Reference table
What became of each peptide's nomination to the 503A bulks list?
The answer
Four dispositions account for every molecule in this index, and two of them — removal without listing, and withdrawal by the nominators — are routinely reported as approvals when they are the opposite of one.
A peptide reaches a pharmacy's shelf through a nomination: a party asks the FDA to place a bulk substance on the section 503A list, and the agency sorts the nomination while it reviews. The sorting has more than two outcomes, and the outcomes that are neither a listing nor a prohibition are the ones the market misreads.
This tracker files each molecule by what actually became of its nomination, with the ledger entry that establishes the disposition beside it.
Denominator
The counts below are counts of the substances this index tracks, and nothing more. They are not a total of all peptides nominated to the 503A bulks list; no source this index has verified states such a total, so this page does not print one.
Rows are read from MOLECULES[].status, MOLECULES[].statusLine, MOLECULES[].record[] — the same dated ledger the molecule index renders. No cell on this page is typed by hand.
| Molecule | Disposition | US status | What the record states |
|---|---|---|---|
| Sermorelin | Category 1 of the interim 503A bulks list | Compoundable (503A) | August 2026. Compounded by 503A pharmacies with a valid prescription; the discontinued approval was withdrawn for commercial, not safety, reasons. |
| NAD+ | Category 1 of the interim 503A bulks list | Compoundable (503A) | August 2026. Listed in Category 1 of the interim 503A bulks list; pharmacies may compound while FDA review continues. |
| Glutathione | Category 1 of the interim 503A bulks list | Compoundable (503A) | August 2026. Listed in Category 1 of the interim 503A bulks list; pharmacies may compound while FDA review continues. |
| Tesamorelin | Approved drug product; no bulks nomination required | FDA-approved | March 2025. FDA approves EGRIFTA WR, an eight-fold concentrated formulation reconstituted weekly rather than daily; it replaces EGRIFTA SV. |
| Semaglutide | Approved drug product; no bulks nomination required | FDA-approved | April 2026. FDA proposes excluding semaglutide from the 503B bulks list, closing the outsourcing-facility route; patient-specific 503A compounding requires a documented clinical need an approved product cannot meet. |
| Tirzepatide | Approved drug product; no bulks nomination required | FDA-approved | April 2026. FDA proposes excluding tirzepatide from the 503B bulks list; the lawful remainder is patient-specific 503A compounding with documented clinical need. |
| BPC-157 | Removed from Category 2 without listing | PCAC-recommended · pending | April 2026. FDA removes BPC-157 and eleven other peptides from Category 2 without adding them to Category 1; the removal ends the explicit prohibition but confers no authorization. |
| GHK-Cu | Removed from Category 2 without listing | No lawful route | April 2026. Injectable GHK-Cu removed from Category 2 without Category 1 listing; not among the seven peptides reviewed at the July 2026 PCAC meeting. |
| MOTS-c | Removed from Category 2 without listing | PCAC-recommended · pending | April 2026. Removed from Category 2 without Category 1 listing. |
| TB-500 | Removed from Category 2 without listing | PCAC-recommended · pending | April 2026. Removed from Category 2 without Category 1 listing. |
| KPV | Removed from Category 2 without listing | PCAC-recommended · pending | April 2026. Removed from Category 2 without Category 1 listing. |
| Semax | Removed from Category 2 without listing | PCAC-recommended · pending | April 2026. Removed from Category 2 without Category 1 listing. |
| Epitalon | Removed from Category 2 without listing | PCAC-recommended · pending | April 2026. Removed from Category 2 without Category 1 listing. |
| DSIP | Removed from Category 2 without listing | No lawful route | April 2026. Removed from Category 2 without Category 1 listing. |
| CJC-1295 | Nomination withdrawn by its nominators | Nomination withdrawn | September 2024. Removed from Category 2 after nominator withdrawal; not added to Category 1. |
| Ipamorelin | Nomination withdrawn by its nominators | Nomination withdrawn | September 2024. Removed from Category 2 after nominator withdrawal; not added to Category 1. |
A withdrawn nomination is the disposition with the least written about it and the most misread; CJC-1295's withdrawal sets out what happened and what it left behind. The research-only page covers both routes into that position, and what removal does not mean covers the other.
Other tables
Evidence reviews
Monographs in this table