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PEPLUX

Traced to FDA primary documents

FDA Peptide Status Tracker

The FDA compounding status of every substance PEPLUX tracks. Each status traces to named, dated FDA documents rather than to a summary of them. Where FDA has not yet published an advisory committee outcome, the record names the secondary report it relies on. Records were last checked between October 13, 2026 and October 14, 2026; each row shows its own date.

Read this first

Removal from FDA Category 2 is not FDA approval.

Removal from FDA's Category 2 is not FDA approval and not a listing. FDA removed several peptides from its 503A Category 2 after their nominators withdrew the nominations, not because the substances were found safe: BPC-157, TB-500, MOTS-c, semax and epitalon among others (removal noticed April 15, 2026, effective after 7 days), and CJC-1295 and ipamorelin earlier (removal notice dated September 27, 2024). None was added to the 503A bulks list, so none has a compounding pathway today. A favorable vote by FDA's Pharmacy Compounding Advisory Committee is a recommendation, not a listing: nothing changes unless FDA publishes a final rule.

An FDA advisory committee recommendation is not a listing. Nothing changes unless FDA publishes a final rule.

The full list

Every substance we track, by FDA status.

Grouped by FDA status, then sorted alphabetically. Select any substance for the full record, the documents it traces to and the date it was last checked.

Scroll the table sideways to see every column.

