How Star Health stays compliant
The rules behind every clinic account, rep relationship, and order.
- Verify the prescriber's active state license and NPI before portal access
- Route patient-specific prescriptions to state-licensed 503A pharmacies and office-use stock to FDA-registered 503B facilities
- Review the formulary against current federal and state rules and remove items when their status changes
- Keep lot numbers and order records for every shipment
- Compound, store or dispense medication ourselves
- Supply research-use-only material to clinics
- Ship without a valid prescription or office-use order
- Pay prescribers for referrals, or claim a compounded product treats, cures or prevents disease
Prescriber verification
Before portal access is activated, we confirm the medical director or prescriber's active state license and NPI. Accounts are reviewed again when a prescriber changes.
Licensed pharmacies only
Patient-specific prescriptions are filled by state-licensed 503A pharmacies. Office-use stock comes from FDA-registered 503B outsourcing facilities. Star Health does not compound, store, or dispense medication.
Formulary review
Every product on the formulary is reviewed against current federal and state compounding rules. When a substance's status changes, it is removed from the portal and open orders are reviewed.
No research-use-only material
Products labeled for research use only are not for human use. Star Health does not supply them to clinics under any circumstances.
Sales rep rules
Reps complete compliance training before contacting clinics. They don't give clinical advice, don't offer anything of value to prescribers, and use approved materials only. Compensation is structured with healthcare regulatory counsel.
Marketing and claims
Compounded products are not FDA-approved. Neither we nor our clinics' approved marketing claim that a compounded product treats, cures, or prevents disease. We offer copy review to clinics on request.
Records
Lot numbers and order records are kept for every shipment.
Questions about compliance: jonathan@stardistro.co.