Prescriber reference
Which peptides can a 503A pharmacy compound right now? FDA's rules for compounded peptides moved three times in 2026, and most summaries get the result wrong. Coming off the do-not-compound list is not permission, and an advisory committee recommendation is not a rule. This page tracks where each commonly prescribed peptide actually stands, with sources, so you can check before you write.
Reviewed September 10, 2026
| Peptide | Status | Where it stands |
|---|---|---|
| BPC-157 | Not yet · PCAC backed (Pending rulemaking) | Off-limits since September 2023, removed from Category 2 in April 2026, and recommended for the 503A bulks list by the FDA advisory committee in July 2026 (8-6-1). Still not lawfully compoundable until FDA finalises a rule. |
| Semaglutide | Approved drug rules (Approved drug) | The shortage was declared resolved in February 2025 and 503A pharmacies had to stop compounding copies by April 2025. Only genuinely individualized, clinically documented formulations remain arguable. Salt forms (semaglutide sodium or acetate) have no lawful basis per FDA. |
| Tirzepatide | Approved drug rules (Approved drug) | Shortage resolved December 2024; 503A copies had to stop by February 2025. Same copy rules as semaglutide, and FDA has proposed excluding both from the 503B bulks list. |
| Ipamorelin | Not compoundable (Off-limits) | The advisory committee voted against adding it in October 2024 and the 503A nomination was withdrawn. Ipamorelin acetate is still Category 2 on the 503B list. |
| CJC-1295 | Not compoundable (Off-limits) | Advisory committee voted decisively against it in December 2024; nomination withdrawn; not on any upcoming FDA docket. |
| Sermorelin | Compoundable (Compoundable) | Never placed in Category 2. Sermorelin acetate was a component of an FDA-approved drug (Geref, discontinued in 2008 for commercial reasons), which keeps a compounding pathway open. Widely compounded today. |
| Tesamorelin | Approved drug rules (Approved drug) | FDA-approved as Egrifta (2010). Compounded versions are constrained by the "essentially a copy" rules rather than the bulks list. |
| TB-500thymosin beta-4 fragment | Not yet · PCAC backed (Pending rulemaking) | Removed from Category 2 in April 2026 and recommended by the advisory committee in July 2026 (8-6-1). Awaiting rulemaking; not yet compoundable. FDA entries cover the LKKTETQ fragment, not full-length thymosin beta-4. |
| Thymosin alpha-1 | Not compoundable (Off-limits) | Category 2 in 2023, advisory committee voted against it in December 2024, nomination withdrawn. No scheduled reconsideration. |
| MOTS-c | Not yet · PCAC backed (Pending rulemaking) | Recommended by the advisory committee in July 2026 (7-5-2). Awaiting rulemaking; not yet compoundable. |
| KPV | Not yet · PCAC backed (Pending rulemaking) | Recommended by the advisory committee in July 2026 (8-6-1). Awaiting rulemaking; not yet compoundable. |
| Semax | Not yet · PCAC backed (Pending rulemaking) | Recommended by the advisory committee in July 2026 (8-5-1). Awaiting rulemaking; not yet compoundable. |
| Epitalon | Not yet · PCAC backed (Pending rulemaking) | Recommended by the advisory committee in July 2026 (7-4-1). Awaiting rulemaking; not yet compoundable. |
| DSIPemideltide | Not compoundable (Off-limits) | The one July 2026 rejection: the advisory committee voted against adding it (6-7-1). Off the category lists with no path back scheduled. |
| Selank | Not compoundable (Off-limits) | Category 2 in 2023, nomination withdrawn since. Unlike Semax, it is not on any advisory committee docket. |
| AOD-9604 | Not compoundable (Off-limits) | Advisory committee voted against it in December 2024; nomination withdrawn; not on upcoming dockets. |
| GHK-Cu, topical | 503A Category 1 (Compoundable) | Non-injectable GHK-Cu sits in Category 1 today (restored in May 2026 after a withdrawal mix-up), so it can be compounded under FDA enforcement discretion. |
| GHK-Cu, injectable | Not compoundable (Off-limits) | The injectable route was removed from the lists in April 2026 and is on the next advisory committee docket, scheduled by February 2027. |
| Melanotan II | Not compoundable (Off-limits) | Removed from Category 2 in April 2026, which did not authorize compounding. On the next advisory committee docket, scheduled by February 2027. |
| PT-141bremelanotide | Approved drug rules (Approved drug) | FDA-approved as Vyleesi (2019), so compounded versions are constrained by the approved-drug copy rules rather than the bulks list. |
| Kisspeptin-10 | 503A Category 2 (Off-limits) | One of the few 2023 entries still sitting in Category 2 today. Off-limits. |
| Cathelicidin LL-37 | Not compoundable (Off-limits) | Removed from Category 2 in April 2026; on the next advisory committee docket, scheduled by February 2027. |
| NAD+ | 503A Category 1 (Compoundable) | NAD and NAD disodium are in Category 1, so compounding proceeds under FDA enforcement discretion. Technically a coenzyme, not a peptide, but it lives on every peptide menu. |
| IbutamorenMK-677 | 503A Category 2 (Off-limits) | Not a peptide (a small-molecule GH secretagogue) but usually shopped alongside them. Category 2 on both the 503A and 503B lists. Off-limits. |
Reference only, not legal or medical advice. Categories shift, state rules differ, and pharmacies make their own calls. Confirm with your 503A pharmacy before writing.
