Sterile Compounding and Quality Control Materials

ELEVATING STERILE COMPOUNDING PRACTICES: QUALITY CONTROL AND QUALITY ASSURANCE

Faculty:

Liz Fredrickson, PharmD, BCPS

Liz Fredrickson is an Associate Professor of Pharmacy Practice and Pharmaceutical Sciences at the Northeast Ohio Medical University (NEOMED) College of Pharmacy.

Pamela Sardo, PharmD, BS

Pamela Sardo is a freelance medical writer, a licensed pharmacist in two states, and the founder and principal at Sardo Solutions. She received her BS from the University of Connecticut and a PharmD from the University of Rhode Island. Pam’s career spans many years in retail, clinics, hospitals, long-term care, Veterans Affairs, pharmaceutical manufacturing, and managed healthcare across broad therapeutic classes and disease states.

Topic Overview:

Quality control and quality assurance are integral to ensuring the safety, efficacy, and compliance of compounded sterile preparations (CSPs). United States Pharmacopeia (USP) Chapter <797> defines quality control and assurance. This continuing education activity focuses on the essential principles, processes, and regulatory requirements of quality control and assurance in sterile compounding.

Accreditation Statement

RxCe.com LLC is accredited by the Accreditation Council for Pharmacy Education (ACPE) as a provider of continuing pharmacy education.

Universal Activity Number (UAN): The ACPE Universal Activity Number assigned to this activity is 

Pharmacist  0669-0000-25-051-H07-P

Pharmacy Technician  0669-0000-25-052-H07-T

Credits: 2 contact hour(s) (0.2 CEU(s)) of continuing education credit

Type of Activity: Knowledge

Media: Internet/Home study Fee Information: $6.99

Estimated time to complete activity: 2 contact hour(s) (0.2 CEU(s)), including Course Test and course evaluation

Release Date: April 28, 2025 Expiration Date: April 28, 2028

Target Audience: This educational activity is for pharmacists and pharmacy technicians.

Secondary Audiences: This educational activity is also for other healthcare professionals, such as nurses, physicians, or others who may be part of a healthcare team and may be interested in this educational topic. A healthcare team approach to patient care may be discussed in this activity, as applicable. No state board or professional organization has evaluated this activity to determine whether it meets the continuing education requirements of nurses, physicians, or other professions not listed under the “Target Audience” described above. Always verify with individual employers or supervisors whether they will accept this educational activity upon completion.

How to Earn Credit: From April 28, 2025, through April 28, 2028, participants must:

Read the “learning objectives” and “author and planning team disclosures;”

Study the section entitled “Educational Activity;” and

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 uploaded to CPE Monitor®.

Learning Objectives: Upon completion of this educational activity, participants should be able to:

Compare and contrast quality control and quality assurance

Describe the essential components of quality systems in sterile compounding

Describe adverse event reporting

Disclosures

The following individuals were involved in developing this activity: Liz Fredrickson, PharmD, BCPS, and Pamela Sardo, PharmD, BS. Liz Fredrickson, PharmD, BCPS, and Pamela Sardo 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.

© RxCe.com LLC 2025: All rights reserved. No reproduction of all or part of any content herein is allowed without the prior, written permission of RxCe.com LLC.

Educational Activity

Elevating Sterile Compounding Practices: Quality Control and Assurance Essentials

Introduction

Quality control and quality assurance are integral to ensuring the safety, efficacy, and compliance of compounded sterile preparations. United States Pharmacopeia, Chapter <797> defines quality control and assurance and guides compounding personnel on regulatory compliance. This continuing educational activity focuses on the essential principles, processes, and regulatory requirements of quality control and assurance in sterile compounding.

Pause and Ponder

How confident are you in your understanding of current USP <797>

requirements for quality control and quality assurance?

