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FDA's interim policy sorts nominated bulk substances into three categories, and only Category 1 gives a 503A pharmacy a workable basis to compound. Here is what each category means, which peptides sit where as of FDA's May 2026 list, and how to check the status yourself.
Under FDA's interim policy on compounding, the Category 2 peptides list is now one entry long for 503A pharmacies: FDA's May 14, 2026 update leaves kisspeptin-10 as the only peptide in 503A Category 2, after twelve others were removed in April. Those twelve left the categories entirely and gained no interim protection, so the category a peptide holds today still decides whether a 503A pharmacy has a workable basis to compound it.
This guide explains what the three categories are, where they came from, which peptides sit in each one today, how a substance actually reaches the 503A Bulks List, and how to check any of it yourself before you write a prescription.
Status as of October 13, 2026. FDA's compounding advisory committee recommended six peptide families for the 503A Bulks List in July 2026. FDA has not published a proposed rule, so none of them has been added, and FDA's category document still carries its May 14, 2026 date. We update this page when either changes.
A 503A pharmacy may compound with a bulk drug substance only when that substance meets one of three conditions in section 503A of the Food, Drug, and Cosmetic Act. It has a USP or NF monograph, it is a component of an FDA-approved drug, or it appears on the 503A Bulks List, the regulation at 21 CFR 216.23. Most peptides used in compounding meet none of the three.
The Bulks List is built by rulemaking, which is slow. FDA opened nominations in 2015 and has finalized only a handful of substances since. To avoid shutting down compounding with every nominated substance while it worked through the backlog, FDA issued an interim policy in 2017 that sorted nominations into categories and promised not to take action against pharmacies using the ones in Category 1.
On January 7, 2025, FDA replaced the 2017 interim policies with revised versions for both 503A and 503B. The categories survived for substances already nominated, and FDA closed the door behind them. In its own words, the agency "does not intend to place bulk drug substances nominated on or after January 7, 2025, into these categories." A new nomination now waits for rulemaking with no interim protection at all.
FDA's 503A bulk substances page defines each one.
Category 1: under evaluation. The substance was nominated with enough supporting information for FDA to evaluate it, may be eligible for the Bulks List, and appears on no other FDA list. FDA does not intend to act against a 503A pharmacy compounding with it, provided the pharmacy meets the other conditions of section 503A and the guidance: a prescription for an identified patient, a bulk substance from an FDA-registered manufacturer, and a valid certificate of analysis.
Category 2: significant safety risks. The substance was also fully nominated, and FDA has identified significant safety risks in its use in compounding. FDA extends it no interim protection and would consider enforcement action under its general policies.
Category 3: nominated without adequate support. The nomination lacked the information FDA needs to evaluate the substance. Category 3 substances get no interim protection either, and under the 2025 policy, supplying the missing information later does not move them into Category 1.
Category 1 is an enforcement posture. It carries no finding that the substance is safe or effective for any indication, and FDA can change it by updating the document, without notice and comment. GHK-Cu showed how fast that can happen: FDA removed its non-injectable routes from Category 1 on April 22, 2026, after the nominations were withdrawn, then announced it would add them back when one nominator clarified on May 5 that it meant to withdraw only the injectable route.
FDA publishes the categories as a single attachment, Bulk Drug Substances Nominated for Use in Compounding Under Section 503A, with its revision date printed at the top of every page. The May 14, 2026 version reads as follows for peptides.
| 503A status | Peptides | What it means for a 503A pharmacy |
|---|---|---|
| Category 1 | Vasoactive intestinal peptide; GHK-Cu for non-injectable routes; the small peptides glutathione and alanyl-L-glutamine | Workable basis to compound under the guidance conditions |
| Category 2 | Kisspeptin-10, the only peptide among six substances | FDA has identified significant safety risks; enforcement risk |
| Category 3 | GHRP-2, GHRP-6, mechano growth factor, thymulin acetate, cibinetide, human secretin | Insufficient nomination; no interim protection |
| Removed from Category 2 in April 2026 | BPC-157, KPV, TB-500, MOTs-C, epitalon, semax, emideltide, LL-37, dihexa, injectable GHK-Cu, PEG-MGF, melanotan II | Outside every category, and absent from the Bulks List |
Two cautions on that table. Category 2 still holds five non-peptide substances, ibutamoren among them, so a pharmacy citing "the Category 2 list" may be talking about either. And the companion page FDA keeps for Category 2, Certain Bulk Drug Substances That May Present Significant Safety Risks, lists 503A and 503B entries together, along with seventeen withdrawn peptide nominations. Read the column for the section that governs your order.
On April 15, 2026, FDA announced that it would remove twelve peptides from 503A Category 2 within seven days because their nominators had withdrawn the nominations. The same day it scheduled a Pharmacy Compounding Advisory Committee meeting for July 23 and 24 on seven of them, and said it would consult the committee on the other five before the end of February 2027.
