Yes — when prescribed by a licensed physician and compounded by an FDA-registered 503A or 503B pharmacy. The caveat is the evolving Category 2 → Category 1 reclassification, which affects which peptides can be compounded at any given time. BPC-157, for example, lacks FDA approval but carries one of the largest clinical datasets of any research peptide — compliant practitioners with IRB documentation will have a clear path forward as reclassification proceeds. Gray market Research Use Only (RUO) sources will not. Full legality breakdown →

503A pharmacies compound for individual patients based on a valid prescription from a licensed practitioner. Patient-specific, relationship-based. 503B outsourcing facilities operate under stricter FDA oversight, compound larger batches, and can sell to practitioners directly without patient-specific prescriptions. Both are FDA-regulated. All Peptide Pure products are sourced from 503A/B compliant compounders with a COA on every batch. This is the compliance moat that separates us from gray market suppliers.

Category 2 → Category 1 reclassification means a peptide moves from "compoundable" to "not compoundable without specific FDA approval." We track every FDA action in real time. When a reclassification is announced, enrolled practitioners receive notice and we update the protocol library accordingly. Practitioners with IRB documentation have a defensible compliance record regardless of what happens — they were practicing within an approved research framework, not operating a gray market.

IRB oversight converts your clinical practice into a documented research framework. It provides:

• A documented ethical basis for off-label and investigational protocols
• An outcomes registry that builds the evidence base over time
• A defensible compliance structure if any protocol is ever scrutinized
• The distinction between "systematically documenting outcomes from evidence-informed care" vs. "operating outside standard practice" — which is legally significant

You're not running experiments on patients. You're doing what good clinicians do — and writing it down in a way regulators can audit.

The fastest path: go to peptidepure.com ↗ — completing a purchase automatically enrolls you in the PPRN-001-2025 registry. Under 10 minutes.

Peptide Pure handles enrollment and dispensing. ONZEN handles everything it's not legal for a pharmacy to do: protocol education, clinical evidence, IRB documentation, and SHERPA.

Providers onboarding patients directly can use the IRB Informed Consent and Patient Health Intake forms here.

Peptide Pure sells injectable, prescription-grade compounded peptides. Access requires IRB enrollment. Every product ships with a Certificate of Analysis (COA). Enrollment is automatic at checkout.

Peptide Buzz sells over-the-counter peptide products — oral and topical formulations, no Rx required. No enrollment required. Providers access wholesale pricing at 50% off retail. The OTC line includes BPC-157 arginate oral, KPV oral, GHK-Cu topical, and SNAP-8 serum.

Under 10 minutes at peptidepure.com. The IRB Informed Consent and Patient Health Intake together take 15–20 minutes for patients who prefer the direct provider-enrollment path. Once enrolled, access to SHERPA, the protocol library, and your clinical documentation is immediate.

No. All services are direct-pay. Compounded peptides, off-label hormone protocols, and regenerative procedures are not covered by insurance. HSA/FSA cards are accepted. Some standard lab panels ordered by your PCP may be separately billable through existing insurance. The concierge model exists precisely because insurance doesn't cover the medicine that actually works.

SHERPA is the physician-trained AI at the core of ONZEN. It interprets labs, generates protocol recommendations, searches clinical literature, drafts patient communications, and tracks outcomes — all grounded in the evidence base and IRB framework. It speaks clinical language, not consumer wellness language. Everything SHERPA generates is reviewable before any action is taken. Access at app.onzen.health ↗

It depends on the protocol, but a comprehensive baseline is always preferable. For most patients we recommend:

• Hormones: Total T, Free T, SHBG, E2 (sensitive), DHEAS, LH, FSH, prolactin
• Metabolic: CMP, fasting glucose, HbA1c, fasting insulin, lipid panel
• Longevity: IGF-1, CRP (hs), homocysteine, CBC, TSH, ferritin
• Optional: Telomere length (TruDiagnostic), methylation panel

SHERPA flags abnormals, identifies optimal vs. reference ranges, and generates protocol recommendations from lab data directly. Upload labs in the Patient Intake form or paste them into SHERPA.

The ONZEN platform and protocol library are designed for licensed practitioners — MDs, DOs, NPs, PAs — who can prescribe and supervise. The educational content and protocol library are accessible to anyone. Peptide Pure requires a valid prescription for injectable compounded peptides. Peptide Buzz OTC products require no prescription and no enrollment. If you're a patient looking to start, go to peptidepure.com ↗ — your provider can be connected from there.

Yes. Patient data is de-identified before entering the outcomes registry. Clinical data is HIPAA-compliant. The IRB research data is aggregate and de-identified — no individual patient is identifiable in research outputs. ONZEN does not sell, share, or monetize patient data. The outcome registry exists to build the evidence base for regenerative medicine, not to commercialize your health information.

A Certificate of Analysis (COA) is a third-party lab document confirming the purity, potency, and identity of a compounded peptide. Every Peptide Pure product ships with a COA. This is the difference between pharmaceutical-grade and gray market peptides — the latter rarely have COAs, and when tested independently, frequently fail purity standards. The COA is also your compliance documentation: if a protocol is ever scrutinized, you have documented evidence of pharmaceutical-grade sourcing.

All ONZEN protocols use unit-based insulin syringe dosing with bacteriostatic water. We standardize on 3mL bac water for most vials — clean math, hard to mess up. Formula: vial mg ÷ mL = mg/mL concentration. Target dose ÷ concentration × 100 = units to draw.

Watch the reconstitution guide: youtube.com/shorts ↗

Every compound in the Protocol Library includes exact reconstitution math.

Tirzepatide (Mounjaro/Zepbound) is a dual GLP-1/GIP agonist — FDA-approved, strong RCT data, 22.5% body weight loss at 72 weeks in SURMOUNT-1. Best choice when regulatory defensibility and insurance pathway matter.

Retatrutide is a triple agonist (GLP-1 + GIP + Glucagon receptor). Phase 2 data showed 24.2% body weight loss at 48 weeks — the highest ever recorded in an obesity trial. The glucagon component adds thermogenic fat burning and hepatic steatosis improvement that tirzepatide lacks. Not yet FDA-approved.

We prefer retatrutide for most patients. Tirzepatide for patients where FDA approval is a priority consideration.

Some can. Most injectable peptides are degraded by gastric acid before they can be absorbed orally — they're effective because SQ injection bypasses digestion entirely.

Peptides that survive oral administration at therapeutic doses include:

• BPC-157 arginate — specifically for GI mucosal repair (oral route preferred for IBD, SIBO, leaky gut)
• KPV — survives gastric acid due to small tripeptide size; oral preferred for GI inflammation
• Semaglutide — FDA-approved oral version (Rybelsus) available

Our Peptide Buzz ↗ OTC line focuses on oral and topical formulations specifically designed for non-injectable delivery.

The Wolverine is our BPC-157 / TB-500 combination protocol — the most effective tissue repair stack available. BPC-157 drives local repair via angiogenesis and nitric oxide synthesis at the injury site. TB-500 drives systemic cell migration via actin upregulation, mobilizing repair cells from anywhere in the body. Together they cover both local and systemic repair pathways simultaneously. Standard maintenance: 20 units SQ daily. Acute injury (rotator cuff, Achilles, post-surgical): 30–50 units near site. Full protocol →