Resource — regulatory reference
Peptide compounding status
Where each substance currently stands with FDA, and what that means for a 503A pharmacy or a product developer.
Last reviewed
Whether a substance can lawfully be compounded turns on which route it qualifies under, not on how widely it is sold. This page sets out where the commonly requested peptides and compounding substances sit today, and on what basis. It is a reference, not legal advice — confirm any substance against FDA's own bulk drug substances list before you formulate or purchase.
Section 503A
Three routes, and only three
Under Section 503A a bulk drug substance qualifies for compounding one of three ways. Everything on this page is sorted by which route applies.
| Route | What it means |
|---|---|
| USP or NF monograph | The substance has an active compendial monograph. Directly eligible. |
| Component of an approved drug | The substance is a component of a currently FDA-approved drug product. Directly eligible. |
| On the 503A bulks list | FDA has placed the substance on the list through rulemaking. This is the route the headline peptides are waiting on. |
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USP or NF monograph
The substance has an active compendial monograph.
EligibleComponent of an approved drug
The substance is a component of a currently FDA-approved drug product.
EligibleOn the 503A bulks list
FDA has placed the substance on the list through rulemaking. This is the route the headline peptides are waiting on.
PendingA substance that qualifies under none of the three cannot be compounded from bulk, whatever its reputation or availability.
Status
Directly eligible today
These qualify through a compendial monograph or as a component of an approved drug. They do not depend on the 503A bulks list.
- Eligible basis shown beside it
- Qualified weaker or less settled footing
- Not recommended committee outcome
| Substance | Basis | Status | Notes |
|---|---|---|---|
| Glutathione | USP monograph | Eligible | — |
| Oxytocin | USP monograph; component of an approved drug | Eligible | — |
| Methylcobalamin | USP monograph | Eligible | Vitamin B12 |
| Ascorbic acid | USP monograph | Eligible | Vitamin C |
| L-Carnitine | USP monograph | Eligible | — |
| NAD+ | Category 1 | Qualified | Under evaluation, not identified as presenting significant safety risks. FDA exercises enforcement discretion — a weaker footing than a monograph. |
| Sermorelin acetate | Component of a formerly approved drug | Qualified | The reference product was withdrawn. Qualifying on a withdrawn product is less settled than on a current approval. Confirm before relying on it. |
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Special case
GLP-1 receptor agonists: a special case
Semaglutide, tirzepatide and liraglutide are components of FDA-approved drugs, so they clear the first hurdle. That is not what governs them.
| What happened | When |
|---|---|
| Tirzepatide removed from FDA's drug shortage list | October 2024 |
| Semaglutide removed from FDA's drug shortage list | February 2025 |
| FDA proposed excluding semaglutide, tirzepatide and liraglutide from the 503B bulks list | 30 April 2026 |
| Comment period closed | 29 June 2026 |
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Where that leaves a 503A pharmacy
A compounded version of a commercially available drug is an "essentially a copy" problem. A pharmacy may compound these only where the prescriber documents a clinically significant difference for that specific patient — a documented allergy to an inactive ingredient in the commercial product, or a clinically justified concentration that is not commercially available. Patient preference and cost are not sufficient. Volume is capped at four or fewer prescriptions of that formulation a month.
Where that leaves a 503B outsourcing facility
If FDA's April proposal is finalised, neither the 503B bulks list nor the shortage list provides a basis to compound these from bulk.
Advisory committee
Recommended, not yet permitted
FDA's Pharmacy Compounding Advisory Committee met on 23–24 July 2026 and voted on seven substances.
| Substance | Considered for | Committee outcome |
|---|---|---|
| BPC-157 | Ulcerative colitis | Recommended |
| KPV | Wound healing, inflammatory conditions | Recommended |
| TB-500 | Wound healing | Recommended |
| MOTS-c | Obesity, osteoporosis | Recommended |
| Epitalon | Insomnia | Recommended |
| Semax | Cerebral ischaemia, migraine, trigeminal neuralgia | Recommended |
| Emideltide (DSIP) | Opioid withdrawal, chronic insomnia, narcolepsy | Not recommended |
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Pending and restricted
Under review, and still restricted
Under review
FDA has scheduled a further advisory committee review for February 2027 covering GHK-Cu, Melanotan II, Cathelicidin (LL-37), Dihexa acetate and PEG-MGF. GHK-Cu was withdrawn from Category 1 in April 2026 ahead of that review.
Category 2
Substances FDA has determined raise significant safety concerns. A Category 2 designation effectively rules the substance out for 503A compounding.
The April 2026 change
FDA removed twelve peptide bulk drug substances from Category 2 in April 2026. Removal is not permission: those substances sit outside both categories pending advisory committee review and final agency action.
Category assignments move. Check FDA's own bulk drug substances list before relying on any status here.
Where we fit
We manufacture and we test. We do not dispense.
TPP Tech operates a sterile injectable manufacturing site in San Diego with an on-site analytical laboratory. We manufacture under contract and we test — identity, purity, content and safety — for compounding pharmacies, product developers and research-use suppliers.
Nothing on this page is a commitment to supply any particular substance. What we can do is tell you what a formulation needs analytically, and test it. See our peptide analytical testing services.
FAQ
Frequently asked questions
Short answers on what the categories mean and what a recommendation does and does not change.
01Can a pharmacy compound BPC-157 or TB-500 right now?
No. FDA's advisory committee recommended both for the 503A bulks list in July 2026, but a recommendation is not authorisation. They reach the list through final rulemaking, which can take more than a year, and cannot lawfully be compounded until that is complete — even where pharmaceutical-grade API is available to buy.
02What does Category 1 actually mean?
That FDA is still evaluating the substance and has not identified significant safety risks, and is exercising enforcement discretion in the meantime. It is a weaker position than a USP monograph or a place on the 503A bulks list, and it can change.
03Is compounded semaglutide still legal?
Only narrowly. Semaglutide came off FDA's shortage list in February 2025, which removed the basis most compounders relied on. A 503A pharmacy may compound it where a prescriber documents a clinically significant difference for that specific patient, and fills four or fewer prescriptions of that formulation a month. Preference and cost do not qualify.
04Why were twelve peptides removed from Category 2 in April 2026?
FDA removed them ahead of advisory committee review. Removal is not permission — those substances now sit outside both categories pending review and final agency action.
05Does a USP monograph make a substance legal to compound?
It satisfies one of the three statutory routes under Section 503A. Other requirements still apply, including the restriction on compounding what is essentially a copy of a commercially available drug.
06Does TPP supply these substances?
We manufacture under contract and we test. We do not dispense compounded medicines, and this page is a regulatory reference rather than a product list.