U.S. Food and Drug Administration (FDA) Review of Compounded Peptides Including BPC-157 (2026)

In 2026 the U.S. Food and Drug Administration took two linked steps on a group of short synthetic peptides, among them BPC-157, TB-500, MOTs-C, KPV, emideltide (DSIP), Semax and epitalon. By April 2026 these peptides appeared on the U.S. Food and Drug Administration’s compounding-safety page under “bulk drug substances nominated but withdrawn” rather than in the agency’s significant-safety-risk category (“Category 2”). On 23–24 July 2026 the U.S. Food and Drug Administration’s Pharmacy Compounding Advisory Committee then met to discuss whether seven of them belong on the list of ingredients that pharmacies may use to compound drugs. For every one of the seven, the U.S. Food and Drug Administration’s own briefing proposed that it not be placed on that list.

This page reports what the U.S. Food and Drug Administration (FDA) documents say: what the agency did and when, what the compounding terms mean, what the U.S. Food and Drug Administration wrote about each peptide’s risks, what the advisory committee was asked, what the U.S. Food and Drug Administration’s review of BPC-157 found, what these steps do not do, and where matters stood on 14 November 2026, including the committee’s votes (section 7) and the interim policy the U.S. Department of Health and Human Services issued in October 2026 (section 10). The page was first written on 11 October 2026 and updated on 14 November 2026.

Update, 14 November 2026: the committee voted to recommend six of the seven peptides for the list, against the U.S. Food and Drug Administration’s proposals; only emideltide was voted down. On 30 October 2026 the U.S. Department of Health and Human Services (HHS) published an interim policy under which it does not intend to take action against pharmacies and physicians compounding those six peptides, in named forms and routes and under ten conditions, until a final rule decides each one. The policy is described in section 10, on the page U.S. Department of Health and Human Services Interim Policy on Compounding Six Peptides (2026) and in the news article Six Peptides: The HHS Compounding Policy and Its Limits. Each peptide has its own page in the Peptides section.

Table of Contents

  1. What the U.S. Food and Drug Administration Did
  2. Compounding, 503A and the “Bulks List” in Plain Terms
  3. Category 2 and the Peptides That Left It
  4. What the U.S. Food and Drug Administration Wrote About Each Peptide’s Risks
  5. The July 2026 Advisory Committee Meeting
  6. The U.S. Food and Drug Administration’s Proposals: None of the Seven on the List
  7. The Committee’s Votes: Six of Seven Recommended
  8. What the U.S. Food and Drug Administration’s Review of BPC-157 Found
  9. What These Steps Do Not Do
  10. What Happened Next: The October 2026 Interim Policy
  11. Dates and Status as of 14 November 2026
  12. How This Fits the U.S. Food and Drug Administration’s Earlier Compounding Actions
  13. Primary Documents
  14. Key Research Papers
  15. Connections
  16. Featured Videos

1. What the U.S. Food and Drug Administration Did

Two U.S. Food and Drug Administration actions in 2026 concern these peptides:

The U.S. Food and Drug Administration’s briefing documents for the meeting record that the nominations for all seven peptides had been withdrawn by their nominators, and that for each one “U.S. Food and Drug Administration is electing to proceed with the presentation” to the committee anyway. For BPC-157 the briefing explains that the U.S. Food and Drug Administration “is evaluating the substances at its discretion” and “has decided to evaluate both [forms] on its own initiative.”

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2. Compounding, 503A and the “Bulks List” in Plain Terms

Compounding is the preparation of a medicine by a pharmacist or physician, usually for an individual patient, rather than by a drug manufacturer. Compounded drugs are not U.S. Food and Drug Administration-approved. Section 503A of the Federal Food, Drug, and Cosmetic Act sets the conditions under which a licensed pharmacist in a state-licensed pharmacy or federal facility, or a licensed physician, can compound drugs that are exempt from three federal requirements: U.S. Food and Drug Administration approval of a new drug application, labeling with adequate directions for use, and current good manufacturing practice rules. (A separate section, 503B, covers larger “outsourcing facilities.”)

