NHIA Roundtables (4 - 25 Minute Rotations)

44. Navigating California’s New Sterile Compounding Regulations

California’s updated sterile compounding regulations represent a significant shift in how pharmacies approach compliance, training, documentation, and quality assurance. With the repeal of previous compounding sections and the introduction of new regulatory articles addressing sterile compounding, pharmacies must reassess policies, workflows, and competency programs to ensure alignment with the updated requirements. This roundtable discussion will explore the practical implications of Article 4.6 (Section 1736) on sterile compounding, including new expectations for personnel training and competency documentation, expanded labeling and recordkeeping requirements, quality assurance procedures, and updated standards for cleaning and environmental control.
California’s updated sterile compounding regulations represent a significant shift in how pharmacies approach compliance, training, documentation, and quality assurance. With the repeal of previous compounding sections and the introduction of new regulatory articles addressing sterile compounding, pharmacies must reassess policies, workflows, and competency programs to ensure alignment with the updated requirements. This roundtable discussion will explore the practical implications of Article 4.6 (Section 1736) on sterile compounding, including new expectations for personnel training and competency documentation, expanded labeling and recordkeeping requirements, quality assurance procedures, and updated standards for cleaning and environmental control.

Learning Objectives

  • Summarize key structural changes in California’s updated compounding regulations.
  • Identify new operational and documentation requirements for sterile compounding under Section 1736.
  • Evaluate common challenges and best practices for maintaining compliance with California’s sterile compounding regulations.
  • Speaker(s)

    Cara Baker PharmD Pharmacy Operations Specialist V
    Kaiser Permanente

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    Speaker

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