The category 2 peptides list is the FDA’s own record of compounds the agency says carry too much safety uncertainty to compound under current rules. It started in September 2023 with 19 peptides and has kept moving since, most recently in April 2026, when the FDA pulled 12 of those peptides off Category 2 without putting any of them back into legal compounding use.
The Compound Universe Take: As of July 2026, the category 2 peptides list still blocks compounding for the peptides FDA has not removed, and removal is not the same as approval. Twelve peptides, including BPC-157, TB-500, and MOTS-c, came off Category 2 in April 2026, but none of them are authorized to compound today. A Pharmacy Compounding Advisory Committee (PCAC) meeting on July 23-24, 2026 will review seven of the twelve; any formal rule would come later and could take over a year to finalize.
Need the bigger picture first? See are peptides legal in the US right now? for how compounding law applies beyond this one list.
What the category 2 peptides list actually means
FDA’s bulk drug substance nomination process sorts candidates into three buckets. Category 1 substances have adequate data and no significant safety risk identified, so FDA extends enforcement discretion for 503A compounding, subject to conditions. Category 2 substances are the opposite: FDA identified a significant safety risk and does not intend to permit compounding. Category 3 substances lack enough data to evaluate and can be renominated later [6].
Regulatory: In September 2023, FDA placed 19 peptides into Category 2, citing impurity and API characterization problems, aggregation risk, and a lack of human safety data for compounds including BPC-157 and MOTS-c [1][7]. That action is the origin of what most people call “the category 2 peptides list.”
| Peptide | Removed from Category 2 (April 2026) | PCAC review batch | Status as of July 2026 |
|---|---|---|---|
| BPC-157 | Yes | Batch 1, July 23 | Under review, not authorized |
| KPV | Yes | Batch 1, July 23 | Under review, not authorized |
| TB-500 | Yes | Batch 1, July 23 | Under review, not authorized |
| MOTS-c | Yes | Batch 1, July 23 | Under review, not authorized |
| DSIP (emideltide) | Yes | Batch 1, July 24 | Under review, not authorized |
| Semax | Yes | Batch 1, July 24 | Under review, not authorized |
| Epitalon | Yes | Batch 1, July 24 | Under review, not authorized |
| LL-37 (cathelicidin) | Yes | Batch 2, before Feb 2027 | Removed, awaiting review |
| Dihexa | Yes | Batch 2, before Feb 2027 | Removed, awaiting review |
| GHK-Cu (injectable) | Yes | Batch 2, before Feb 2027 | Removed, awaiting review |
| PEG-MGF | Yes | Batch 2, before Feb 2027 | Removed, awaiting review |
| Melanotan II | Yes | Batch 2, before Feb 2027 | Removed, awaiting review |
The remaining seven peptides from the original 2023 list were not part of the April 2026 action. They stay in Category 2, with no compounding permitted and no review date announced as of this writing.
The April 2026 removal: what changed, and what did not
FDA republished its interim 503A bulks list in April 2026 and took the 12 peptides above out of Category 2 [2][3]. Regulatory attorneys describe the result as a neutral limbo rather than a green light: removal from Category 2 does not make a peptide eligible for compounding under Section 503A [3]. The substances moved from “flagged as a significant safety risk” to “not yet evaluated for the authorized list.”
FDA’s current enforcement discretion for 503A compounding extends only to Category 1 substances, and none of the 12 removed peptides sit there. A compounding pharmacy cannot legally compound BPC-157 or TB-500 today just because the Category 2 flag came off in April.
The July 2026 PCAC meeting: an advisory vote, not a final rule
The Pharmacy Compounding Advisory Committee meets at FDA White Oak on July 23-24, 2026 to evaluate seven of the twelve removed peptides for possible inclusion on the 503A authorized list [3]. July 23 covers BPC-157, KPV, TB-500, and MOTS-c; July 24 covers DSIP, Semax, and Epitalon. The other five removed peptides get a second PCAC meeting before the end of February 2027.
Regulatory (advisory, not final): NPR reported that FDA’s own career scientists reviewed the evidence and recommended against changing status for the seven peptides on this docket, citing gaps in human safety and efficacy data for uses like tendon injury and inflammatory bowel disease [4]. A PCAC recommendation is advisory only; even a favorable vote would trigger formal rulemaking that has historically taken over a year. As of early July 2026, no vote has happened and no final rule exists for any peptide on this list.
