Community / anecdotal. Community / anecdotal — no regulatory basis. Not medical advice.
Typical — reference only
SC ~200-500 mcg/day; oral 250-500 mcg 2x/day (gut-local); topical ~1 mg (vendor '7.5 mg' is a ~7x outlier)
Worked reconstitution example
5 mg vial + 2 mL BAC = 2.5 mg/mL; 250 mcg = 10 U, 500 mcg = 20 U on U-100.
Titration
4-6 wk cycles (community)
Units are not milligrams. mg-vs-mcg confusion drives documented 5–1000× overdoses — always recompute for your own vial (use the calculator →).
Removal from Category 2 ≠ legal to compound ≠ FDA-approved. Removal != legal/approved. Vendor 'excellent safety / 20+ yrs research' claims contradict FDA (no human data).
StatusRemoved from Cat 2 · pending PCAC
503A bulksNot on the bulks list
Category 2 (2026)Removed from Category 2 ~22 Apr 2026
PCAC review2026-07-23 (FDA-evaluated uses: wound healing, obesity/osteoporosis - NOT the gut use driving demand)
WADANot listed
03Evidence — the honest read
Danimal-only
Animal/in-vitro only (PepT1 uptake, NF-kB inhibition); NO human RCTs, no human PK, no FDA approval. FDA: no human exposure data identified.
Contraindications
- Pregnancy/breastfeedinghard stop
- Active/history of cancer (precautionary)
- Active autoimmune disease / immunosuppression (uncharacterized)
Key interactions
- Immunosuppressants/biologics (theoretical additive immunomodulation)
- Chemotherapy (uncharacterized)
Serious signals
- Zero human safety/efficacy data
- RUO identity/purity/immunogenicity risk
Monitoring
None validated.
01FDA PCAC docket FDA-2025-N-6895
+PepTrack research dossier — iterations 1–4, 584 de-duplicated sources, adversarially verified.
Not medical or legal advice. Educational / harm-reduction reference. Regulatory and dosing claims in this field move monthly — re-verify against primary sources (FDA docket FDA-2025-N-6895, DailyMed, ClinicalTrials.gov) before acting.
Last reviewed — 2026-06-13 · confidence: medium