Definitions

Quality control (QC) and quality assurance (QA) are complementary yet distinct aspects of quality management in sterile compounding that are integral to ensuring the safety, efficacy, and compliance of compounded sterile preparations (CSPs). United States Pharmacopeia (USP), Chapter <797>, defines QC as the sampling, testing, and documentation of results that, taken together, ensure that specifications have been met before the release of the CSP.1 This includes routine testing, monitoring, and inspection to ensure processes meet predefined standards.1 In contrast, QA is a system of procedures, activities, and oversight that ensures that the compounding process consistently meets quality standards.1 Activities such as policy

development, staff training, and regular audits fall under QA.1 Quality assurance examples are described in Table 1.2

Table 1

USP General Chapter <1163> Quality Assurance in Pharmaceutical Compounding2

Under USP <797>, facilities must establish and document QA and QC programs in their standard operating procedures (SOPs) to ensure compliance with USP <797>.1 It is also crucial that compounders understand the requirements for compliance with their state board or boards of pharmacy.3 Designated persons are responsible for implementing formal, written QA and QC programs that include the following:3

Adherence to procedures

Prevention and detection of errors and quality issues

Evaluation of complaints and adverse events

Investigation and corrective actions as necessary

Standard operating procedures must outline the roles, responsibilities, and training requirements for personnel involved in QA.1 Designated individuals must possess the necessary training, experience, and authority to oversee these programs.1 These programs must be reviewed annually, with corrective actions implemented if required.1

Essential Components of Quality Systems in Sterile Compounding

Effective quality systems in sterile compounding, as outlined in USP

<797>, are essential for maintaining the sterility, accuracy, and consistency of CSPs. These systems are built on several key components, which will be described in detail below.

Facility Design and Environmental Controls

Facility design is a foundational aspect of quality systems. Cleanroom environments must meet specific ISO classifications, with primary engineering controls (PECs) achieving ISO Class 5 conditions.1 Environmental monitoring programs assess particulate levels, microbial contamination, temperature, and humidity to ensure that the cleanroom environment remains within acceptable parameters.1 Regular maintenance and validation of these controls are critical.1

Personnel Training and Competency

Training is a cornerstone of sterile compounding. Personnel must be thoroughly trained in aseptic techniques, garbing, hand hygiene, and cleanroom behavior.1 Competency is assessed through methods such as glove fingertip and thumb sampling (GFT), which evaluates hand hygiene and aseptic handling skills, and media fill testing, which simulates compounding activities to detect potential contamination risks.1 Ongoing training and periodic reassessments ensure that staff members maintain proficiency and stay updated on best practices.1

Competency Testing in Aseptic Manipulation

Per USP <797>, all compounding personnel who prepare Category 1, Category 2, and Category 3 CSPs must complete an evaluation of their competency in aseptic manipulation that includes the following:

Media-fill testing

Gloved fingertip and thumb sampling and

Surface sampling of the direct compounding area.

Factors associated with the length of the process that can pose contamination risk (e.g., operator fatigue, quality of equipment)

Number of aseptic additions or transfers

Number, type, and complexity of manipulations

Number of personnel in the cleanroom suite

Compounding personnel complete this simulation by replacing components used for CSPs with soybean-casein digest media.1 After testing, these vials are incubated at 20⁰C to 25⁰C for 7 days followed by incubation at 30⁰C to 35⁰C for 7 days.1 The presence of visible turbidity within the medium indicates failure.1 Gloved fingertip and thumb sampling is done immediately after the media fill test, with success indicated by ≤3 CFU total from both hands. An action level of 3 CFU is recommended for personnel to be retrained and re-evaluated.1

Planned testing, monitoring, and documentation are all required to demonstrate adequate personnel practices and procedures.1 Results of personnel evaluations and corrective actions in the event of a competency failure must be documented.1 This documentation provides a long-term assessment of personnel competency demonstration.1 The following items must be documented at a minimum:

Name of the individual who was evaluated

Evaluation date and time

Media and components used (including the name of the manufacturer)

Expiration date and lot number

Starting temperature for each interval of incubation

Dates of incubation

Results and identification of the observer and personnel reading and documenting the results

Documentation

Comprehensive documentation (Table 2) is vital for compliance, traceability, and quality assurance.1 USP 797 states that all facilities that prepare CSPs must have and maintain written or electronic documentation of the following:1

Personnel training, competency assessments, and qualification records, including corrective actions for any failures

Certification reports, including corrective actions for any failures

Environmental air and surface monitoring procedures and results

Equipment records (e.g., calibration, verification, and maintenance reports)

Receipt of components

SOPs, MFRs (if required), and CRs (if required)

Release inspection and testing records

Information related to complaints and adverse events, including corrective actions taken

Results of investigations and corrective actions

Accurate and accessible documentation facilitates regulatory compliance and supports investigations in case of adverse events or deviations.1 Proper documentation has implications for patient safety, legal compliance, and quality assurance, and meticulous record-keeping is crucial in promoting optimal outcomes.