A bulk drug substance is the raw active ingredient, typically a powder, that a compounder turns into a capsule, injection, nasal spray or other dosage form. Under section 503A, the U.S. Food and Drug Administration explains, a compounder may use a bulk drug substance only if it:

  1. meets an applicable United States Pharmacopeia (USP) or National Formulary monograph, where one exists, and the USP chapter on pharmacy compounding; or
  2. where no monograph exists, is a component of a U.S. Food and Drug Administration-approved drug; or
  3. where neither applies, appears on a list the U.S. Food and Drug Administration develops by regulation — the 503A Bulks List.

The peptides discussed here were considered for the third route, the 503A Bulks List. The U.S. Food and Drug Administration’s 503A page adds that bulk drug substances must also come with a valid certificate of analysis and be made by an establishment registered with the U.S. Food and Drug Administration.

The U.S. Food and Drug Administration decides what goes on the list through notice-and-comment rulemaking: it publishes a proposed rule in the Federal Register (the government’s daily journal of agency actions), takes public comment in a numbered docket (a public file of comments and documents), and then issues a final rule. Under a 2019 final rule (84 FR 4696, 19 February 2019) the U.S. Food and Drug Administration weighs four criteria together in a “balancing test”: the substance’s physical and chemical characterization, safety issues, evidence of effectiveness or lack of it, and historical use in compounding.

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3. Category 2 and the Peptides That Left It

While the U.S. Food and Drug Administration works through nominations, an interim policy sorts nominated substances into three categories, as the U.S. Food and Drug Administration’s 503A page describes:

The U.S. Food and Drug Administration’s 503A page also states that, under a revised guidance, the agency “does not intend to place bulk drug substances nominated on or after January 7, 2025, into these categories.”

On the Category 2 page as updated in April 2026, the table of substances “nominated but withdrawn” lists: AOD-9604; BPC-157; cathelicidin LL-37; CJC-1295; dihexa acetate; emideltide (DSIP); epitalon; GHK-Cu (for injectable routes); ipamorelin acetate (which the page notes still appears in Category 2 under the 503B interim policy); KPV; mechano growth factor pegylated (PEG-MGF); melanotan II; MOTs-C; selank acetate (TP-7); Semax (heptapeptide); thymosin alpha-1; and thymosin beta-4 fragment (LKKTETQ), also known as TB-500. The page does not give a date for each withdrawal, so it does not show which of these left Category 2 in 2026 and which left earlier.

Being moved to the withdrawn table did not erase the U.S. Food and Drug Administration’s safety notes: the page keeps a “potential significant safety risks” entry for every substance in that table, summarized in the next section.

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4. What the U.S. Food and Drug Administration Wrote About Each Peptide’s Risks

The Category 2 page’s notes for the seven peptides later taken to the advisory committee read, in summary:

Immunogenicity means the ability of a substance to provoke an immune response, for example antibodies against the peptide. The U.S. Food and Drug Administration’s concern, repeated across these entries, is that peptides can clump together (aggregate) or carry closely related impurities from manufacture, both of which can make an immune reaction more likely.

For some of the other withdrawn peptides the page records more specific findings, for example: for cathelicidin LL-37, “nonclinical research findings suggest detrimental effects on male reproduction” and that it “can be protumorigenic in some tissues”; for melanotan II, “published case reports discuss serious adverse events including melanoma, posterior reversible encephalopathy syndrome, sympathomimetic toxidrome and priapism”; for CJC-1295, “serious adverse events … including increased heart rate and systemic vasodilatory reaction”; and for dihexa acetate and PEG-MGF, no human exposure data at all.