Sermorelin, tesamorelin, and peptides that were never on this list
Some growth-hormone-axis peptides get lumped into “category 2 peptides” talk even though they follow different rules. Sermorelin is legally compoundable today under Section 503A, but only with a documented medical-necessity attestation, not as an open-access product.
Tesamorelin (Egrifta) and bremelanotide/PT-141 (Vyleesi) are FDA-approved drugs, not compounding stories, and neither has appeared on a Category 2 list. CJC-1295, ipamorelin, and thymosin alpha-1 remain barred from compounding; PCAC voted against them at its 2024 meetings, and none sit on the July 2026 docket above [9].
Regulatory status, not medical advice: This page tracks FDA compounding categories as of July 2026; it is not legal advice, medical advice, or a dosing guide. Removal from Category 2 does not mean a peptide is approved, legal to compound, or safe for human use. Rules differ by state and by pharmacy license, and this status can change after publication. Consult a licensed prescriber or pharmacist and check FDA.gov before assuming any compound’s status.
GLP-1 compounding: a parallel, separate crackdown
The category 2 peptides list and the GLP-1 compounding rules are different tracks people often confuse. Regulatory: FDA declared the tirzepatide shortage resolved in October 2024, reconfirmed by order in December 2024; semaglutide’s shortage was declared resolved February 21, 2025 [10]. Tirzepatide compounding discretion closed February 18, 2025 (503A) and March 19, 2025 (503B); semaglutide’s ran longer, closing April 22, 2025 (503A) and May 22, 2025 (503B) [10].
Mass compounding marketed as “essentially a copy” of Ozempic, Wegovy, Mounjaro, or Zepbound is illegal today; only narrow, patient-specific compounding survives. In April 2026, FDA proposed permanently excluding semaglutide, tirzepatide, and liraglutide from the 503B bulks list; the comment period, first set to close June 29, 2026, was extended to July 30, and a final rule remains pending [5].
FDA also ran 2026 warning-letter waves against GLP-1 and “research use only” peptide marketers: 30 telehealth companies in March, 7 peptide sellers in April, 25 more telehealth companies in June [8]. An “RUO” label is not a legal shield once a seller markets a product for human use.
| Category | What it means | Compounding under 503A? | Where the category 2 peptides sit |
|---|---|---|---|
| Category 1 | Adequate data, no significant safety risk identified | Enforcement discretion, conditions apply | No peptide from this list is here yet |
| Category 2 | Significant safety risk identified | Not permitted | 7 of the original 19 peptides remain here |
| Removed, unlisted | Taken off Category 2, not added to the 503A list | Not permitted | 12 peptides, incl. BPC-157, TB-500, MOTS-c |
| Category 3 | Insufficient data to evaluate | Not permitted until renominated | Not applicable to this list |
Key takeaways
- The category 2 peptides list began with 19 peptides in September 2023, flagged for impurity, characterization, and safety-data gaps [1].
- In April 2026, FDA removed 12 of those peptides from Category 2, but removal is not authorization; none are legal to compound yet [2][3].
- The PCAC meeting on July 23-24, 2026 reviews seven peptides, including BPC-157 and MOTS-c, with a second batch of five slated before February 2027.
- FDA’s own scientists recommended against changing status for the seven peptides under review, according to NPR reporting [4].
- GLP-1 compounding rules run on a separate track from the category 2 peptides list, with their own 2025 enforcement deadlines and a pending 2026 bulks-list exclusion [5].
Frequently asked questions
What is the category 2 peptides list?
It is FDA’s list of bulk drug substances the agency says present a significant safety risk for compounding under Section 503A. FDA placed 19 peptides on it in September 2023, citing impurity and safety-data concerns [1].
Is BPC-157 still illegal to compound?
BPC-157 was removed from Category 2 in April 2026, but it was never added to the authorized 503A bulks list. As of July 2026, compounding it is still not permitted, and its status is under PCAC review.
Does removal from Category 2 mean a peptide is legal now?
No. Removal takes a peptide out of the “flagged as unsafe” category but does not place it on the authorized compounding list. Regulatory attorneys describe this middle status as unresolved, not approved [3].
What happens at the July 2026 PCAC meeting?