Section 503A lets a licensed pharmacy compound a drug for an individual patient from bulk substances that are FDA-approved, covered by a USP monograph, or on the 503A bulks list. Most peptides are none of the three yet, so they live or die by where FDA's interim review has sorted their nomination.
- Category 1
- Nominated substances FDA has not flagged while it reviews the bulks list. 503A pharmacies can compound them in the meantime. This is the lane most prescribable peptides sit in.
- Category 2
- Nominated substances FDA says raise significant safety risks. Pharmacies that compound these invite enforcement, and most simply refuse. Off-limits in practice.
- On no list at all
- When a nomination is withdrawn, the substance drops off both categories. That is where the 12 peptides removed in April 2026 landed. No list means no enforcement discretion, so it is still not compoundable. Removal is not permission.
- Advisory committee backing
- A recommendation that a peptide be added to the 503A bulks list is the first step, not the finish line. Nothing changes until FDA finalises a rule, which can take a year or more.
- FDA-approved drugs
- Peptides with an approved product, like semaglutide or tirzepatide, follow different rules. Compounded copies were allowed during shortages; with shortages resolved, that lane has closed.
How we got here, from the 2023 Category 2 listings to the rulemaking that decides what happens next.
- Sep 202319 peptides moved to Category 2FDA placed 19 substances, including BPC-157, CJC-1295, ipamorelin, and TB-500, into Category 2 of the interim 503A list, citing significant safety risks. This ended most legitimate pharmacy compounding of these agents.
- Oct - Dec 2024Advisory committee rejects the first waveThe Pharmacy Compounding Advisory Committee reviewed ipamorelin, ibutamoren, kisspeptin-10, CJC-1295, AOD-9604, and thymosin alpha-1, and voted against adding any of them to the 503A bulks list.
- Dec 2024 - Apr 2025GLP-1 shortages end, compounded copies wind downFDA declared the tirzepatide shortage resolved in December 2024 and semaglutide in February 2025. 503A pharmacies had to stop compounding copies by February and April 2025 respectively.
- Feb 2026HHS signals a reversalThe HHS Secretary announced that most of the 2023 Category 2 peptides would be brought back into the compounding conversation, citing roughly 14 substances.
- Apr 202612 peptides removed from Category 2, with a catchFDA removed 12 peptides, including BPC-157, TB-500, KPV, and MOTS-c, from Category 2 via withdrawn nominations. FDA was explicit that removal does not make them eligible for compounding. They landed on no list at all.
- Jul 2026Advisory committee backs six peptidesAgainst FDA staff recommendations, the committee voted to recommend BPC-157, KPV, TB-500, MOTS-c, Epitalon, and Semax for the 503A bulks list, and voted down DSIP. The votes are nonbinding.
- By Feb 2027Second committee meeting scheduledA follow-up meeting will review the remaining removed peptides: injectable GHK-Cu, Melanotan II, Cathelicidin LL-37, Dihexa, and PEG-MGF.
- NextRulemaking decides itAdding anything to the 503A bulks list requires notice-and-comment rulemaking. Analysts put the earliest finish in 2027. Until then, or until FDA states enforcement discretion, the recommended six stay off-limits.
Status is the easy part. 503A compounding is for an individual patient with a documented clinical need. That means medical necessity, written consent, baseline labs, a monitoring plan, and follow-up notes that justify every renewal.
Ena writes that chart from the consult itself.
See the peptide workflowFollow-up noteGH secretagogue protocol
- Indication and necessityDiagnosis, why an FDA-approved alternative is not suitable, rationale for this peptide
- Written informed consentCompounded and off-label status, known and unknown risks, monitoring expectations
- Baseline and monitoring labsIGF-1, fasting glucose, HbA1c, lipids reviewed; repeat at 12 weeks
- Pharmacy sourceNamed 503A pharmacy, licensed in the patient's state
- Titration and stop pointDose response recorded against a defined stop point
Written from the visit, in your format, sent to your EMR
Not yet. BPC-157 was removed from FDA Category 2 in April 2026 and the FDA advisory committee recommended it for the 503A bulks list in July 2026, but a recommendation is not a rule. Until FDA finalises rulemaking or states enforcement discretion, a 503A pharmacy has no lawful basis to compound it. As of our last review, FDA had done neither.
Sources
Last reviewed September 10, 2026
- May 2026FDA: Bulk drug substances used in compounding under 503A (opens in a new tab)
- May 2026FDA: 503A nominated substances category list (PDF) (opens in a new tab)
- 2026FDA: Bulk substances that may present significant safety risks (opens in a new tab)
- Jul 2026FDA: July 23-24, 2026 Pharmacy Compounding Advisory Committee (opens in a new tab)
- Sep 2026FDA: Concerns with unapproved GLP-1 drugs used for weight loss (opens in a new tab)
- Apr 2026Frier Levitt: FDA peptides do-not-compound list update (opens in a new tab)
- Jul 2026McDermott: PCAC backs majority of peptides in two-day meeting (opens in a new tab)
- Aug 2026Holland & Knight: FDA advisory committee endorses compounding of certain peptides (opens in a new tab)
Keep reading
- Peptide therapy workflowNotes that document necessity and consent, titration in the care plan, follow-ups that justify renewal.
- Labs analysisBaseline and monitoring labs read in your order, flagged against your ranges.
- AI care plansTitration, instructions and repeat labs drafted into a plan in your format.
- Skills libraryFree, clinician-written skills for GI-MAP, DUTCH, thyroid, OAT and bloodwork review.
Ena drafts the note, the titration plan and the follow-ups from the consult, and sends them to your EMR when you approve.
