What the committee decides
The Pharmacy Compounding Advisory Committee gives the FDA independent expert advice. It makes a recommendation. The recommendation does not bind the FDA, and the FDA usually follows it.
The 503A Bulks List controls which raw substances a compounding pharmacy may legally use. A substance reaches a pharmacy through one of three routes. It holds a USP or NF monograph, it sits inside an FDA-approved drug, or it appears on the 503A Bulks List.
The FDA sorts nominated substances into three categories:
Category 1
The FDA does not intend to act against a pharmacy that compounds with it, under stated conditions.
Category 2
The FDA identified significant safety risks. Do not compound.
Category 3
The nomination lacked enough information for a review.
What the FDA reviewed on 23 July
| Substance | Use the FDA evaluated |
|---|---|
| BPC-157 (free base and acetate) | Ulcerative colitis |
| KPV (free base and acetate) | Wound healing and inflammatory conditions |
| TB-500 (free base and acetate) | Wound healing |
| MOTS-c (free base and acetate) | Obesity and osteoporosis |
What the FDA reviewed on 24 July
| Substance | Use the FDA evaluated |
|---|---|
| Emideltide (delta sleep-inducing peptide) | Opioid withdrawal, chronic insomnia and narcolepsy |
| Semax (free base and acetate) | Cerebral ischemia, migraine and trigeminal neuralgia |
| Epitalon (free base and acetate) | Insomnia |
Read the FDA's own reviews
The FDA published a scientific briefing document for each substance. Each one sets out what the FDA found on safety and effectiveness. We link them here and we summarise each one this week.
What each outcome means for you
If a substance reaches Category 1
Compounding pharmacies may prepare it under stated conditions. A legal clinical route opens.
If a substance stays in Category 2
Compounding pharmacies cannot use it. Demand moves to the research-chemical channel, where no quality oversight exists. Vendor verification then carries the whole burden.
If the FDA takes no action
The current status stays.
We track the result
The FDA plans a live webcast and an archived video. We publish the outcome within 48 hours of the vote and we update every affected profile the same day.