FDA compounding status of 24 substances, grouped by status. Records were last checked between October 13, 2026 and October 14, 2026; each row shows its own date.
SubstanceFDA statusCompounding basisAdvisory committeeWADA 2026OfferedChecked on
FDA interim enforcement discretion (Category 1). Not a listing. Not FDA-approved.
Enclomiphene CitrateEnclomipheneFDA interim enforcement discretion (Category 1). Not a listing. Not FDA-approved.503A pharmacy (Category 1, interim policy)Not reviewedS4.2No
GHK-CuCopper tripeptide-1, Copper peptide GHK-CuFDA interim enforcement discretion (Category 1). Not a listing. Not FDA-approved.503A pharmacy (Category 1, interim policy)Injectable routes (subcutaneous, intramuscular and intravenous): No compounding pathway today.Review announced, expected by Feb 28, 2027Not namedYesGHK-Cu Injection
GlutathioneL-glutathioneFDA interim enforcement discretion (Category 1). Not a listing. Not FDA-approved.503A pharmacy (Category 1, interim policy)503B outsourcing facility (Category 1, interim policy)Not reviewedNot namedYesGlutathione
MethylcobalaminMethyl B12, MecobalaminFDA interim enforcement discretion (Category 1). Not a listing. Not FDA-approved.503A pharmacy (Category 1, interim policy)503B outsourcing facility (Category 1, interim policy)Not reviewedNot namedYesMethylcobalamin B12
Nicotinamide Adenine Dinucleotide (NAD)NAD+, NAD, Nicotinamide adenine dinucleotideFDA interim enforcement discretion (Category 1). Not a listing. Not FDA-approved.503A pharmacy (Category 1, interim policy)503B outsourcing facility (Category 1, interim policy)Not reviewedNot namedYesNAD+
Nicotinamide Adenine Dinucleotide Disodium Reduced (NADH)NADH, Reduced nicotinamide adenine dinucleotideFDA interim enforcement discretion (Category 1). Not a listing. Not FDA-approved.503A pharmacy (Category 1, interim policy)Not reviewedNot namedNo
Sermorelin AcetateSermorelinFDA interim enforcement discretion (Category 1). Not a listing. Not FDA-approved.503B outsourcing facility (Category 1, interim policy)Not reviewedS2.2.4YesSermorelin
Vasoactive Intestinal PeptideVIP, AviptadilFDA interim enforcement discretion (Category 1). Not a listing. Not FDA-approved.503A pharmacy (Category 1, interim policy)Not reviewedNot namedNo
Narrow compounding pathway, limited by the rule on copies of approved drugs. Compounded versions are not FDA-approved.
Bremelanotide (PT-141)PT-141, BremelanotideNarrow compounding pathway, limited by the rule on copies of approved drugs. Compounded versions are not FDA-approved.503A pharmacy (component of an approved drug)Not reviewedNot namedYesPT-141
No compounding pathway today. An FDA advisory committee recommendation is not a listing.
BPC-157Body Protection Compound-157No compounding pathway today. An FDA advisory committee recommendation is not a listing.No compounding pathwayRecommended, not added, Jul 23, 2026S0YesBPC-157 Injection
EpitalonEpithalonNo compounding pathway today. An FDA advisory committee recommendation is not a listing.No compounding pathwayRecommended, not added, Jul 24, 2026Not namedYesEpitalon
KPVLys-Pro-ValNo compounding pathway today. An FDA advisory committee recommendation is not a listing.No compounding pathwayRecommended, not added, Jul 23, 2026Not namedYesKLOW Stack
MOTS-cMOTs-CNo compounding pathway today. An FDA advisory committee recommendation is not a listing.No compounding pathwayRecommended, not added, Jul 23, 2026S4.4.1YesMOTS-c
Semax (heptapeptide)SemaxNo compounding pathway today. An FDA advisory committee recommendation is not a listing.No compounding pathwayRecommended, not added, Jul 24, 2026Not namedYesSemax
Thymosin beta-4, fragment (LKKTETQ)TB-500No compounding pathway today. An FDA advisory committee recommendation is not a listing.No compounding pathwayRecommended, not added, Jul 23, 2026S2.3YesWolverine Stack
No compounding pathway today.
AOD-9604No compounding pathway today.No compounding pathwayVoted against, Dec 4, 2024S2.2.3YesAOD-9604
CJC-1295No compounding pathway today.No compounding pathwayVoted against, Dec 4, 2024S2.2.4YesCJC-1295 and Ipamorelin
Emideltide (DSIP)DSIP, Delta sleep-inducing peptideNo compounding pathway today.No compounding pathwayNot recommended, Jul 24, 2026Not namedYesDSIP Injection
Ipamorelin acetateIpamorelinNo compounding pathway today.No compounding pathwayVoted against, Oct 29, 2024S2.2.4YesCJC-1295 and Ipamorelin
Kisspeptin-10Kisspeptin, KP-10No compounding pathway today.No compounding pathwayVoted against, Oct 29, 2024S2.2.1 (males)YesKisspeptin Injection
RetatrutideNo compounding pathway today.No compounding pathwayNot reviewedS0No
Selank acetate (TP-7)Selank, TP-7No compounding pathway today.No compounding pathwayNot reviewedNot namedYesSelank
Thymosin beta-4 (full-length)No compounding pathway today.No compounding pathwayNot reviewedS2.3No
Cannot be compounded.
TesamorelinCannot be compounded.Branded product onlyNot reviewedS2.2.4No

“Offered” means a PEPLUX product contains the substance. It says nothing about FDA approval, and it is not a recommendation to use any substance on this page.

Methodology

Where each status comes from.

Two FDA documents carry most of the weight, and confusing them is the source of most published errors. The 503A document governs state-licensed pharmacies compounding against patient-specific prescriptions. The 503B document governs outsourcing facilities registered with FDA. A substance can appear in one and not the other.

  1. FDA 503A categoriesBulk drug substances nominated for use in compounding under section 503A (categories), updated May 14, 2026Document dated . Checked .
  2. FDA 503B categoriesBulk drug substances nominated for use in compounding under section 503B (categories), updated March 21, 2025Document dated . Checked .

What we do not use as a source

  • Vendor and telehealth marketing pages, which often conflate the 503A and 503B documents.
  • Content-farm summaries and automated status roundups that repeat those errors.
  • Supplier and research-chemical listings. That a substance can be bought says nothing about whether it can be compounded.
  • Anything we cannot trace to a dated document. Where a fact is not confirmed, or rests on a secondary report because FDA has not published it, the record says so.

