In short
- As of October 26, 2026, neither BPC-157 nor TB-500 is FDA-approved, and a licensed pharmacy may not compound either one.
- In its July 2026 briefing documents, the FDA’s review team proposed not adding either peptide to the 503A compounding list. The advisory committee voted 8 to 6 to recommend each one, according to law-firm reports, and the FDA has not acted.
- The FDA found 5 small clinical studies that used BPC-157, none by injection under the skin, and no studies of TB-500 in people at all.
- TB-500 is a 7-amino-acid fragment of thymosin beta-4, a 43-amino-acid protein. The FDA says the two are not the same substance. BPC-157 is a 15-amino-acid peptide.
- Both are banned in sport at all times under WADA’s 2026 Prohibited List: BPC-157 by name in class S0, TB-500 by name in class S2.
BPC-157 and TB-500 are the two peptides most often sold together online for injuries, tendons and recovery, sometimes as the “Wolverine stack.” Their legal status is the same: as of October 26, 2026, neither is FDA-approved, and a licensed pharmacy may not compound either one. Where they differ is in what they are and how much is known about them in people. The FDA’s own review, published for its July 2026 advisory committee meeting, found a handful of small human studies for BPC-157 and none for TB-500. This guide compares the two on status and evidence only. It doesn’t point to any seller, because there is no lawful source for either.
BPC-157 vs TB-500 side by side
| BPC-157 | TB-500 | |
|---|---|---|
| What it is | 15-amino-acid fragment of a protein first found in human gastric juice | 7-amino-acid synthetic fragment of thymosin beta-4 |
| FDA-approved? | No | No |
| Approved anywhere? | No approved product in any country, per the FDA | None in the EU, the UK, Canada, Australia and 7 other countries the FDA checked |
| Can a 503A pharmacy compound it? | No | No |
| FDA category, Oct 26, 2026 | None: nomination withdrawn, moved off Category 2 in April 2026 | None: nomination withdrawn, moved off Category 2 in April 2026 |
| Use the FDA reviewed in July 2026 | Ulcerative colitis | Wound healing |
| FDA review team’s proposal | Don’t add it to the 503A list | Don’t add it to the 503A list |
| Advisory committee vote (reported) | 8 to 6 in favor, 1 abstention | 8 to 6 in favor, 1 abstention |
| Human studies the FDA found | 5 small studies | None |
| Reports in FDA’s adverse event database | 3, all with injected products (through Dec 4, 2025) | None (through Mar 26, 2025) |
| Controlled substance? | No | No |
| WADA 2026 | Banned at all times (S0) | Banned at all times (S2) |
Sources: the FDA’s BPC-157 and TB-500 briefing documents, its categories list, the DEA list and the WADA 2026 list.
What each one is
BPC-157 is a lab-made chain of 15 amino acids. The FDA describes it as a fragment of a larger protein originally isolated from human gastric juice, first described in the scientific literature in 1993. Online it is marketed as an oral capsule, oral spray, nasal spray and injection, for uses from gut problems to injuries.
TB-500 is a lab-made chain of 7 amino acids, matching positions 17 to 23 of thymosin beta-4, a 43-amino-acid protein found throughout the body. The FDA traces its first synthesis to 2003 and notes that a veterinary preparation appeared in 2011, marketed to boost performance in horse and greyhound racing. Many sellers call TB-500 “synthetic thymosin beta-4.” The FDA’s briefing document says plainly that “thymosin beta-4 and TB-500 are not the same substance,” so research on the full protein doesn’t tell you about TB-500.
Where they stand with the FDA
Both peptides followed the same path in 2026.
- April 2026. After the groups that nominated them withdrew their nominations, the FDA moved both off Category 2, its list of substances that raise significant safety risks, onto a list of substances “nominated but withdrawn” (FDA). That left them in no category, which isn’t a path to compounding.
- July 23, 2026. The FDA’s Pharmacy Compounding Advisory Committee considered BPC-157 for ulcerative colitis and TB-500 for wound healing (FDA). The FDA’s review team proposed adding neither. According to law-firm reports, the committee voted 8 to 6 with 1 abstention to recommend each one (McDermott). The FDA has not posted minutes or an official vote record.
- Since then. As of October 26, 2026, the FDA has published no proposed rule to add either peptide to the 503A bulks list, and its categories list is still the version updated May 14, 2026.
Under section 503A, a pharmacy may compound from a bulk ingredient only if it has a USP or National Formulary monograph, is a component of an FDA-approved drug, or is on the FDA’s bulks list (FDA interim policy). BPC-157 and TB-500 meet none of these tests. Our BPC-157 guide explains what a final rule would and wouldn’t change, and are peptides legal in 2026 covers the other five peptides the committee reviewed.
What human evidence exists
BPC-157: five small studies
The FDA searched the medical literature and found five clinical studies that used BPC-157 in people:
- A rectal enema in 24 healthy volunteers.
- A rectal enema in people with ulcerative colitis: a trial of 53 people split between BPC-157 and placebo, reported only as a meeting abstract.
- Injection into the knee joint in 17 people with knee pain.
- Injection into the bladder wall in 12 people with interstitial cystitis.
