Sterile Compounding 101: Stability, Sterility, and Beyond-Use Dating
Monograph
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Course Summary
Compounded sterile preparations (CSPs) should be assigned a beyond-use date (BUD). Pharmacists and pharmacy technicians involved in sterile compounding should have a good understanding of how to assign beyond-use dates. Compounding personnel are awaiting revisions to the United States Pharmacopeia (USP) Chapter <797> “Pharmaceutical Compounding—Sterile Preparations,” which includes expanded guidance for assigning beyond-use dates. This course will assist pharmacists and pharmacy technicians in understanding the roles stability and sterility play in determining beyond-use dates for CSPs and will provide recommendations for establishing appropriate beyond-use dates for these types of preparations. USP Chapter <797> guidelines will also be reviewed.
Course Objectives
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
I. Introduction
II. A Brief Overview of Sterile Compounding
Useful Acronyms
III. Beyond-Use Date Basics
1. Regulatory Oversight
2. Stability and Sterility
IV. Assigning Beyond-Use Dates
1. Terminology
2. Process for Assigning Beyond-use Dates
3. Evidence of Stability
4. USP Chapter <797> Proposed Guidelines
5. Other Important Beyond-use Dates
V. Beyond-use Date Labeling and Documentation
1. Labeling
2. Documentation
VI. Beyond-use Dates: Dos and Do Nots
1. Dos
2. Do Nots
VII. Frequently Asked Questions
VIII. Summary
- Read the course objectives and faculty planner disclosure
- Read the course material
- Complete the post-test with a minimum score of 70% and complete the course evaluation form.
- Results are automatically submitted to CPE Monitor
Faculty Planner Disclosure
The following individuals were involved in the development of this activity: Liz Fredrickson, PharmD, BDPS, and Susan DePasquale, MSN, PMHNP-BC. There are no financial relationships relevant to this activity to report or disclose by any of the individuals involved in the development of this activity.
Unlabeled Use Disclosures
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.
Computer Hardware/Software Requirements
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Rating: 4.94/5
Based on the ratings of 370 customers
- Target Audience: Pharmacy Tech
- Contact Hours: 1.0 (0.1 CEUs)
- Activity Release Date: 11/1/2022
- Activity Expiration Date: 11/1/2025
- Activity Type: Knowledge
- UAN: 0669-0000-22-059-H07-T
- Topic: Compounding
- CeBroker Number: 20-958592
Author:
RxCe.com, LLC is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.
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".