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# Is TB-500 Legal? What the 2026 HHS Policy Says

TB-500 acetate by injection is one of six peptides HHS now lets 503A pharmacies compound with a prescription. What qualifies, and what we offer instead.

URL: https://peptides.build/legal/tb-500/

Legal status · Updated after the HHS policy

# Is TB-500 legal? Yes, by prescription. Here is what we offer.

Updated October 29, 2026 · Sourced to HHS and the Federal Register

## 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.

![Wolverine Peptide Stack prescription vial](/media/products/wolverine-stack.webp)

 US-supervised · all 50 states

[Wolverine Peptide Stack](https://peptides.build/protocols/wolverine-stack/)Blend: outside the HHS policy

**$183**/mo*$1,099 billed every 6 months*

-   🇺🇸 Prescribed by a licensed US provider
-   🇺🇸 Made by a licensed US 503A pharmacy
-   Arrives pre-mixed and labeled
-   HealthProtect verified

Pay over time at checkout![Klarna](/media/payments/klarna.png)![Afterpay](/media/payments/afterpay.png)![Affirm](/media/payments/affirm.png)

Prescription required. Your provider decides if it is appropriate. Compounded medications are not FDA-approved.

What counts

## 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.

TB-500 under the HHS policy of October 28, 2026
| 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 |

What we offer

## 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.

TB-500 options at Peptides.build, USD, October 29, 2026
| Option | Status | From |  |
| --- | --- | --- | --- |
| [TB-500 alone](https://peptides.build/news/hhs-peptide-policy/) | Covered | Not offered here |  |
| [BPC-157](https://peptides.build/legal/bpc-157/) | Covered | $158/mo |  |
| [Wolverine Stack (BPC-157 + TB-500)](https://peptides.build/protocols/wolverine-stack/) | Blend: outside policy | $183/mo |  |

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.

Four steps

## How does a prescription work online?

1.  **Online intake.** About five minutes: your health history and goals.
2.  **Provider review.** A licensed US provider decides whether a protocol is appropriate for you and, if so, writes a patient-specific prescription.
3.  **Pharmacy compounding.** A licensed US 503A pharmacy compounds it and mixes it for you.
4.  **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](https://peptides.build/news/hhs-peptide-policy/), see the [BPC-157 legal status](https://peptides.build/legal/bpc-157/), or every peptide on the [legal status page](https://peptides.build/legal/peptides/).

Price

## What do the closest options cost?

BPC-157 and Wolverine Stack at Peptides.build, USD, October 29, 2026
| Protocol | Monthly | 3 months | 6 months |  |
| --- | --- | --- | --- | --- |
| [BPC-157](https://peptides.build/protocols/bpc-157/) | $163 | $499 | $949 |  |
| [Wolverine Stack](https://peptides.build/protocols/wolverine-stack/) | $225 | $599 | $1,099 |  |

Includes the provider review, compounding by a licensed 503A pharmacy and cold-chain shipping. No membership fee. Compare every protocol on the [pricing page](https://peptides.build/pricing/).

Why Peptides.build

## Prescribed by a provider. Made by a pharmacy. Verified.

**Prescribed**A licensed US provider reviews your intake and prescribes only if it is appropriate. Physician oversight by Arora Health & Aesthetics, LLC.

**Pharmacy-made**A licensed US 503A pharmacy compounds it for you and ships it directly, cold-chain. Nothing is mixed by us, and nothing is mixed by you.

**Verified**Peptides.build is a HealthProtect verified telehealth brand. Check the public register entry yourself.

Common questions

## 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.

Prescribed, not mixed at home

## 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.

-   [BPC-157: plans, who it is for, FAQ](https://peptides.build/protocols/bpc-157/)
-   [Wolverine Stack: plans, who it is for, FAQ](https://peptides.build/protocols/wolverine-stack/)
-   [Every protocol price, side by side](https://peptides.build/pricing/)
-   [Our pharmacies and provider](https://peptides.build/pharmacy-providers/)
-   By state: [California](https://peptides.build/states/california/) · [Florida](https://peptides.build/states/florida/) · [Texas](https://peptides.build/states/texas/) · [Nevada](https://peptides.build/states/nevada/) · [Maryland](https://peptides.build/states/maryland/)

Sources

## Where these facts come from

1.  [HHS 503A peptide enforcement-discretion policy, Appendices A and B](https://www.hhs.gov/sites/default/files/hhs-503a-peptide-enforcement-discretion-policy-appendix-b.pdf)
2.  [Federal Register notice, FR Doc 2026-22192](https://public-inspection.federalregister.gov/2026-22192.pdf)
3.  [FDA: bulk drug substances used in compounding under section 503A](https://www.fda.gov/drugs/human-drug-compounding/bulk-drug-substances-used-compounding-under-section-503a-fdc-act)
4.  [Our full explainer of the HHS policy](https://peptides.build/news/hhs-peptide-policy/)

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.