Resources
Compliance Guide.
For partner clinics.
A reference document for licensed healthcare providers sourcing through Golden Lotus Labs. This is not legal advice. Consult your healthcare attorney for practice-specific guidance.
Who Can Order
All Golden Lotus Labs products are available exclusively to licensed healthcare providers. Eligible providers include MDs, DOs, NPs, and PAs with a valid NPI number. NPI verification through the CMS NPPES registry is required before account activation.
Peptide Language & Claims
Peptides distributed by Golden Lotus Labs are research-grade compounds for use in physician-supervised clinical research protocols. Never use language claiming that a peptide "treats," "heals," or "reverses" any condition. Use: "studied for their potential role in," "researched for applications in," or "used in clinical research protocols under medical supervision."
BPC-157 & TB-500 — Regulatory Status
BPC-157 and TB-500 were removed from FDA Category 2 in April 2026. The July 23–24, 2026 PCAC hearing is the next key inflection point. These compounds may only be distributed through a licensed 503A compounding pharmacy for patient-specific prescriptions, or through a 503B outsourcing facility. Contact your account manager for current sourcing options.
Biologics — HCT/P Compliance
All biologic products are distributed in compliance with FDA 21 CFR Part 1271 (Human Cells, Tissues, and Cellular and Tissue-Based Products regulations). Full chain-of-custody documentation, certificate of conformance, and applicable regulatory records are provided with every order.
ProxiGene™ — Not a Diagnostic
ProxiGene™ provides genetic insights to inform protocol development. It is not a diagnostic tool and does not diagnose, treat, or prevent any medical condition. Use language such as "genetic insights to inform protocol development" rather than claiming diagnostic utility.
Storage & Cold Chain
All peptide products must be stored per the CoA specifications provided with each order. Most lyophilized peptides require refrigeration at 2–8°C and protection from light. Reconstituted peptides should be stored at 2–8°C and used within the timeframe specified in the accompanying documentation.
This compliance guide is provided for general informational purposes only and does not constitute legal or regulatory advice. Regulations governing pharmaceutical-grade peptide distribution, biologics, and compounding pharmacy requirements change frequently. Always consult a qualified healthcare attorney and your state medical board for current, practice-specific guidance. Last updated: May 2026.