FDA Panel to Evaluate 7 Popular Peptides for Compounding Substances List

The FDA Pharmacy Compounding Advisory Committee (PCAC) will convene July 23 and July 24, 2026, at the agency's White Oak campus in Silver Spring, Maryland, to review 7 bulk drug substances that pharmacies have compounded into injectable, nasal spray, oral, and topical products for years without them ever appearing on FDA's official list of approved 503A bulk drug substances.¹

The substances—BPC-157, KPV, TB-500, and MOTS-c, which will be reviewed on July 23, and emideltide (also known as DSIP), epitalon, and Semax, reviewed on July 24—have circulated for years through wellness clinics, medical spas, and online retailers, marketed for uses ranging from wound healing and weight loss to antiaging and sleep.

In briefing documents posted ahead of the meeting, FDA reviewers concluded that none of the 7 substances should be added to the section 503A Bulks List, a regulatory list that allows pharmacists and physicians to compound drug products from bulk substances that lack an approved drug application or applicable United States Pharmacopeia (USP) monograph.² The advisory committee's recommendations are nonbinding, but FDA generally follows them.

Why These 7 Substances Are Being Reviewed

Under section 503A of the Federal Food, Drug, and Cosmetic Act, a compounded human drug product is exempt from new drug approval, labeling, and current good manufacturing practice requirements only if, among other conditions, the bulk drug substance used complies with a USP or National Formulary monograph, is a component of an FDA-approved drug, or appears on the 503A Bulks List. None of the 7 substances under review meets any of those criteria, and FDA is evaluating all of them on its own initiative after the original nominations—submitted years ago by Wells Pharmacy Network and LDT Health Solutions on behalf of the International Peptide Society—were withdrawn by the nominators.³

If the committee agrees with the FDA’s proposal, compounders would continue to lack a clear regulatory pathway for these substances, a fact that has done little to slow their marketing. The FDA's review found the peptides being sold through integrative medicine clinics, concierge practices, med spas, and online retailers frequently without clarity on whether products are compounded, dietary supplements, or labeled "research use only."⁴

A Common Set of Concerns Across All 7 Substances

Reviewers applied the same 4-part balancing test to each substance: physical and chemical characterization, historical use in compounding, evidence of effectiveness, and safety.³ Nearly every substance shared the same underlying problems.

Naming and characterization.

For all 7 substances, nominators submitted inconsistent or contradictory information about whether they were nominating the free base or the acetate salt form—chemically distinct substances with different solubility, stability, and potentially different safety and efficacy profiles.³ The FDA noted that common names like "BPC-157" or "Semax" are not United States Adopted Names and have been applied inconsistently across suppliers, creating a risk that patients could be dosed with a different substance than intended.

Thin or absent effectiveness data.

For several substances—KPV, TB-500, and MOTS-c—the FDA found no human clinical studies at all supporting the proposed uses.^5-7 For BPC-157, reviewers identified a single small trial, presented only as a decades-old meeting abstract, evaluating ulcerative colitis, and no studies used the oral, subcutaneous, nasal, or transdermal routes actually proposed by compounders.⁸ For emideltide, published trials on chronic insomnia reached contradictory conclusions, with some researchers reporting improved sleep and others, using similar designs, finding no benefit over placebo.⁹ For Semax, the only relevant human data were 2 small, uncontrolled studies that found the peptide did not meaningfully resolve pain in patients with migraine or trigeminal neuralgia.¹⁰

Immunogenicity and manufacturing gaps.

Because most of these substances are peptides intended for injection or nasal administration, the FDA repeatedly flagged concerns about immunogenicity—the potential for the body to mount an immune response to the peptide or manufacturing impurities and aggregates. Few of the certificates of analysis submitted included testing for impurities, aggregates, or bacterial endotoxins, information the FDA considers critical for injectable products.

Existing approved alternatives.

For every condition evaluated—including ulcerative colitis, wound healing, obesity, osteoporosis, insomnia, narcolepsy, opioid withdrawal, migraine, and cerebral ischemia—the FDA pointed to multiple existing FDA-approved therapies with established safety and efficacy profiles.

Substance-Specific Red Flags

Beyond the shared concerns, several substances drew additional scrutiny unique to their pharmacology.

