Injury Recovery & Tissue Repair
BPC-157 and TB-500 FDA Status
Neither substance was evaluated by FDA for tendon, ligament or post-surgical recovery
BPC-157 and TB-500 are sold into sports medicine and orthopedic settings for tendon, ligament and post-surgical recovery. That is not what FDA was asked to evaluate. Its briefing documents, prepared for the advisory committee meeting of 23 July 2026, record the nominated use for TB-500 as wound healing, and for BPC-157 as ulcerative colitis. We reviewed the current federal record in September 2026. FDA evaluated TB-500 for wound healing and BPC-157 for ulcerative colitis; it did not evaluate either substance for the tendon, ligament or post-surgical uses discussed on this page.
Neither BPC-157 nor TB-500 appears on the 503A Bulks List at 21 CFR 216.23, the 503B Bulk Drug Substances List, or the list of withdrawn substances at 21 CFR 216.24. Neither is currently listed in Category 1, 2 or 3 of FDA’s 503A nominations document (updated 14 May 2026) or its separate 503B nominations document (updated 21 March 2025). That is not the whole history: FDA’s safety-risks page lists both under “bulk drug substances nominated but withdrawn”, stating that these were “previously in category 2 of the interim policies” and “withdrawn by the nominators.” Based on the federal sources reviewed in September 2026, we did not identify an applicable 503A or 503B basis for compounding either substance from bulk under the circumstances reviewed here.
Both were reviewed by the Pharmacy Compounding Advisory Committee (PCAC) on 23 July 2026. FDA’s briefing document for each proposed against inclusion. The meeting was advisory and did not itself amend the 503A Bulks List. As of our September 2026 review, we did not identify a subsequent rulemaking adding either substance to that list.
This page provides regulatory tracking and compliance analysis only, not medical or legal advice.
Why the nominated use matters here more than elsewhere. For the July 2026 review, FDA identified the specific use it was evaluating for each substance. For TB-500 that was wound healing by subcutaneous or intramuscular injection. For BPC-157 it was ulcerative colitis. Tendon repair, ligament injury, post-operative recovery and sports injury were not the questions in front of the agency. The July 2026 proceedings should therefore be described by the uses FDA actually evaluated. They were not reviews of tendon injury, ligament repair, post-operative recovery or sports injury.
Scope. This page addresses federal requirements under the Federal Food, Drug, and Cosmetic Act. State pharmacy law, medical practice acts and prescribing rules apply on top. For the framework this rests on, see how the compounding rules work.
HOW WE SUPPORT CLINICS
Phoenix Meds Regulatory Support Model
Tissue repair sourcing turns on a gap most suppliers never raise: the use FDA reviewed and the use being sold to you are not the same. Our support in this category is built around closing that gap before an order, not after one.
Nominated Use Checked Against Yours
We read what the nomination actually asked for and put it beside what the supplier is selling. For both substances on this page those are different things, and the difference is quotable from FDA’s own documents.
Fragment or Whole Molecule
FDA describes TB-500 as a synthetic N-acetylated seven-amino-acid fragment corresponding to residues 17 through 23 of thymosin beta-4. It is not the full-length thymosin beta-4 protein, and FDA notes that inconsistent naming has complicated characterization of substances sold as TB-500. Literature cited for one is routinely cited for the other. We check which substance a study actually used before it goes in a file.
Both Nominations Documents
FDA publishes separate nomination category documents for sections 503A and 503B, with different contents. We check both. Neither substance here appears in either, and that absence is a finding worth having in writing.
Prescribing Discretion Separated From Sourcing
Broad discretion to prescribe an approved drug off-label is real. It is a different question from what a pharmacy may lawfully compound. In this category the two get treated as one more often than anywhere else on the site.
Pharmacy Partner Checks
For substances with an identified basis, we run credential and documentation checks on pharmacy partners — state-licensed pharmacies compounding under section 503A and FDA-registered 503B outsourcing facilities. Facility registration is not product-specific eligibility, and we check the product separately.
Monitoring
We track both Bulks Lists, both nominations documents, FDA’s safety-risks page, warning letters and Federal Register notices, and re-date this page when something moves.
Regulatory Support Delivered
Clinic Benefits
The work is the same whichever way a finding lands. Knowing what FDA was actually asked is as useful as knowing what it decided.
✓ The Nomination Gap Documented
What each substance was nominated for, quoted from FDA’s briefing document, beside what your supplier is selling it for.
✓ Both Documents Checked
503A and 503B nomination categories are separate documents with different contents. We check both and record the result, including absence.
✓ Fragment Confusion Resolved
Which studies used TB-500 and which used full-length thymosin beta-4, so your file does not rest on the wrong molecule.