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5. The July 2026 Advisory Committee Meeting

The Pharmacy Compounding Advisory Committee is one of the U.S. Food and Drug Administration’s panels of outside experts. The U.S. Food and Drug Administration calendar page for the meeting explains that advisory committees “make non-binding recommendations to the U.S. Food and Drug Administration, which generally follows the recommendations but is not legally bound to do so.”

The Federal Register notice and the calendar page set out the substances and the uses the U.S. Food and Drug Administration reviewed for each. Each peptide was considered in two forms, the “free base” and the “acetate” salt, which the U.S. Food and Drug Administration treats as different bulk drug substances.

Thursday 23 July 2026

Friday 24 July 2026

The notice opened Docket No. FDA-2025-N-6895 for public comments, which closed on 22 July 2026; comments received by 9 July 2026 were to be given to the committee. An update on the calendar page dated 14 July 2026 extended the meeting’s end times (to 6:20 p.m. Eastern Time on 23 July and 4:15 p.m. on 24 July) and moved the open public hearing sessions. The final agenda lists, for each peptide, an open public hearing, a U.S. Food and Drug Administration presentation, clarifying questions, and a “committee discussion and vote.” The U.S. Food and Drug Administration’s posted questions ask the committee to vote separately, for each free base and each acetate — fourteen votes in all — on whether that substance be placed on the 503A Bulks List.

Before the meeting the U.S. Food and Drug Administration posted an introductory briefing document, a separate briefing document for each of the seven peptides, the questions, the final agenda, the final meeting roster and the U.S. Food and Drug Administration presentations for both days.

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6. The U.S. Food and Drug Administration’s Proposals: None of the Seven on the List

The introductory briefing document’s “Points to Consider” lists fourteen proposals, one per substance and form. Each takes the same form: “U.S. Food and Drug Administration is proposing that [substance] NOT be included on the 503A Bulks List.” The fourteen cover BPC-157, KPV, TB-500, MOTs-C, emideltide, epitalon and Semax, each as free base and as acetate.

The same document explains that the U.S. Food and Drug Administration brought these questions to the committee “to obtain the advisory committee’s advice,” and that “the U.S. Food and Drug Administration does not intend to issue a final determination on the issues at hand until input from the advisory committee process has been considered and all reviews have been finalized. The final determination may be affected by issues not discussed at the advisory committee meeting.”

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7. The Committee’s Votes: Six of Seven Recommended

The committee voted against the U.S. Food and Drug Administration’s proposals for six of the seven peptides. No written minutes, summary or transcript of the meeting had been posted on the U.S. Food and Drug Administration calendar page when it was checked on 14 November 2026 (the page is marked “content current as of 08/06/2026”). The counts below come from the agency’s own webcast of the meeting, whose links the U.S. Food and Drug Administration published in its webcast information document: after each vote the agency’s Designated Federal Officer read the count aloud “for the record.” Each peptide’s two forms, the free base and the acetate, were voted on separately and received the same count both times.

Peptide (each form)YesNoAbstainCommittee result
BPC-157861Recommended
KPV861Recommended
TB-500861Recommended
MOTs-C752Recommended
Emideltide (DSIP)671Not recommended
Epitalon741Recommended
Semax851Recommended

A “yes” vote, as the chair explained before one of the votes, recommended that the U.S. Food and Drug Administration place the substance on the 503A Bulks List. The totals match the U.S. Food and Drug Administration’s final meeting roster, which lists who was eligible to vote on each topic: 15 members for BPC-157, KPV and TB-500; 14 for MOTs-C, emideltide and Semax; and 12 for epitalon. Some news reports gave epitalon’s count as 7–5 with one abstention; with 12 eligible voters that total is impossible, and the webcast records 7–4–1.

The committee therefore agreed with the U.S. Food and Drug Administration’s written proposal only for emideltide. During the meeting an U.S. Food and Drug Administration participant told the committee: “So we made recommendations that you heard today and that were in the memos, but those weren’t final decisions. So the final decisions would come out through rulemaking.” Earlier the same day an agency participant said: “we don’t have a deadline for entering into that rule making.” As section 9 notes, a committee vote is a non-binding recommendation.