The committee reviews evidence on seven removed peptides and issues an advisory recommendation on adding them to the 503A list. A vote is not a final rule; rulemaking would follow separately and can take over a year.
Is sermorelin on the category 2 peptides list?
No. Sermorelin is compoundable today under 503A with a documented medical-necessity attestation. It has never appeared on a Category 2 list and is governed by different conditions than BPC-157 or MOTS-c.
Are compounded GLP-1 peptides part of the category 2 list?
No. Semaglutide and tirzepatide compounding is governed by separate 503A/503B shortage rules and a 2026 bulks-list proposal, not by the Category 2 significant-safety-risk designation covered here [5].
The category 2 peptides list sits inside a broader framework built on Section 503A pharmacy compounding, Section 503B outsourcing facilities, and the PCAC that recommends which substances belong on each authorized list; peptides like BPC-157, TB-500, MOTS-c, DSIP, Semax, and Epitalon sit between Category 2 and formal authorization, while sermorelin, tesamorelin, and the GLP-1 rules follow separate tracks, and Compound Universe follows all of them against FDA’s own published dockets rather than secondhand summaries.
Bottom line: the category 2 peptides list has moved twice in under three years, expanding in 2023 and partially clearing in April 2026, but no peptide here has moved from restricted to authorized. Anyone tracking BPC-157, TB-500, MOTS-c, or the other removed peptides should watch the July 2026 PCAC outcome, not the removal announcement, before assuming anything on the category 2 peptides list is settled.
References
- FDA. Certain Bulk Drug Substances for Use in Compounding That May Present Significant Safety Risks. fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks.
- FDA. Bulk Drug Substances Used in Compounding Under Section 503A of the FD&C Act. fda.gov/drugs/human-drug-compounding/bulk-drug-substances-used-compounding-under-section-503a-fdc-act.
- Frier Levitt. FDA to Remove 12 Popular Peptides from the Category 2 “Do Not Compound” List. frierlevitt.com/articles/fda-peptides-do-not-compound-list-update-2026/ (April 2026 update).
- NPR. FDA scientists flag concerns with peptides, the trendy molecules RFK Jr. supports. npr.org/2026/06/30/nx-s1-5876301/peptides-fda-panel-compounding-rfk.
- FDA. FDA Proposes to Exclude Semaglutide, Tirzepatide, and Liraglutide on 503B Bulks List. fda.gov/news-events/press-announcements/fda-proposes-exclude-semaglutide-tirzepatide-and-liraglutide-503b-bulks-list; comment period extended to July 30, 2026 per Federal Register notice, federalregister.gov/documents/2026/06/26/2026-12937/.
- FDA. Evaluation of Bulk Drug Substances Nominated for Use in Compounding Under Section 503A (Category 1/2/3 definitions). fda.gov/media/121315/download.
- Restore Health Consulting. FDA Adds Several Peptides to Category 2 Bulks List, Restricting Them From Compounding. restorehealthconsulting.com/news/fda-adds-several-peptides-to-category-2-bulks-list-restricting-them-from-compounding.
- FDA. FDA Warns 30 Telehealth Companies Against Illegal Marketing of Compounded GLP-1s (March 2026); FDA Warning Letters database, e.g. Gram Peptides, 721806 (March 31, 2026), covering the April 2026 peptide-seller wave and the June 2026 telehealth wave. fda.gov/news-events/press-announcements/fda-warns-30-telehealth-companies-against-illegal-marketing-compounded-glp-1s; fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/gram-peptides-721806-03312026.
- FDA. Pharmacy Compounding Advisory Committee Meeting Records (October 29, 2024 and December 4, 2024), covering votes on CJC-1295, ipamorelin, and thymosin alpha-1. fda.gov/media/185641/download.
- FDA. Declaratory Order: Resolution of Shortages of Tirzepatide Injection Products (December 19, 2024) and Declaratory Order: Resolution of Shortages of Semaglutide Injection Products (February 2025); compounding deadlines summarized in Harris Beach Murtha, GLP-1 Weight-Loss Drugs Off Shortage List; Deadlines to Stop Compounding. fda.gov/media/184606/download; fda.gov/media/185526/download; harrisbeachmurtha.com/insights/glp-1-weight-loss-drugs-off-shortage-list-deadlines-to-stop-compounding/.