✓ Supplier Claims Tested
Where a supplier asserts a statutory basis, we compare that against the primary record and tell you whether it holds.
✓ Documentation Support
Where a clinic is assembling a file for its own counsel, we help put together what the FDA record shows, with dates.
✓ Counsel-Ready Sources
The primary documents assembled and linked, so your attorney reads FDA rather than our summary of FDA.
Tissue Repair & Recovery in Clinical Practice
Tissue repair practitioners work in a distinct domain: the goal is structural recovery from acute injury or post-operative trauma rather than cosmetic optimization. This shapes the evidence framework, the protocol timelines (typically acute, weeks to months), and the outcome metrics clinics use to assess functional recovery and tissue integrity.
Licensed providers in sports medicine, orthopedic surgery, and post-operative care have explored peptide-based approaches based on preclinical research suggesting activity in collagen synthesis, angiogenesis, and extracellular matrix remodeling. Human clinical evidence for these tissue-repair uses remains limited. Clinical decision-making is separate from the federal compounding analysis addressed on this page.
The Two Peptides in This Category
Each checked independently on September 2026 against 21 CFR 216.23, 21 CFR 216.24, the 503B Bulk Drug Substances List, both FDA nominations documents, FDA’s safety-risks page and the July 2026 briefing documents. Nothing below is carried over from the other substance.
TB-500 (Thymosin Beta-4 Fragment)
What it is: an N-acetylated seven-amino-acid synthetic fragment corresponding to residues 17 through 23 of thymosin beta-4. Not the full-length protein, and FDA evaluates the two separately.
What FDA was asked about: wound healing, by subcutaneous or intramuscular injection at 3 mg/mL. Not tendon or ligament repair.
What FDA found. The briefing document is blunt on the human evidence: “The nomination did not include, and FDA did not find any information in the medical literature where TB-500 was administered to patients to treat any disease or condition.” It also records that the substance is not well characterised, and that injectable routes may pose a significant immunogenicity risk.
FDA’s proposal, verbatim: “Accordingly, we propose not adding TB-500 (free base) or TB-500 acetate to the 503A Bulks List.” FDA proposed against inclusion on the 503A Bulks List. The July 23, 2026 advisory committee meeting did not itself amend the list. No rulemaking has followed.
One thing to check in any study: papers cited for TB-500 frequently tested full-length thymosin beta-4. See our comparison of the two peptides.
BPC-157 (Body Protection Compound)
What it is: a 15-residue peptide from human gastric juice, which FDA describes as a pentadecapeptide fragment of Body Protection Compound. Again a partial sequence, not the whole molecule.
What FDA was asked about: ulcerative colitis, across capsules, injections, nasal sprays, suppositories and transdermal cream. Not tissue repair, not post-surgical recovery.
What FDA found. One small trial in ulcerative colitis — roughly 53 subjects randomised, 46 completing, rectal enemas once daily for two weeks. FDA “did not identify any studies that administered BPC-157 via the oral, SC, nasal, or transdermal ROA in subjects with UC.” It also found the substance not well characterised, with an immunogenicity risk noted for parenteral and nasal routes.
FDA’s proposal: against including either the free base or the acetate on the 503A Bulks List. FDA proposed against inclusion on the 503A Bulks List. The July 23, 2026 advisory committee meeting did not itself amend the list.
BPC-157 also appears in our gut health and inflammation category, where the context matches what FDA actually reviewed.
STATUS SUMMARY
Regulatory Status Compared
Updated September 2026. Every source below changes without notice; please verify before relying on any row.
| Question | BPC-157 | TB-500 |
|---|---|---|
| FDA-approved US drug product | None identified | None identified |
| Applicable USP or NF monograph | None identified | None identified |
| Component of an FDA-approved drug product | None identified | None identified |
| 503A Bulks List (21 CFR 216.23) | Not listed | Not listed |
| 503B Bulk Drug Substances List | Not listed | Not listed |
| 21 CFR 216.24 — blocks compounding regardless of the rows above | Not listed | Not listed |
| 503A nominations document (14 May 2026) | Does not appear | Does not appear |
| 503B nominations document (21 Mar 2025) | Does not appear | Does not appear |
| Nominated use FDA evaluated | Ulcerative colitis | Wound healing, SC/IM, 3 mg/mL |
| Human data FDA identified | One trial, 53 subjects, rectal enema, two weeks | None — no record of administration to patients for any condition |
| PCAC 23 July 2026 | Briefing document proposed against inclusion; meeting advisory | Briefing document proposed against inclusion; meeting advisory |
| FDA’s stated concerns | Not well characterized; immunogenicity risk noted for parenteral and nasal routes | Not well characterized; immunogenicity risk noted for injectable routes |
| Our finding | No applicable 503A or 503B basis identified | No applicable 503A or 503B basis identified |
Reading the nomination rows correctly.
