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Our Changing Industry

The past decade has brought dramatic and necessary change to the outsourced sterile compounding industry, or 503B facilities.

Historically, hospitals and health care systems compounded drugs in house but the practice of outsourcing these services has grown rapidly. Since the tragic New England Compounding Center (NECC ) tragedy in 2012, sweeping new guideline have been put into place that provide for more oversight and require outsourcing companies adhere to more stringent safety regulations.

The Drug Quality and Security Act (DQSA) was signed into law on November 27, 2013. The act identified 503B “Outsourcing Facilities” and stated they must comply with the following requirements:

  • Voluntary registration with the FDA
  • Compound of sterile drugs
  • Is not required to obtain a patient-specific prescription prior to compounding
  • If not a licensed pharmacy, all compounding must be done under the supervision of a licensed pharmacist subject to state licensing laws
  • Must comply with cGMP (current good manufacturing process) requirements and subject to FDA inspections
  • Must report which products they are compounding and any adverse events
  • Must pay establishment, annual fees, and reinspection fee if applicable

This important regulatory elevation has changed the way the entire segment must operate. 503B compounding facilities must migrate from the previous guidance offered by USP <797> to cGMP regulations.

The chart below shows the stark difference between the two regulations.

Key Components/Sections< USP 797 >cGMP
WorkflowNot specifiedUnidirectional flow of personnel and materials
ProductionCan allow multiple products simultaneously in a cleanroomDefined areas for production with line clearances
Beyond-Use-Date (BUD)/ Expiration Date, Stability, and Endotoxin testingOnly for high-risk or Extended BUDRequired for all products; Stability testing data used to establish expiration dating
Final Container Sterility/Potency/Stability Testing and Reserve SamplesNot requiredRequired for every batch created
Material TestingNot requiredRequired
Quality Control (QC) Quarantine, Release Testing, and StorageNot requiredRequired prior to release
Environmental ControlDaily temperature monitoringContinuous temperature, pressure, and humidity, with monitoring
Environmental MonitoringAir: 6 months
Surface: periodically (>6 months)
Personnel: 1-2 times/year
Air: daily
Surface: daily
Personnel: daily (with monitoring during production)
Sterile GarbingSterile glovesFULL Sterile garb
Sterile DisinfectantsIsopropyl alcoholRotation of disinfectants, & sporicidal agents; including validation
Equipment, Process, IT System, and Cleaning ValidationNot requiredRequired
Documentation (GDP)As required per prescription and by stateRequired for all batches, testing, processes and validation.
Change Control (Process, Equipment, Material, and Document)Not requiredRequired
Adverse Drug Event (ADE) Reporting with Root Cause Analysis, investigation, and CAPANot requiredRequired
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