Peptide Source Vetting Checklist
10 questions to answer before committing to a new supplier
Use this checklist when evaluating any peptide source — a compounding pharmacy, distributor, or
research-chemical supplier. Every "no" or "unclear" is a data point, not necessarily a
dealbreaker, but the weight of unanswered questions should drive the decision.
Regulatory and legal posture
1. Is the supplier a 503A pharmacy, a 503B outsourcing facility, or a research-chemical vendor?
503A and 503B are both FDA- and state-regulated. Research-chemical vendors are not. Know which
regulatory regime the product you are buying falls under — it dictates labeling, what you can
tell patients, and your downstream liability.
2. Is the product manufactured in the United States?
US-based manufacturing does not guarantee quality, but it places the product inside
FDA jurisdiction and generally correlates with more rigorous process controls.
3. Does the supplier hold current state licensure and (for 503B) FDA registration?
Verify directly with the state board of pharmacy and, for 503B, the FDA registration list.
Do not rely on the supplier's own marketing claim.
Quality and testing
4. Will the supplier produce a Certificate of Analysis (COA) for the specific lot shipped?
A legitimate COA is lot-specific and includes identity, purity (by HPLC), mass-spec identity
confirmation, endotoxin testing, and manufacture/retest dates. A generic COA that repeats
across shipments is a red flag.
5. Is purity tested by a third-party lab, or only in-house?
Third-party testing is a stronger quality signal. For higher-risk products, ask for both.
6. What is the reported purity by HPLC, and what is the identity confirmation method?
Clinical-grade peptides should typically be ≥ 98% purity. Identity should be confirmed by mass
spectrometry or an equivalent orthogonal method — HPLC alone can miss substitutions.
Logistics and supply
7. Is the product shipped lyophilized (powder) or pre-reconstituted?
Lyophilized products generally have a longer shelf life (often 12+ months). Pre-reconstituted
solutions may expire in as little as 3 months, creating real inventory risk if demand is
uneven.
8. Does the supplier ship directly to patients on a valid prescription, or only to the clinic?
Direct-to-patient shipping on a valid prescription is the standard workflow for compounded
medications and is operationally simpler. Clinic-only shipping puts storage and inventory
burden on your practice.
9. What are the wholesale unit economics, and do they permit a sustainable cash markup?
Benchmark the supplier's wholesale pricing against research-chemical retail prices
(which many patients can find themselves). If the cost to you already exceeds typical
retail, the unit economics will not work.
Operational track record
10. What is the supplier's regulatory and enforcement history?
Search the FDA warning letter database, FDA Form 483 observations, state board disciplinary
actions, and public news coverage. A history of recalls or enforcement action does not
automatically disqualify a supplier, but it should change what you require of them going
forward.