Only Category 1 opens the door to compounding
Being removed from Category 2 isn't the same as being allowed. Pharmacies can only compound a nominated substance if it's in Category 1 or on the final bulks list.
If you've followed peptide news in 2026, you've seen "Category 2" everywhere. This system decides, in practice, whether a pharmacy can make a peptide for you. Here's how it works in plain terms.
Why categories exist at all
A US compounding pharmacy (a "503A" pharmacy, named for the section of federal law that governs it) can only use certain ingredients. An ingredient generally qualifies if it has an official USP drug monograph, is part of an FDA-approved drug, or appears on the FDA's 503A bulks list.
Most popular wellness peptides meet none of those tests. Getting onto the bulks list requires formal rulemaking, which is slow. So while the FDA reviews nominated ingredients, it sorts them into interim categories.
The three categories
Category 1: Under evaluation. The FDA received enough information to review the substance, and it may be eligible for the bulks list. While the review is pending, the FDA generally doesn't take action against pharmacies that compound with it, as long as they meet the other conditions in its guidance. This is the only category that permits compounding in practice.
Category 2: Significant safety risks. The FDA had enough information to review the substance and found significant safety concerns. Pharmacies can't rely on the interim policy to compound these.
Category 3: Nominated without adequate support. The nomination didn't include enough information for the FDA to evaluate it. These can't be compounded under the interim policy either.
How peptides moved in 2023 and 2026
In 2023, the FDA placed 19 peptides and related substances in Category 2, including BPC-157, TB-500, and others popular in wellness and fitness circles. The non-injectable forms of GHK-Cu went into Category 1.
In April 2026, the FDA removed 12 peptides from Category 2 because their nominations had been withdrawn. That list included BPC-157, TB-500, MOTS-c, injectable GHK-Cu, Melanotan II, Semax, and PEG-MGF.
The catch: off Category 2 doesn't mean allowed
This is the most misunderstood part of the 2026 news. Removing a substance from Category 2 doesn't authorize compounding with it, and doesn't move it into Category 1. Peptides like BPC-157 ended up in a gray zone: no longer flagged as a safety risk, but with no legal pathway to compounding either.
What would change things
A peptide becomes legally compoundable if the FDA either places it in Category 1, or adds it to the 503A bulks list through a final rule. The July 2026 advisory committee votes were a step toward the second route, and an interim access policy under White House review since October 14, 2026 may create another temporary route. Our explainer on the July vote covers what comes next.
What this means for you
If a clinic or pharmacy offers a peptide that isn't FDA-approved, it's reasonable to ask which legal pathway lets them compound it. Check our FDA status tracker for each peptide's current standing.
What this article is based on
Checked October 27, 2026. Primary FDA documents are listed first where available.
About this content: The Peptide Verdict is an independent educational publication. Articles are researched and written with AI assistance, edited by our editorial team, and checked against the primary sources listed on each page. They are not reviewed by a medical professional and are not medical, legal, or pharmacy advice. Peptide regulations change quickly; always check the dates shown and confirm current rules. Talk to a licensed clinician before using any peptide or medication.