Sterile Compounding 101: Standards, Guidelines, and Regulations
Monograph
Are you a Pharmacy Tech? Check out the Pharmacy Tech version of this course.
Want another way to take this test? Check out the video-based version of this course.
Course Summary
Compounded sterile preparations (CSPs) are critical for patient care, and compounding personnel must adhere to various regulations, standards, and guidelines to ensure the quality, safety, and efficacy of these preparations. The risks associated with sterile compounding, including contamination, incorrect potency, and compromised sterility, can lead to serious patient harm. To ensure quality, facilities and equipment must be clean and monitored, and staff must maintain competency in personal hygiene and compounding techniques. This continuing education activity delves into the essential elements of sterile compounding practices, focusing on the regulatory frameworks, standards, and guidelines that govern these processes.
Course Objectives
Define terms associated with sterile compounding standards, regulations, and guidelines
Describe standards and guidelines pertaining to the preparation of sterile compounds
Compare and Contrast federal and state regulation of sterile compounding
Discuss the importance of continuous professional development and education in maintaining sterile compounding competency
I. Introduction
II. Key Acronyms and Terms
III. Pharmaceutical Compounding Defined
IV. The Importance of Regulation
V. A History of Pharmaceutical Compounding
A. Food, Drug, & Cosmetic Act, Section 503A
B. Food, Drug, & Cosmetic Act, Section 503B
VI. Organizational Oversight
A. Federal and State Oversight of Sterile Compounding
B. Occupational Safety and Health Administration Regulations
VII. United States Pharmacopeia
A. USP Chapter <797>
B. Scope and Applicability of USP <797>
C. Other Relevant Chapters
VIII. Sterile Compounding Guidelines
IX. Sterile Compounding Continuing Education
X. Useful Tips
XI. 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 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 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.
- Target Audience: Pharmacist
- Contact Hours: 2.0 (0.2 CEUs)
- Activity Release Date: 12/16/2024
- Activity Expiration Date: 12/16/2027
- Activity Type: Knowledge
- UAN: 0669-0000-24-177-H07-P
- Topic: Compounding
- CeBroker Number: 20-1272630
Author:
Preview the Materials:
RxCe.com, LLC is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.