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8. What the U.S. Food and Drug Administration’s Review of BPC-157 Found

BPC-157 (from “body protection compound”) is described in the U.S. Food and Drug Administration briefing as a peptide “reported to be comprised of 15 amino acids,” first described in the literature in 1993. It had been nominated in oral capsule, injectable, nasal spray, rectal suppository and other forms, for ulcerative colitis, Crohn’s disease, celiac disease and tendonitis. The U.S. Food and Drug Administration evaluated only ulcerative colitis, stating that the nominations lacked enough information on the other uses and that it found no clinical studies of BPC-157 in those conditions. The U.S. Food and Drug Administration’s findings under each of the four criteria were:

The briefing concludes that “a balancing of the criteria weighs against BPC-157 (free base) and BPC-157 acetate being placed on that list.”

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9. What These Steps Do Not Do

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10. What Happened Next: The October 2026 Interim Policy

On 30 October 2026 the Federal Register published a notice (91 FR 68526–68527, FR Doc. 2026-22192, docket HHS-OASH-2026-0496), signed by the Secretary of Health and Human Services, announcing the availability of a “draft” enforcement-discretion policy; the policy document itself calls it an “interim” policy. It was issued by the Office of the Secretary of the U.S. Department of Health and Human Services rather than by the U.S. Food and Drug Administration. It states that “until a peptide bulk drug substance is addressed in a final rule as being included or not included on the 503A bulks list,” the department “does not intend to take action” against a state-licensed pharmacy, federal facility or licensed physician compounding with one of the six peptides listed in its Appendix A — BPC-157, epitalon, KPV, MOTS-c, Semax and TB-500 — when all ten of its conditions are met. Emideltide, the one peptide the committee voted down, is not on that list.

Each peptide is covered in one form and for named routes only: BPC-157 acetate for injection under the skin or into a muscle, and for oral and topical forms; TB-500 acetate and MOTS-c acetate for injection under the skin or into a muscle; epitalon acetate for the same injections “dispensed in intermittent courses”; KPV acetate for topical and oral forms; and Semax free base for use in the nose. The conditions include an ingredient made by a manufacturer registered with the U.S. Food and Drug Administration and accompanied by a certificate of analysis showing tests for identity, purity, potency and contaminants; one active ingredient per product; reporting of serious adverse events and product-quality problems to the agency’s MedWatch program; the label statement “This is a compounded drug product. Not for resale.”; a 510(k)-cleared syringe as the only device; and a valid patient-specific prescription.

The policy states that compounded drugs “are not FDA-approved,” and the Federal Register notice states that it “does not establish any rights for any person and is not binding on HHS or the public.” It does not place any peptide on the 503A Bulks List. For each of the six, the department’s document records that the U.S. Food and Drug Administration’s drug-review center (the Center for Drug Evaluation and Research) “recommended against listing either form” and that the committee voted in favor. Written comments were accepted until 13 November 2026. The full conditions, the department’s stated reasons and the dates are on the page U.S. Department of Health and Human Services Interim Policy on Compounding Six Peptides (2026).

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11. Dates and Status as of 14 November 2026

Status: open. When checked on 14 November 2026, the U.S. Food and Drug Administration calendar page for the meeting still held no meeting minutes, summary or transcript; the vote counts in section 7 are taken from the agency’s own webcast. The Category 2 page was still marked “content current as of 04/22/2026,” with its table of withdrawn substances and safety notes unchanged, and the agency’s Category 1 list (“Updated May 14, 2026”) included none of the seven peptides. A check of the Federal Register found no U.S. Food and Drug Administration proposed or final rule adding these peptides to, or excluding them from, the 503A Bulks List; the agency’s final determination had not been published. The agency’s categories list states that it intends to consult the committee again “before the end of February 2027” about GHK-Cu. The U.S. Department of Health and Human Services interim policy covers six of the peptides until a final rule addresses each one.

