● FDA record · checked July 26, 2026
Seven peptide-related substances went before FDA’s compounding advisory committee.
On July 23–24, 2026, FDA’s Pharmacy Compounding Advisory Committee discussed seven peptide-related bulk substances being considered for the section 503A Bulks List. FDA published a briefing document for each substance.
● Substances and uses FDA evaluated
The meeting record.
| Date | Bulk drug substance | Use(s) FDA evaluated |
|---|---|---|
| July 23 | BPC-157 | Ulcerative colitis |
| July 23 | KPV | Wound healing and inflammatory conditions |
| July 23 | TB-500 | Wound healing |
| July 23 | MOTS-C | Obesity and osteoporosis |
| July 24 | Emideltide (DSIP) | Opioid withdrawal, chronic insomnia, and narcolepsy |
| July 24 | Semax | Cerebral ischemia, migraine, and trigeminal neuralgia |
| July 24 | Epitalon | Insomnia |
Source: FDA meeting page and event materials ↗. The evaluated-use wording above follows FDA’s chart.
● Keep the categories separate
Four statements that are not interchangeable.
FDA-approved medicine
A product has received FDA marketing approval for specified conditions and labeling.
Considered for the 503A Bulks List
FDA and its advisory committee are evaluating whether a substance may be used in qualifying pharmacy compounding under section 503A.
Category 2 under interim policy
FDA has identified potential significant safety risks while reviewing a nomination. This is a compounding-policy category, not an approval status.
Research-use listing
A vendor’s “research use only” label does not establish FDA approval, pharmacy-compounding eligibility, identity, or purity.
● Primary records
Read FDA directly.
- July 23–24, 2026 PCAC meeting, briefing documents, and presentations ↗
- FDA Category 2 and potential significant safety-risk descriptions ↗
This page reports regulatory records; it does not provide legal or medical advice. Regulatory pages change, so every pepmg summary carries a checked date.