503B Outsourced Sterile Compounding Services

FDA REGISTERED 503B OUTSOURCING FACILITY

Overview

Pentec Health has built a new, state-of-the-art, sterile compounding facility and has registered it with the U.S. Food and Drug Administration (FDA) as a Human Drug Outsourcing Facility under Section 503B of the Federal Food, Drug, and Cosmetic Act.  The new facility and registration allows Pentec Health to enter the high volume, non-patient specific compounded sterile preparation market.  This new capability builds upon its 30+ year heritage of being a nationwide, patient-specific sterile compounding pharmacy operation.  The impressive facility represents a new standard in an evolving industry and mirrors traditional pharmaceutical manufacturing practices.

  • Fully cGMP compliant by design and operation
    • One product, in one room, at one time
    • Fully validated operations from raw material receipt to finished product release
    • Onsite Chemistry and Microbiology Laboratories to ensure stability and sterility
    • Quality Assurance, Quality Control and product production is all managed through a validated and 21 CFR; Part 11 compliant Enterprise Resource Planning system
    • All finished products are tested prior to release to ensure quality
  • Precision and scale is supported by automation and robotic compounding systems
    • Enables cost effective and consistent end product production
    • Minimizes the potential of human error and technician variability
    • Ensures consistent high volume production to meet customer needs

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