PCAC July 23, 2026: Four peptides under review (preview)

Background

The U.S. Food and Drug Administration’s Pharmacy Compounding Advisory Committee (PCAC) will convene a public meeting on July 23, 2026 to receive presentations and provide non-binding advice on bulk drug substances nominated for inclusion on the 503A bulks list. The FDA described the committee’s role on its advisory-committee landing page, where the agency outlined the statutory advisory function (FDA PCAC).

The agenda for July 23 includes four peptides: BPC-157, KPV, thymosin beta-4 / TB-500, and MOTS-c. None of the four currently has an FDA-approved drug application; each has been nominated by sponsors who request that licensed pharmacists be permitted to compound the substance under section 503A of the Federal Food, Drug, and Cosmetic Act.

What’s on the agenda

The FDA’s evaluation framework is set out in the agency’s March 2018 guidance, Evaluation of Bulk Drug Substances Nominated for Use in Compounding Under Section 503A. The guidance described four factors the agency weighs (FDA Guidance, 2018):

FDA evaluates each substance under four factors: (1) the physical and chemical characterization of the substance; (2) any safety issues raised by the use of the substance in compounding; (3) the available evidence of effectiveness or lack of effectiveness of a drug product compounded with the substance; and (4) historical use of the substance in compounded drug products, including information about the medical condition(s) the substance has been used to treat and any references in peer-reviewed medical literature.

Briefly, here is what the cited literature reports about each substance on the July 23 agenda:

BPC-157

A synthetic 15-amino-acid peptide originally derived from a fragment of a protein isolated from human gastric juice. A 2025 literature and patent review by Józwiak and colleagues in Pharmaceuticals (Basel) surveyed preclinical reports across tissue-injury, gastrointestinal, and CNS models and noted that the peptide is not approved for use in standard medicine by the FDA or other global regulators (PMID:40005999). See pepi.ninja’s BPC-157 page for fuller citations.

KPV

The C-terminal tripeptide (Lys-Pro-Val) of α-melanocyte-stimulating hormone (α-MSH). A 2020 review in Current Pharmaceutical Design by Bhattacharya and colleagues summarized preclinical anti-inflammatory and antimicrobial reports across rodent models of colitis, candidiasis, and skin inflammation (PMID:32814059). The review noted that no Phase 3 clinical trial of KPV had been completed at the time of writing.

Thymosin beta-4 / TB-500

“TB-500” is the name commonly applied in the unapproved-product market to thymosin beta-4 (or to a fragment thereof). The parent molecule has been the subject of clinical investigation by RegeneRx Biopharmaceuticals, including a Phase 2 trial in pressure ulcers (ClinicalTrials.gov NCT00072592). No FDA approval has been granted for any thymosin beta-4 product as of this writing.

MOTS-c

A mitochondrial-derived peptide of 16 amino acids encoded within the 12S rRNA region of mitochondrial DNA. The original characterization was published by Lee and colleagues at USC in Cell Metabolism in 2015, which reported metabolic effects in mouse models of diet-induced obesity and insulin resistance (PMID:26687472). Human clinical trial data are limited.

Why it matters

The PCAC vote on each substance will not, by itself, determine whether the peptide may be compounded. Under section 503A, a substance may be compounded if it is the subject of a USP or NF monograph, is a component of an FDA-approved drug, or appears on the FDA’s 503A bulks list. The FDA reference page on nominated substances catalogues the universe of pending nominations and the evaluation categories the agency applies (FDA bulks page).

PCAC’s recommendations are advisory; the FDA makes the final listing decision. Where the agency has previously declined to add nominated peptides — as happened with several earlier nominations — pharmacies that continued to compound the substance have been the subject of FDA inspections and enforcement actions documented in the agency’s warning-letter archive.

The July 23 meeting will be open to the public and will accept written and oral comment in the docket the FDA opens for each substance. Briefing materials are typically posted by the FDA roughly two weeks ahead of the meeting; pepi.ninja will summarize the briefing documents on each peptide’s individual page when they are released. This preview reports the agenda and the framework; it does not predict the committee’s recommendations or the agency’s final decisions.