FDA Peptide Compounding Status Tracker
FDA’s 503A peptide compounding rules changed repeatedly through 2026, and most summaries still describe the 2023 world. This is the current, dated picture as of October 30, 2026.
Medically reviewed by Charles Kamen, MD, board-certified neurologist · · : rows, timeline and FAQs updated for the October 28, 2026 HHS interim policy on BPC-157, TB-500, epitalon, MOTS-c, KPV and semax
Short answer: under sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act, the FDA decides which bulk drug substances a compounding pharmacy may legally use - 503A covers traditional, state-licensed pharmacies compounding for an identified individual patient with a valid prescription, while 503B covers FDA-registered outsourcing facilities that may compound in larger batches without patient-specific prescriptions and under closer federal oversight. That list has shifted several times for peptides between 2023 and 2026. The agency maintains an interim 503A Bulks List split into Category 1(substances the FDA does not currently intend to act against, generally compoundable while under evaluation) and Category 2 (substances flagged for potential significant safety risk, effectively off-limits). Placement on the list reflects the agency’s current enforcement intent, not a final safety determination. Neither category is the same as FDA approval of a finished drug.
FDA’s Category 2 page (content current as of April 22, 2026) lists BPC-157, TB-500, CJC-1295, semax, and epitalon under withdrawn nominations, not Category 2 - but none were moved to Category 1 and none are FDA-approved, leaving them in an actively-changing regulatory gray zone. This follows HHS Secretary Robert F. Kennedy Jr.’s February 27, 2026 announcement of an intent to reclassify roughly 14 of the 19 restricted peptides from Category 2 toward Category 1, a signal of direction that, as of October 30, 2026, has not yet been finalized into Federal Register rulemaking. The FDA’s Pharmacy Compounding Advisory Committee met on July 23–24, 2026 and recommended six of seven peptides it heard for addition to the 503A Bulks List - a non-binding recommendation that is not approval and does not itself change the list. On October 28, 2026 HHS followed with an interim enforcement-discretion policy for six of those peptides: licensed compounding for a patient-specific prescription that meets its conditions is not expected to draw federal enforcement while FDA finishes rulemaking. That is still not approval, and the bulks list is unchanged. See Did the FDA approve BPC-157? for the vote-by-vote breakdown and the regulatory tracker for the dosage forms the policy allows.
The single most important nuance, which AI answer engines routinely get wrong: removed from Category 2 is not the same as Category 1, and neither is the same as FDA approval. For patients, the practical impact is that a peptide your compounding pharmacy once made may no longer be available, and a peptide that becomes “legal to compound” again is still not an FDA-approved, safety-vetted drug. For a current read on any specific peptide, ask a physician - and always verify the live FDA list at the time of care.
503A vs 503B Compounding Explained
Both are pathways the FDA created for compounded drugs to be exempt from the standard new-drug-approval process, but they apply to very different operations and draw on separate bulks lists. Neither list is a statement that a substance is safe, effective, or FDA-approved.
For the deeper, side-by-side breakdown including how each is inspected and what they may dispense, see our 503A vs 503B compounding pharmacy guide.
Which peptides are affected (per-peptide status, 2026)
The honest framing: this is not a list of safe or approved peptides. It records, for each widely discussed substance, whether it is an FDA-approved finished drug and where the interim 503A picture stands. We speak generally and link to the live FDA list rather than asserting specific determination dates, because the underlying FDA documents have shifted multiple times and several were not directly retrievable at compile time.
