Product status
FDA approval attaches to an exact commercial product—not every salt, route, dose, use, or copy.
PolicyAtlasVerified through Aug 22, 2026
Evidence before access
Know what’s approved.
Know what isn’t.
A transcript-sourced guide to peptide claims, federal status, and telehealth eligibility across every U.S. jurisdiction.
- Compounds
- 42
- Regulated forms
- 52
- Jurisdictions
- 51
01 / Method
One word is not enough.
Compounding status
Category 1 is interim enforcement discretion, not approval. Categories 2 and 3 do not receive it.
Practice authority
The clinician and pharmacy must be authorized where the patient is physically located.
02 / Inventory
Explore every compound.
42 resultsScreening conclusion for CA
01BPC-157Synthetic peptideDo not launch2 forms
What the transcripts discuss
Transcript discusses tissue, tendon, gut, and neurologic effects largely from animal data and anecdotes.
Evidence and regulatory caution
No FDA-approved human drug. Free-base and acetate forms received July 2026 PCAC review; committee review is not final FDA authorization.
Exact form / routeFDA product stage503A screenCA conclusion
BPC-157 acetateAll or unspecifiedNo FDA-approved human drug identifiedInvestigational · Recruiting phase 2 trial listed · 503a bulks review is separateAdvisory review complete; no final determination verifiedFDA obtained non-binding advisory input in July 2026. Advisory review is not approval or final inclusion on the 503A bulks list.Do not launchFDA obtained non-binding advisory input in July 2026. Advisory review is not approval or final inclusion on the 503A bulks list.
BPC-157 free baseAll or unspecifiedNo FDA-approved human drug identifiedInvestigational · Recruiting phase 2 trial listed · 503a bulks review is separateAdvisory review complete; no final determination verifiedFDA obtained non-binding advisory input in July 2026. Advisory review is not approval or final inclusion on the 503A bulks list.Do not launchFDA obtained non-binding advisory input in July 2026. Advisory review is not approval or final inclusion on the 503A bulks list.
02BremelanotidePeptide drugCommercial product1 form
What the transcripts discuss
Treatment of acquired, generalized hypoactive sexual desire disorder in certain premenopausal women under the label.
Evidence and regulatory caution
FDA-approved Vyleesi exists; not approved as a general sexual-performance or tanning drug.
Exact form / routeFDA product stage503A screenCA conclusion
BremelanotideAll or unspecifiedFDA-approved product existsFda approved product exists · Verify exact product and current labelApproved component; all 503A conditions still applyAn FDA-approved product exists. This does not approve every salt, route, dosage form, indication, or compounded copy.Commercial productCommercial product may be prescribed only after all patient, indication, clinician, telehealth, pharmacy, and state gates are satisfied.
03CJC-1295Synthetic peptideDo not launch1 form
What the transcripts discuss
Transcript discusses stimulation of endogenous growth-hormone release.
Evidence and regulatory caution
No FDA-approved human drug; no current Category 1 pathway verified.
Exact form / routeFDA product stage503A screenCA conclusion
CJC-1295All or unspecifiedNo FDA-approved human drug identifiedNo verified fda approval program stage · Compounding review is separate from drug approvalNo verified 503A bulk pathwayNo approved product or current federal compounding pathway was verified for this transcript item.Do not launchNo approved product or current federal compounding pathway was verified for this transcript item.
04CardiogenSynthetic tetrapeptide unapprovedDo not launch1 form
What the transcripts discuss
Transcript mentions an organ-targeted heart peptide/bioregulator claim.
Evidence and regulatory caution
No FDA-approved U.S. human drug; incidental transcript mention and limited foreign/preclinical evidence.
Exact form / routeFDA product stage503A screenCA conclusion
CardiogenAll or unspecifiedNo FDA-approved human drug identifiedNo verified fda approval program stage · Compounding review is separate from drug approvalNo verified 503A bulk pathwayNo approved product or current federal compounding pathway was verified for this transcript item.Do not launchNo approved product or current federal compounding pathway was verified for this transcript item.
05CarnosineNaturally occurring dipeptideDo not launch1 form
What the transcripts discuss
Transcript mentions carnosine historically as an early identified peptide; commonly discussed as a muscle buffer/antioxidant.
Evidence and regulatory caution
Dietary/supplement and drug questions are product- and claim-specific; inclusion here does not classify every carnosine product as a drug.
