pepmg_

● 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.

What this means: the committee gives independent, non-binding recommendations to FDA. Discussion at the meeting is not approval, inclusion on the Bulks List, or a final FDA decision. The FDA event page reviewed on July 26 lists the agenda, briefing documents, questions, and presentations; this page does not infer an outcome beyond that published record.

● Substances and uses FDA evaluated

The meeting record.

DateBulk drug substanceUse(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.

This page reports regulatory records; it does not provide legal or medical advice. Regulatory pages change, so every pepmg summary carries a checked date.