Peptide APIs, each listed with its FDA status.
Sermorelin, gonadorelin and oxytocin are in 503B Category 1. Most other peptides here have no 503B pathway, and each line says so.

Read before ordering
- None of the peptides on this page is on FDA's 503B bulks list.
- For 503A pharmacies: HHS published a draft enforcement policy on Oct 30, 2026 for six peptides in specific forms and routes (BPC-157 acetate, TB-500 acetate, Epitalon acetate, MOTS-c acetate, KPV acetate, Semax free base). It is a draft and nonbinding, it doesn't cover 503B facilities, and it has 10 conditions. See For 503A pharmacies.
- Items FDA treats as biologics (proteins over 40 amino acids) are labeled not compoundable.
What we list (53)
Status as of Nov 14, 2026. Sources: FDA 503B categories list (updated Mar 21, 2025), FDA Category 2 page (current Apr 22, 2026), 21 CFR 216.24, 21 CFR 530.41, 21 CFR 600.3(h)(6), HHS FR 2026-22192. No item we list is on the 503B bulks list today. Shortage status is checked when we price your request. Labels are a starting point, not a determination for your facility.
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503B Category 3 (nominated without adequate support).
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FDA previously listed safety concerns (nomination withdrawn from Category 2).
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503A: covered by the HHS draft six-peptide policy (Oct 30, 2026) in the acetate form, by the listed routes, if all 10 conditions are met. Draft, nonbinding.
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Outside the HHS 503A draft policy (acetate form only).
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Not found in FDA’s 503B category list; status to be verified.
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FDA previously listed safety concerns (nomination withdrawn from Category 2).
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FDA previously listed safety concerns (nomination withdrawn from Category 2).
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FDA previously listed safety concerns (nomination withdrawn from Category 2).
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503A: covered by the HHS draft six-peptide policy (Oct 30, 2026) in the acetate form, by the listed routes, if all 10 conditions are met. Draft, nonbinding.
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503A: Category 2 (FDA safety risk).
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503A: covered by the HHS draft six-peptide policy (Oct 30, 2026) in the acetate form, by the listed routes, if all 10 conditions are met. Draft, nonbinding.
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FDA previously listed safety concerns (nomination withdrawn from Category 2).
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FDA previously listed safety concerns (nomination withdrawn from Category 2).
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503A: covered by the HHS draft six-peptide policy (Oct 30, 2026) in the acetate form, by the listed routes, if all 10 conditions are met. Draft, nonbinding.
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Outside the HHS 503A draft policy (acetate form only).
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FDA previously listed safety concerns (nomination withdrawn from Category 2).
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Outside the HHS 503A draft policy (acetate form only).
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503B Category 3 (nominated without adequate support).
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FDA previously listed safety concerns (nomination withdrawn from Category 2).
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HHS draft 503A policy lists Semax free base (intranasal), not the acetate.
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44 amino acids; biologic status unverified.
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503B Category 3 (nominated without adequate support). Also on the withdrawn-from-Category-2 list.
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503A: covered by the HHS draft six-peptide policy (Oct 30, 2026) in the acetate form, by the listed routes, if all 10 conditions are met. Draft, nonbinding.
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Category 2 for injectable and nasal use; Category 1 for other routes.
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Treated as a likely biologic (protein over 40 amino acids); FDA has not ruled on this item.
Questions
Which peptides have a 503B route?
None is on the 503B bulks list. Sermorelin, gonadorelin and oxytocin are in 503B Category 1 (interim policy).
What does "FDA previously listed safety concerns" mean?
FDA had placed the substance in Category 2 before its nomination was withdrawn. It has no 503B pathway today.
Do you state the form?
Yes. Salt and form are on every quote line.
Every quote includes
A written price and pack size per item, the lot COA, and each item's FDA status as of the date we price it. Nothing ships until you approve the price sheet.
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