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BPC-157 vs TB-500

Neither BPC-157 nor TB-500 can be legally compounded or sold as a drug in the US, because neither is in FDA's Category 1 or on the 503A bulks list [1], and we found no FDA-approved drug that contains either.

Updated By the Wellchosen Health editorial team

Both got the same nonbinding 8 to 6 vote, with 1 abstention, from an FDA advisory committee on July 23, 2026, and FDA has not acted [2] [5]. The real difference is evidence: FDA found five small human studies of BPC-157 [3], and no study in which TB-500 was given to people [4].

BPC-157 is a lab-made peptide also called Body Protection Compound 157, and TB-500 is a synthetic seven-amino-acid fragment of the protein thymosin beta-4; both are sold online for healing claims without FDA approval [3] [4].

At a glance

Human studies FDA found
5 vs 0BPC-157 five small studies [3]; TB-500 none [4]
Sports (WADA)
Both bannedBPC-157 class S0, TB-500 class S2 [7]
Legal price
NoneNo legal product exists for either [1]

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Quick answer

On the law, BPC-157 and TB-500 are in the same place: no pharmacy may compound either, and a prescription does not change that, because the limit is on the ingredient [1]. On evidence, BPC-157 is ahead only in a narrow sense. It has a handful of small human studies, none a completed, fully published randomized trial [3]. TB-500 has none [4]. The two are often sold together as a "Wolverine" stack, which Healthline notes "isn't approved by the FDA and hasn't been tested in humans for safety or effectiveness" [15].

An opened shipping box with a foam liner and cold packs on a kitchen counter

Side by side

BPC-157 vs TB-500, checked Oct 25, 2026
BPC-157TB-500
What it isPeptide also called Body Protection Compound 157 or PL 14736 [3]Synthetic seven-amino-acid fragment of thymosin beta-4 (amino acids 17 to 23) [4]
FDA-approved productNone foundNone found
Legal to compoundNo [1]No [1]
July 23, 2026 committee vote8-6-1 in favor, for ulcerative colitis; nonbinding [2] [10]8-6-1 in favor, for wound healing; nonbinding [2] [10]
FDA staff viewRecommended against listing [3]Recommended against listing [4]
Human evidence5 small studies plus 1 registered trial with no posted results [3]No study in which it was given to people [4]
Main risks FDA namedPossible immune reactions; clotting and liver signals in animal studies; no cancer studies [3]Possible immune reactions; up to 1.0% unidentified impurities; no cancer studies [4]
Sports (WADA)Banned at all times, class S0 [7]Banned at all times, class S2 [7]
How to get it legallyNo legal route [1]No legal route [1]
PriceNo legal price [1]No legal price [1]
Status is checked against FDA's 503A categories document through our peptide status file. A favorable committee vote does not make either peptide legal; FDA must still act [6].

FDA removed both from Category 2, its significant-safety-risk list, in April 2026 after the nominators withdrew, and a pharmacy law firm wrote that this removal "does not render these bulk drug substances eligible for compounding" [9]. On July 23, 2026, the Pharmacy Compounding Advisory Committee voted 8 yes, 6 no and 1 abstain on each [2]. FDA staff had recommended against both [3] [4]. To make either legal, FDA must write a rule, place it in Category 1 or announce enforcement discretion, and one law firm says there is no reliable timetable [6].

In mid-October 2026, HHS sent an interim peptide access policy to the White House budget office for review; its text is not public [5]. The AP, citing two unnamed people, reported it is meant to let pharmacies temporarily compound some popular peptides, including BPC-157 [11]. We could not confirm whether TB-500 is covered. On Oct 16, 2026, the Partnership for Safe Medicines petitioned FDA not to allow compounding of seven peptides, TB-500 among them [12].

Legal status of BPC-157

Waiting on FDA after a favorable vote

BPC-157 won a favorable but nonbinding advisory committee vote in July 2026, and FDA has not acted on it [5]. It still cannot be legally compounded or sold as a drug [1].

