Quality Without Compromise
As a state-licensed 503A sterile compounding pharmacy, CarePoint integrates quality into every stage of the compounding process—from ingredient sourcing and environmental controls to independent laboratory testing and pharmacist verification. Our quality systems are designed to support patient safety, product quality, documentation, and regulatory compliance.
Quality Program
- Patient-specific prescription compounding
- Two-pharmacist prescription review and verification workflow
- Independent third-party laboratory testing where applicable
- Potency testing where applicable
- Sterility testing where applicable
- Endotoxin testing where applicable
- Stability studies supporting assigned beyond-use dating where applicable
- Environmental monitoring program
- Personnel training and competency assessments
- Cleanroom certification and controlled environments
- Comprehensive batch documentation and lot traceability
- Cold-chain handling procedures where applicable
Independent Testing & Verification
CarePoint utilizes independent laboratory partners to support product quality verification. Depending on the preparation and applicable requirements, testing may include potency testing, sterility testing, endotoxin testing, stability studies, and analytical quality assessments.
Ingredient & Component Quality
- Active pharmaceutical ingredients sourced from FDA-registered facilities and qualified suppliers
- USP-grade excipients where applicable
- Incoming component verification
- Lot-level documentation and traceability
- Quality review prior to use and release
Sterile Compounding Environment
- USP aligned sterile compounding practices
- Controlled cleanroom environments
- HEPA-filtered engineering controls
- Environmental monitoring and certification
- Cleaning and disinfection procedures
- Personnel qualification, garbing, and aseptic technique training
What Is a 503A Pharmacy?
CarePoint Infusion Pharmacy operates as a state-licensed 503A sterile compounding pharmacy. Medications are compounded for individually identified patients pursuant to valid prescriptions from licensed healthcare providers. CarePoint does not manufacture medications for general distribution and provides patient-specific pharmacy services in accordance with applicable state and federal requirements.
