FDA PCAC July 2026 Results: Committee Recommendations for All 7 Peptide Compounds
Live outcomes from the July 23–24, 2026 FDA Pharmacy Compounding Advisory Committee meeting on 503A bulk drug substance status for BPC-157, KPV, TB-500, MOTS-c, DSIP, Semax, and Epitalon. Updated as recommendations are announced.
Research reference only. The information in this article is a summary of peer-reviewed scientific literature. It does not constitute medical advice and is not intended to guide human use. See our full disclaimer.
The FDA Pharmacy Compounding Advisory Committee is convening today and tomorrow (July 23–24, 2026) to evaluate the 503A bulk drug substance status of seven peptide compounds. This article will be updated throughout the two-day meeting with committee recommendations as they are announced. For background on what the PCAC review means and the four-factor analysis applied to each compound, see the full PCAC 2026 reference page.
Research reference only. Committee recommendations reported here are sourced from FDA public meeting records. They are advisory — not final regulatory determinations. A formal FDA rulemaking process with public comment period follows before any final determination takes effect. See the PCAC Outcomes Tracker for a structured view of all outcomes.
Day 1 Results — July 23, 2026
BPC-157
Scheduled hearing: July 23, 2026
Current status: 503A Category 2
Committee recommendation: [OUTCOME: PENDING — Update with result after July 23 session]
Background: BPC-157 is a synthetic pentadecapeptide with a substantial preclinical evidence base in tissue repair and GI cytoprotection models. It is the highest-profile compound on the July 2026 docket by search volume and compounding use. See the BPC-157 PCAC preview article for the full four-factor analysis.
KPV (Lys-Pro-Val)
Scheduled hearing: July 23, 2026
Current status: 503A Category 2
Committee recommendation: [OUTCOME: PENDING — Update with result after July 23 session]
Background: KPV is a tripeptide fragment of α-MSH with preclinical anti-inflammatory activity in IBD models, including NF-κB suppression and cytokine reduction. See the KPV PCAC preview article and the BPC-157 vs KPV comparison.
TB-500 (Thymosin β-4)
Scheduled hearing: July 23, 2026
Current status: 503A Category 2
Committee recommendation: [OUTCOME: PENDING — Update with result after July 23 session]
Background: TB-500 is a synthetic analogue of Thymosin β-4, studied in cardiac and wound-healing animal models for actin-sequestration and VEGF pathway activity. See the TB-500 PCAC preview article and the BPC-157 vs TB-500 comparison.
MOTS-c
Scheduled hearing: July 23, 2026
Current status: 503A Category 2
Committee recommendation: [OUTCOME: PENDING — Update with result after July 23 session]
Background: MOTS-c is a mitochondria-derived peptide encoded in the 12S rRNA gene, with AMPK-activation evidence in Cell (Lee et al., 2015) and aging-related data in Nature Aging (Reynolds et al., 2021) — the strongest journal-prestige evidence base of any July 2026 compound. See the MOTS-c PCAC preview article.
Day 2 Results — July 24, 2026
DSIP (Delta Sleep-Inducing Peptide)
Scheduled hearing: July 24, 2026
Current status: 503A Category 2
Committee recommendation: [OUTCOME: PENDING — Update with result after July 24 session]
Background: DSIP is an endogenous nonapeptide naturally produced by the human hypothalamus and pituitary, studied for sleep-architecture modulation and neuroendocrine regulation since its isolation in 1977. Its endogenous status is a distinct regulatory argument among the July 2026 compounds. See the DSIP PCAC preview article.
Semax
Scheduled hearing: July 24, 2026
Current status: 503A Category 2
Committee recommendation: [OUTCOME: PENDING — Update with result after July 24 session]
Background: Semax is a synthetic ACTH analogue approved as a pharmaceutical drug in Russia, with human cognitive and neuroprotective trial data — making it the only July 2026 compound with existing national drug approval. See the Semax PCAC preview article and the Semax vs Selank comparison.
Epitalon (Epithalon)
Scheduled hearing: July 24, 2026
Current status: 503A Category 2
Committee recommendation: [OUTCOME: PENDING — Update with result after July 24 session]
Background: Epitalon is a synthetic tetrapeptide analogue of pineal-derived Epithalamin, with Khavinson group research reporting telomerase activation in human fetal fibroblasts and extended lifespan in rodent models. See the Epitalon PCAC preview article and the Epitalon vs Humanin comparison.
What happens next
Advisory committee recommendations are not final regulatory actions. Following the July 23–24 meeting, FDA will publish the committee recommendations and open a public comment period — typically 60 days — during which researchers, clinicians, compounding pharmacies, and patient advocates may submit evidence or clinical need documentation to the FDA docket. A formal agency determination, which constitutes the actual regulatory outcome, typically follows six months to over one year after the advisory committee meeting.
Researchers and clinicians who want to submit public comments should monitor the FDA Federal Register for the notice of proposed rulemaking associated with each compound's determination. The docket number will be published in the Federal Register following the July meeting.
For a structured view of all seven outcomes with status indicators, see the PCAC Outcomes Tracker. For compound-level research profiles, see the Peptide Library.
This article is updated as committee recommendations are announced. All outcomes reflect PCAC advisory recommendations, not final FDA determinations. Last updated: [UPDATE DATE HERE]