Exact form / routeFDA product stage503A screenCA conclusion
CarnosineAll or unspecifiedNo FDA-approved human drug identifiedNo verified fda approval program stage · Compounding review is separate from drug approvalNo verified 503A bulk pathwayNo approved product or current federal compounding pathway was verified for this transcript item.Do not launchNo approved product or current federal compounding pathway was verified for this transcript item.
06CerebrolysinAnimal-derived peptide mixtureDo not launch1 form
What the transcripts discuss
Transcript discusses neurologic and traumatic-brain-injury claims.
Evidence and regulatory caution
No FDA-approved U.S. human drug; FDA warning-letter history includes compounded Cerebrolysin products.
Exact form / routeFDA product stage503A screenCA conclusion
CerebrolysinAll or unspecifiedNo FDA-approved human drug identifiedNo verified fda approval program stage · Compounding review is separate from drug approvalNo verified 503A bulk pathwayNo U.S. approval or compounding path was verified; mixture identity and animal-source quality risks require heightened review.Do not launchNo U.S. approval or compounding path was verified; mixture identity and animal-source quality risks require heightened review.
07CortexinAnimal-derived peptide mixtureDo not launch1 form
What the transcripts discuss
Transcript discusses neurologic/TBI-related and brain-extract claims.
Evidence and regulatory caution
No FDA-approved U.S. human drug; animal-derived mixture with identity and biologic-source risks.
Exact form / routeFDA product stage503A screenCA conclusion
CortexinAll or unspecifiedNo FDA-approved human drug identifiedNo verified fda approval program stage · Compounding review is separate from drug approvalNo verified 503A bulk pathwayNo U.S. approval or compounding path was verified; mixture identity and animal-source quality risks require heightened review.Do not launchNo U.S. approval or compounding path was verified; mixture identity and animal-source quality risks require heightened review.
08CrystagenSynthetic tripeptide unapprovedDo not launch1 form
What the transcripts discuss
Transcript discusses a thymic bioregulator.
Evidence and regulatory caution
No FDA-approved U.S. human drug; transcription/identity and evidence require confirmation.
Exact form / routeFDA product stage503A screenCA conclusion
CrystagenAll or unspecifiedNo FDA-approved human drug identifiedNo verified fda approval program stage · Compounding review is separate from drug approvalNo verified 503A bulk pathwayNo approved product or current federal compounding pathway was verified for this transcript item.Do not launchNo approved product or current federal compounding pathway was verified for this transcript item.
09Emideltide (DSIP)Synthetic peptideDo not launch2 forms
What the transcripts discuss
FDA nomination materials discuss sleep-related claims.
Evidence and regulatory caution
No FDA-approved human drug; free-base and acetate forms received July 2026 PCAC review without a final-list inference.
Exact form / routeFDA product stage503A screenCA conclusion
Emideltide (DSIP) acetateAll or unspecifiedNo FDA-approved human drug identified503a bulks advisory review · Not an fda drug approval stageAdvisory review complete; no final determination verifiedFDA obtained non-binding advisory input in July 2026. Advisory review is not approval or final inclusion on the 503A bulks list.Do not launchFDA obtained non-binding advisory input in July 2026. Advisory review is not approval or final inclusion on the 503A bulks list.
Emideltide (DSIP) free baseAll or unspecifiedNo FDA-approved human drug identified503a bulks advisory review · Not an fda drug approval stageAdvisory review complete; no final determination verifiedFDA obtained non-binding advisory input in July 2026. Advisory review is not approval or final inclusion on the 503A bulks list.Do not launchFDA obtained non-binding advisory input in July 2026. Advisory review is not approval or final inclusion on the 503A bulks list.
10EpitalonTetrapeptide unapprovedDo not launch2 forms
What the transcripts discuss
Transcript discusses circadian, pineal, DNA/telomere, eye, and longevity hypotheses based heavily on Russian/Eastern European literature.
Evidence and regulatory caution
No FDA-approved human drug; free-base and acetate forms received July 2026 PCAC review without final-list placement inferred.
Exact form / routeFDA product stage503A screenCA conclusion
Epitalon acetateAll or unspecifiedNo FDA-approved human drug identified503a bulks advisory review · Not an fda drug approval stageAdvisory review complete; no final determination verifiedFDA obtained non-binding advisory input in July 2026. Advisory review is not approval or final inclusion on the 503A bulks list.Do not launchFDA obtained non-binding advisory input in July 2026. Advisory review is not approval or final inclusion on the 503A bulks list.
