What Happens Now? A Review of USP <797> Revisions
Monograph
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Course Summary
Every part of the sterile compounding process should be driven by one, critical element: patient safety. The key to achieving this is maintaining excellent aseptic technique, which is defined as a series of methods used to ensure compounded sterile preparations (CSPs) are free from microorganisms, pyrogens, and particulate matter. Preparing CSPs involves numerous factors, each of which has the potential to impact the sterility of these products. These include the environment in which the product is compounded, the equipment utilized to compound the product, and the individual who compounds the CSP. Should a CSP become contaminated and then administered to a patient, major harm and possible death could result. Thus, each factor must be optimized to ensure the safety of the final preparation. This course will provide a review of garbing and hand washing procedures and detail proper aseptic manipulations for pharmacists and pharmacy technicians who compound CSPs. USP Chapter <797> guidelines will be referenced.
Course Objectives
Recall training and evaluation requirements for compounding personnel
Assign beyond-use dates to compounded sterile preparations (CSPs)
Identify components of Master Formulation and Compounding Records
Recall sterility testing and endotoxin requirements
I. Introduction: Where We’ve Been with USP <797>
II. Compounded Sterile Preparations Categories
1. Immediate-use CSPs
2. Preparation Per Approved Labeling
III. Establishing Beyond-Use Dates
1. Use of Conventionally Manufactured Products as Components
2. Sterility Testing
3. Endotoxins Testing
IV. Personnel Training and Evaluation
1. Competency in Garbing and Hand Hygiene
2. Competency in Aseptic Technique
V. Facilities and Engineering Controls
Certification and Recertification
VI. Cleaning, Disinfecting, and Applying Sporicidal Disinfectants and Sterile 70% IPA
Sterilization and Depyrogenation
VII. Records and Labeling
1. Master Formulation Records
2. Compounding Records
3. Labeling
VIII. SOPs and Documentation
1. Standard Operating Procedures
2. Documentation
IX. Next Steps for Compounding Personnel
X. 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, BCPS, 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
Please ensure the device you plan to use meets these requirements and specifications:
- Operating System: Windows 7,8,10, or 11 /Mac OS X 10.9 or later/iOS/Android
- Supported Browsers: Microsoft Edge, Firefox, Google Chrome, Safari, Opera
- A connection to the internet
- For Live Webinars or Conferences: GoToWebinar application for iOS, Android, Mac, or PC. You cannot 'call into' a live conference.
Rating: 4.95/5
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- Target Audience: Pharmacist
- Contact Hours: 1.0 (0.1 CEUs)
- Activity Release Date: 12/17/2022
- Activity Expiration Date: 12/17/2025
- Activity Type: Knowledge
- UAN: 0669-0000-22-088-H07-P
- Topic: Compounding
- CeBroker Number: 20-931187
Author:
RxCe.com, LLC is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.