1. Which peptides can a clinic legally source right now?
None of the peptides in this year’s review are on the 503A bulks list yet. Coming off the do-not-compound list is not permission, and an advisory committee vote is not a rule. Both happened in 2026, and the practical position at the time of writing is that these substances sit outside all three interim categories while the FDA works through rulemaking.
| Peptide | Where it sits (16 Sep 2026) | What that means for sourcing | Electronic prescribing |
|---|---|---|---|
| BPC-157 | Removed from Category 2 on 22 Apr 2026. Recommended for the 503A bulks list by the Pharmacy Compounding Advisory Committee on 23–24 Jul 2026, 8–6 with 1 abstention. | Not on the list. The recommendation is non-binding, and FDA must complete notice-and-comment rulemaking before a compounder has unambiguous authority. | No. No entry in the national drug database e-prescribing runs on — it goes by fax. |
| KPV | Removed from Category 2 on 22 Apr 2026. Recommended 23–24 Jul 2026, 8–6 with 1 abstention. | Same position as BPC-157 — recommended, not listed. | No. Fax only. |
| TB-500 (thymosin beta-4 fragment) | Removed from Category 2 on 22 Apr 2026. Recommended 23–24 Jul 2026, 8–6 with 1 abstention. | Same position — recommended, not listed. | No. Fax only. |
| MOTS-c | Removed from Category 2 on 22 Apr 2026. Recommended 23–24 Jul 2026, 7–5 with 2 abstentions. | Same position, on a narrower vote. | No. Fax only. |
| Semax | Removed from Category 2 on 22 Apr 2026. Recommended by the committee in the same meeting. | Same position — recommended, not listed. | No. Fax only. |
| Epitalon | Removed from Category 2 on 22 Apr 2026. Recommended by the committee in the same meeting. | Same position — recommended, not listed. | No. Fax only. |
| DSIP (emideltide) | Removed from Category 2 on 22 Apr 2026. Voted down 23–24 Jul 2026, 7–6 with 1 abstention — the only peptide of the seven the committee declined to recommend. | No route onto the list from this review. Anyone offering it is working outside the process that is currently running. | No. Fax only. |
| GHK-Cu (injectable), Melanotan II, LL-37 (cathelicidin), DiHexa, PEG-MGF | Removed from Category 2 on 22 Apr 2026. FDA has said the committee will consider these before the end of February 2027. | Unlisted and not yet reviewed — the same gray area as the six above, with the hearing still ahead of them rather than behind. | No. Fax only. |
| Semaglutide, tirzepatide, liraglutide | Off the shortage list (tirzepatide Dec 2024, semaglutide Feb 2025). FDA proposed not to include them on the 503B bulks list (Federal Register, 1 May 2026); the comment period was extended to 30 Jul 2026 and no final determination had published as of 16 Sep 2026. | The FDA-approved products are prescribed normally. What is closing is compounding from bulk substance at outsourcing-facility scale. | Yes — the approved products carry database entries and transmit like any other prescription. |
Two things follow from that table, and they point in opposite directions. The peptide side is more permissive than it was in March and still not permissive: the do-not-compound designation is gone, the endorsement exists, the legal authority does not. The GLP-1 side is moving the other way — the shortage that justified compounding is over, and the FDA has proposed closing the bulk route for good.
2. What do the FDA categories actually mean?
They are an interim filing system, not a drug schedule. The FDA sorts substances nominated for the 503A bulks list into three buckets while it evaluates them, and the bucket determines what the agency says it will do about a pharmacy that compounds with the substance.
| Category | What FDA says | Practical effect |
|---|---|---|
| Category 1 | Nominated with enough supporting information to evaluate, and no significant safety risk identified so far. | FDA does not intend to take enforcement action against compounding with it while the evaluation runs, provided the other conditions are met. |
| Category 2 | Nominated with enough information to evaluate, and FDA has identified significant safety risks pending further evaluation. | The do-not-compound bucket. FDA would consider action under its general enforcement policies. |
| Category 3 | Nominated without enough supporting information for FDA to evaluate. | No Category 1 protection. Same exposure to general enforcement policy. |
Separately from the categories, a bulk substance is eligible for 503A compounding at all only if it is a component of an FDA-approved drug, is the subject of a USP or NF monograph, or appears on the 503A bulks list. That is the test that matters, and it is why removal from Category 2 does not create a right to compound: it deletes a warning, it does not satisfy the eligibility test.
One more piece of 2026 housekeeping worth knowing if you read the lists yourself: the FDA has said it does not intend to place substances nominated on or after 7 January 2025 into the interim categories at all.
3. What did the July 2026 vote actually change?
It produced a recommendation, and recommendations are not law. The Pharmacy Compounding Advisory Committee met on 23–24 July 2026 and recommended six of the seven peptides in front of it for the 503A bulks list. The votes were close — 8–6, 7–5 — and reporting from the meeting noted the panel landed against the position FDA’s own reviewers had taken on the seven.
