COMPLIANCE ISN'T
A FEATURE.
IT'S THE FOUNDATION.
Every product Core Distro distributes meets the highest regulatory standards. We maintain rigorous oversight of our entire supply chain so your pharmacy can focus on patient care.
OUR QUALITY CREDENTIALS.
FDA-Registered Importer
Core Distro is an agent of the registered FDA Importer of Record, ensuring all imported pharmaceutical products meet U.S. regulatory requirements.
USP-Grade Components
All packaging components meet United States Pharmacopeia standards for identity, strength, quality, and purity.
GMP Compliance
Our manufacturing partners operate under current Good Manufacturing Practice regulations for pharmaceutical products.
ISO 13485
Quality management systems for medical devices and pharmaceutical packaging components aligned with ISO 13485 standards.
EVERY BATCH.
FULL DOCUMENTATION.
Core Distro provides a complete documentation package with every order. No chasing down paperwork — everything you need for your quality management system is included automatically.
THE STANDARDS WE UPHOLD.
Current GMP for Finished Pharmaceuticals
All packaging and equipment suppliers comply with FDA's current Good Manufacturing Practice regulations.
Pharmaceutical Compounding — Sterile Preparations
Our packaging components meet USP <797> requirements for sterile compounding environments.
Hazardous Drugs — Handling in Healthcare Settings
Compliance support for pharmacies handling hazardous drug compounds.
Injection Containers for Injectables
All glass vials meet ISO 8362-1 standards for injectable pharmaceutical containers.
SUPPLY CHAIN INTEGRITY.
Vendor Qualification
All suppliers undergo rigorous on-site GMP audits before any product enters our supply chain. We verify manufacturing practices, quality systems, and regulatory compliance.
Cold-Chain Logistics
Pharmaceutical-specialized temperature-controlled logistics for all temperature-sensitive products. Every shipment is monitored end-to-end with full chain of custody documentation.
Batch Traceability
Complete lot traceability from manufacturer to your pharmacy. Every product can be traced back to its origin, manufacturing date, and quality release records.
QUESTIONS ABOUT OUR
COMPLIANCE PROGRAM?
Our compliance team is ready to answer any questions about our quality systems, documentation, or regulatory requirements.