- An IV infusion in 2 healthy volunteers.
The FDA’s verdict on these studies: they “were of short duration, had small sample sizes, evaluated doses that were likely exploratory in nature,” and gave limited safety information. On the ulcerative colitis abstract, the only controlled trial of the use it reviewed, the FDA said the data “are therefore inadequate to support the efficacy and safety of BPC-157” for that use.
None of the five studies gave BPC-157 by mouth, under the skin or as a nasal spray, the ways it is sold online, and the FDA found no human data on how the body absorbs or clears it by those routes. A phase 1 trial of BPC-157 tablets registered in Mexico has posted no results, and the FDA could find no published study from it.
TB-500: none found
For TB-500 the FDA found nothing in people. Its briefing document says the nomination “did not include, and FDA has not identified, any clinical studies or human exposure data using TB-500” by any route. None of the three references the nominator cited studied TB-500 in people. The FDA’s conclusion: “potential safety risks associated with the use of these substances in humans are unknown.”
What the FDA says about safety
For both peptides, the FDA’s main concern is that it doesn’t have the information to judge. On its safety page it says, for BPC-157, that it “lacks sufficient information to know whether the drug would cause harm when administered to humans,” and for TB-500, that it “has not identified any human exposure data” on drug products containing it.
The briefing documents add three specific concerns for both:
- Immune reactions. Peptides can trigger an immune response, with outcomes the FDA says range from no symptoms to life-threatening reactions. It says injection under the skin generally carries more of this risk than other routes.
- Clumping and impurities. Peptides can aggregate, and leftovers from manufacturing can carry over into the product, both of which can raise the immune risk.
- Poor characterization. The FDA found that neither peptide is well characterized: names are inconsistent, and the data needed to confirm identity, purity and microbial quality were missing or inadequate.
The FDA’s adverse event database had 3 reports for BPC-157 through December 4, 2025, all for injected products. One described redness and swelling at the injection site, one shortness of breath that led to an emergency room visit, and one, involving a BPC-157 and TB-500 blend labeled for research, darkening of the skin and gums that came back when the person restarted the product. The FDA says it is unclear whether these effects were caused by BPC-157 (the blend held two peptides, and the other reports had limited detail or a second injected product), and that compounders under 503A generally don’t report adverse events to the FDA, so the database may not capture them. For TB-500 alone, the search found no reports through March 26, 2025.
Banned in sport
Both peptides are on WADA’s 2026 Prohibited List, in force from January 1, 2026, and prohibited in and out of competition (WADA). BPC-157 is named in class S0, which covers substances with “no current approval by any governmental regulatory health authority for human therapeutic use.” TB-500 is named in class S2, among growth factors, as a derivative of thymosin beta-4. Athletes in tested sport can’t use either one.
Research vials are not a lawful source
Both peptides are widely sold online in vials labeled for laboratory research only. The FDA has called these unapproved new drugs: in June 2023 it sent a warning letter to a seller of injectable BPC-157 and TB-500 labeled this way (FDA). Buying them for personal use is unsafe and unregulated. No prescriber decides whether it suits you, no licensed pharmacy answers for what is in the vial, and no one has checked its identity, strength or sterility. A blend of the two adds a second unknown to the first. Our guide on whether peptides are safe covers how to spot the warning signs.
If a website offers you a prescription for compounded BPC-157 or TB-500 today, it is offering something a licensed pharmacy may not lawfully make. For the peptides a pharmacy may compound, see the peptides hub.
The bottom line
BPC-157 and TB-500 share a legal status: not FDA-approved, not legal to compound, banned in sport and sold online only as unregulated research vials. They differ on evidence. BPC-157 has five small, short human studies that the FDA judged inadequate, and TB-500 has none the FDA could find. The July 2026 advisory votes are recommendations the FDA hasn’t acted on, and its own reviewers proposed against both. We’ll update this page when the FDA publishes a decision.
Questions, answered
Is BPC-157 or TB-500 legal in 2026?
Is TB-500 the same as thymosin beta-4?
Are BPC-157 and TB-500 banned in sports?
Is it safe to take BPC-157 and TB-500 together?
Sources
- FDA briefing document: BPC-157-related bulk drug substances, Pharmacy Compounding Advisory Committee (July 23-24, 2026)
- FDA briefing document: TB-500-related bulk drug substances, Pharmacy Compounding Advisory Committee (July 23-24, 2026)
- FDA: July 23-24, 2026 meeting of the Pharmacy Compounding Advisory Committee (content current Aug 6, 2026)
- McDermott Will & Schulte: PCAC backs majority of peptides in two-day public meeting (Jul 27, 2026)
- FDA: Certain bulk drug substances for use in compounding that may present significant safety risks (content current Apr 22, 2026)
- FDA: Bulk drug substances nominated for use in compounding under section 503A (categories list, updated May 14, 2026)
- FDA: Interim policy on compounding using bulk drug substances under section 503A (Jan 2025)
- FDA warning letter on BPC-157 and TB-500 sold for research (Jun 12, 2023)
- WADA: 2026 Prohibited List (in force Jan 1, 2026)
- DEA: Controlled substances, alphabetical order (Oct 21, 2026)