Compliance Is Our
Foundation, Not an Afterthought
MedClinic Partners was founded by professionals with mass-tort pharmaceutical backgrounds and pharmaceutical operators. Our compliance infrastructure is built by people who have deep familiarity with these regulations — not just read them.
Regulatory Standards
The Standards We Operate Under
Every product, facility, and process in our network is held to the following regulatory standards. We do not work with facilities that cannot demonstrate full compliance.
FDA 503A Compounding
- Patient-specific prescriptions required
- State-licensed compounding pharmacies only
- Compliant with DQSA Section 503A requirements
- Shortage list compliance monitored in real time
FDA 503B Outsourcing Facilities
- FDA-registered outsourcing facilities only
- cGMP manufacturing standards required
- Office stock supply without patient-specific Rx for eligible SKUs — semaglutide and tirzepatide are not eligible
- Bulk supply available to licensed pharmacies and providers
USP ‹797› / ‹800› Standards
- Sterile compounding under USP ‹797› guidelines
- Hazardous drug handling per USP ‹800›
- Environmental monitoring documentation required
- BUD validation per USP stability protocols
cGMP Manufacturing
- Current Good Manufacturing Practice compliance
- Certificate of Analysis on every shipment
- Third-party testing documentation available
- Facility registration numbers provided on request
Ongoing Monitoring
We Track Regulatory Changes So You Don't Have To
FDA guidance on compounding changes frequently — shortage list updates, new enforcement letters, state board rule changes. Most supply companies send you a product. We send you a compliance partner.
Our team — professionals with 15+ years of mass-tort pharmaceutical backgrounds and licensed PharmDs — monitors FDA 503A/503B guidance, USP ‹797›/‹800› updates, and state pharmacy board requirements in real time. When regulations shift, we notify our provider network proactively.
Get connected with our compliance teamFDA Shortage List Monitoring
Real-time tracking of FDA drug shortage list changes that affect compounding eligibility.
Enforcement Letter Alerts
Our legal team reviews FDA warning letters and enforcement actions affecting compounding facilities.
State Board Updates
State pharmacy board rule changes tracked across all 50 states — your network is notified before changes take effect.
Proactive Provider Notifications
When regulations shift, we contact our provider network directly — not through a newsletter, through your account contact.
Documentation Provided on Every Order
Your compliance file is complete before the shipment arrives.