Table 2 Documentation Defintions1,4,5,6

Standard Operating Procedures

Standard operating procedures are living documents that detail written instructions describing specific steps to follow in all activities under defined conditions. The purpose of an SOP is to carry out operations correctly and always in the same manner, ensuring that staff perform all tasks uniformly.7 These procedures are a set of step-by-step instructions on how to do a task under defined conditions and include the use of a log sheet to document the activity.7 SOPs should focus on procedure adherence, preventing and detecting errors, and investigating corrective actions.8 USP <797> requires compounding facilities to have formal, written SOPs.1 Any procedure that is considered significant should be covered by a facility’s SOP and documented.4 All SOPs should be numbered, and the last revision should be dated to avoid mix-ups.4,7

Standard operating procedure components include the title of the SOP, which identifies the task.7 The SOP number is an internal number that is assigned to the SOP to identify it.7 In some cases, the numbering system of an SOP is elaborate.7 The SOP should also include a written purpose.7 This purpose must be clearly stated so all staff understand the reasoning for the SOP, as the task is more likely to be completed when everyone understands the “why” behind it.7 The SOP procedure should be presented in a detailed, step-by-step manner, and references used to create the SOP should be included.7 The designated person (or persons) responsible for creating and approving the SOP should be listed with the date of the most recent revision.1 Components of SOPs are summarized in Table 3.

Table 3

Components of Standard Operating Procedures7

Standard operating procedures encompass many compounding areas, including personnel, facilities, equipment, and preparing and packaging the compounded preparations.4 For compounding equipment, maintenance records ensure all equipment is tested and maintained regularly.4

Master Formulation Records

Master formulation records are required for the sterile compounding process.1 Per USP 797, an MFR should be created for all CSPs that are prepared from nonsterile ingredient(s) or prepared for more than one patient.7 If an MFR is altered or updated, these changes should be approved and documented according to the compounding facility’s SOP.1 The following are required components of MFRs for CSPs:1

Name, strength or activity, and dosage form of the CSP

Identities and amounts of all ingredients; if applicable, relevant characteristics of components (e.g., particle size, salt form, purity grade, solubility)

Type and size of container closure system(s)

Complete instructions for preparing the CSP, including equipment, supplies, a description of the compounding steps, and any special precautions

Physical description of the final CSP

Beyond-use dates (BUDs) and storage requirements

Reference source to support the stability of the CSP

Quality control (QC) procedures (e.g., pH testing, filter integrity testing)

Other information as needed to describe the compounding process and ensure repeatability (e.g., adjusting pH and tonicity; sterilization method, such as steam, dry heat, irradiation, or filter)

Compounding Records

Compounding records (CRs) are used to document the process of compounding each CSP.1 A CR is required for all categories of CSPs, including Category 1, Category 2, and Category 3.1 If an immediate-use CSP is made for more than one patient, this also requires the creation of a CR.1 In this case of CSPs, MFRs, prescription orders, medication orders, or a label may serve as the CR. Compounding records can be stored electronically as long as they are readily retrievable and contain all required components.1

The following are required components of CRs per USP:1

Name, strength or activity, and dosage form of the CSP

Date and time of preparation of the CSP

Assigned internal identification number (e.g., prescription, order, or lot number)

A method to identify the individuals involved in the compounding process and those verifying the final CSP

Name of each component

Vendor, lot number, and expiration date for each component for CSPs prepared for more than one patient and for CSPs prepared from nonsterile ingredient(s)

Weight or volume of each component

Strength or activity of each component

Total quantity compounded

Final yield (e.g., quantity, containers, number of units)

Assigned BUD and storage requirements

Results of QC procedures (e.g., visual inspection, filter integrity testing, pH testing)

