$44.00

i 3.50 Hours

Course Overview

Compounded pharmaceutical preparations provide customized treatments that may otherwise not be commercially available. The United States Pharmacopeia (USP) provides and continually updates guidelines for the compounding of pharmaceutical preparations. While compounded preparations are not FDA-approved, the guidelines provided by the USP assist in ensuring their quality and safety. The purpose of this course is to introduce the reader to the art of pharmaceutical compounding, the differences between nonsterile and sterile compounded preparations, and current guidelines for the handling and compounding of hazardous drugs.

About the Course Author

Laura Bell, BSN, RN, CCRN is a SME writer for Relias with over 12 years of acute care experience in nursing. She began working in adult critical care at Wake Med Cary Hospital in 2011, obtained her CCRN certification in 2016, and served in the role of Rapid Response/Code Blue/Rounding RN for over 2 years. Laura has a passion for education and excellence in nursing care. She has been involved in numerous special projects and educational activities to improve staff development, evidence-based clinical practice, and patient satisfaction. She continues to strive for excellence in education and clinical development as an acute care course writer. Laura Bell, BSN, RN, CCRN has declared that no conflict of interest, Relevant Financial Relationship or Relevant Non-Financial Relationship exists.
Megan Kolb, BSPharm, is a pharmacist from Ohio with 18 years of experience. Her career began in long-term care pharmacy, where she was first trained in sterile compounding while serving as a staff pharmacist and later as operations manager. She then spent 3 years working for a specialty compounding pharmacy where she further developed her skills in sterile and nonsterile compounding, including veterinary compounding. She currently is a patient care pharmacist for a regional medical center in the central Ohio area. Megan enjoys training and writing, and she has written various training and operations guides, policies and procedures, and other guidelines for use in her places of work. Megan Kolb, BSPharm has declared that no conflict of interest, Relevant Financial Relationship or Relevant Non-Financial Relationship exists.

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Detailed Transcripts

License Tracking/Reminders

Accreditation Information

Certificates provided by accrediting body (3 Match)

  • Accreditation Council for Pharmacy Education

    3.50HOURS

    In support of improving patient care, Relias LLC 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.


    Type Activity: Knowledge
    Target Audience Designation: P
    ACPE Universal Activity Number: JA4008266-0000-21-025-H07-P
  • Accreditation Council for Pharmacy Education

    3.50HOURS

    In support of improving patient care, Relias LLC 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.


    Type Activity: Knowledge
    Target Audience Designation: T
    ACPE Universal Activity Number: JA4008266-0000-21-025-H07-T
  • Florida Board of Pharmacy

    3.50HOURS

    This module is approved for 3.5 contact hours by Florida Board of Pharmacy


Course Details
  • Course Code:

    REL-ACU-0-MPLS2
  • Hours:

    3.50
  • Type:

    Online Course
  • Release Date:

    2021-05-01
  • Expiration Date:

    2024-03-31
  • Learning Objectives:

    Define and differentiate between the risk levels involved in compounding nonsterile vs. sterile products, and review USP <800> guidelines for the handling of hazardous drugs.; Differentiate between products that require nonsterile vs. sterile compounding preparation, and review key guidelines for nonsterile and sterile compounding from the United States Pharmacopeia (USP) chapters <795> and <797>.; Identify equipment commonly used in nonsterile vs. sterile compounding and key compounding abbreviations, terms, and phrases related to pharmaceutical compounding via the United States Pharmacopeia (USP).; Identify the governing agencies and professional organizations responsible for regulating and creating standards of practice for compounding medications, and review the main responsibilities of compounding personnel in the preparation of compounded products.
  • Outline:

