Why some peptides are still Category 2 after the 2026 reclassification news
Headlines move fast. Federal Register notices do not.
TL;DR
- FDA removed 12 peptides from Category 2 on April 22, 2026, after their nominations were withdrawn. Of the 19 peptides FDA added in 2023, only MK-677 (ibutamoren) and kisspeptin-10 remain in Category 2 as of September 14, 2026.
- Category 2 is FDA's list of substances that raise significant safety risks. FDA's interim policy of not taking action against compounding with a substance not yet on the 503A bulks list applies only to Category 1 substances.
- Status can change each time FDA updates its category list (last updated May 14, 2026). Patients and physicians should check the current FDA list, not last week's news cycle.
What it is
The FDA sorts nominated bulk drug substances for 503A compounding into categories. Category 1 includes substances under evaluation. Category 2 includes substances FDA says raise significant safety risks (FDA Bulk Drug Substances List 1 — 503A). Category 3 includes substances nominated without adequate support. FDA's interim policy of not taking action against compounding with a substance not yet on the 503A bulks list applies only to Category 1 substances, when other conditions are met.
How it works
Picture a long staircase with two landings. Category 1 is the upper landing — FDA's interim policy of not taking action applies to substances there, when other conditions are met. Category 2 is the lower landing — FDA says substances there raise significant safety risks. Leaving the lower landing does not mean reaching the upper one. In February 2026, HHS Secretary Robert F. Kennedy Jr. said in a podcast interview that FDA would soon make more peptides accessible. That was not a formal proposal; the formal step was FDA's April 2026 change to its category list. On April 22, 2026, FDA took 12 peptides off the lower landing, but it did not place them on the upper landing. They are in no category. MK-677 and kisspeptin-10 are still on the lower landing.
Who asks about it
People usually ask this question after reading a headline that sounded like everything had changed and finding their compound of interest still unavailable. The disconnect between news coverage and FDA's actual category list is real — and worth understanding before booking a physician appointment expecting access.
What the literature and federal record show
As of September 14, 2026, KPV, MOTS-c, DSIP, epitalon, Semax, and melanotan-2 are not in Category 2. FDA removed them on April 22, 2026, together with BPC-157, TB-500, and four other peptides. FDA removed Selank earlier, on September 27, 2024. None of these peptides is in any FDA 503A category, and none is on the 503A bulks list. Of the 19 peptides FDA added to Category 2 in 2023, only MK-677 (ibutamoren) and kisspeptin-10 remain there. At its October 29, 2024 meeting, FDA's Pharmacy Compounding Advisory Committee voted against adding ibutamoren (MK-677) to the 503A bulks list. Each peptide is evaluated separately — manufacturing standards, identity testing, and safety review proceed compound by compound (Federal Register, FDA notices). As of September 2026, FDA has not made a final decision on BPC-157 or TB-500. At its July 23–24, 2026 meeting, FDA's Pharmacy Compounding Advisory Committee voted separately on each. Both votes were 8 yes, 6 no, and 1 abstention to recommend adding the peptide to the Section 503A bulk drug substances list. The committee is advisory, and formal addition to the list requires further FDA action. At the same meeting, the committee voted to recommend KPV, MOTS-c, Semax, and Epitalon, and voted against emideltide (DSIP).
What to know before considering it
Always check the current FDA category list before assuming a peptide is available through a 503A pharmacy. Status changes are public but not always promoted. A physician's prescription cannot create access for a peptide that 503A pharmacies cannot legally compound.
The Halftime POV
Reclassification news cycles move faster than regulatory action. The honest read: progress is real and partial. The right answer when a peptide of interest is still Category 2 is patience plus accuracy — not a workaround through gray-market sources.
Related reading:
- Category 1 vs Category 2 peptides: the access framework
- Secretary Kennedy's February 2026 peptide remarks
- The 12 peptides removed from FDA restriction in 2026
FAQ
Q: What does Category 2 mean for peptide access? A: Category 2 means a substance has been nominated for the FDA's 503A bulk drug substance list and FDA says it raises significant safety risks. FDA's interim policy of not taking action against compounding with a substance not yet on the bulks list applies only to Category 1 substances, when other conditions are met.