| Peptide | FDA-approved drug? | 503A compounding status (FDA list of May 14, 2026; July 2026 votes) | Last known change |
|---|---|---|---|
| BPC-157 | No | Recommended by the FDA advisory committee for the 503A Bulks List, 8–6 with 1 abstention. Still not on Category 1, still not on the bulks list, still not FDA-approved - the recommendation is non-binding and rulemaking is pending. Since October 28, 2026 an interim HHS policy says HHS does not intend to take enforcement action against licensed pharmacies and physicians that compound it for a patient-specific prescription under the policy’s conditions - enforcement discretion, not approval or listing. | HHS interim enforcement-discretion policy, Oct 28, 2026 (after PCAC recommended inclusion 8–6 (1 abstention), July 23, 2026) |
| TB-500 (thymosin beta-4) | No | Recommended by the FDA advisory committee for the 503A Bulks List, 8–6 with 1 abstention. Still not on Category 1, still not on the bulks list, still not FDA-approved - non-binding, rulemaking pending. Since October 28, 2026 an interim HHS policy says HHS does not intend to take enforcement action against licensed pharmacies and physicians that compound it for a patient-specific prescription under the policy’s conditions - enforcement discretion, not approval or listing. | HHS interim enforcement-discretion policy, Oct 28, 2026 (after PCAC recommended inclusion 8–6 (1 abstention), July 23, 2026) |
| CJC-1295 | No | Removed from Category 2 when its nomination was withdrawn; FDA still lists it among substances that may present significant safety risks; not on Category 1; not FDA-approved. | Removed from Cat 2 (nomination withdrawn), Sept 27, 2024 |
| Ipamorelin | No | Removed from Category 2 when its nomination was withdrawn; FDA still lists it among substances that may present significant safety risks; not on Category 1; not FDA-approved. FDA lists ipamorelin acetate in Category 2 for 503B outsourcing facilities. | Removed from Cat 2 (nomination withdrawn), Sept 27, 2024 |
| Thymosin alpha-1 | No (approved in 35+ countries, not the U.S.) | Removed from Category 2 when its nomination was withdrawn; FDA still lists it among substances that may present significant safety risks; not on Category 1; not FDA-approved in the U.S. | Removed from Cat 2 (nomination withdrawn), Sept 27, 2024 |
| Selank | No | Removed from Category 2 when its nomination was withdrawn; FDA still lists it among substances that may present significant safety risks; not on Category 1; not FDA-approved. | Removed from Cat 2 (nomination withdrawn), Sept 27, 2024 |
| Semax | No (approved in some Eastern European countries, not the U.S.) | Recommended by the FDA advisory committee for the 503A Bulks List, 8–5. Still not on Category 1, still not on the bulks list, still not FDA-approved in the U.S. - non-binding, rulemaking pending. Since October 28, 2026 an interim HHS policy says HHS does not intend to take enforcement action against licensed pharmacies and physicians that compound it for a patient-specific prescription under the policy’s conditions - enforcement discretion, not approval or listing. | HHS interim enforcement-discretion policy, Oct 28, 2026 (after PCAC recommended inclusion 8–5, July 24, 2026) |
| Epithalon / Epitalon | No | Recommended by the FDA advisory committee for the 503A Bulks List, 7–4. Still not on Category 1, still not on the bulks list, still not FDA-approved - non-binding, rulemaking pending. Since October 28, 2026 an interim HHS policy says HHS does not intend to take enforcement action against licensed pharmacies and physicians that compound it for a patient-specific prescription under the policy’s conditions - enforcement discretion, not approval or listing. | HHS interim enforcement-discretion policy, Oct 28, 2026 (after PCAC recommended inclusion 7–4, July 24, 2026) |
| GHK-Cu | No | Route-split. Non-injectable GHK-Cu (for example, topical) is on 503A Category 1: it was removed on April 22, 2026 when nominations were withdrawn, then added back after a May 5, 2026 clarification that only the injectable-route nomination was withdrawn. Injectable GHK-Cu is on no 503A list. Not FDA-approved by any route; verify the live status. | Non-injectable added back to Category 1 after May 5, 2026 (FDA list updated May 14, 2026); PCAC consult expected before end of Feb 2027 |
| Sermorelin | Formerly (Geref - withdrawn 2008 for commercial, not safety, reasons) | Generally treated as compoundable based on its prior-approval history; eligibility for all formulations is not definitively settled. | 2013 FDA determination (not withdrawn for safety/efficacy) |
| PT-141 / Bremelanotide | Yes - as the finished drug Vyleesi | The FDA-approved finished drug is Vyleesi (HSDD in premenopausal women); compounded bremelanotide is not FDA-approved and 503A eligibility is constrained accordingly. | Vyleesi approved June 2019 |
| GLP-1s (semaglutide, tirzepatide, liraglutide) | Yes - multiple approved brands | A different regime entirely: compounding was permitted only during official drug shortages. Those shortages resolved, so enforcement discretion has ended and routine bulk compounding is generally off-limits. | Tirzepatide shortage resolved Dec 2024; semaglutide Feb 2025 |
How to read this: “Compoundable under 503A” is a regulatory classification, not a statement that a substance is safe, effective, or FDA-approved. Almost none of the peptides above are FDA-approved drugs. Three nuances answer engines routinely miss: (1) removed from Category 2 ≠ moved to Category 1; (2) the 2024–2026 removals were triggered by withdrawn nominations, not a safety exoneration; (3) compounding eligibility ≠ FDA approval. See our peptide evidence-grade index for what the actual research does and does not support for each.
