Regulatory lookup

FDA Approval Status & Compounding Checker

Verify approval, investigation, compounding, and anti-doping classifications.

Reviewed against FDA and WADA source material
Regulatory status
Peptide / BrandFDA StatusClinical Indication / Scope503A Compounding LawWADA Status
Semaglutide
Ozempic, Wegovy, Rybelsus
GLP-1 Receptor Agonist
FDA ApprovedT2D Glycemic Control, Chronic Weight Management, MACE CVD Risk ReductionPrescription only; restricted compounding post-shortage resolutionNot Prohibited
Tirzepatide
Mounjaro, Zepbound
Dual GIP / GLP-1 Agonist
FDA ApprovedT2D Glycemic Control, Chronic Weight ManagementPrescription only; subject to ongoing patent litigationNot Prohibited
Liraglutide
Victoza, Saxenda
GLP-1 Receptor Agonist
FDA ApprovedT2D Glycemic Control, Chronic Weight ManagementPrescription only; generic versions under reviewNot Prohibited
Retatrutide
LY3437943 (Investigational)
Triple Agonist (GLP-1/GIP/Glucagon)
Phase 3 InvestigationalInvestigational: Severe Obesity, T2D, MASHIllegal to compound outside authorized clinical trialsProhibited (S0 Non-Approved)
BPC-157
PL 14736, Bepecin
Gastric Pentadecapeptide
FDA 503A Restricted (Category 2)Preclinical: Tissue & Gut Repair (No FDA Approved Indication)Banned from 503A pharmacy compounding due to safety risksProhibited (S0 Non-Approved)
TB-500
Thymosin Beta-4 Fragment
Actin-Sequestering Peptide
FDA 503A Restricted (Category 2)Preclinical: Tissue Regeneration, Wound RepairBanned from 503A pharmacy compoundingProhibited (S2 Growth Factors)
CJC-1295
Mod GRF 1-29, DAC:GRF
GHRH Analog
FDA 503A Restricted (Category 2)Investigational: Growth Hormone SecretagogueBanned from 503A pharmacy compoundingProhibited (S2 Peptide Hormones)
Ipamorelin
NNC 26-0161
GHRP Secretagogue
FDA 503A Restricted (Category 2)Investigational: Postoperative Bowel Function (Discontinued)Banned from 503A pharmacy compoundingProhibited (S2 Growth Factors)
Tesamorelin
Egrifta, Egrifta SV
Stabilized GHRH Analog
FDA ApprovedHIV-Associated Lipodystrophy (Visceral Adiposity)Available via commercial prescription (Rx only)Prohibited in Competition (S2)
Sermorelin
Geref (Historical)
GHRH (1-29)
FDA Approved / 503A Category 1Diagnostic Evaluation of Pituitary GH FunctionPermitted under valid 503A patient-specific prescriptionProhibited (S2 Peptide Hormones)
Bremelanotide (PT-141)
Vyleesi
MC4R Agonist
FDA ApprovedHypoactive Sexual Desire Disorder (HSDD) in Premenopausal WomenPrescription only (auto-injector format)Not Prohibited
Melanotan II
MT-2
Non-Selective Melanocortin Agonist
FDA Banned / UnlawfulNone (Associated with Severe Toxicities & Melanoma Risk)Completely illegal for human compounding or salesProhibited (S0 Non-Approved)
GHK-Cu
Copper Tripeptide-1
Copper Chelate Tripeptide
Cosmetic IngredientCosmetic: Topical Skin Remodeling (Unapproved as Injectable)Topical compounding permissible; unapproved as injectableNot Prohibited
MOTS-c
Mitochondrial 12S rRNA-c
Mitochondrial-Derived Peptide
FDA 503A Restricted (Category 2)Preclinical: Metabolic Signaling & AMPK ActivationBanned from 503A compoundingProhibited (S2 Metabolic Modulators)
SS-31 (Elamipretide)
Bendavia (Investigational)
Mitochondrial Cardiolipin Stabilizer
Phase 3 Investigational (FDA Fast Track)Investigational: Barth Syndrome, Mitochondrial MyopathyIllegal outside authorized clinical trialsProhibited (S0 Non-Approved)
Epitalon
Epithalamin Synthetic
Synthetic Pineal Tetrapeptide
Unapproved / Category 2Preclinical: Telomerase Induction (No Human Phase 3 Data)Restricted from 503A compoundingProhibited (S0 Non-Approved)