Course Outline – IV Certification

Pharmacy Education Resources National Sterile Compounding Training Manual for Pharmacists

UAN: 0156-9999-23-065-B07-P
Live Credit Hours: 2.0 (0.02 CEUs)
Home-Study Credit Hours: 18.0 (0.18 CEUs)
Type: Practice-based
Expiration: 07/10/2026

The Texas Society of Health-System Pharmacist (TSHP) is accredited by the Accreditation Council Pharmacy Education as a provider of continuing education. Pharmacist documenting 20 hours of training, passing exams, demonstrating proper process in preparing sterile products, and completing course of instructor evaluations will receive a statement of credit within 6 weeks of completion of the program.

At the completion of this activity, the participant will be able to:

1. Express appropriate formulations and methods for the calculation of various sterile compounded preparations.
2. Describe the 3 Risk levels used in sterile compounding and the compounding, storage and cleaning requirements for each risk level.
3. Identify the various ISO Class 5 Hoods and Isolators with the appropriate sterile compounding procedure that applies to each.
4. Recognize different tests and methods which can verify that the compounded preparation is sterile.
5. Demonstrate @ 100% accuracy on Process Validation (PV) Checklist aseptic hand washing.
6. Demonstrate @ 100% accuracy on PV Checklist proper gowning and sterile gloving technique.
7. Demonstrate @ 100% accuracy on PV Checklist proper horizontal hood cleaning technique.
8. Demonstrate @ 100% accuracy on PV Checklist proper vertical hood or Barrier Isolator cleaning technique.
9. Demonstrate @ 100% accuracy on PV Checklist proper powder vial reconstitution technique.
10. Demonstrate @ 100% accuracy on PV checklist proper liquid vial and ampule technique.
11. Demonstrate @ 100% accuracy on PV Checklist proper hazardous drug preparation technique.

This book is designed to assist medical professionals in going beyond the basic knowledge of
sterile compounding but also into understanding why the United States Pharmacopeial Convention developed the 6 General Chapters for Compounding.

This book covers:

• Policies and procedures for aseptic techniques USP <797> Pharmaceutical Compounding Sterile Preparation
• Proper use of supplies and equipment including USP <1176> Prescription Balances and Volumetric Apparatus.
• Guidelines to procedures necessary to perform calculations properly when compounding USP <1160> Pharmaceutical Calculations in Prescription Compounding.
• Responsibilities and Practices to assure USP <1163> Quality Assurance in Pharmaceutical Compounding are met.
• Guidelines regarding the handling of hazardous drugs in order to protect both patient and health care professional USP <800> Hazardous Drugs — Handling in Healthcare Settings.
• Guidelines on how to extemporaneously compound preparations that are of acceptable strength, quality and purity USP<795> Pharmaceutical Compounding —Nonsterile Preparations.

This book is a platform to build upon and refers the participant to various USP websites which
are updated regularly with new information to keep you up-to-date and current with compounding practices. Many USP chapters are referenced and not discussed in length, therefore it is left up
to the participant to follow end of the chapter references to obtain more knowledge and a deeper understanding of the topic if so desired.

The book is formulated in such a manner that each chapter is comprehensive and builds upon the knowledge gained from previous chapters. Therefore, it is vital, that the participant begin reading with the first chapter. Each chapter has a set of Objectives prior to the opening statement and a set of Self-Assessment questions at the end of each chapter. This book can be used by either a Pharmacist or a Pharmacy Technician since a separate set of Pharmacist and Pharmacy Technician
Objectives and Self-Assessment questions are included for each Chapter, as well as separate ACPE exams. Pharmacists and Pharmacy Technicians will not receive the same amount of total CE credit because of the Live (hands-on) section of this program is different. (Please see ACPE statement page for credit hours listed for each program.)

It will be necessary for readers who are unfamiliar with certain terms, conversions, formulas, etc, to memorize facts, in order to utilize the information within this book. To obtain CE credit an evaluation and written comprehensive post test must be successfully completed with a score of 75% or better, as well as completed hands-on process validation checklists. The process validation checklists need to be submitted at least 31 days prior to the program’s expiration date 06/30/2020. Please read the enclosed instructions and complete all forms to be submitted for CE credit.