The Pharmaceutical Compounding Series, Part 2: Essentials of Compounding

Outline:
Section 1:Introduction

About This Course

Learning Objectives

Section 2:Compounding Regulations and Standards

What is Compounding?

Why Might a Compounded Medication be Necessary?

Which Agencies Regulate Pharmacy Compounding?

FDA Regulation of Pharmacy Compounding

Section 503A of the FD and C Act

Section 503B of the FD and C Act

Drug Quality and Security Act:Section 105

Which Agencies Regulate Compounding?

Pharmacy Compounding Accreditation Bodies

What is USP?

Which USP Chapters are Concerned with Compounding?

Section 3:USP 795:Nonsterile Compounding

Nonsterile Compounded Medications

USP 795 Compounding Categories*

USP 795 Standards

Responsibilities of the Pharmacist

A Summary of the Compounding Process

USP Standards for Compounding Facilities and Equipment

Essential Nonsterile Compounding Equipment:Balances

How is the Minimum Weighable Quantity Determined for Electronic Balances?

Formulas with Less Than the Minimum Weighable Quantity

Essential Compounding Equipment:Graduated Cylinders and Syringes

Essential Compounding Equipment:Mortar and Pestle

Essential Compounding Equipment:Pill Tile(or Ointment Slab)and Spatula

Essential Compounding Equipment and Supplies:Miscellaneous

Selected Specialty Compounding Equipment

Compounding Capsules

USP 795 Standards for Selection, Storage, and Handling of Ingredients

USP 795 Standards for Stability Criteria and BUD*

USP 795 General Guidelines for BUD Assignment*

USP 795 Standards for Packaging and Containers

USP 795 Standards for Documentation

USP 795 Standards for Quality Control

USP 795 Standards for Patient Counseling

USP 795 Standards for Personnel Training

USP 795 Standards for Animal Patients

Section 4:USP 797 Compounding Sterile Preparations

USP 797 Overview:Sterile Compounding

USP 797 Standards for Personnel Responsibility

USP 797 Standards Regarding CSP Microbial Contamination Risk Levels

USP 797 Standards for Ampules, Single-Dose, and Multiple-Dose Containers*

USP 797 Standards on Hazardous Drugs, Radiopharmaceuticals, and Allergen Extracts as CSPs

USP 797 Standards for Verification of Accuracy and Sterility

USP 797 Standards for Environmental Quality and Control

USP 797 Standards for Environmental Quality and Control

Sample Layouts of Compliant Facilities

USP 797 Standards for Environmental Quality and Control

USP 797 Standards for Environmental Quality and Control

USP 797 Standards: Suggested Standard Operating Procedures

USP 797 Standards for Automated Compounding Devices (ACDs)

USP 797 Standards: Finished Preparation Release Checks and Tests

USP 797 Standards:Finished Preparation Release Checks and Tests

USP 797 Standards for Storage and Beyond-Use Dating

USP 797 Standards:Maintaining Sterility, Purity, and Stability of Dispensed CSPs

USP 797 Standards:Patient/Caregiver Training, Patient Monitoring, and Reporting of Adverse Events

USP 797 Standards for Quality Assurance Programs

Section 5:USP 800 Hazardous Drug(HD)Handling and Compounding

USP 800:Overview

USP 800 Standards:List of Hazardous Drugs

USP 800 Standards:Types of Exposure

USP 800 Standards on the Responsibilities of Personnel Handling HDs

USP 800 Standards for Facilities and Engineering Controls

USP 800 Standards for Facilities and Engineering Controls

USP 800 Standards for Environmental Quality and Control

USP 800 Standards for Personal Protective Equipment(PPE)

USP 800 Standards for Hazard Communication Programs

USP 800 Standards for Personnel Training

USP 800 Standards for Receiving of HDs

What if a Hazardous Drug is Spilled?

USP 800 Standards for Labeling, Packaging, Transport, and Disposal

USP 800 Standards for Administration of HDs

USP 800 Standards for Deactivation, Decontamination, Cleaning, and Disinfection

USP 800 Standards for SOPs and Documentation for HD Handling

USP 800 Standards for Medical Surveillance and Follow-Up Plans

Section 6:Preventing and Reporting Errors

Medication Error Prevention and Reporting

Professional Resources

Section 7:Conclusion

Summary

Course Contributors

Resources

References

Megan Kolb, BSPharm, is a pharmacist from Ohio with 18 years of experience. Her career began in long-term care pharmacy, where she was first trained in sterile compounding while serving as a staff pharmacist and later as operations manager. She then spent 3 years working for a specialty compounding pharmacy where she further developed her skills in sterile and nonsterile compounding, including veterinary compounding. She currently is a patient care pharmacist for a regional medical center in the central Ohio area. Megan enjoys training and writing, and she has written various training and operations guides, policies and procedures, and other guidelines for use in her places of work. Disclosure: Megan Kolb, BSPharm has declared that no conflict of interest, Relevant Financial Relationship or Relevant Non-Financial Relationship exists.

Laura Bell, BSN, RN, CCRN is a SME writer for Relias with over 13 years of acute care experience in nursing. She began working in adult critical care at Wake Med Cary Hospital in 2011, obtained her CCRN certification in 2016, and served in the role of Rapid Response/Code Blue/Rounding RN for over 2 years. She continues to work as a staff nurse in the intensive care unit. Laura has a passion for education and excellence in nursing care. She has been involved in numerous special projects and educational activities to improve staff development, evidence-based clinical practice, and patient satisfaction. She continues to strive for excellence in education and clinical development as an acute care course writer. Disclosure: Laura Bell, BSN, RN, CCRN discloses the following potential conflict of interests/commercial interests: Relevant Financial Relationship with Relias LLC as a Salaried Employee Relevant Non-Financial Relationship with No Entities Exists as a Contributor