Neither substance is currently listed in Category 1, 2 or 3. That should not be read as FDA never having evaluated or categorised either one. FDA’s safety-risks page records both as previously in Category 2, with the nominations subsequently withdrawn by the nominators, and FDA separately took both to the advisory committee in July 2026. Current absence from the category documents is not an adverse placement and it is not a favourable one; it is a different thing from either.
The Current Research Landscape
The preclinical literature on both peptides is genuine and peer-reviewed, covering collagen synthesis, angiogenesis and extracellular matrix remodeling in animal models. That work exists and we are not disputing it.
The human record is a different matter, and FDA’s own briefing documents set it out. For TB-500 the agency found no information in the medical literature of the substance being administered to patients for any condition. For BPC-157 it identified one small trial in ulcerative colitis, 53 subjects, rectal enema, two weeks — a route and an indication that have nothing to do with tissue repair.
ClinicalTrials.gov currently lists NCT07437547, a recruiting Phase 2 study of BPC-157 in acute hamstring strain. No study results are posted. A registered or ongoing trial does not establish safety or effectiveness and does not alter the federal compounding analysis described on this page, so the design details, enrollment and current status are not confirmed as of this date. Verify the record directly rather than relying on this summary. What does not change either way: a trial in progress does not alter what a pharmacy may lawfully compound today. In our September 2026 review, we did not identify a completed randomized controlled trial establishing a tissue-repair indication for either substance.
What follows from that, stated plainly and without inference: safety profiles in humans for tissue repair applications are not established, effective dosing ranges for repair endpoints are not clinically established, and candidate populations, contraindications and outcome measures are not clinically defined. None of the above is a recommendation to use these compounds.
CATEGORY-SPECIFIC RISK
Two Questions Specific to This Category
Prescribing discretion is not sourcing eligibility
Off-label prescribing authority does not itself create a federal compounding pathway for a bulk drug substance. Prescribing authority and compounding eligibility are separate questions. The two questions are commonly, and incorrectly, treated as one.
This category produces the confusion more than any other, because the clinical setting is one where off-label judgement is routine and defensible. Clinical prescribing considerations and pharmacy compounding eligibility are separate questions, and a determination about one does not establish the other. A clinical decision does not by itself establish that the applicable federal compounding requirements have been satisfied.
A combination inherits every component's position
Some protocols combine BPC-157 and TB-500 on the reasoning that they act on different parts of the repair process. Whether administered separately or blended, the regulatory analysis runs one bulk substance at a time. FDA does not evaluate a blend under a trade name, and no determination attaches to one.
So combining two substances does not by itself establish a compounding basis for either component. Each substance is checked on its own, then the preparation is checked as a preparation — the prescription, the compounder’s standing, the labelling and the quality requirements all apply to the thing actually being made.
Regulatory Checks Before Relying on a Supplier Claim
The regulatory file should identify the section being relied on, the facility’s status, and the product-specific basis claimed for the preparation. A facility registration, pharmacy license or Certificate of Analysis does not by itself establish that a particular bulk substance qualifies for compounding.
On research-use material: Research Use Only or Not for Human Use labeling does not by itself determine how FDA treats a product. Under 21 CFR 201.128, intended use is established by the circumstances surrounding an article’s distribution — website content, promotional statements, how the product is described to buyers, and distribution practices, alongside the label. In a warning letter dated 17 June 2026 to a distributor in Brooksville, Florida, FDA concluded that two products were unapproved new drugs on the evidence of the firm’s own marketing, notwithstanding how they were labelled. That letter concerned those products and that firm; the principle it illustrates is general. Phoenix Meds does not treat RUO labeling as a basis for concluding that a product may lawfully be supplied or used.
Answers that should stop the conversation: that the July 2026 committee vote authorizes compounding; that removal from a list means clearance; that a 503B registration number settles product eligibility; that a certificate of analysis establishes a statutory basis; or that a study on thymosin beta-4 is a study on TB-500.
Regulatory Position and Phoenix Meds Coordination Policy
For BPC-157 and TB-500, singly or combined, we have not identified a currently applicable statutory pathway under Section 503A or Section 503B based on the FDA record reviewed. Each bulk drug substance must independently satisfy the applicable statutory requirements.