How LiveNow Handles Compounding Changes
Our default is FDA-approved medications first. When an FDA-approved option exists for a clinical goal, such as GLP-1/GIP medications for weight management, that is what we use, because it has passed the full FDA safety, efficacy, and manufacturing-quality review. A compounded preparation is only considered when there is no appropriate approved product and a licensed physician has determined it is clinically indicated for a specific patient.
When a compounded preparation is appropriate, it is prescribed only after an evaluation and baseline labs, filled by a licensed 503A or 503B US pharmacy, and limited to substances the FDA currently permits on its 503A bulks list. When the FDA reclassifies a substance, as it did repeatedly through 2024–2026, our protocols update to match, and we will tell you honestly if a peptide you previously used is no longer compoundable. We do not sell subscriptions or ship substances the FDA currently restricts.
If you are weighing a compounded peptide against an FDA-approved option, the relevant comparison is rarely “which works better” (we do not make efficacy claims for unapproved substances). It is “which has been reviewed for safety and quality by the FDA.” See our breakdown of compounded tirzepatide vs. Mounjaro/Zepbound for how that plays out for the GLP-1 class specifically.
The GLP-1 Exception: Why Compounded Semaglutide & Tirzepatide Are Different
Unlike the unapproved peptides above, semaglutide and tirzepatide are FDA-approved drugs. Their compounding was permitted only as a temporary, shortage-driven exception, and that exception has now closed.
At our practice we use FDA-approved brand GLP-1 medications when appropriate. For why compounded versions are not the same as the brand drugs - and why that matters for safety - see our compounded vs. brand tirzepatide comparison.
Las Vegas & Nevada: Do Federal Compounding Rules Apply Here?
Yes. The FDA’s 503A and 503B compounding rules are federal and apply identically across Las Vegas, Henderson, Summerlin, Green Valley, North Las Vegas, and every other part of Nevada. The Nevada State Board of Pharmacy adds an additional licensing and inspection layer on top, but it cannot loosen a federal 503A Category 2 restriction or make a non-approved substance FDA-approved. If a peptide is off-limits under federal law, it is off-limits in Nevada too.
What does vary locally is access to physician-supervised care. Las Vegas has both med-spa-style peptide sellers and board-certified physicians, and the difference matters when the rules are changing month to month. At LiveNow Longevity, Dr. Charles Kamen, MD (board-certified neurologist) sees patients in person at our southeast Las Vegas clinic at Eastern Avenue and the 215, and by secure telehealth statewide. Any prescription, FDA-approved or compounded, is written only after an evaluation and labs, and dispensed by a licensed US pharmacy.
For local access to physician-led care, see our Las Vegas peptide clinic page. To understand which peptides are FDA-approved (the cleanest regulatory category of all), start with our FDA-approved peptide list.
Dated regulatory timeline (2023 → 2026)
Each entry is a real, sourced event. Items tagged reported rest on legal/industry commentary rather than a directly-retrievable primary FDA document.
- Sept 2023reportedFDA placed roughly 20 peptide bulk substances (including BPC-157, TB-500, CJC-1295, ipamorelin, and others) into interim 503A Category 2, citing significant safety concerns. These were never on Category 1, so they were never freely compoundable.
- Dec 19, 2024FDA determined the tirzepatide injection shortage resolved, starting the clock on the end of GLP-1 compounding enforcement discretion.
