Appendix E: Supplier Evaluation Checklist

# Appendix E: Supplier Evaluation Checklist

HOW TO USE THIS CHECKLIST

Use this checklist to evaluate any peptide manufacturer, supplier, or pharmacy before entering into an agreement. Complete each section by requesting documentation and conducting verification. Do not rely solely on what a supplier tells you — verify independently. A score of 80% or higher on the documentation verification items suggests a legitimate supplier. However, this checklist is a tool, not a guarantee. Your attorney should conduct a full regulatory review before signing any agreement. ---

SECTION 1: REGULATORY STATUS VERIFICATION

### 1A: If the Supplier is a Pharmacy | Item | What to Verify | How to Verify | Pass | Fail | N/A | |------|---------------|---------------|------|------|-----| | 1A-1 | State pharmacy license is current and in good standing | Request a copy; verify with state board of pharmacy | ☐ | ☐ | ☐ | | 1A-2 | No pending state board disciplinary actions | Search state board website; request representation | ☐ | ☐ | ☐ | | 1A-3 | Last state board inspection report available | Request copy; review for material findings | ☐ | ☐ | ☐ | | 1A-4 | Pharmacy is registered as 503A (patient-specific) | Verify on FDA registration database | ☐ | ☐ | ☐ | | 1A-5 | If claiming 503B status: active FDA 503B registration | Verify on FDA 503B facility list | ☐ | ☐ | ☐ | | 1A-6 | No FDA warning letters or enforcement actions | Search FDA warning letter database | ☐ | ☐ | ☐ | | 1A-7 | No import alerts affecting their products | Search FDA import alert database | ☐ | ☐ | ☐ | ### 1B: If the Supplier is an API/Ingredient Supplier | Item | What to Verify | How to Verify | Pass | Fail | N/A | |------|---------------|---------------|------|------|-----| | 1B-1 | Manufacturing facility is FDA-registered (if required) | Verify on FDA registration database | ☐ | ☐ | ☐ | | 1B-2 | No FDA warning letters or import alerts | Search FDA databases | ☐ | ☐ | ☐ | | 1B-3 | Supplier can document API regulatory status | Request written representation | ☐ | ☐ | ☐ | | 1B-4 | Supplier is not marketing APIs as FDA-approved drug products | Review marketing materials; request representation | ☐ | ☐ | ☐ | ---

SECTION 2: QUALITY AND TESTING

SECTION 3: AGREEMENT STRUCTURE

SECTION 4: PRICING AND FINANCIAL TERMS

SECTION 5: OPERATIONAL DUE DILIGENCE

SECTION 6: RED FLAGS — IMMEDIATE DISQUALIFICATION

Score each item as YES (red flag present) or NO: | Red Flag | Present? | |----------|----------| | Supplier refuses to provide state pharmacy license or FDA registration | ☐ Yes ☐ No | | Supplier cannot explain the regulatory basis for their business model | ☐ Yes ☐ No | | Agreement is structured as a "distribution" or "resale" arrangement | ☐ Yes ☐ No | | Supplier asks you to operate as a drug distributor without requiring a distributor license | ☐ Yes ☐ No | | Pricing is structured as a percentage of prescription or per-unit prescribing incentive | ☐ Yes ☐ No | | Supplier cannot provide a COA or testing documentation | ☐ Yes ☐ No | | Supplier is an offshore company with no US regulatory presence | ☐ Yes ☐ No | | Supplier's products are labeled "not for human use" or "research use only" | ☐ Yes ☐ No | | Supplier asks you to sign a document that misrepresents your business relationship | ☐ Yes ☐ No | If any red flag is present: Do not proceed. Find a different supplier. ---

SECTION 7: SUMMARY SCORECARD

Complete this after reviewing all sections above. Total Pass Items: _____ / _____ Total Fail Items: _____ / _____ N/A Items: _____ / _____ Compliance Score: Pass ÷ (Pass + Fail) × 100 = _____% --- Recommended action based on score: | Score | Action | |-------|--------| | 90–100% | Proceed with attorney review of agreement | | 75–89% | Address all failing items before proceeding | | 60–74% | Significant concerns; proceed only if all items can be resolved | | Below 60% | Do not proceed; find a different supplier | ---

SECTION 8: DOCUMENTATION PACKAGE TO REQUEST

Before signing any agreement, request and retain: ☐ Current state pharmacy license(s) ☐ Current FDA registration certificate(s) ☐ Most recent state board inspection report ☐ Professional liability insurance certificate ☐ Third-party testing SOP ☐ Sample COA format ☐ Stability data for each peptide in scope ☐ Recall SOP ☐ List of current customers (reference list) ☐ FDA warning letters (if any) — written confirmation of none received ☐ Adverse event reporting SOP ☐ HIPAA/BAA (if applicable) ☐ Business references ---

SECTION 9: QUESTIONS TO ASK THE SUPPLIER

Ask these questions directly. Document the answers. If the supplier cannot or will not answer these questions clearly, that is itself a significant red flag. 1. What specific regulatory framework permits you to supply peptides in the manner described in your agreement? (They should cite Section 503A, 503B, or API supply — not "distribution.") 2. Can you walk me through how a peptide moves from your facility to a patient's prescription? (The answer should describe a prescription-first chain, not a distribution chain.) 3. Are your peptides FDA-approved drug products or compounded peptides? (This is a fundamental question that determines the entire regulatory framework.) 4. What is your state pharmacy license number and how can I verify it with the state board? (Any legitimate pharmacy will provide this.) 5. Have you received any FDA warning letters, import alerts, or state board disciplinary actions? (They should disclose. Silence is a red flag.) 6. What does your testing include and who performs it? (Should be third-party, accredited lab, with COA provided.) 7. What happens if a batch fails testing? What is your recall procedure? (Should have a documented procedure.) 8. Can I tour your facility? (If they refuse, that is a significant red flag.) 9. Who are your current customers? Can I speak with them? (Legitimate suppliers should have reference customers.) 10. How do you ensure that the prescriptions we send are reviewed by your pharmacy for clinical appropriateness? (The pharmacy should be a clinical partner, not just a vendor.) --- *END OF APPENDIX E*