Epitalon free baseAll or unspecifiedNo FDA-approved human drug identified503a bulks advisory review · Not an fda drug approval stageAdvisory review complete; no final determination verifiedFDA obtained non-binding advisory input in July 2026. Advisory review is not approval or final inclusion on the 503A bulks list.Do not launchFDA obtained non-binding advisory input in July 2026. Advisory review is not approval or final inclusion on the 503A bulks list.
11EpithalaminAnimal-derived peptide mixtureDo not launch1 form
What the transcripts discuss
Transcript discusses pineal extract, circadian rhythm, melatonin, and longevity claims.
Evidence and regulatory caution
No FDA-approved U.S. human drug; animal-derived extract/mixture.
Exact form / routeFDA product stage503A screenCA conclusion
EpithalaminAll or unspecifiedNo FDA-approved human drug identifiedNo verified fda approval program stage · Compounding review is separate from drug approvalNo verified 503A bulk pathwayNo U.S. approval or compounding path was verified; mixture identity and animal-source quality risks require heightened review.Do not launchNo U.S. approval or compounding path was verified; mixture identity and animal-source quality risks require heightened review.
12ExenatidePeptide drugCommercial product1 form
What the transcripts discuss
Type 2 diabetes.
Evidence and regulatory caution
FDA-approved products exist; verify current label and market status.
Exact form / routeFDA product stage503A screenCA conclusion
ExenatideAll or unspecifiedFDA-approved product existsFda approved product exists · Verify exact product and current labelApproved component; all 503A conditions still applyAn FDA-approved product exists. This does not approve every salt, route, dosage form, indication, or compounded copy.Commercial productCommercial product may be prescribed only after all patient, indication, clinician, telehealth, pharmacy, and state gates are satisfied.
03 / California
The state gates still open.
Clinician authority
Provider must hold a full license, compact privilege, telehealth registration, or a valid narrow exception for this profession and encounter.
Telehealth encounter
Verify current consent, identity, modality, prescribing, examination, follow-up, recordkeeping, and standard-of-care requirements.
Pharmacy authority
Dispensing pharmacy must hold every resident/nonresident, sterile/nonsterile compounding, and controlled-substance permit required for shipment into this jurisdiction.
Business structure
Verify corporate-practice-of-medicine, ownership, fee-splitting, kickback, advertising, supervision, and professional-entity rules.
Launch requirement: This row deliberately does not claim that silence by a state board is approval. Verify the current medical, pharmacy, nursing/PA (if applicable), and telehealth rules for the operating model.
04 / Source ledger
Claims need receipts.
01Bulk Drug Substances Used in Compounding Under Section 503A of the FD&C ActU.S. Food and Drug Administration
accessed 2026-08-22↗02Bulk Drug Substances Nominated for Use in Compounding Under Section 503AU.S. Food and Drug Administration
2026-05-14↗03July 23-24, 2026 Meeting of the Pharmacy Compounding Advisory CommitteeU.S. Food and Drug Administration
2026-07-24↗04Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety RisksU.S. Food and Drug Administration
accessed 2026-08-22↗05FDA's Concerns with Unapproved GLP-1 Drugs Used for Weight LossU.S. Food and Drug Administration
accessed 2026-08-22↗06Licensing Across State LinesU.S. Department of Health and Human Services
2025-04-30↗
accessed 2026-08-22↗02Bulk Drug Substances Nominated for Use in Compounding Under Section 503AU.S. Food and Drug Administration
2026-05-14↗03July 23-24, 2026 Meeting of the Pharmacy Compounding Advisory CommitteeU.S. Food and Drug Administration
2026-07-24↗04Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety RisksU.S. Food and Drug Administration
accessed 2026-08-22↗05FDA's Concerns with Unapproved GLP-1 Drugs Used for Weight LossU.S. Food and Drug Administration
accessed 2026-08-22↗06Licensing Across State LinesU.S. Department of Health and Human Services
2025-04-30↗
Podcast library
Apr 20, 2026Peptides podcast with Dr. Alex Tatum (user-supplied transcript)The Diary of a CEO
Jun 1, 2026Peptides: The Science, Uses & Safety | Dr. Abud BakriHuberman Lab
Use responsibly
This is a screening atlas,
not a prescription or legal opinion.
Podcast statements are discussion topics, not verified medical claims. Regulations change, and every proposed offering requires current product, patient, provider, pharmacy, and state-specific review.