FDA status
FDA removed it from Category 2 in April 2026 because the nominators withdrew their nominations [17]. That removal did not make it legal to compound [9]. FDA now lists it as "nominated but withdrawn," which is outside every category [18]. It is not in Category 1 and is not on the 503A bulks list, so a 503A pharmacy may not lawfully compound it today [1]. FDA's briefing says there is not enough clinical safety information to describe its safety profile, and no carcinogenicity studies are available [3].
Advisory committee
On July 23, 2026, the committee voted 8 yes, 6 no and 1 abstain to recommend adding BPC-157 to the 503A bulks list [2] [19]. The committee reviewed it for ulcerative colitis [10]. FDA staff had recommended against listing it [3]. FDA has not posted its own vote count on the meeting page [10]. Advisory committee votes are not binding. Nothing changes until FDA acts [6].
FDA-approved products
None. We found no FDA-approved drug that contains BPC-157.
Sports (WADA)
Prohibited at all times under class S0 (non-approved substances). BPC-157 is named as an example [7].
What happens next
To add it to the 503A bulks list, FDA must go through notice-and-comment rulemaking, starting with a proposed rule. FDA could also place it in Category 1 or announce enforcement discretion in the meantime [6]. As of Oct 16, 2026, FDA had not started rulemaking or moved any of these peptides to Category 1 [5]. HHS has sent an "Interim Access Policy for Compounding Using Certain Peptides" to the White House budget office for review. Holland & Knight dates that submission Oct 14, 2026 [5], while the AP reported it appeared on a government website on Oct 15 [11]. The policy has not been issued and its text is not public [5]. The AP, citing two unnamed people familiar with the plan, reported that it is meant to let pharmacies temporarily compound some of the most popular peptides, including BPC-157 [11]. Holland & Knight says the details are unknown [5]. One law firm says there is no reliable timetable for final action [6].

Checked against FDA sources on . We update this box when FDA acts. Report a change: [email protected].

Legal status of TB-500

Waiting on FDA after a favorable vote

TB-500 won a favorable but nonbinding advisory committee vote in July 2026, and FDA has not acted on it [5]. It still cannot be legally compounded or sold as a drug [1].

FDA status
FDA removed it from Category 2 in April 2026 because the nominators withdrew their nominations [17]. That removal did not make it legal to compound [9]. FDA now lists it as "nominated but withdrawn," which is outside every category [18]. It is not in Category 1 and is not on the 503A bulks list, so a 503A pharmacy may not lawfully compound it today [1]. FDA found no clinical studies, no human drug level data and no published case reports for TB-500 [4].
Advisory committee
On July 23, 2026, the committee voted 8 yes, 6 no and 1 abstain to recommend adding TB-500 to the 503A bulks list [2]. The committee reviewed it for wound healing [10]. FDA staff had recommended against listing it [4]. FDA has not posted its own vote count on the meeting page [10]. Advisory committee votes are not binding. Nothing changes until FDA acts [6].
FDA-approved products
None. We found no FDA-approved drug that contains TB-500.
Sports (WADA)
Prohibited at all times under class S2 (growth factors). The list names thymosin beta-4 and its derivatives, such as TB-500 [7].
What happens next
To add it to the 503A bulks list, FDA must go through notice-and-comment rulemaking, starting with a proposed rule. FDA could also place it in Category 1 or announce enforcement discretion in the meantime [6]. As of Oct 16, 2026, FDA had not started rulemaking or moved any of these peptides to Category 1 [5]. HHS has sent an "Interim Access Policy for Compounding Using Certain Peptides" to the White House budget office for review. Holland & Knight dates that submission Oct 14, 2026 [5], while the AP reported it appeared on a government website on Oct 15 [11]. The policy has not been issued and its text is not public [5]; reporting on Oct 21, 2026 still described it as under review [21]. Reports say it would cover some popular peptides, but we could not confirm whether TB-500 is one of them [11]. One law firm says there is no reliable timetable for final action [6]. A drug safety group petitioned FDA on Oct 16, 2026 not to allow it [12].