If applicable, the CR must also include the following information:7

MFR reference for the CSP

Calculations made to determine and verify quantities and/or concentrations of each component

Per USP 797, documentation for specific CSPs, including the MFR and CR, release inspection and testing results, should be readily retrievable for a minimum of 2 years after preparation.1 Laws and regulations may vary from state to state, and compounding personnel should follow the timeline that is more stringent between USP 797 and their local jurisdiction.1 A summary of MFRs and CRs is provided in Tables 7.7

Table 4

Summary of Master Formulation Records and Compounding Records8

Quality Control Measures

Verification

Verification in compounding ensures that all aspects of the compounding process, including calculations, measurements, mixing, and techniques, are performed accurately and appropriately.4 This may include external laboratory testing or qualitative assessments of processes like sterilization.4 Equipment verification can rely on manufacturer guidelines or custom methods, with compounding personnel responsible for oversight, though contractors may perform the actual verification.4

The final product should be inspected both after preparation and prior to administration.1 This inspection involves checking for container leaks, integrity, solution cloudiness, phase separation, particulates, appropriate color, and accurate volume.1 The pharmacist must confirm the product was compounded correctly, ensuring the proper ingredients, quantities, containers, and reservoirs were used.1 End-product verification may include observation, calculation checks, and reviewing documented records. Additionally, techniques like refractive index measurement can verify specific components, such as dextrose in parenteral nutrient solutions.1

Sterility and Endotoxin Testing

Testing for sterility and endotoxins is critical. For all in-house testing, periodic validation by an external laboratory is recommended to ensure accuracy and reliability.

Sterility Testing: Sterility tests can be performed using commercial kits or validated USP protocols, with standards outlined in USP <71>.10 Identifying specific contaminants, if needed, is covered in USP < 1163>.2

Endotoxin Testing: Endotoxins are tested using Limulus amebocyte lysate (LAL), as described in USP <85>.11 While effective, this process requires training and precision to interpret results accurately.

Risk Assessment and Mitigation

Risk assessment involves identifying potential hazards in compounding processes and implementing mitigation strategies. For example, establishing BUDs based on stability and sterility data ensures that CSPs remain safe and effective.9

Pause and Ponder

How does your current workplace culture support or hinder the reporting of compounding errors or near-misses?

Notification About and Recall of Out-of-Specification Dispensed CSPs

Releasing a CSP before completion of release testing introduces significant risk, and facilities must have robust procedures in place to mitigate potential harm. When a CSP is dispensed or administered before receiving final results, such as sterility, potency, or endotoxin testing, and subsequently fails to meet specifications, the facility must act immediately to protect patient safety. This includes promptly notifying the prescriber of any quality failure

that could cause patient harm and initiating a recall of all unused, dispensed units. Additionally, any in-house stock must be quarantined, and an investigation must be conducted to determine whether other lots are affected.

Per USP <797>, facilities must maintain a written SOP that outlines the steps for managing such recalls.1 This SOP should include procedures for assessing the severity and urgency of the situation, tracing distribution records to identify affected patients and quantities, safely disposing of recalled CSPs, and documenting the underlying cause of the failure.1 Facilities are required to document each phase of the recall process, from initiation to completion, and to report the incident to applicable regulatory authorities per federal and state laws.1,2 Timely and comprehensive recall management not only supports regulatory compliance but also strengthens public trust and upholds patient safety. A proactive recall SOP, combined with real-time inventory tracking systems and well-trained personnel, enhances a facility's ability to respond rapidly to out-of-specification events, minimize exposure risk, and facilitate continuous quality improvement in sterile compounding environments.

Complaint Handling

Compounding facilities must develop and implement SOPs for handling complaints. Complaints may include, but are not limited to, concerns or reports on the quality, labeling, or possible adverse reactions related to a specific CSP. A designated person(s) must review all complaints to determine whether the complaint indicates a potential quality problem with the CSP. If it does, a thorough investigation into the cause of the problem must be initiated and completed. The investigation must consider whether the quality problem extends to other CSPs. Corrective action, if necessary, must be implemented for all potentially affected CSPs. Consider initiating a recall of potentially affected CSPs and ceasing sterile compounding processes until all underlying problems have been identified and corrected.