What has to happen next is a formal notice-and-comment rulemaking, which typically runs eight to twelve months. Until that concludes, a compounding pharmacy preparing these substances is not operating under a rule that permits it; it is operating in the space left by a deleted warning.
| What people say it means | What it means |
|---|---|
| “BPC-157 is FDA approved now.” | It is not approved, and approval is not what was voted on. An advisory committee recommended adding a bulk substance to a compounding list. |
| “It came off Category 2, so it is cleared.” | Removal followed the nominations being withdrawn. It deletes the significant-safety-risk designation; it does not put the substance on the list that permits compounding. |
| “The vote makes it legal to compound.” | The vote is non-binding. FDA must run rulemaking before there is unambiguous authority. |
| “My pharmacy says it is fine.” | That is a question for the pharmacy’s own regulator and counsel. What you can do is require the paperwork: licence, state, and what the pharmacy is relying on. |
The durable version of this pattern — why sourcing keeps moving and what to build around it — is in the 2026 compounding squeeze.
4. Where do the GLP-1s sit now?
The two legal doors that allowed large-scale compounded GLP-1s are both closing, and for different reasons. The first was shortage: compounding expanded because the approved products were in shortage, and that justification ended when tirzepatide came off the shortage list in December 2024 and semaglutide in February 2025.
The second is the 503B bulks list. On 30 April 2026 the FDA announced, and on 1 May published in the Federal Register, a proposal not to include semaglutide, tirzepatide or liraglutide on that list — the agency’s position being that there is no clinical need for outsourcing facilities to compound them from bulk substance. The comment period was extended to 30 July 2026. As of 16 September 2026 no final determination had published.
For a clinic, the operational read is simple: plan around the approved products, and treat any compounded GLP-1 supply as a position that may not survive the final determination. That is a sourcing and patient-communication question more than a clinical one, and it is worth answering before a patient asks.
5. Which of these can your software actually send electronically?
None of the peptides above. Not in our system and not in anyone else’s. Electronic prescribing runs on a national drug database, and a prescription is transmitted by referencing a database entry for the product. A substance with no entry cannot be represented in the message at all, so there is nothing for any EMR to send. We checked the database our own e-prescribing runs on in September 2026: BPC-157, ipamorelin, CJC-1295 and TB-500 have no entry.
That is not a limitation of one vendor, and any vendor telling you their system e-prescribes BPC-157 is describing a fax. The honest architecture is the fax route, built properly:
| What you need | Why |
|---|---|
| A tracked fax from inside the chart | A peptide order that leaves the chart as an attachment on a personal email or a standalone fax machine has no audit trail, and the order is the only record that it was prescribed at all. |
| The formula stored, not retyped | Compounded orders are re-sent constantly. Retyping a formulation each time is how a strength changes by accident. |
| Delivery confirmation on the order | Fax fails silently. Without a confirmation written back to the order, a failed send looks identical to a filled prescription. |
| The same record for both routes | A clinic prescribing both approved products and compounded peptides should not be keeping two medication histories. One chart, two transmission paths. |
The prescribing side of this — what transmits, what does not, and why compounded orders behave differently — is covered in EMRs with EPCS for controlled substances.
6. What to check before you order
Five checks, in this order. The first one is the only one that changes month to month.
| # | Check | Where |
|---|---|---|
| 1 | Is the substance on the 503A bulks list, or in Category 1, today? | FDA’s bulk drug substances pages for section 503A. The lists move; a status you read in the spring is not a status you can rely on in the autumn. |
| 2 | Is your pharmacy licensed in your patient’s state, and is it a 503A or a 503B? | The pharmacy’s licence and the state board. A 503A compounds patient-specific prescriptions; a 503B is an outsourcing facility, and the lists that bind them are different. |
| 3 | What is the pharmacy relying on for this substance? | Ask in writing. A pharmacy that cannot say what authority it is compounding under is a pharmacy whose supply can stop without notice. |
| 4 | Does every dispense in your own records trace to a licensed source? | Your inventory. Lot, expiry, source, and the order it was dispensed against — the paper trail is the thing that survives a question about sourcing. |
| 5 | What do you tell a patient whose medication becomes unavailable? | Write the script before you need it. The clinics that handled the GLP-1 transition well had the conversation drafted in advance. |
If you are building the formulary from scratch, the sequencing question — licensing, pharmacy, software, sourcing — is laid out in how to start a peptide clinic.
7. Frequently asked questions
Is BPC-157 legal to prescribe now?
The July 2026 advisory committee recommended it for the 503A bulks list, which is a step toward compounding being permitted — not a decision that it is. It is not on the list, and the FDA has to complete rulemaking first. What a prescriber can lawfully do also depends on the pharmacy’s position and state law, which is a question for your own counsel rather than a blog.
What does “removed from Category 2” actually mean?
Category 2 is the bucket for nominated substances where the FDA has identified significant safety risks. The twelve peptides came off it on 22 April 2026 because the nominations were withdrawn, not because the safety questions were resolved. Removal deletes a designation; it does not add the substance to the list that permits compounding.
Can a 503B outsourcing facility make these instead?
The 503A and 503B routes run on different lists, and being under review for one says nothing about the other. For the GLP-1s, the 503B route is the one the FDA has proposed to close — that proposal is specifically about the 503B bulks list.
Why can my EMR not e-prescribe a peptide?
Because electronic prescribing transmits a reference to an entry in a national drug database, and these substances have no entry. There is nothing to reference, so no system can build the message. Compounded peptide orders go by fax, which is why it is worth having a fax route that is tracked inside the chart rather than a machine in the back office.
How long until the FDA decides?
Notice-and-comment rulemaking typically runs eight to twelve months from the point the agency starts it, and the committee recommendation was July 2026. There is no published date, and the GLP-1 determination from a comment period that closed in July 2026 had not published by mid-September — which is a fair indication of the pace.