FDA compounding status
Selank acetate (TP-7)
Also listed as Selank, TP-7.
Selank 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 on September 27, 2024, because the nominator had meant to nominate a different substance. FDA's Pharmacy Compounding Advisory Committee has not reviewed it, and nothing 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 reviewed
- Sport (WADA 2026)
- Not named on the WADA 2026 Prohibited List.
- Offered by PEPLUX
- Yes, as Selank
- Checked on
Offered by PEPLUX
Selank
PEPLUX offers selank acetate (TP-7) as Selank. 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 September 27, 2024 removed selank from Category 2 because the nominator meant to nominate a different bulk drug substance. 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 selank acetate may pose a risk of immunogenicity and that FDA lacks important information on any safety issues it raises in people.
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 September 27, 2024Document dated . Checked .
- FDACertain Bulk Drug Substances for Use in Compounding that May Present Significant Safety RisksDocument 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 has not reviewed it.
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.
Common questions
Selank acetate (TP-7), answered plainly.
- What is the FDA compounding status of Selank acetate (TP-7)?
- Selank 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 on September 27, 2024, because the nominator had meant to nominate a different substance. FDA's Pharmacy Compounding Advisory Committee has not reviewed it, and nothing is pending.
- What does the status of selank acetate (TP-7) trace to?
- FDA's 503A categories document of September 27, 2024 removed selank from Category 2 because the nominator meant to nominate a different bulk drug substance. 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 selank acetate may pose a risk of immunogenicity and that FDA lacks important information on any safety issues it raises in people. Checked against the primary sources on October 13, 2026.
- Does a Category 2 removal or an advisory committee recommendation change the status of selank acetate (TP-7)?
- 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 selank acetate (TP-7)?
- PEPLUX offers selank acetate (TP-7) as Selank. Compounded medications are not approved by the FDA and have not been reviewed for safety, effectiveness, or quality. Selank acetate (TP-7) 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 selank acetate (TP-7) 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.