Peptide policy update
What changed when peptide nominations left FDA Category 2
Published · Updated · Reviewed by the Rite Aid Health Team
In April 2026, several peptide nominations moved from FDA’s active Category 2 table to its withdrawn-nomination table. Their nominations ended in that form, while their bulks-list and drug-approval status stayed unchanged.
| Subject | Official record | What it means |
|---|---|---|
| Named peptide nominations | Nominations withdrawn | The substances moved off the active Category 2 table. |
| Section 503A Bulks List status | Not added by this update | The table move did not authorize patient-specific compounding. |
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What happened in April 2026
The nominators withdrew a group of bulk-substance nominations that had appeared in FDA Category 2. FDA moved them to a separate withdrawn-nomination table. The group includes BPC-157, CJC-1295, emideltide, Epitalon, injectable GHK-Cu, KPV, MOTS-c, Semax, TB-500, and other substances.
Withdrawal ends those nominations in their submitted form. A substance would need another applicable regulatory path before its federal compounding status changes.
What changed for compounding status
The substances left the active Category 2 nomination table because the nominations were withdrawn. They were not added to the Section 503A or 503B Bulks List through this update. FDA continues to display its prior risk summaries with the withdrawn entries.
For pharmacies and patients, the table move did not open a new federal compounding route or approve a finished product. It changed the nomination record.
Nomination, Category 2, bulks-list status, and approval
A nomination asks FDA to evaluate a bulk substance for compounding. Category 2 is an interim-policy category for nominated substances that FDA identified as presenting potential significant safety risks. A bulks-list entry can support compounding under defined legal conditions. Drug approval covers a specific finished product and use.
These statuses answer different questions. The April update changed the nomination location only.
Which FDA safety notes still matter
FDA’s table continues to summarize substance-specific concerns. Its BPC-157 entry discusses immune reactions, impurities, and active-ingredient characterization. The KPV, MOTS-c, and TB-500 entries describe the lack of human exposure data found during those reviews and unresolved injectable-product questions.
CJC-1295, emideltide, Epitalon, Semax, and the other entries have their own evidence records. Reading the note beside the exact substance is more useful than treating Category 2 as one shared risk score.
How to check a claim about the update
Start with the current FDA table and match the exact substance and chemical form. Then look for a bulks-list entry, final rule, approved label, or enforcement policy that supports the claimed access change.
For a product claim, match the lot to its test report and check which quality attributes were measured. A purity result answers a different question from identity, quantity, sterility, or endotoxin.
What happened next
In July 2026, FDA brought seven peptide-related substances to the Pharmacy Compounding Advisory Committee under new or continuing nominations. The committee supported six and voted against emideltide.
FDA must still take formal action before compounding eligibility changes. The July article tracks that next stage.