FDA's stated reason was procedural: the nominators withdrew. The political backdrop was public. In late February 2026, HHS Secretary Robert F. Kennedy Jr. said he expected FDA to make roughly fourteen peptides more accessible through lawful compounding, which is the February news behind most searches for new FDA peptide guidance that month. FDA issued no new compounding guidance in February; its formal action came in April.
What the removals changed is narrow. A withdrawn nomination leaves the substance uncategorized, and an uncategorized substance has no interim enforcement protection. Law firms tracking the change, Polsinelli among them, reached the same reading: the twelve left the list of identified safety risks and entered a gray zone that still offers a pharmacy no safe harbor.
The Bulks List is the only status that makes a substance permanently lawful for 503A compounding, and it runs through four steps.
A substance is nominated to FDA's public docket with data on its chemistry, safety, historical use in compounding, and evidence of effectiveness, the four criteria FDA weighs. FDA evaluates the nomination and presents its review to the Pharmacy Compounding Advisory Committee, which votes on whether to recommend the substance. FDA then publishes a proposed rule in the Federal Register and takes comment. Finally it publishes a final rule amending 21 CFR 216.23.
The July 2026 meeting completed step two for seven peptide families. The committee voted for six, BPC-157, KPV, TB-500, MOTs-C, epitalon, and semax, and against emideltide. For six of the seven, the committee reached a different conclusion from FDA's staff. Our PCAC meeting takeaways cover the votes in detail. The vote is advisory. Until FDA publishes and finalizes a rule, none of the six is on the Bulks List, and because their nominations were withdrawn, none of them is in Category 1 either.
Everything above concerns 503A pharmacies, which compound for named patients. A 503B outsourcing facility works from a different statute section, a different bulks list based on clinical need, and its own interim categories. A substance can sit in Category 1 for 503A and have no 503B status at all, and the reverse.
The peptide entries diverge in practice. FDA's safety page lists GHRP-2, GHRP-6, and ipamorelin acetate in 503B Category 2, while for 503A the first two sit in Category 3 and ipamorelin's nomination was withdrawn. FDA keeps the 503B lists on its own 503B bulk substances page. Ask which section covers your order before you check a category, because the answer changes which list applies.
For a peptide in 503A Category 1, the category gives the pharmacy a workable basis to compound, and your remaining diligence is the pharmacy itself: license, sterile compounding standards, registered manufacturer, certificate of analysis. Our compounding pharmacy guide is the checklist for that conversation.
For anything in Category 2 or Category 3, or removed from Category 2 and not yet on the Bulks List, a pharmacy that compounds it is accepting enforcement risk, and a prescriber writing for it shares the exposure. A favorable committee vote changes none of that until a final rule publishes. Neither does a "research use only" vial from an online vendor, which sits outside the compounding framework entirely.
Whatever you prescribe, record the source and the status you relied on, with the date, in the chart next to the consent discussion. The peptide consent form template carries the sourcing disclosure a compounded prescription calls for, and the US legality guide covers the state rules layered on top of FDA's.
Pharmacy lists and vendor pages lag FDA by months, so check the source whenever a status matters:
Building that habit into a practice is part of what Peptavo's course teaches in its sourcing and compounding module, alongside accredited peptide CME and the prescribing, consent, and monitoring work around it.
It is the set of nominated bulk substances for which FDA has identified significant safety risks in compounding, published in FDA's 503A category document and summarized on its safety risks page. As of the May 14, 2026 version, kisspeptin-10 is the only peptide in 503A Category 2. GHRP-2, GHRP-6, and ipamorelin acetate remain in Category 2 for 503B outsourcing facilities.
Category 1 peptides are nominated substances FDA is still evaluating, with nominations complete enough to review, so it does not intend to act against 503A pharmacies that compound with them under the guidance conditions. In the May 2026 document they include vasoactive intestinal peptide and GHK-Cu for non-injectable routes. Category 1 is an interim enforcement position, and FDA can change it without rulemaking.
No. The 503A Bulks List is a regulation, 21 CFR 216.23, and a substance on it is lawful for 503A compounding until another rule removes it. Category 1 is FDA's interim enforcement policy for substances still under evaluation. A Category 1 substance reaches the Bulks List only through a proposed and final rule.
Yes. FDA announced on April 15, 2026, that twelve peptides would leave 503A Category 2 within seven days because their nominations were withdrawn. They did not move to Category 1, and none is on the Bulks List, so they currently have no interim enforcement protection.
No. The February 2026 news was HHS Secretary Kennedy's statement that he expected FDA to widen lawful access to about fourteen peptides. The governing guidance is still the January 2025 interim policy, and FDA's formal peptide actions came on April 15, 2026.
Only after FDA publishes a proposed rule, takes comment, and issues a final rule amending 21 CFR 216.23. As of October 13, 2026, FDA has not published a proposed rule for any of the six. Past Bulks List rules have taken years from committee vote to final rule.