BPC-157, evaluated for ulcerative colitis, drew the FDA attention over 3 FDA Adverse Event Reporting System (FAERS) case reports tied to compounded injectable products, including a patient who developed shortness of breath and another who developed diffuse hyperpigmentation and gingival darkening after using a blended BPC-157/TB-500 product labeled "research purposes only."⁸

Epitalon, proposed for insomnia, raised the most distinctive safety concern of the 7, which included nonclinical data showing the peptide activates telomerase and lengthens telomeres in human cells. Researchers have proposed this explains antiaging and tumor-suppressing effects seen in some mouse studies, but the FDA noted that longer telomeres are also associated with increased cancer risk, and that available studies were far too short and narrow in scope to characterize epitalon's carcinogenic potential.¹¹ Separately, the FDA noted epitalon received an orphan drug designation for retinitis pigmentosa in 2010 that was later withdrawn.

Semax, evaluated for cerebral ischemia, migraine, and trigeminal neuralgia, prompted the FDA to flag a possible bleeding risk based on nonclinical evidence of anticoagulant and antithrombotic activity, along with a finding that the peptide potentiated amphetamine-induced dopamine release in mice—a response the FDA noted is typically associated with drugs of abuse.¹⁰ A 2025 FAERS report described a consumer hospitalized with persistent eye pain after using an intranasal Semax product purchased online.

MOTS-c, nominated for insulin resistance, obesity, osteoporosis, and related metabolic uses, is listed as a prohibited substance in the World Anti-Doping Agency's Global Drug Reference Online database, and FDA found no evidence that any outsourcing facility has ever compounded it.⁷

TB-500, evaluated for wound healing, is also on WADA's prohibited list. An in vitro study the FDA identified found the intact peptide did not actually promote wound closure in cultured fibroblasts, though a breakdown metabolite did show modest activity.⁶

Emideltide (DSIP) had the deepest human-study history of the group, dating to 1981, but the FDA said the trials were small, poorly controlled, and inconsistent and noted a theoretical concern that emideltide's mechanism—stimulating endorphin release—could carry addictive potential similar to that of other reward-pathway stimulants.⁹

Public Comment and Next Steps

The FDA has opened a public docket for comment on the meeting, closing July 22, 2026. Comments submitted by July 9, 2026, will be provided directly to the committee. Later submissions will still be considered by the FDA before any final determination. Oral public comment is scheduled throughout both meeting days, and the public may participate in person or via webcast.¹

For pharmacists currently compounding products containing any of these 7 peptides, the meeting's outcome could shape whether such products remain legally compoundable under section 503A, though FDA has emphasized it will not issue a final determination until it has reviewed the committee's input.¹

REFERENCES

1. July 23-24, 2026: Meeting of the Pharmacy Compounding Advisory Committee - 07/23/2026. Advisory Committee Calendar. FDA. Accessed July 6, 2026. https://www.fda.gov/advisory-committees/advisory-committee-calendar/july-23-24-2026-meeting-pharmacy-compounding-advisory-committee-07232026

2. FDA Briefing Document Introduction. Pharmacy Compounding Advisory Committee Meeting. FDA. Accessed July 6, 2026. https://www.fda.gov/media/193342/download

3. FDA Briefing Document Introduction. Pharmacy Compounding Advisory Committee Meeting. FDA. Accessed July 6, 2026. https://www.fda.gov/media/193342/download

4. FDA Evaluation of BPC-157-Related Bulk Drug Substances. Pharmacy Compounding Advisory Committee Meeting. FDA. Accessed July 6, 2026. https://www.fda.gov/media/193343/download

5. FDA Evaluation of KPV-Related Bulk Drug Substances. Pharmacy Compounding Advisory Committee Meeting. FDA. Accessed July 6, 2026. https://www.fda.gov/media/193346/download

6. FDA Evaluation of TB-500-Related Bulk Drug Substances. Pharmacy Compounding Advisory Committee Meeting. FDA. Accessed July 6, 2026. https://www.fda.gov/media/193349/download

7. FDA Evaluation of MOTS-c-Related Bulk Drug Substances. Pharmacy Compounding Advisory Committee Meeting. FDA. Accessed July 6, 2026. https://www.fda.gov/media/193347/download

8. FDA Evaluation of BPC-157-Related Bulk Drug Substances. Pharmacy Compounding Advisory Committee Meeting. FDA. Accessed July 6, 2026. https://www.fda.gov/media/193343/download

9. FDA Evaluation of Emideltide-Related Bulk Drug Substances. Pharmacy Compounding Advisory Committee Meeting. FDA. Accessed July 6, 2026. https://www.fda.gov/media/193344/download

10. FDA Evaluation of Semax-Related Bulk Drug Substances. Pharmacy Compounding Advisory Committee Meeting. FDA. Accessed July 6, 2026. https://www.fda.gov/media/193348/download

11. FDA Evaluation of Epitalon-Related Bulk Drug Substances. Pharmacy Compounding Advisory Committee Meeting. FDA. Accessed July 6, 2026. https://www.fda.gov/media/193345/download