Peptides Removed From Category 2: What It Meant and What Happened Next

Status as of October 3, 2026: None of the 12 peptide-related substances FDA removed from Category 2 in April 2026 is on FDA’s final 503A bulks list. Seven went to FDA’s advisory committee in July 2026: six received favorable votes and one did not. The other five have not yet been reviewed by the committee.

What Category 2 is

While FDA evaluates substances nominated for the 503A bulks list, it sorts them into three categories. Category 1 is substances under evaluation. Category 2 is substances that raise significant safety risks. Category 3 is substances nominated without enough supporting information. These categories are part of FDA’s interim policy. The final list is a separate regulation, 21 CFR 216.23.

What removal meant

In April 2026, the parties that had nominated these 12 substances withdrew their nominations. On April 15, 2026, FDA gave notice that it would remove them from Category 2 after seven calendar days. FDA’s safety page now lists them as “nominated but withdrawn” and still describes its safety concerns about each one.

• Removal happened because the nominations were withdrawn. It was not a new FDA finding that the substances are safe.
• Removal did not move the substances into Category 1.
• Removal did not add them to the final 503A bulks list.
• Removal did not make any of them an FDA-approved drug.

What happened next

May 14, 2026: non-injectable GHK-Cu returned to Category 1

One GHK-Cu nominator told FDA it had meant to withdraw only its nomination for injectable use. FDA put GHK-Cu for non-injectable routes back in Category 1. Injectable GHK-Cu remains outside the categories.

July 23–24, 2026: the committee reviewed seven substances

FDA presented seven of the substances to PCAC even though their nominations had been withdrawn. FDA’s briefing documents proposed that none of the seven be added. The committee voted to recommend six: BPC-157, KPV, TB-500, MOTS-c, Semax, and Epitalon. It voted against Emideltide (DSIP). Full details: PCAC recommended six peptides. FDA has not added them.

As of October 3, 2026: the final list has not changed

The final 503A bulks list, 21 CFR 216.23(a), still contains six substances, and none is a peptide. The eCFR text is current through October 1, 2026; the section was last amended in 2019. FDA would need to publish a proposed rule, take comments, and issue a final rule to add any of these peptides.

Where each substance stands

How to describe these substances

1. Name the event and the date. For example: “Removed from Category 2 in April 2026 after the nominations were withdrawn,” or “Recommended by PCAC on July 23, 2026; not on FDA’s final 503A list as of October 3, 2026.”
2. Do not use “withdrawn” by itself as a status. Say what was withdrawn: the nominators withdrew their nominations.
3. Do not describe removal from Category 2 or a favorable committee vote as FDA approval or permission to compound.
4. Before prescribing, confirm with the dispensing pharmacy which legal pathway it relies on, and get legal review where needed.

Operational takeaway

Use this page as a dated reference. It helps staff explain what changed in April, what the committee did in July, and what FDA has and has not done since, without overstating any of it.