A readily retrievable written or electronic record of each complaint must be kept by the facility, regardless of the source of the complaint (e.g., email,

telephone, or mail). The record must contain the name of the complainant or other unique identifier, the date the complaint was received, the nature of the complaint, and the response to the complaint. To the extent that the name and strength of the CSP, and the assigned internal identification number (e.g., prescription, order, or lot number) are known, this information should be recorded.

The record must also include the findings of any investigation and any follow-up. Records of complaints must be easily retrievable for review and evaluation for possible trends and must be retained in accordance with the record-keeping requirements in USP <797>. Following the completion of the investigation, the CSP that was returned in connection with the complaint must be quarantined until it is destroyed in accordance with the laws and regulations of the applicable regulatory jurisdiction.

Inspections

The Food and Drug Administration (FDA) issues Form 483, which is sent to a company’s management after an inspection when an investigator(s) has observed conditions that, in their judgment, may violate the Food Drug and Cosmetic (FD&C) Act or related Acts.13 The FDA’s Office of Regulatory Affairs (ORA) oversees all field activities, including inspections and enforcement.13 During an inspection, ORA investigators may identify conditions they find objectionable, which are documented on Form FDA 483. The purpose of Form FDA 483 is to notify a company’s management of any observed objectionable conditions.13 At the end of the inspection, this form is presented and discussed with senior management to ensure a complete understanding of the findings.13 However, Form FDA 483 is not necessarily an all-inclusive list of all potential violations, as there may be other objectionable conditions that exist but were not observed during the inspection.13 FDA investigators only document what they directly observe during the inspection process.13

While the issuance of Form FDA 483 is a critical step in the regulatory process, it does not constitute a final determination of whether a violation of the FD&C Act has occurred. Instead, it is considered alongside the

Establishment Inspection Report (EIR), supporting evidence, and responses provided by the company before the FDA determines

any the

appropriate next steps.13 Among the most frequently cited violations on Form FDA 483 are deficiencies in environmental monitoring systems (21 CFR 211.42(c)(10)(iv)), lack of adequate procedures for sterile drug products (21 CFR 21l.113(b)), failure to properly investigate discrepancies and product failures (21 CFR 211.192), inadequate cleaning systems (21 CFR 211.42(c)(10)(v)), and missing validation for sterile drug products (21 CFR 211.113(b)).13 Figure 1 shows a publicly available image of page 1 from an FDA Form 483.14

Figure 1

Inspectional Observations, Known as FDA Form 483, Page 1

Adverse Event Reporting

Adverse event reporting is a critical element of any sterile compounding QA program. Understanding the structure and expectations of reporting systems is vital for pharmacy personnel to protect patient safety and ensure compliance with regulatory standards. Given this, sterile compounding facilities must establish procedures to handle situations where CSPs fail quality specifications, are subject to complaints, or result in adverse events.1 If a CSP is dispensed or administered before release testing results are available, facilities must immediately notify prescribers if the failure poses potential patient harm (e.g., sterility, strength, or purity issues).1 Facilities must also recall unused CSPs, quarantine stock, investigate other potentially affected lots, and document recall procedures. Standard operating procedures should define the severity of the issue, track CSP distribution, identify affected patients, manage disposal, and investigate the failure's cause.1 Regulatory bodies must be informed of recalls per jurisdictional requirements.1

Compounding facilities must also maintain SOPs for complaint handling. Complaints may involve quality, labeling, or adverse reactions.1 A designated individual must review complaints to determine if they indicate quality issues requiring a thorough investigation. If broader impacts are identified, corrective actions, recalls, or suspension of compounding processes may be necessary.1 Facilities must document all complaints, including the complainant's information, CSP details, investigation findings, and follow-up actions, retaining records for trend analysis and regulatory compliance.1

Reporting processes are essential for identifying systemic weaknesses and implementing corrective actions. It fosters a culture of continuous improvement by enabling organizations to learn from past mistakes and prevent future occurrences. Comprehensive documentation ensures accountability and will help prevent future occurrences.1 Importantly, adherence to best practices in adverse event reporting is an expectation of many accrediting bodies, including state boards of pharmacy, The Joint Commission, and the National Association of Boards of Pharmacy (NABP).15 During inspections and audits, facilities may be asked to present

documentation of reported events, CAPA plans, staff training records, and evidence of trend analysis. A well-organized reporting system and a proactive QA culture enhance audit readiness and demonstrate a commitment to excellence in patient care.