Accordingly, Phoenix Meds does not represent these peptides as having an established pharmacy-compounding pathway where the applicable federal criteria have not been satisfied. Our sourcing coordination is limited to pathways supported by the applicable statutory and regulatory requirements.
For BPC-157 and TB-500, our support focuses on regulatory tracking, review of FDA proceedings and nomination materials, and preparation of compliance documentation for your legal counsel or other qualified regulatory professional to assess.
Our approach in this category is compliance-first.
Phoenix Meds works with licensed pharmacy partners where an appropriate federal compounding pathway is established. For BPC-157 and TB-500, our role is limited to documenting the current regulatory record and identifying what that record does and does not establish. We do not represent a pharmacy-compounding pathway where we have not identified an applicable federal basis. We review supplier representations against the primary FDA record, including applicable Bulks List status, FDA proceedings, and supporting regulatory documentation. Where a supplier relies on the July 2026 proceedings, we distinguish the committee’s consideration of a substance from actual FDA authorization or inclusion on the applicable Bulks List.
This allows clinics to understand exactly what is being represented, what documentation supports the claim, and where regulatory questions remain before relying on a proposed sourcing pathway. If FDA subsequently changes the applicable Bulks List, completes a relevant rulemaking, or otherwise changes the regulatory status of these substances, we will update this page and re-date it.
Verify This Yourself
The regulatory and factual statements above are based on these public FDA sources (checked in September 2026)
FDA briefing document — BPC-157 — the nominated use, the single human trial identified, the characterisation and immunogenicity findings, and FDA’s proposal. Prepared for the 23 July 2026 meeting.
FDA briefing document — TB-500 — the nominated use quoted on this page, the finding that no administration to patients was identified, and FDA’s proposal in its own words.
21 CFR 216.23 — the 503A Bulks List as codified, plus the paragraph naming substances that may not be used. Neither peptide appears in either.
21 CFR 216.24 — drug products withdrawn or removed for safety or effectiveness reasons. Neither peptide appears.
FDA — 503B Bulk Drug Substances List — the substances outsourcing facilities may use. Neither peptide appears.
FDA — bulk drug substances nominated under section 503A — the 503A categories document, updated 14 May 2026. Neither peptide appears in Category 1, 2 or 3.
FDA — certain bulk drug substances that may present significant safety risks — carries the separate list of substances “nominated but withdrawn”, which includes BPC-157 and Thymosin beta-4 fragment (LKKTETQ), also known as TB-500. Content current 22 April 2026 when checked.
FDA — bulk drug substances nominated under section 503B — the separate 503B categories document, updated 21 March 2025. Neither peptide appears.
FDA — PCAC meeting, 23–24 July 2026 — agenda, roster, questions and both days’ presentations. FDA has published no minutes, transcript or vote record.
21 CFR 201.128 — how intended use is established from the circumstances surrounding distribution.
ClinicalTrials.gov — NCT07437547 — the BPC-157 hamstring strain study. We could not retrieve this record on 2 September 2026; check it directly.
Related Clinic Resources
FDA Regulatory Status & Compounding Considerations
The statutory framework behind every page on this site, with 503A and 503B kept separate.
BPC-157 vs TB-500 for Clinics
The two substances compared, including what each nomination actually asked for.
Gut Health & Inflammation
BPC-157 in the context of the indication it was actually nominated for, alongside KPV.
Skin, Hair & Aesthetic
GHK-Cu by route, and why a blend’s trade name carries no FDA determination.
Immune Support & Healthy Aging
Thymosin Alpha-1 and Epitalon, and why foreign approval reaches neither.
Storage and Handling of Lyophilized Peptides
Maintaining integrity from arrival through reconstitution.
Medical Supply Chain
How the coordination arrangement works end to end, and what documentation sits behind it.
Choosing a Supplier
The questions worth asking, and the answers that should end the conversation.
Disclaimer and regulatory scope:
This page is regulatory information for licensed clinics, compiled from public FDA materials. It is not medical or legal advice, and not a determination that any product or preparation is lawful.
On the federal sources reviewed in September 2026 we did not identify a 503A or 503B basis permitting BPC-157 or TB-500, singly or combined, to be compounded from bulk. That is our finding on those sources at that time, not a legal conclusion.
State pharmacy law and medical practice acts apply on top. For how 503A and 503B differ and what the bulks lists are, see our Legal & Regulatory Status Overview. Work with counsel in your state.
Phoenix Meds Inc. is not a pharmacy, clinic, prescriber or medical provider, and we do not dispense. We coordinate sourcing between licensed clinics and licensed pharmacies. The pharmacy or outsourcing facility prepares, dispenses and ships; any clinical decision rests with the prescriber. Last reviewed: September 2026.