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CPOM Certification Program
Module 13: Sterile & Non-Sterile Compounding Operations
From an Art to a Science: Mastering the High-Stakes World of Pharmaceutical Preparation.
Beyond the Counting Tray: Building a Culture of Compounding Excellence
As an experienced pharmacist, you’ve certainly practiced the art of compounding. You’ve prepared a “magic mouthwash,” mixed a topical cream, or perhaps even reconstituted the occasional oral antibiotic. You have mastered the small-scale, patient-specific preparations that are a hallmark of our profession. You understand the fundamental importance of accuracy and technique.
This module is designed to bridge the immense gap between that foundational experience and the responsibilities of managing a modern hospital compounding operation. Here, compounding is not an occasional task; it is a high-volume, high-risk, and intensely regulated manufacturing division within your pharmacy. The stakes are exponentially higher. An error in a non-sterile cream may cause a rash; an error in a sterile IV preparation can be catastrophic.
We will elevate your perspective from that of a practitioner to that of an operations manager and a compliance officer. You will learn to see the cleanroom not just as a place where IVs are made, but as a complex, engineered environment that must be meticulously controlled and monitored. You will master the dense but critical standards of USP <795>, <797>, and <800>, transforming them from abstract chapter numbers into a concrete operational playbook. This module is your deep dive into building and leading a compounding program that is not only efficient but is built on an unwavering foundation of safety, quality, and compliance.
Your Roadmap to Compounding Mastery
This module provides the comprehensive framework required to lead a safe, compliant, and efficient pharmacy compounding service.
USP <795>, <797>, and <800> Standards Overview
A manager’s guide to the foundational chapters governing all compounding. We will translate the dense regulatory text into actionable operational requirements for non-sterile, sterile, and hazardous drug preparations.
Facility Design, Environmental Monitoring, and Quality Controls
A deep dive into the science of the cleanroom. Learn the principles of facility design, air quality control, and the rigorous environmental and personnel monitoring required to maintain a state of control.
Compounding Workflow, Labeling, and Documentation
An exploration of the end-to-end process, from recipe formulation and master records to the critical details of beyond-use dating, accurate labeling, and compliant record-keeping.
Training and Competency Assessments for Compounding Staff
Learn how to build a robust training program that goes beyond initial instruction, focusing on the required gloved fingertip testing, media-fill tests, and ongoing competency assessments to ensure staff proficiency.
Audit Preparation, Compliance Gaps, and Remediation
A practical guide to being “inspection ready” at all times. Learn how to conduct self-audits, identify common compliance gaps, and develop effective Corrective and Preventive Action (CAPA) plans.