Checked against FDA sources on . We update this box when FDA acts. Report a change: [email protected].

What the research has and has not shown

BPC-157

FDA's May 2026 briefing found five clinical studies: a rectal enema study in 24 healthy volunteers, an ulcerative colitis enema trial with 53 people reported only as a 2005 meeting abstract, knee injections in 17 people, bladder instillation in 12 people and an IV infusion in 2 people, plus one registered Phase 1 trial with no posted results [3]. FDA concluded: "There is insufficient clinical safety information to characterize the safety profile of BPC-157" [3]. A 2025 orthopedic review counted 35 preclinical studies and 1 clinical study [8]. Full detail: BPC-157 legal status and evidence.

TB-500

FDA staff wrote that "no articles were found in which TB-500 was administered to humans," and found no human studies of how it is absorbed or cleared [4]. In one lab study, TB-500 itself "appeared to be devoid of wound-healing properties," while one of its breakdown products showed some activity in the lab [4]. FDA also notes TB-500 is a common name, not an official drug name, and different salts are sold under it [4]. Studies of the full thymosin beta-4 protein are not studies of TB-500. Full detail: TB-500 legal status and evidence.

What this means for healing claims

Claims that either peptide heals tendons, joints, muscle or the gut come mostly from animal and lab work [8] [4]. No completed, fully published randomized human trial supports them in the sources FDA reviewed [3] [4].

Known risks

  • Immune reactions (both): FDA wrote that BPC-157 "may pose a significant risk for immunogenicity," possibly more so with under-the-skin or nasal use [3], and raised the same concern for injected TB-500 [4].
  • BPC-157 animal findings: In 28-day studies in rats and dogs, FDA saw changes in blood clotting measures and liver-related signals [3].
  • Cancer questions: No carcinogenicity studies exist for either [3] [4]. A 2025 review argued BPC-157's effect on blood vessel growth could be risky if cancer is present but undiagnosed [16].
  • TB-500 purity: Impurities in TB-500 acetate can reach 1.0%, with no information on what they are [4].
  • Sports: Both are banned at all times by WADA [7].

If you have used either one

Tell your doctor what you used and where it came from, and mention it before any surgery, since FDA noted clotting signals for BPC-157 in animals [3]. Hives, swelling of the face, lips or throat, or trouble breathing after an injection is an emergency. Call 911.

There is no legal price for either peptide, because no legal product exists [1]. Vials labeled "research use only" are not a legal route; FDA rejected that label in a 2025 warning letter [13]. In April 2026, a federal grand jury in Utah indicted a physician on charges tied to misbranded drugs from China, including BPC-157 and TB-500, given to more than 200 patients; those are allegations, and he is presumed innocent [14]. Telehealth menus that list these peptides are covered in our FrontCare review and PeRx review; we rate both Avoid. More enforcement: FDA warning letters.

If you were looking at either one for an injury or a gut condition, a doctor can go over FDA-approved treatments for the diagnosis. For peptides that can be prescribed legally, see the legal peptide price tracker and tesamorelin. Four-peptide blends are covered on our KLOW page, and every peptide's status is on the peptide FDA status tracker.

How we check

Legal status comes from FDA's 503A categories document and safety-risk page, through our peptide status file, rechecked for news on Oct 25, 2026. Evidence comes from FDA's own briefing documents for the July 2026 meeting. FDA has not posted minutes for that meeting, so vote counts come from law firm reports [2]. We do not link to sellers. Our method: editorial standards.

Questions people ask

What is the difference between BPC-157 and TB-500?

BPC-157 is a peptide called Body Protection Compound 157 [3]; TB-500 is a synthetic seven-amino-acid fragment of thymosin beta-4 [4]. Neither can be legally compounded [1]. FDA found five small human studies of BPC-157 [3] and none of TB-500 [4].

