FDA Peptide Status Tracker: Category 2, PCAC Votes, and 503A (2026)
Every row below is checked against FDA's own pages, linked in the sources section. We built this tracker because peptide regulatory status is widely misreported: withdrawal from Category 2 gets rewritten as "FDA cleared," and advisory committee votes get rewritten as "added to the legal list." Neither is true, and the table shows exactly what is.
How to read this table
Three separate FDA concepts appear here, and they are not interchangeable:
- Category 2 is FDA's list of bulk substances that "may present significant safety risks" in compounding. Placement is a safety flag, not a ban; withdrawal of a nomination is a procedural step, not a clearance.
- PCAC recommendation is an advisory committee vote on whether a substance should be added to the 503A bulks list. The committee recommends; only HHS/FDA can act.
- 503A bulks list is the list that gives compounding pharmacies a clear legal pathway to use a substance. No peptide in this table is on it.
Status table (verified September 4, 2026)
| Peptide | Category 2 status | July 2026 PCAC vote | 503A bulks list |
|---|---|---|---|
| BPC-157 | Nomination withdrawn | Recommended, 8-6-1 | Not listed |
| KPV | Nomination withdrawn | Recommended, 8-6-1 | Not listed |
| TB-500 (thymosin beta-4 fragment) | Nomination withdrawn | Recommended, 8-6-1 | Not listed |
| MOTS-c | Nomination withdrawn | Recommended, 7-5-2 | Not listed |
| Semax | Nomination withdrawn | Recommended | Not listed |
| Epitalon | Nomination withdrawn | Recommended | Not listed |
| Emideltide (DSIP) | Nomination withdrawn | Vote AGAINST adding | Not listed |
| AOD-9604 | Nomination withdrawn | No July 2026 vote | Not listed |
| CJC-1295 | Nomination withdrawn | No July 2026 vote | Not listed |
| Cathelicidin LL-37 | Nomination withdrawn | No July 2026 vote | Not listed |
| Dihexa | Nomination withdrawn | No July 2026 vote | Not listed |
| GHK-Cu (injectable routes) | Nomination withdrawn | No July 2026 vote | Not listed |
| Ipamorelin (503A nomination) | Nomination withdrawn | No July 2026 vote | Not listed |
| PEG-MGF | Nomination withdrawn | No July 2026 vote | Not listed |
| Melanotan II | Nomination withdrawn | No July 2026 vote | Not listed |
| Thymosin alpha-1 | Nomination withdrawn | No July 2026 vote | Not listed |
| Ibutamoren (MK-677) | ACTIVE Category 2 (503A and 503B) | No July 2026 vote | Not listed |
| Ipamorelin acetate (503B) | ACTIVE Category 2 (503B only) | No July 2026 vote | Not listed |
What changed in 2026
In April 2026, HHS announced the removal of a dozen peptides from Category 2, with FDA's Category 2 page updated April 22, 2026; the withdrawn-nomination rows above reflect that page as currently published. Then on July 23-24, 2026, the Pharmacy Compounding Advisory Committee met and voted to recommend six peptides for the 503A bulks list while voting against emideltide (DSIP). As of this page's review date, no peptide from those votes has actually been added to the list.
What "withdrawn" does and does not mean
A withdrawn nomination means the parties who nominated the substance into the Category 2 review pulled that nomination. It does not mean FDA evaluated the substance and found it safe, does not create any approval, and does not place the substance on the 503A bulks list. FDA's published safety concerns for these substances remain available on the Category 2 page. Interim-policy enforcement discretion that once applied to nominated substances no longer covers them after withdrawal.
The two active Category 2 entries carry specific FDA-cited concerns: a potential congestive-heart-failure signal for ibutamoren (MK-677), and immunogenicity risk plus a literature report of serious adverse events for ipamorelin acetate in 503B use.
Sources
- FDA: Certain bulk drug substances that may present significant safety risks (Category 2 page, content current April 22, 2026)
- FDA: Bulk drug substances used in compounding under section 503A (framework and bulks list)
- FDA: July 23-24, 2026 meeting of the Pharmacy Compounding Advisory Committee
Deeper reading on individual substances: KPV's FDA status, the PCAC vote explained, and the KPV overview.
Citing this tracker: journalists and researchers are welcome to reference this table with attribution to HealthRX.com. We verify it against the FDA source pages above and note the verification date in the header.