FDA Review of Compounded Peptides Including BPC-157 (2026)

Table of Contents

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

1. What the FDA Did

Two FDA actions in 2026 concern these peptides:

• The Category 2 page changed. The FDA web page “Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks,” marked “content current as of 04/22/2026,” lists BPC-157 and a number of other peptides in a table headed “Bulk drug substances nominated but withdrawn,” described as substances “previously in category 2 of the interim policies” that “were withdrawn by the nominators.” Withdrawal letters from the nominators appear in the FDA’s public nominations docket, FDA-2015-N-3534, as documents posted in April 2026 (FDA-2015-N-3534-0484 and -0485 on 14 April 2026, and -0487 on 29 April 2026, according to the docket records on regulations.gov).
• An advisory committee meeting was called. A Federal Register notice published on 16 April 2026 (91 FR 20465–20467, FR Doc. 2026-07361, Docket No. FDA-2025-N-6895) announced a meeting of the Pharmacy Compounding Advisory Committee for 23 and 24 July 2026 at the FDA’s White Oak campus in Silver Spring, Maryland, with online participation. The meeting would discuss seven groups of peptides “being considered for inclusion on the 503A Bulks List.”

The FDA’s briefing documents for the meeting record that the nominations for all seven peptides had been withdrawn by their nominators, and that for each one “FDA is electing to proceed with the presentation” to the committee anyway. For BPC-157 the briefing explains that the FDA “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 FDA-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: FDA 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 FDA 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 an FDA-approved drug; or
3. where neither applies, appears on a list the FDA develops by regulation — the 503A Bulks List.

The peptides discussed here were considered for the third route, the 503A Bulks List. The FDA’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 FDA.

The FDA 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 FDA 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 FDA works through nominations, an interim policy sorts nominated substances into three categories, as the FDA’s 503A page describes:

• Category 1 — nominated with enough supporting information to evaluate; the FDA does not intend to take action against compounders using them, provided the guidance’s conditions are met, until it decides on listing.
• Category 2 — nominated with enough information to evaluate, but the FDA “has identified significant safety risks relating to the use of these substances in compounding.” The FDA “would consider taking action against a compounder” using them under its general enforcement policies.
• Category 3 — nominated with insufficient information to evaluate; they can be re-nominated with more information and are not covered by the Category 1 policy.

The FDA’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 FDA’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 FDA 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:

• BPC-157: compounded drugs containing it “may pose risk for immunogenicity for certain routes of administration” and “may have complexities with regard to peptide-related impurities and active pharmaceutical ingredient (API) characterization.” The FDA “has identified no, or only limited, safety-related information for the proposed routes of administration,” so it “lacks sufficient information to know whether the drug would cause harm when administered to humans.”
• TB-500 (thymosin beta-4 fragment): possible immunogenicity from aggregation and peptide-related impurities; the FDA “has not identified any human exposure data.”
• KPV: the FDA “has not identified any human exposure data on drug products containing KPV administered via any route of administration.”
• MOTs-C: possible significant immunogenicity risk and characterization complexities; no human exposure data identified.
• Emideltide (DSIP): possible immunogenicity and characterization complexities; no safety-related information identified for the proposed route.
• Epitalon: possible immunogenicity from aggregation and peptide-related impurities; no safety-related information identified for the proposed route.
• Semax: possible immunogenicity; “no, or limited, safety-related information for proposed routes of administration.”

Immunogenicity means the ability of a substance to provoke an immune response, for example antibodies against the peptide. The FDA’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 FDA’s panels of outside experts. The FDA calendar page for the meeting explains that advisory committees “make non-binding recommendations to the FDA, 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 FDA reviewed for each. Each peptide was considered in two forms, the “free base” and the “acetate” salt, which the FDA treats as different bulk drug substances.

Thursday 23 July 2026

• BPC-157 — ulcerative colitis
• KPV — wound healing and inflammatory conditions
• TB-500 — wound healing
• MOTs-C — obesity and osteoporosis

Friday 24 July 2026

• Emideltide (delta sleep-inducing peptide, DSIP) — opioid withdrawal, chronic insomnia and narcolepsy
• Epitalon — insomnia
• Semax — cerebral ischemia (reduced blood flow to the brain), migraine and trigeminal neuralgia

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, an FDA presentation, clarifying questions, and a “committee discussion and vote.” The FDA’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 FDA 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 FDA presentations for both days.