Each record carries the date it was last checked. If a date looks old to you, treat that record as possibly out of date.

Common questions

The questions this tracker exists to answer.

Does removal from FDA Category 2 mean FDA has approved a peptide, or that it can be compounded?
Removal from FDA's Category 2 is not FDA approval and not a listing. FDA removed several peptides from its 503A Category 2 after their nominators withdrew the nominations, not because the substances were found safe: BPC-157, TB-500, MOTS-c, semax and epitalon among others (removal noticed April 15, 2026, effective after 7 days), and CJC-1295 and ipamorelin earlier (removal notice dated September 27, 2024). None was added to the 503A bulks list, so none has a compounding pathway today. A favorable vote by FDA's Pharmacy Compounding Advisory Committee is a recommendation, not a listing: nothing changes unless FDA publishes a final rule.
How is each substance on this tracker grouped?
Enclomiphene Citrate, GHK-Cu, Glutathione, Methylcobalamin, Nicotinamide Adenine Dinucleotide (NAD), Nicotinamide Adenine Dinucleotide Disodium Reduced (NADH), Sermorelin Acetate, Vasoactive Intestinal Peptide: FDA interim enforcement discretion (Category 1). Not a listing. Not FDA-approved. Bremelanotide (PT-141): Narrow compounding pathway, limited by the rule on copies of approved drugs. Compounded versions are not FDA-approved. BPC-157, Epitalon, KPV, MOTS-c, Semax (heptapeptide), Thymosin beta-4, fragment (LKKTETQ): No compounding pathway today. An FDA advisory committee recommendation is not a listing. AOD-9604, CJC-1295, Emideltide (DSIP), Ipamorelin acetate, Kisspeptin-10, Retatrutide, Selank acetate (TP-7), Thymosin beta-4 (full-length): No compounding pathway today. Tesamorelin: Cannot be compounded.
Which of these substances does PEPLUX offer?
PEPLUX offers Sermorelin, which contains Sermorelin Acetate; NAD+, which contains Nicotinamide Adenine Dinucleotide (NAD); Glutathione, which contains Glutathione; Methylcobalamin B12, which contains Methylcobalamin; CJC-1295 and Ipamorelin, which contains CJC-1295 and Ipamorelin acetate; MOTS-c, which contains MOTS-c; BPC-157 Injection, which contains BPC-157; Epitalon, which contains Epitalon; Semax, which contains Semax (heptapeptide); Selank, which contains Selank acetate (TP-7); AOD-9604, which contains AOD-9604; PT-141, which contains Bremelanotide (PT-141); GHK-Cu Injection, which contains GHK-Cu; BPC-157 Capsules, which contains BPC-157; Topical GHK-Cu, which contains GHK-Cu; Wolverine Stack, which contains BPC-157 and Thymosin beta-4, fragment (LKKTETQ); GLOW Stack, which contains BPC-157 and GHK-Cu and Thymosin beta-4, fragment (LKKTETQ); KLOW Stack, which contains BPC-157 and GHK-Cu and KPV and Thymosin beta-4, fragment (LKKTETQ); Semax / Selank Injection, which contains Semax (heptapeptide) and Selank acetate (TP-7); Kisspeptin Injection, which contains Kisspeptin-10; DSIP Injection, which contains Emideltide (DSIP). Every other substance on this tracker is not offered. Compounded medications are not approved by the FDA and have not been reviewed for safety, effectiveness, or quality.
Where does this tracker get its data?
Each status traces to dated primary documents: FDA's 503A and 503B category documents, the Federal Register, the eCFR, approved drug labels and FDA advisory committee records. Each record shows the date printed on every document and the date it was last checked. Where FDA has not yet published the outcome of an advisory committee meeting, a record may report that outcome from a named secondary report, and the record says so. Vendor and content-farm sites are never used as sources.