- Sept 27, 2024FDA’s Category 2 page moved five substances (AOD-9604, CJC-1295, ipamorelin, thymosin alpha-1, selank) out of Category 2 because their nominations were withdrawn. FDA still lists them as substances that may present significant safety risks. This was not an approval.
- Feb 21, 2025FDA determined the semaglutide injection shortage resolved (Ozempic/Wegovy), ending the shortage basis for compounding.
- Spring 2025GLP-1 compounding enforcement discretion ended; 503A and 503B pharmacies were directed to stop compounding tirzepatide and semaglutide on staggered deadlines, which held after a court declined to enjoin them.
- Feb 27, 2026reportedHHS Secretary Robert F. Kennedy Jr. publicly announced an intent to reclassify roughly 14 of the 19 Category 2 peptides - including BPC-157, TB-500, CJC-1295, and thymosin alpha-1 - from Category 2 back toward Category 1, which would permit 503A compounding. The announcement signaled direction only; it did not itself change the formal Federal Register status, and it is distinct from the April 2026 FDA action below.
- April 2026reportedFDA reported to have removed about a dozen peptides from Category 2 (including BPC-157, TB-500, semax, epitalon, injectable GHK-Cu) because the nominations were withdrawn - crucially NOT moving them to Category 1; they returned to an unlisted, under-review state and remain unapproved.
- June 29, 2026Public comment period closes on the FDA proposed rule to permanently bar 503B bulk compounding of GLP-1 agonists (semaglutide, tirzepatide, liraglutide).
- July 23, 2026reportedPCAC day one: the committee voted to recommend BPC-157 (8–6, 1 abstention), KPV (8–6, 1 abstention), TB-500 (8–6, 1 abstention) and MOTS-c (7–5, 2 abstentions) for addition to the 503A Bulks List - over the objection of FDA's own review scientists, who argued the substances are not chemically well-characterized enough to evaluate. Recommendations are non-binding; formal rulemaking is still required, and none of these is FDA-approved.
- July 24, 2026reportedPCAC day two: epitalon (7–4) and semax (8–5) were recommended for the 503A Bulks List; emideltide (DSIP) was voted down 6–7, the only rejection of the two-day meeting. Six of seven peptides heard therefore carry a favorable, non-binding recommendation - which is not approval and does not itself change what a pharmacy may compound.
- October 28, 2026HHS issued an interim enforcement-discretion policy for 503A compounding of six peptides - BPC-157, epitalon, KPV, MOTS-c, semax and TB-500, not emideltide. Until FDA finishes rulemaking, HHS does not intend to take enforcement action against state-licensed pharmacies, federal facilities or licensed physicians that compound them for a patient-specific prescription under the policy's conditions (registered manufacturer with a certificate of analysis, single-ingredient products, listed dosage forms, adverse-event reporting). Not FDA approval, and the 503A Bulks List is unchanged. Federal Register notice published October 30, 2026.
The precise effective dates and the exact list of affected peptides should be confirmed against the live FDA 503A bulks page and the Federal Register before relying on them. The scheduling of the July 23–24, 2026 advisory-committee meeting and the GLP-1 shortage-resolution dates are drawn from primary FDA materials. Vote tallies are from contemporaneous reporting of the public meeting; FDA has not yet posted minutes.
This is a regulatory-status reference, not medical or legal advice. It does not recommend, endorse, or describe how to use any peptide, and it contains no doses, titration, or efficacy claims. Compounding decisions are made by a licensed prescriber and a licensed pharmacy under current federal and state law. Categories, dates, and effective dates have shifted multiple times in 2025–2026 - always confirm the live status on the FDA 503A bulks page before relying on it for care. Maintained by Charles Kamen, MD.
FDA Peptide Compounding - FAQ
What is the FDA peptide compounding status in 2026?