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6. The FDA’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: “FDA 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 FDA brought these questions to the committee “to obtain the advisory committee’s advice,” and that “the FDA 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. What the FDA’s Review of BPC-157 Found

BPC-157 (from “body protection compound”) is described in the FDA 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 FDA 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 FDA’s findings under each of the four criteria were:

• Characterization. Both the free base and the acetate are “considered not well-characterized,” because of inconsistent naming and because data establishing identity, purity and quality (such as tests for peptide-related impurities, aggregates, bacterial endotoxins and microbial contamination) were missing or inadequate. The FDA notes it “would have strong concerns” about a compounded nasal spray because nothing was provided about the container and pump, and is “concerned about the potential for immunogenicity” in injectable forms.
• Effectiveness. The FDA found a single meeting abstract of a randomized, placebo-controlled trial in 53 people with mild-to-moderate ulcerative colitis given a BPC-157 enema or placebo daily for two weeks. It judged the data “inadequate to support the efficacy and safety” of that treatment, found no studies of oral, injected, nasal or skin-applied BPC-157 in ulcerative colitis, and concluded: “There is a lack of evidence to support the effectiveness of BPC-157 … as a treatment for UC.” It notes that the American College of Gastroenterology and American Gastroenterological Association guidelines on ulcerative colitis do not mention BPC-157, and that several FDA-approved drugs treat the condition.
• Safety. The FDA found “insufficient clinical safety information to characterize the safety profile.” Two human studies gave BPC-157 as a rectal enema for at most two weeks; no serious adverse events were reported, but the authors gave limited safety information. There were no human pharmacokinetic data (how the body absorbs and clears the drug) for oral, injected, nasal or skin routes. A search of the FDA Adverse Event Reporting System through 4 December 2025 found three reports, all with injectable BPC-157, describing an injection-site reaction, shortness of breath, and diffuse darkening of the skin and gums; the FDA states it is unclear whether BPC-157 caused them. In animal studies, rats showed protective effects on gut and liver injury, but dose-response relationships, molecular targets and mechanism of action had not been established.
• Historical use. “There is no approved product containing BPC-157-related BDSs in any country at this time,” and it is not in the European, Japanese or International Pharmacopeias. Data on its past use in compounding were “too limited” for the FDA to assess.

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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8. What These Steps Do Not Do

• Leaving Category 2 is not an approval. The withdrawn table on the Category 2 page keeps the FDA’s safety notes. Moving out of Category 2 does not place a peptide on the 503A Bulks List, and under section 503A a substance without a monograph or an approved-drug component needs to be on that list to be eligible for compounding.
• None of these peptides is an FDA-approved drug. The FDA’s BPC-157 briefing states that no product containing it is approved in any country.
• An advisory committee vote is advice, not a decision. The FDA calls committee recommendations “non-binding,” and adding or refusing a substance on the 503A Bulks List is done by rulemaking published in the Federal Register.
• The meeting covered seven peptides, not all of them. Other withdrawn peptides on the Category 2 page, such as AOD-9604, CJC-1295, GHK-Cu, LL-37, melanotan II, selank and thymosin alpha-1, were not on the July 2026 agenda.
• The review covered named uses only. Each peptide was evaluated for the specific conditions listed in section 5; the FDA notes that, if listed, a substance’s inclusion “may not be limited to a specific use.”

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9. Dates and Status as of 11 October 2026

• April 2026: withdrawal letters posted to nominations docket FDA-2015-N-3534; the Category 2 page updated (“content current as of 04/22/2026”) with the peptides in the withdrawn table.
• 16 April 2026: meeting notice published, 91 FR 20465, Docket No. FDA-2025-N-6895.
• 9 July 2026: last day for comments to be forwarded to the committee.
• 14 July 2026: meeting times updated on the FDA calendar page.
• 22 July 2026: comment docket closed.
• 23–24 July 2026: committee meeting held, with FDA presentations posted for both days.

Status: open. When the FDA calendar page for the meeting was checked on 11 October 2026, its “Event Materials” list held the briefing documents, webcast information, questions, final agenda, final roster and FDA presentations, but no meeting minutes, summary or record of the committee’s votes. Vote counts reported elsewhere are therefore not given on this page. A check of the Federal Register for FDA documents from 2026 mentioning section 503A or bulk drug substances found no proposed or final rule adding these peptides to, or excluding them from, the 503A Bulks List. As of that date, the FDA’s final determination on the seven peptides had not been published.

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10. How This Fits the FDA’s Earlier Compounding Actions

2015: nominations. The FDA’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 FDA’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 FDA 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 FDA proposal on compounded GLP-1 drugs (see Connections).

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11. 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, 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. FDA Briefing Document Introduction, Pharmacy Compounding Advisory Committee, 23–24 July 2026 — fda.gov/media/193342
5. FDA 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

The FDA also posted separate briefing documents for KPV, TB-500, MOTs-C, emideltide, epitalon and Semax, and FDA presentations for 23 and 24 July 2026, all listed under “Event Materials” on the meeting page above.

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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 FDA 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

• FDA and Regulation
• FDA Proposal on Compounded Semaglutide and Tirzepatide (2026)
• FDA Public Meeting on What Counts as a Dietary Ingredient (2026)
• 7-OH Kratom Products: The 2026 Scheduling Steps
• FDA Reopens the DSHEA Innovation Door
• Longevity Protocols
• Gut Healing: Benefits
• Collagen
• Ulcerative Colitis
• Obesity
• Insomnia
• Narcolepsy
• Trigeminal Neuralgia

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