FDA Advisory Committee Recommends Adding Six of Seven Peptides to Compounding List

On Thursday, July 23, an FDA advisory committee recommended four popular peptide substances be added to the list of drugs that compounding pharmacies are allowed to make. On Friday, the PCAC recommended two more peptides, choosing to exclude the sleep peptide emideltide.

These votes are non-binding and still need sign-off from the FDA.

View the FDA Introductory Remarks, presented July 23, 2026 at the Pharmacy Compounding Advisory Committee Meeting. 

July 23

BPC-157

Proposed use: ulcerative colitis (an inflammatory bowel disease)
Outcome: Yes
Margin: 8-6 in favor, with one abstention
What the FDA was saying: There is a lack of evidence to support using; multiple approved drugs treat this condition.
Positive comments from the committee: Yes votes were in support of patient safety, “the greater good and medical freedom.” To “put this decision back into the hands of the patient, the physician and the pharmacist,” according to reporting by NBC.
Concerns from the panel: “I’m concerned that we’re responding to a market-induced demand rather than a decision based in solid science,” said Elizabeth Rebello, a panel member and professor at the University of Texas.

KPV

Proposed use: wound healing and inflammatory conditions
Outcome: Yes
Margin: 8-6 in favor, with one abstention
What the FDA was saying: The nominator did not provide clinical evidence for that proposed use, and lacked human studies.

TB-500

Proposed use: wound healing
Outcome: Yes
Margin: 8-6 in favor, with one abstention
What the FDA was saying: There is not enough evidence of effectiveness for the proposed use; various approved therapies already manage wounds.

MOTs-C

Proposed use: obesity and osteoporosis
Outcome: Yes
Margin: 7-5 in favor, with two abstentions
What the FDA was saying: Could not find enough evidence to evaluate the peptide’s effectiveness to treat those conditions.

July 24

Epitalon

Proposed use: insomnia
Outcome: Yes
Margin: 7-4 in favor, with one abstention
What the FDA was saying: Not enough effectiveness evidence for the proposed use.

Emideltide (aka DSIP: delta sleep-inducing peptide)

Proposed use: opioid withdrawal, chronic insomnia, and narcolepsy
Outcome: No
Margin: 6-7 in favor, with one abstention
What the FDA was saying: Not enough evidence to support effectiveness for these proposed uses.

Semax

Proposed use: cerebral ischemia, migraine, and trigeminal neuralgia
Outcome: Yes
Margin: 8-5 in favor, with one abstention
What the FDA was saying: Criteria weighs against expanding access.