA-approved or on the FDA's compounding list, but HHS now says it generally won't take enforcement action against pharmacies and physicians that compound them under set conditions, including a patient-specific prescription. It's an interim policy that HHS can revisit, and state rules still apply. 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. HHS's October policy doesn't change that: it covers pharmacy compounding, not these sellers. 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 Interim HHS relief for six peptides | 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. The six are also the peptides covered by HHS's Oct 28 interim policy.
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 | HHS interim policy |
| KPV | Short fragment of the hormone alpha-MSH. FDA reviewed it for wound healing and inflammatory conditions. Human data is limited. | Recommended 8–6 | HHS interim policy |
| TB-500 | Synthetic peptide related to thymosin beta-4. FDA reviewed it for wound healing. Most research is in animals. | Recommended 8–6 | HHS interim policy |
| 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 | HHS interim policy |
| Epitalon | Short synthetic peptide studied for aging-related and sleep effects, mostly in small, older studies. | Recommended | HHS interim policy |
| Semax | Synthetic peptide developed in Russia and used there for certain neurological conditions. Not approved in the US. | Recommended | HHS interim policy |
| Emideltide (DSIP) | Peptide studied for sleep, with weak and inconsistent evidence. | Not recommended 7–6 | Not recommended Not covered by the HHS policy |
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. On February 20, 2026 it sent warning letters to 30 telehealth companies over how they market compounded GLP-1s, announced in March, and on June 16 it sent 25 more. 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. Eli Lilly says it plans to submit an application in the first quarter of 2027, and a standard FDA review usually takes 10 to 12 months, so approval is unlikely before late 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 →
HHS has issued a stopgap. The FDA's formal process is still ahead. Here's the path from here.
On timing, estimates vary a lot. Pharmacies don't have to wait for a final rule to rely on the HHS policy, but state boards and individual pharmacies decide whether and when to offer these, so availability will be uneven. Law firms following the formal 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.