503B Outsourcing Facilities Consulting Services

On November 27, 2013, the Drug Quality Security Act (DQSA) created a new section 503B in the Federal Food, Drug, and Cosmetic Act (FDCA). Under section 503B, a compounding pharmacy can become an outsourcing facility.

Outsourcing facilities must comply with current good manufacturing practice (CGMP) requirements and will be inspected by the FDA.

Request 503B Outsourcing Facilities Services

Detailed Services

FDA Inspection Preparation
  • “Front Door” Operations – Receiving
  • Inventory Controls
  • Product Shelf Life
  • Product Beyond Use Dates
  • Analytical Testing
  • Microbial Contaminants
  • Recall Processes
  • Establish Quality Assurance measures
  • Establish Continuous Quality Improvement (CQI) Program
  • Policies and Procedures
FDA 483 Warning Letter Support
  • In-Depth Warning Letter Analysis and Explanation to Staff & Management
  • Assess and Evaluate Facility and Operations (Digging Deeper into the Root Cause of Problem)
  • Remediation Support and Education
Training & Education
  • Educate and Train Staff and Owners on Handling FDA Inspections
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