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12. How This Fits the U.S. Food and Drug Administration’s Earlier Compounding Actions

2015: nominations. The U.S. Food and Drug Administration’s 503A page records that the agency solicited nominations for the 503A Bulks List in 2015 and consults the Pharmacy Compounding Advisory Committee and the U.S. Pharmacopeial Convention as it evaluates them. The BPC-157 nominations cited in the 2026 briefing are filed in dockets numbered FDA-2015-N-3534 and FDA-2018-N-2973.

2019: the first list. A final rule in February 2019 placed six substances on the 503A Bulks List, declined to place four others, and set the four evaluation criteria. A proposed rule in September 2019 would place five more on the list and decline 26; the U.S. Food and Drug Administration’s 503A page says the agency will issue a final regulation after considering comments, and will address remaining substances “on a rolling basis through notice-and-comment rulemaking.”

2015–2023: Category 2 additions. The Category 2 page dates its current entries from 2015 to 2023. Several peptides were added on 29 September 2023, among them growth hormone releasing peptides 2 and 6 and ipamorelin acetate (503B) and kisspeptin-10 (503A), each with notes about immunogenicity and peptide impurities similar to those for BPC-157.

2025: no new categorization. Under a revised guidance, substances nominated on or after 7 January 2025 are not placed in Categories 1, 2 or 3.

2026: withdrawal and review. The 2026 steps differ from earlier ones in one respect the briefing documents make explicit: although the nominations had been withdrawn, the U.S. Food and Drug Administration chose to evaluate the seven peptides itself and to bring them before the committee, with a proposal not to list each one. Another 2026 compounding action, on the outsourcing-facility (503B) side, is described on the page about the U.S. Food and Drug Administration proposal on compounded glucagon-like peptide-1 (GLP-1) drugs (see Connections).

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13. Primary Documents

  1. U.S. Food and Drug Administration. Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks (Category 2 page). Content current as of 22 April 2026 — fda.gov Category 2 page
  2. Food and Drug Administration, U.S. Department of Health and Human Services (HHS) (2026). Pharmacy Compounding Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments—Bulk Drug Substances Nominated for Inclusion on the Section 503A Bulk Drug Substances List. Federal Register 91:20465–20467, 16 April 2026. Docket No. FDA-2025-N-6895 — FR Doc. 2026-07361 (official PDF, govinfo.gov)
  3. U.S. Food and Drug Administration. July 23-24, 2026: Meeting of the Pharmacy Compounding Advisory Committee (advisory committee calendar page, checked 11 October 2026) — fda.gov meeting page
  4. U.S. Food and Drug Administration Briefing Document Introduction, Pharmacy Compounding Advisory Committee, 23–24 July 2026 — fda.gov/media/193342
  5. U.S. Food and Drug Administration Briefing Document for BPC-157-Related Bulk Drug Substances (BPC-157 (free base) and BPC-157 acetate), 23–24 July 2026 — fda.gov/media/193343
  6. Pharmacy Compounding Advisory Committee, 23–24 July 2026: Questions — fda.gov/media/193711
  7. Pharmacy Compounding Advisory Committee, 23–24 July 2026: Final Agenda — fda.gov/media/193771
  8. Public docket FDA-2025-N-6895 (meeting comments) — regulations.gov FDA-2025-N-6895
  9. Nomination withdrawal letters, docket FDA-2015-N-3534 (posted April 2026) — FDA-2015-N-3534-0484, FDA-2015-N-3534-0485, FDA-2015-N-3534-0487
  10. U.S. Food and Drug Administration. Bulk Drug Substances Used in Compounding Under Section 503A of the FD&C Act. Content current as of 14 May 2026 — fda.gov 503A bulks page
  11. U.S. Food and Drug Administration. Bulk drug substances nominated for use in compounding under section 503A: categories list. Updated 14 May 2026 — fda.gov/media/94155
  12. Pharmacy Compounding Advisory Committee, 23–24 July 2026: Final Meeting Roster — fda.gov/media/193772
  13. Pharmacy Compounding Advisory Committee, 23–24 July 2026: Webcast Information (links to the agency’s broadcasts of both days, in which each vote count was read for the record) — fda.gov/media/193710
  14. U.S. Food and Drug Administration Briefing Documents, 23–24 July 2026: KPV — fda.gov/media/193346; TB-500 — fda.gov/media/193349; MOTs-C — fda.gov/media/193347; emideltide — fda.gov/media/193344; epitalon — fda.gov/media/193345; Semax — fda.gov/media/193348
  15. Office of the Secretary, U.S. Department of Health and Human Services (2026). Enforcement Discretion Policy Regarding 503A Compounding Using Certain Peptide Bulk Drug Substances. Federal Register 91:68526–68527, 30 October 2026. Docket No. HHS-OASH-2026-0496 — FR Doc. 2026-22192 (official PDF, govinfo.gov)
  16. U.S. Department of Health and Human Services. HHS Enforcement Discretion Policy Regarding 503A Compounding Using Certain Peptide Bulk Drug Substances, with Appendices A and B (re-issued 6 November 2026) — hhs.gov policy PDF
  17. Public docket HHS-OASH-2026-0496 (interim policy comments) — regulations.gov HHS-OASH-2026-0496