    Section 1: Introduction
    About This Course
    Learning Objectives
    Section 2: Compounding Regulations and Standards
    What is Compounding?
    Why Might a Compounded Medication be Necessary?
    Which Agencies Regulate Pharmacy Compounding?
    FDA Regulation of Pharmacy Compounding
    Section 503A of the FD&C Act
    Section 503B of the FD&C Act
    Drug Quality and Security Act: Section 105
    Which Agencies Regulate Compounding?
    Pharmacy Compounding Accreditation Bodies
    What is USP?
    Which USP Chapters are Concerned with Compounding?
    Section 3: USP <795>: Nonsterile Compounding
    Nonsterile Compounded Medications
    USP <795> Compounding Categories*
    USP <795> Standards
    Responsibilities of the Pharmacist
    A Summary of the Compounding Process
    USP Standards for Compounding Facilities and Equipment
    Essential Nonsterile Compounding Equipment: Balances
    How is the Minimum Weighable Quantity Determined for Electronic Balances?
    Formulas with Less Than the Minimum Weighable Quantity
    Essential Compounding Equipment: Graduated Cylinders and Syringes
    Essential Compounding Equipment: Mortar and Pestle
    Essential Compounding Equipment: Pill Tile (or Ointment Slab) and Spatula
    Essential Compounding Equipment and Supplies: Miscellaneous
    Selected Specialty Compounding Equipment
    Compounding Capsules
    USP <795> Standards for Selection, Storage, and Handling of Ingredients
    USP <795> Standards for Stability Criteria and BUD*
    USP <795> General Guidelines for BUD Assignment*
    USP <795> Standards for Packaging and Containers
    USP <795> Standards for Documentation
    USP <795> Standards for Quality Control
    USP <795> Standards for Patient Counseling
    USP <795> Standards for Personnel Training
    USP <795> Standards for Animal Patients
    Section 4: USP <797> Compounding Sterile Preparations
    USP <797> Overview: Sterile Compounding
    USP <797> Standards for Personnel Responsibility
    USP <797> Standards Regarding CSP Microbial Contamination Risk Levels
    USP <797> Standards for Ampules, Single-Dose, and Multiple-Dose Containers*
    USP <797> Standards on Hazardous Drugs, Radiopharmaceuticals, and Allergen Extracts as CSPs
    USP <797> Standards for Verification of Accuracy and Sterility
    USP <797> Standards for Environmental Quality and Control
    USP <797> Standards for Environmental Quality and Control
    Sample Layouts of Compliant Facilities
    USP <797> Standards for Environmental Quality and Control
    USP <797> Standards for Environmental Quality and Control
    USP <797> Standards: Suggested Standard Operating Procedures
    USP <797> Standards for Automated Compounding Devices (ACDs)
    USP <797> Standards: Finished Preparation Release Checks and Tests
    USP <797> Standards: Finished Preparation Release Checks and Tests
    USP <797> Standards for Storage and Beyond-Use Dating
    USP <797> Standards: Maintaining Sterility, Purity, and Stability of Dispensed CSPs
    USP <797> Standards: Patient/Caregiver Training, Patient Monitoring, and Reporting of Adverse Events
    USP <797> Standards for Quality Assurance Programs
    Section 5: USP <800> Hazardous Drug (HD) Handling and Compounding
    USP <800>: Overview
    USP <800> Standards: List of Hazardous Drugs
    USP <800> Standards: Types of Exposure
    USP <800> Standards on the Responsibilities of Personnel Handling HDs
    USP <800> Standards for Facilities and Engineering Controls
    USP <800> Standards for Facilities and Engineering Controls
    USP <800> Standards for Environmental Quality and Control
    USP <800> Standards for Personal Protective Equipment (PPE)
    USP <800> Standards for Hazard Communication Programs
    USP <800> Standards for Personnel Training
    USP <800> Standards for Receiving of HDs
    What if a Hazardous Drug is Spilled?
    USP <800> Standards for Labeling, Packaging, Transport, and Disposal
    USP <800> Standards for Administration of HDs
    USP <800> Standards for Deactivation, Decontamination, Cleaning, and Disinfection
    USP <800> Standards for SOPs and Documentation for HD Handling
    USP <800> Standards for Medical Surveillance and Follow-Up Plans
    Section 6: Preventing and Reporting Errors
    Medication Error Prevention and Reporting
    Professional Resources
    Section 7: Conclusion
    Summary
    Course Contributors
    Resources
    References
  • Target Audience:

    The target audience for this course is: Pharmacists; Pharmacy Technicians; in the following settings: Acute Care Facility.
  • Course Delivery Method and Format:

    Asynchronous/Online Distance Learning; please see certificate details for specifics on delivery format.
    Relias has a grievance policy in place to facilitate reports of dissatisfaction. Relias will make every effort to resolve each grievance in a mutually satisfactory manner. In order to report a complaint or grievance please contact Relias.
    If you require special accommodations to complete this module, please contact Relias Support by completing the web form (https://www.relias.com/help) or by using the chat functionality.
    All courses offered by Relias, LLC are developed from a foundation of diversity, inclusiveness, and a multicultural perspective. Knowledge, values and awareness related to cultural competency are infused throughout the course content.
    Reference herein to any specific commercial product, process, or service by trade name, trademark, service mark, manufacturer or otherwise does not constitute or imply any endorsement, recommendation, or favoring of, or affiliation with, Relias, LLC.
    All characteristics and organizations referenced in the following training are fictional. Any resemblance to any actual organizations or persons living or dead, is purely coincidental.
    To earn continuing education credit for this course you must achieve a passing score of 80% on the post-test and complete the course evaluation.
  • Accommodations:

    If you require special accommodations to complete this module, please contact Relias Customer Support here.
  • Disclosures:

    Expert Reviewers, Instructors, and Staff Writers disclosures will be listed above after the individuals' biographical paragraph. All other members involved within the planning of this educational activity have declared no conflict of interest exists when planning and developing this course.