It is the FDA's current, evolving determination of which peptide bulk substances may be used by compounding pharmacies under Section 503A of the FD&C Act, organized through interim Category 1 (generally compoundable while under evaluation) and Category 2 (flagged for significant safety risk and effectively off-limits) classifications. The source dates are April 22, 2026 for the cited FDA Category 2 page and July 23–24, 2026 for the Pharmacy Compounding Advisory Committee meeting. Several widely discussed peptides - including BPC-157, TB-500, CJC-1295, semax, and epitalon - are reported to have been removed from Category 2 without being placed on Category 1 or FDA-approved, leaving them in a regulatory gray zone. On October 28, 2026 HHS added an interim enforcement-discretion policy for six of them (BPC-157, epitalon, KPV, MOTS-c, semax and TB-500): licensed compounding for a patient-specific prescription that meets the policy's conditions is not expected to draw federal enforcement while FDA finishes rulemaking. The live FDA 503A bulks list and the HHS policy are the authoritative sources and should be verified at the time of care.
Are compounded peptides safe?
Compounded drugs are not FDA-approved - they bypass the new-drug-approval process for safety, efficacy, and manufacturing quality. A compounded preparation is only as reliable as the specific pharmacy that makes it. Safety is highest when compounding is done by a licensed 503A or 503B pharmacy for an identified patient under a valid prescription, using substances the FDA currently permits on its 503A bulks list. "Permitted for compounding" is a regulatory classification, not a statement that the substance itself is safe or effective - and it is never the same as FDA approval.
What is the difference between 503A and 503B compounding?
A 503A pharmacy is a traditional compounding pharmacy that compounds patient-specific prescriptions dispensed to an identified patient (no cGMP requirement, but limited to roughly a 5% cap on office-use compounding). A 503B outsourcing facility is a larger, cGMP-compliant, FDA-registered facility that can compound bulk batches without patient-specific prescriptions for use in healthcare settings - at the cost of heavier federal oversight and product reporting. Both must draw only from their respective FDA bulks lists. See our detailed breakdown of 503A vs 503B compounding pharmacies.
Why was my peptide (e.g., BPC-157, CJC-1295) discontinued by my compounding pharmacy?
Because the FDA's 503A classification for that substance changed. Several peptides were placed into Category 2 (significant safety risk) in September 2023 and became effectively off-limits to compound. Some were then reported removed from Category 2 in 2024–2026 after their nominations were withdrawn - but removal is not an approval, and because they were not placed on Category 1 and are not FDA-approved, many licensed pharmacies still decline to compound them rather than risk enforcement. The safest assumption is that any specific peptide's status can change month to month; verify the live FDA list before relying on it.
Is compounded semaglutide or tirzepatide allowed?
Generally, no - not anymore. Semaglutide and tirzepatide are FDA-approved drugs (Ozempic/Wegovy and Mounjaro/Zepbound), and their compounding was permitted only during official FDA-declared drug shortages. Tirzepatide's shortage was determined resolved (late 2024) and semaglutide's in February 2025; enforcement discretion has ended, and the FDA has proposed permanently excluding semaglutide, tirzepatide, and liraglutide from the 503B bulks list. At our practice we use FDA-approved brand GLP-1 medications when appropriate. See our comparison of compounded tirzepatide vs Mounjaro/Zepbound.
Does "removed from Category 2" mean a peptide is now safe and FDA-approved?
No - removal from Category 2 only ends the prior compounding restriction. It does not make the substance FDA-approved, does not place it on Category 1, and does not constitute an FDA judgment that it is safe or effective. FDA approval requires a separate, far higher bar (clinical trials, manufacturing review, and an FDA-approval decision). The 2024–2026 removals were triggered by withdrawn nominations, not by a safety exoneration.
Did RFK Jr. make BPC-157 and other peptides legal again in 2026?
