FDA compounding status
Emideltide (DSIP)
Also listed as DSIP, Delta sleep-inducing peptide.
Emideltide (DSIP) is not FDA-approved, and there is no pathway for a US pharmacy to compound it today. FDA removed it from its 503A Category 2 in April 2026 after the nominations were withdrawn, but removal is not a listing. FDA's Pharmacy Compounding Advisory Committee did not recommend it on July 24, 2026, and nothing favorable is pending.
Checked against the primary sources on .
The record
- FDA status
- No compounding pathway today.
- Compounding basis
- No compounding pathwayNo facility type may compound this substance today.
- FDA advisory committee
- Not recommended, Jul 24, 2026
- Sport (WADA 2026)
- Not named on the WADA 2026 Prohibited List.
- Offered by PEPLUX
- Yes, as DSIP Injection
- Checked on
Offered by PEPLUX
DSIP Injection
PEPLUX offers emideltide (DSIP) as DSIP Injection. The product page covers what it is, its risks, and how prescribing and pricing work.
Basis
What this status traces to.
FDA's 503A categories document of April 15, 2026 announced the removal of emideltide from Category 2, effective seven days later, because its nominations were withdrawn. It has no entry in FDA's current 503A or 503B category documents, it is not on the 503A bulks list (21 CFR 216.23) or the 503B bulks list, and it is not a component of an FDA-approved drug. FDA's safety page says compounded emideltide may pose a risk of immunogenicity and that FDA has not identified safety-related information for the proposed route of administration.
Primary sources
- FDA 503A categoriesBulk drug substances nominated for use in compounding under section 503A (categories), updated May 14, 2026Document dated . Checked .
- FDA 503B categoriesBulk drug substances nominated for use in compounding under section 503B (categories), updated March 21, 2025Document dated . Checked .
- FDA503B Bulk Drug Substances ListDocument dated . Checked .
- eCFR21 CFR 216.23, Bulk drug substances that can be used to compound drug productsDocument dated . Checked .
- FDA 503A categoriesBulk drug substances nominated for use in compounding under section 503A (categories), updated April 15, 2026Document dated . Checked .
- FDACertain Bulk Drug Substances for Use in Compounding that May Present Significant Safety RisksDocument dated . Checked .
- Federal RegisterFR Doc 2026-07361: Pharmacy Compounding Advisory Committee; notice of meetingDocument dated . Checked .
- FDA advisory committeeJuly 23-24, 2026: Meeting of the Pharmacy Compounding Advisory CommitteeDocument dated . Checked .
- FDA advisory committeePharmacy Compounding Advisory Committee, July 23-24, 2026: voting questionsDocument dated . Checked .
- WADAWorld Anti-Doping Code, 2026 Prohibited ListDocument dated . Checked .
Context
A removal or a committee vote is not a listing.
Removal from FDA's Category 2 is not FDA approval and not a listing. FDA removed several peptides from its 503A Category 2 after their nominators withdrew the nominations, not because the substances were found safe: BPC-157, TB-500, MOTS-c, semax and epitalon among others (removal noticed April 15, 2026, effective after 7 days), and CJC-1295 and ipamorelin earlier (removal notice dated September 27, 2024). None was added to the 503A bulks list, so none has a compounding pathway today. A favorable vote by FDA's Pharmacy Compounding Advisory Committee is a recommendation, not a listing: nothing changes unless FDA publishes a final rule.
FDA advisory committee
FDA's Pharmacy Compounding Advisory Committee did not recommend it at its meeting of July 24, 2026. FDA has not posted minutes for that meeting.
If you are subject to anti-doping rules
Not named on the WADA 2026 Prohibited List.
Not named on the 2026 list. Whether the S0 class (substances with no government approval for human therapeutic use) reaches it has not been confirmed.
Pending or unconfirmed
FDA had posted no minutes or outcome for the July 2026 committee meeting as of October 13, 2026. The committee outcome stated here rests on LegitScript's report of July 27, 2026, not on an FDA document.
Common questions
Emideltide (DSIP), answered plainly.
- What is the FDA compounding status of Emideltide (DSIP)?
- Emideltide (DSIP) is not FDA-approved, and there is no pathway for a US pharmacy to compound it today. FDA removed it from its 503A Category 2 in April 2026 after the nominations were withdrawn, but removal is not a listing. FDA's Pharmacy Compounding Advisory Committee did not recommend it on July 24, 2026, and nothing favorable is pending.
- What does the status of emideltide (DSIP) trace to?
- FDA's 503A categories document of April 15, 2026 announced the removal of emideltide from Category 2, effective seven days later, because its nominations were withdrawn. It has no entry in FDA's current 503A or 503B category documents, it is not on the 503A bulks list (21 CFR 216.23) or the 503B bulks list, and it is not a component of an FDA-approved drug. FDA's safety page says compounded emideltide may pose a risk of immunogenicity and that FDA has not identified safety-related information for the proposed route of administration. Checked against the primary sources on October 13, 2026.
- Does a Category 2 removal or an advisory committee recommendation change the status of emideltide (DSIP)?
- Removal from FDA's Category 2 is not FDA approval and not a listing. FDA removed several peptides from its 503A Category 2 after their nominators withdrew the nominations, not because the substances were found safe: BPC-157, TB-500, MOTS-c, semax and epitalon among others (removal noticed April 15, 2026, effective after 7 days), and CJC-1295 and ipamorelin earlier (removal notice dated September 27, 2024). None was added to the 503A bulks list, so none has a compounding pathway today. A favorable vote by FDA's Pharmacy Compounding Advisory Committee is a recommendation, not a listing: nothing changes unless FDA publishes a final rule.
- Does PEPLUX offer emideltide (DSIP)?
- PEPLUX offers emideltide (DSIP) as DSIP Injection. Compounded medications are not approved by the FDA and have not been reviewed for safety, effectiveness, or quality. Emideltide (DSIP) is not FDA-approved, and there is no lawful pathway for a US pharmacy to compound it today. Its safety and effectiveness in people have not been established.
- Is emideltide (DSIP) prohibited in sport?
- Not named on the WADA 2026 Prohibited List. Not named on the 2026 list. Whether the S0 class (substances with no government approval for human therapeutic use) reaches it has not been confirmed.
- Is anything about the status of emideltide (DSIP) pending or unconfirmed?
- FDA had posted no minutes or outcome for the July 2026 committee meeting as of October 13, 2026. The committee outcome stated here rests on LegitScript's report of July 27, 2026, not on an FDA document.