Introduction
Pharmacy compounding plays a critical role in providing individualized care by preparing customized medications that meet the specific needs of patients. In the context of non-sterile compounding, precision, safety, and adherence to regulatory standards are essential to ensure the quality and efficacy of each preparation. This reference book serves as a practical guide for pharmacy professionals and students, offering comprehensive insights into the core components of non-sterile compounding operations.
Throughout this text, readers will be guided through the preparatory steps required before compounding begins, including environmental and personal readiness, appropriate reference checks, and risk assessment strategies. It emphasizes the selection and proper use of compounding equipment and techniques that align with best practices and current regulatory requirements, both provincially and federally through NAPRA standards of practice and guidance documents. The evaluation of formulation records, compound records, and supporting documentation is covered in detail, reinforcing the importance of accuracy and traceability in every step of the compounding process.
Further chapters explore the technical assessment of finished products, including checks for accuracy, consistency, and overall quality. The supervision of compounding personnel is addressed, highlighting effective delegation, oversight, and the promotion of a culture of continuous quality improvement. Readers will also find guidance on contributing effectively to day-to-day compounding operations, fostering collaborative workflows and adherence to established procedures.
Lastly, inventory management is discussed in the context of compounding, focusing on maintaining appropriate stock levels, ensuring proper storage conditions, and managing expiry tracking to support safe and efficient compounding practices.
Whether you are a student, technician, or practicing pharmacist, this reference is designed to support your understanding and application of key concepts in non-sterile compounding. By integrating practical knowledge with regulatory expectations, this book aims to strengthen the foundation of quality assurance in pharmacy compounding environments.
- This book was developed with the assistance of ChatGPT (accessed [2025]). It was used to generate drafts of the introduction and some chapters, which were then reviewed, revised, and exampled on with my own writing and the incorporation of resources. Examples of prompts that were used can be found in Appendix B.”
Acknowledgments:
I would like to gratefully acknowledge the National Association of Pharmacy Regulatory Authorities (NAPRA) for allowing the use of their documents:
NAPRA Model Standards For Pharmacy Compounding of Non-Sterile Preparations
Guidance Document for Pharmacy Compounding of Non-sterile Preparations
I would also like to gratefully acknowledge Saskatchewan College of Pharmacy Professionals (SCPP). Although this reference can be used nation wide, some provincial considerations were provided through SCPP’s CompEX – Compounding Excellence program.
Many people helped make this book happen. Special thanks go out to Janice Brenner, Courtney Junop, Deanne Riese, Chelsea Johnson, Sue Mack-Klinger and Amanda Johnson for their assistance and expertise.
I would also like to acknowledge the Government of Saskatchewan, Ministry of Education for the grant that made this project possible and Saskatchewan Polytechnic for the support in completing this project.
