An Overview of Nonsterile Compounding Regulations, Standards, and Guidelines
Target Audience: Pharmacist, Pharmacy Tech
Course Overview
Compounded nonsterile medications play a critical role in meeting patient-specific therapeutic needs. However, these processes also introduce risks related to contamination, dosing variability, and preparation quality. Such risks have led to the development of a complex regulatory framework involving federal and state agencies, as well as standardized guidance from organizations such as the United States Pharmacopeia (USP). This continuing education activity provides an overview of the key legislation, regulatory bodies, and standards governing nonsterile compounding, including the Federal Food, Drug, and Cosmetic Act, the Drug Quality and Security Act, and USP Chapters <795> and <800>. It also reviews the roles of oversight organizations, including state boards of pharmacy, the FDA, OSHA, and NIOSH. Understanding these regulations and standards is essential to ensure compliance, minimize compounding-related risks, and promote patient safety in nonsterile compounding practice.
Learning Objectives
Upon completion of this educational activity, participants should be able to:
- Recall key terminology and regulatory concepts in nonsterile compounding
- Describe major legislation governing compounding
- Discuss regulatory oversight and the roles of governing organizations in nonsterile compounding processes
- Describe the roles of pharmacy staff in nonsterile compounding
Faculty
- Introduction
- A Brief History of Compounding
- Important Acronyms and Definitions
- Sterile vs. Nonsterile Compounding
- Hazardous vs. Non-Hazardous Compounding
- Relevant Legislation
- Food, Drug, and Cosmetic Act (FDCA)
- Food and Drug Administration Modernization Act
- Drug Quality and Security Act
- Occupational Safety and Health Act
- Oversight of Pharmaceutical Compounding
- Guidelines for Nonsterile Compounding
- USP 795: Pharmaceutical Compounding – Nonsterile Preparation
- USP 800: Hazardous Drugs – Handling in Healthcare Settings
- Compounding Reference Information
- The Role of the Pharmacy Technician
- Summary
From May 19, 2026 through May 19, 2029, 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 planning, developing, and/or authoring this activity: Liz Fredrickson, PharmD, BCPS; and Pamela Sardo, PharmD, BS. None of the individuals involved in developing this activity has a conflict of interest or financial relationships related to 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 designed solely 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 must consult their employer, healthcare facility, hospital, or other organization for guidelines, protocols, and procedures 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 is constantly changing. Any person taking this course understands that such a person must make an independent review of medication information before 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".