Q: Which peptides are still Category 2 as of September 2026? A: As of September 14, 2026, two of the 19 peptides FDA added to Category 2 in 2023 remain there: ibutamoren mesylate (MK-677) and kisspeptin-10. FDA removed BPC-157, TB-500, KPV, MOTS-c, DSIP, epitalon, Semax, and melanotan-2 from Category 2 on April 22, 2026, and removed Selank on September 27, 2024. Those peptides are not in any FDA 503A category and are not on the 503A bulks list. Always check the current FDA list before relying on availability. As of September 2026, FDA has not made a final decision on BPC-157 or TB-500. At its July 23–24, 2026 meeting, FDA's Pharmacy Compounding Advisory Committee voted separately on each. Both votes were 8 yes, 6 no, and 1 abstention to recommend adding the peptide to the Section 503A bulk drug substances list. The committee is advisory, and formal addition to the list requires further FDA action.
Q: Why has the FDA not moved every peptide back to Category 1? A: FDA has not moved the removed peptides into Category 1. The 12 peptides FDA removed on April 22, 2026 left Category 2 because their nominations were withdrawn, and they are now in no category. FDA's July 23, 2026 advisory committee slides say FDA is evaluating these substances at its discretion. Each peptide is reviewed individually. Reclassification depends on the peptide's identity, purity, manufacturing track record, and the FDA's safety review of the published evidence. Some peptides have decades of animal data but limited human trials, which slows the review.
Disclaimer
Several peptides discussed in this article — including KPV, MOTS-c, DSIP, epitalon, Selank, Semax, and melanotan-2 — were previously in FDA's Category 2. FDA removed them from Category 2 (September 2024 or April 2026, depending on the peptide). As of September 14, 2026, they are not in any FDA 503A category and are not on the 503A bulks list. As of September 2026, FDA has not made a final decision on BPC-157 or TB-500. At its July 23–24, 2026 meeting, FDA's Pharmacy Compounding Advisory Committee voted separately on each. Both votes were 8 yes, 6 no, and 1 abstention to recommend adding the peptide to the Section 503A bulk drug substances list. The committee is advisory, and formal addition to the list requires further FDA action. This article is educational and is not medical advice. Halftime Health only prescribes through licensed physicians in states where our partner physicians are credentialed.
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Sources
- FDA. Bulk Drug Substances Nominated for Use in Compounding Under Section 503A — Category 1.
- Federal Register. Food and Drug Administration agency notices.
This article discusses compounds whose FDA compounding status has been under review (see our FDA categorization explainer). Halftime Health protocols are prescribed by licensed physicians and prepared by licensed 503A compounding pharmacies. Compounded drugs are not FDA-approved and have not been evaluated by FDA for safety or effectiveness. This article is provided for educational purposes only and does not constitute medical advice or an offer to sell.
Frequently asked questions
What does Category 2 mean for peptide access?
Category 2 means a substance has been nominated for the FDA's 503A bulk drug substance list and FDA says it raises significant safety risks. FDA's interim policy of not taking action against compounding with a substance not yet on the bulks list applies only to Category 1 substances, when other conditions are met.
Which peptides are still Category 2 as of September 2026?
As of September 14, 2026, two of the 19 peptides FDA added to Category 2 in 2023 remain there: ibutamoren mesylate (MK-677) and kisspeptin-10. FDA removed BPC-157, TB-500, KPV, MOTS-c, DSIP, epitalon, Semax, and melanotan-2 from Category 2 on April 22, 2026, and removed Selank on September 27, 2024. Those peptides are not in any FDA 503A category and are not on the 503A bulks list. Always check the current FDA list before relying on availability. As of September 2026, FDA has not made a final decision on BPC-157 or TB-500. At its July 23–24, 2026 meeting, FDA's Pharmacy Compounding Advisory Committee voted separately on each. Both votes were 8 yes, 6 no, and 1 abstention to recommend adding the peptide to the Section 503A bulk drug substances list. The committee is advisory, and formal addition to the list requires further FDA action.
Why has the FDA not moved every peptide back to Category 1?
FDA has not moved the removed peptides into Category 1. The 12 peptides FDA removed on April 22, 2026 left Category 2 because their nominations were withdrawn, and they are now in no category. FDA's July 23, 2026 advisory committee slides say FDA is evaluating these substances at its discretion. Each peptide is reviewed individually. Reclassification depends on the peptide's identity, purity, manufacturing track record, and the FDA's safety review of the published evidence. Some peptides have decades of animal data but limited human trials, which slows the review.
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