The U.S. Food and Drug Administration presentations for 23 and 24 July 2026 are listed under “Event Materials” on the meeting page above. The five warning letters of 24 August 2026 are in the agency’s warning-letter database under reference numbers 733652, 734884, 735063, 735067 and 735127.

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Key Research Papers

  1. Vasireddi N, Hahamyan H, Salata MJ, Karns M, Calcei JG, Voos JE, Apostolakos JM (2025). Emerging Use of BPC-157 in Orthopaedic Sports Medicine: A Systematic Review. HSS Journal 21(4):485-495 — PubMed PMID: 40756949
  2. McGuire FP, Martinez R, Lenz A, Skinner L, Cushman DM (2025). Regeneration or Risk? A Narrative Review of BPC-157 for Musculoskeletal Healing. Current Reviews in Musculoskeletal Medicine 18(12):611-619 — PubMed PMID: 40789979
  3. Lee E, Burgess K (2025). Safety of Intravenous Infusion of BPC157 in Humans: A Pilot Study. Alternative Therapies in Health and Medicine 31(5):20-24 — PubMed PMID: 40131143
  4. Lee E, Padgett B (2021). Intra-Articular Injection of BPC 157 for Multiple Types of Knee Pain. Alternative Therapies in Health and Medicine 27(4):8-13 — PubMed PMID: 34324435
  5. Mayfield CK, Bolia IK, Feingold CL, Lin EH, Liu JN, Rick Hatch GF, Gamradt SC, Weber AE (2026). Injectable Peptide Therapy: A Primer for Orthopaedic and Sports Medicine Physicians. American Journal of Sports Medicine 54(1):223-229 — PubMed PMID: 41476424
  6. Lee C, Zeng J, Drew BG, Sallam T, Martin-Montalvo A, Wan J, Kim SJ, Mehta H, Hevener AL, de Cabo R, Cohen P (2015). The mitochondrial-derived peptide MOTS-c promotes metabolic homeostasis and reduces obesity and insulin resistance. Cell Metabolism 21(3):443-454 — PubMed PMID: 25738459

These papers are background reading on the substances; they are not cited in the U.S. Food and Drug Administration documents above. The MOTs-C paper is a laboratory and animal study.

PubMed Topic Searches

  1. PubMed: BPC-157
  2. PubMed: thymosin beta-4 and wound healing
  3. PubMed: peptide drugs, immunogenicity and impurities
  4. PubMed: pharmacy compounding and bulk drug substances

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Connections

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