Is TB-500 legal? Yes, by prescription. Here is what we offer.
The short answer
Yes, with a prescription, in one form. Since October 28, 2026, HHS says it will not take enforcement action against licensed 503A pharmacies and physicians that compound TB-500 acetate for injection for a patient with a prescription, if ten conditions are met. It is not FDA approval. TB-500 alone is not offered here. Peptides.build offers single-ingredient BPC-157, which the policy also covers, from $158/mo, and the Wolverine Stack (BPC-157 + TB-500), a blend outside the policy, from $183/mo.
Which kind of TB-500 is legal?
The policy is narrow. It names one form of TB-500, one route and one device. Everything else, including the popular blends with BPC-157, is outside it.
| What you get | Status | Why |
|---|---|---|
| Prescribed, single-ingredient TB-500 acetate from a licensed 503A pharmacy | Covered by the HHS policy | Injection (SC or IM) |
| TB-500 blended with BPC-157 or other peptides | Outside the policy | The policy covers one active ingredient only |
| Oral or nasal TB-500, or a different salt form | Outside the policy | Only the acetate form, by injection, is listed |
| Pre-filled pens and auto-injectors | Outside the policy | The only covered device is an FDA 510(k)-cleared syringe |
| "Research use only" vials sold online | Not for human use | No prescription, no licensed pharmacy, no adverse-event reporting |
Want a product inside the policy? Single-ingredient BPC-157, prescribed and pharmacy-mixed.
Can I get TB-500 here?
Not on its own. TB-500 is covered by the policy, but a single-ingredient TB-500 protocol is not offered here. These are the closest live options, with their status stated plainly.
| Option | Status | From | |
|---|---|---|---|
| TB-500 alone | Covered | Not offered here | |
| BPC-157 | Covered | $158/mo | Start |
| Wolverine Stack (BPC-157 + TB-500) | Blend: outside policy | $183/mo | Start |
The Wolverine Stack combines BPC-157 and TB-500 in one vial. Because it has two active ingredients, it is not covered by the HHS policy. It is still prescribed when a licensed provider decides it is appropriate after reviewing your intake, and compounded by a licensed 503A pharmacy. Pick single-ingredient BPC-157 if you want a product inside the policy.
How does a prescription work online?
- Online intake. About five minutes: your health history and goals.
- Provider review. A licensed US provider decides whether a protocol is appropriate for you and, if so, writes a patient-specific prescription.
- Pharmacy compounding. A licensed US 503A pharmacy compounds it and mixes it for you.
- Delivered ready to draw. Shipped cold-chain to your door, already reconstituted and labeled with the concentration.
The policy is interim: it lasts until FDA rulemaking decides each peptide's permanent status, and HHS can withdraw it. Read the ten conditions in our HHS peptide policy explainer, see the BPC-157 legal status, or every peptide on the legal status page.
What do the closest options cost?
| Protocol | Monthly | 3 months | 6 months | |
|---|---|---|---|---|
| BPC-157 | $163 | $499 | $949 | Start |
| Wolverine Stack | $225 | $599 | $1,099 | Start |
Includes the provider review, compounding by a licensed 503A pharmacy and cold-chain shipping. No membership fee. Compare every protocol on the pricing page.
Prescribed by a provider. Made by a pharmacy. Verified.
Ready? The intake takes about five minutes. A licensed US provider decides what is appropriate.
FAQ
Is TB-500 legal in the US?
Prescribed TB-500 acetate for injection, compounded by a licensed 503A pharmacy, falls under the HHS enforcement-discretion policy of October 28, 2026, if its ten conditions are met. It is still not FDA-approved, and research-use-only TB-500 is still not sold for human use.
Is TB-500 FDA-approved?
No. Compounded medications are not FDA-approved, and the HHS policy says it does not establish safety or effectiveness.
Can I get TB-500 prescribed at Peptides.build?
Not on its own. TB-500 alone is not offered here. It is one of the two ingredients of the Wolverine Stack, which is a blend and therefore outside the HHS policy. Single-ingredient BPC-157, which the policy covers, is offered.
Is the BPC-157 and TB-500 stack legal?
The stack is outside the HHS policy because the policy covers one active ingredient per product. Peptides.build still offers the Wolverine Stack when a licensed provider prescribes it after an intake, compounded by a licensed 503A pharmacy.
Is it legal to buy TB-500 online without a prescription?
Vials sold as "research use only" are labeled not for human use. They come with no prescription, no licensed pharmacy and no adverse-event reporting, and the policy does not cover them.
Are TB-500 peptides safe?
Their safety has not been established by FDA. FDA's drug center recommended against listing TB-500, citing limited human data, and much of the research is preclinical. A licensed provider reviews your health history before deciding whether any protocol is appropriate.
Is TB-500 allowed in sport?
No. TB-500 is on the World Anti-Doping Agency prohibited list.
Can state law still restrict TB-500?
Yes. State pharmacy and medical boards can set their own rules. The federal policy does not override them.
Tired of reconstituting?
A licensed US provider reviews a short online intake. If a prescription is appropriate, a licensed US 503A pharmacy fills it and ships it cold-chain, already reconstituted and labeled with the concentration.
This page is educational and is not medical advice. Compounded medications are not FDA-approved. No results are implied or guaranteed. A licensed provider decides whether any protocol is appropriate for you, and sets any dose.