Not exactly. On February 27, 2026, HHS Secretary Robert F. Kennedy Jr. announced an intent to reclassify roughly 14 of the 19 Category 2 peptides (including BPC-157, TB-500, CJC-1295, and thymosin alpha-1) from Category 2 toward Category 1, which would permit 503A compounding. That announcement signaled direction, but it did not itself finalize a Federal Register rule change, and the subsequent FDA action moved the substances off Category 2 without placing them on Category 1. At the July 23–24, 2026 advisory-committee meeting, the panel then recommended six of seven peptides it heard for addition to the 503A Bulks List - BPC-157, KPV, TB-500, MOTS-c, epitalon and semax - and voted down emideltide. Those recommendations are non-binding and are not approval: the substances remain unapproved drugs, and FDA must still complete formal rulemaking before the bulks list itself changes. Then, on October 28, 2026, Secretary Kennedy issued an interim HHS policy: until that rulemaking is finished, HHS does not intend to take enforcement action against licensed pharmacies and physicians that compound those six peptides for a patient-specific prescription under the policy's conditions. So for those six, licensed compounding on prescription is now tolerated by federal regulators - but none of them is FDA-approved, none is on the bulks list yet, and HHS says it may revisit the policy if safety or quality problems appear.
How can I get a peptide through telehealth in Nevada?
Nevada residents can complete a physician evaluation and follow-ups by secure telehealth, with labs drawn at a location near you. Importantly, telehealth does not change which substances are legally compoundable - the same FDA 503A rules apply regardless of whether a prescription originates in person or online. Any clinic offering to mail you a substance the FDA currently restricts is taking a regulatory risk you are paying for. At LiveNow Longevity, FDA-approved medications are available after evaluation, and any compounded prescription is filled by a licensed US pharmacy using only substances the FDA currently permits.
What about Henderson or Summerlin - do the same FDA rules apply?
Yes - FDA compounding rules are federal and apply identically across Las Vegas, Henderson, Summerlin, Green Valley, and every other part of Nevada. State pharmacy boards add an additional layer on top, but they cannot loosen the federal 503A/503B categories. If a substance is off-limits under federal law, it is off-limits in Henderson and Summerlin too. What does vary locally is access to physician-supervised care: we see patients in person at our southeast Las Vegas clinic and by telehealth statewide.
How does LiveNow Longevity handle compounding changes?
FDA-approved medications first. When a compounded preparation is clinically appropriate, it is prescribed only after an evaluation and labs, dispensed by a licensed 503A or 503B US pharmacy, and limited to substances the FDA currently permits on its 503A bulks list. When the FDA reclassifies a substance - as it did throughout 2024–2026 - our protocols update to match, and we will tell you honestly if a peptide you previously used is no longer compoundable. The point of care is a board-certified physician conversation, not a checkout cart.
Related reading: 503A vs 503B compounding pharmacies · Which peptides are FDA-approved? · Is compounded tirzepatide the same as Mounjaro? · Peptide evidence-grade index · Peptide clinic in Las Vegas · Peptide regulatory status tracker · New FDA-approved peptides · Is compounded semaglutide going away?
Sources & Selected Research
- U.S. FDA - Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks (Category 2 under the 503A and 503B interim policies, and withdrawn nominations; content current as of April 22, 2026).
- The same FDA page as archived on January 20, 2025 (content current as of September 27, 2024): AOD-9604, CJC-1295, ipamorelin, selank and thymosin alpha-1 already listed outside Category 2.
- U.S. FDA - Human Drug Compounding (program hub: Sections 503A and 503B).
- U.S. FDA - Human Drug Compounding Laws (conditions for 503A and 503B exemptions).
- U.S. FDA - Bulk Drug Substances Used in Compounding Under Section 503A (the 503A bulks list; Category 1 / Category 2).
- U.S. FDA - Bulk Drug Substances Used in Compounding Under Section 503B (outsourcing-facility bulks list).
- U.S. FDA - Information for Outsourcing Facilities (503B).
- U.S. FDA - FDA clarifies policies for compounders as national GLP-1 supply begins to stabilize (tirzepatide/semaglutide shortage resolution).
- U.S. FDA - FDA Proposes to Exclude Semaglutide, Tirzepatide, and Liraglutide from the 503B Bulks List.
- Müller TD, et al. Mol Metab. 2019;30:72-130. (Glucagon-like peptide 1 (GLP-1): physiology, satiety, and metabolism - background mechanism only.)
Primary regulatory and background-mechanism sources only. Not a treatment claim. Per-substance FDA determinations and dates should be re-verified against the live FDA list at the time of care, as they have shifted repeatedly in 2024–2026.
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