Is BPC-157 or TB-500 legal?

Neither, as of Oct 25, 2026. Neither is in FDA's Category 1 or on the 503A bulks list, so a pharmacy may not compound them [1]. We found no FDA-approved drug that contains either. The July 23, 2026 committee votes of 8-6-1 in favor are nonbinding [2] [6].

Which has more evidence, BPC-157 or TB-500?

BPC-157, but only slightly. FDA found five small human studies, the largest a 53-person trial reported only as a 2005 abstract [3]. For TB-500, FDA found no article in which it was given to people [4].

Are BPC-157 and TB-500 safe?

No regulator has found either safe. FDA said there is not enough clinical safety information to describe BPC-157's safety profile [3], found no human safety data for TB-500 [4], and flagged possible immune reactions for both [3] [4].

Can I take BPC-157 and TB-500 together?

There is no legal product of either to combine, and no human study has tested the pair. Healthline notes the "Wolverine" stack "isn't approved by the FDA and hasn't been tested in humans for safety or effectiveness" [15]. We do not give stacking or dosing advice.

Are BPC-157 and TB-500 banned in sports?

Yes. The 2026 WADA Prohibited List bans BPC-157 under class S0 and TB-500 under class S2, both at all times [7].

Medical review: pending. A licensed clinician has not yet reviewed this page.

Sources

21 cited
  1. Bulk drug substances nominated for use in compounding under section 503A (categories document). FDA, May 14, 2026.
  2. Bulk list bound: PCAC backs majority of peptides in two-day public meeting. McDermott Will & Emery, Jul 27, 2026.
  3. PCAC briefing document: BPC-157. FDA, May 11, 2026.
  4. PCAC briefing document: TB-500. FDA, May 15, 2026.
  5. Peptides at a crossroads: what wellness providers need to know. Holland & Knight, Oct 16, 2026.
  6. FDA voted yes on six peptides. Now what? The regulatory road ahead. Buchanan Ingersoll & Rooney, Aug 18, 2026.
  7. 2026 Prohibited List. World Anti-Doping Agency (copy hosted by Asia Rugby), Sep 2025.
  8. Systematic review of BPC-157 in orthopedic and sports medicine (PMID 40756949). HSS Journal (Vasireddi et al.), Jul 31, 2025.
  9. FDA peptides do-not-compound list update (2026). Frier Levitt, Apr 16, 2026.
  10. July 23-24, 2026 Meeting of the Pharmacy Compounding Advisory Committee. FDA, Jul 23, 2026.
  11. AP report on FDA interim peptide compounding policy. STAT / Associated Press, Oct 15, 2026.
  12. PSM files citizen petition with FDA to stop unsafe compounding of untested peptides. Partnership for Safe Medicines, Oct 21, 2026.
  13. Warning letter: USApeptide.com. FDA, Feb 26, 2025.
  14. Utah licensed osteopathic physician indicted for allegedly receiving misbranded drugs from China. U.S. Attorney's Office, District of Utah, Apr 2026.
  15. Wolverine peptides (BPC-157 and TB-500). Healthline, Oct 14, 2026.
  16. Literature and patent review of BPC 157. Pharmaceuticals (Jozwiak et al.), Jan 30, 2025.
  17. FDA Announces Removal of 12 Peptides from Category 2 and Schedules PCAC Meetings. Orrick, Apr 16, 2026.
  18. Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks. FDA, Apr 22, 2026.
  19. FDA advisory committee backs two controversial peptides. RAPS Regulatory Focus, Jul 23, 2026.
  20. 503A categories update, September 2023. FDA (hosted by Alliance for Pharmacy Compounding), Sep 29, 2023.
  21. RFK Jr. calls for regulated peptide marketplace. C101 (iHeartMedia), Oct 21, 2026.

This page is general information, not medical advice. Talk with a licensed clinician about your own care.

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