Mastering Sterile Compounding: Stability, Sterility, and Beyond-Use Dating
Target Audience: Pharmacy Tech
Course Overview
Compounded sterile preparations (CSP) must be assigned a beyond-use date (BUD). Once this date has passed, the preparation is at risk of physical and chemical degradation and microbial contamination, thus placing a patient who may receive it at risk. This continuing education activity will assist pharmacists and pharmacy technicians in understanding the role of stability and sterility in determining beyond-use dates for CSPs and will provide recommendations for establishing BUDs for these preparations.
Learning Objectives
Upon completion of this educational activity, participants should be able to:
- Describe factors that affect the stability of compounded sterile preparations
- Describe factors that influence the sterility of compounded sterile preparations
- Discuss how to evaluate stability and sterility to determine a beyond-use date
- Assign appropriate beyond-use dates to compounded sterile preparations
Faculty
I. Introduction
II. Compounded Sterile Preparations Categories
A. Comparing CSP Categories
B. Immediate-use CSPs
III. Beyond-use Date Basics: Definition
IV. Parameters for Establishing Beyond-Use Dates
A. Sterilization Methods and Aseptic Processing
B. Stability Considerations
V. Establishing Beyond-Use Dates
A. Use of Conventionally Manufactured Products as Components
B. Sterility Testing
C. Endotoxins Testing
VI. Beyond-use Date Labeling and Documentation
A. Labeling
B. Documentation
VII. Beyond-use Dates: Dos and Do Nots
VIII. Summary
From March 22, 2025 through March 22, 2028, participants must:
- Read the "learning objectives" and "author and planning team disclosures"
- Study the section entitled "educational activity"
- Complete the Course Test and Evaluation form. The Course Test will be graded automatically. Following successful completion of the Course Test with a score of 70% or higher, a statement of participation will be made available immediately. (No partial credit will be given.)
Credit for this course will be automatically uploaded to CPE Monitor®.
Faculty Planner Disclosure
The following individuals were involved in developing this activity: Liz Fredrickson, PharmD, and Pamela Sardo, PharmD, BS. Pamela Sardo and Liz Fredrickson have no conflicts of interest or financial relationships regarding the subject matter. There are no financial relationships or commercial or financial support relevant to this activity to report or disclose by RxCe.com or any of the individuals involved in the development of this activity.
Unlabeled Use Disclosure
The information provided in this course is general in nature and it is solely designed to provide participants with continuing education credit(s). This course and materials are not meant to substitute for the independent, professional judgment of any participant regarding that participant’s professional practice, including but not limited to patient assessment, diagnosis, treatment and/or health management. Medical and pharmacy practices, rules, and laws vary from state to state, and this course does not cover the laws of each state; therefore, participants must consult the laws of their state as they relate to their professional practice. Healthcare professionals, including pharmacists and pharmacy technicians, must consult with their employer, healthcare facility, hospital, or other organization, for guidelines, protocols, and procedures they are to follow. The information provided in this course does not replace those guidelines, protocols, and procedures but is for academic purposes only, and this course’s limited purpose is for the completion of continuing education credits. Participants are advised and acknowledge that information related to medications, their administration, dosing, contraindications, adverse reactions, interactions, warnings, precautions, or accepted uses are constantly changing, and any person taking this course understands that such person must make an independent review of medication information prior to any patient assessment, diagnosis, treatment and/or health management. Any discussion of off-label use of any medication, device, or procedure is informational only and such uses are not endorsed hereby. Nothing contained in this course represents the opinions, views, judgments, or conclusions of RxCe.com LLC. RxCe.com LLC is not liable or responsible to any person for any inaccuracy, error, or omission with respect to this course, or course material.
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Accreditation
In support of improving patient care, RxCE.com is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.
PTCB Recognition
RxCe.com, LLC, offers pharmacy technician continuing education courses for PTCB recertification. Pharmacy technician courses are indicated both in the Target Audience description and the ACPE UAN which will end with a "T".