Key Components of Adverse Event Reporting

It is vital that facilities systematically evaluate adverse events via formal investigative processes. Each event must be analyzed to identify the root cause, followed by implementing corrective and preventive action, or CAPA, plans. CAPA plans need to address both immediate and potential system-level vulnerabilities. For example, a recurring error in labeling may prompt revisions to the verification workflow, retraining of staff, or updates to technology systems used in the labeling process.

Effective reporting systems involve the following steps:16

Identification: Recognizing adverse events or near-misses during compounding or administration.

Documentation: Recording all relevant details, such as the nature of the event, contributing factors, and outcomes. Documentation should be clear, accurate, and timely, and should include the root cause analysis described next.

Root Cause Analysis: Conducting root cause analysis to identify underlying issues and contributing factors. This step often involves a multidisciplinary team.

Implementation: Developing and enacting corrective and preventive actions to address identified issues and prevent recurrence.

Facilities must regularly review and analyze reported events to identify broader trends and systemic issues. Tracking and trending errors over time allows pharmacy leaders to detect patterns—such as specific shifts, personnel, or tasks associated with increased risk. This information can guide risk mitigation strategies, such as staffing adjustments, targeted retraining, equipment upgrades, or workflow redesign. Pharmacists and technicians both

play an active role in this process by accurately documenting incidents, participating in root cause analysis, and contributing to the development of practical solutions.

Encouraging a Culture of Reporting

The foundation of any robust reporting program should be a culture of transparency and accountability; this is essential for effective adverse event reporting. Facilities should work to foster an environment in which staff feel empowered to report errors, near-misses, and deviations from SOPs without fear of retribution. A non-punitive approach will enhance continuous quality improvement and allow for early identification of process breakdowns before patient harm occurs.17 Training programs, open communication, and regular feedback can reinforce the importance of reporting and demonstrate management’s commitment to safety.

Summary

The integration of robust quality systems, as outlined in USP <797>, is essential for ensuring the safety and efficacy of sterile compounding practices. By understanding the distinctions between quality control and quality assurance, implementing comprehensive quality systems, and prioritizing adverse event reporting, healthcare professionals can uphold the highest standards of patient care. Continuous education and process improvements will ensure that pharmacies remain vigilant against emerging challenges in sterile compounding.

Course Test

Which of the following best describes quality control (QC)?

Developing policies and conducting audits

Sampling, testing, and documenting results to meet predefined standards

Training staff on aseptic techniques

Reporting adverse events

Which activity is primarily a part of quality assurance (QA)?

Routine sterility testing of compounded sterile preparations (CSPs)

Gloved fingertip and thumb sampling

Policy development and staff training

Monitoring environmental conditions

What is the primary purpose of QC in sterile compounding?

To ensure staff compliance with policies

To identify and prevent errors in compounded sterile preparations

To verify that compounded products meet specifications before release

To maintain cleanroom environmental conditions

How often must personnel competency in aseptic manipulation be reassessed for Category 2 CSPs after their initial assessment?

Every 6 months

Every 3 months

Annually

Every 9 months

Which of the following is not a required component of a Master Formulation Record (MFR)?

Beyond-use date and storage requirements

Results of sterility testing

Description of the compounding steps

Name, strength, and dosage form of the CSP

Which of the following is an essential component of documentation in sterile compounding?

Routine patient feedback forms

Pharmacist licensure information

Facility design plans

Calibration and maintenance records for equipment

According to regulatory guidance, what must sterile compounding facilities do if a CSP is administered before release testing and poses a potential risk of harm to patients?

Immediately report to the FDA and CDC

Resume compounding and test the next batch for quality

Notify the prescriber immediately

Destroy all lots from the same batch

What is a key component of effective adverse event documentation?

Punitive policies for error reporting

Calibration records for equipment

Employee training logs

Root cause analysis findings

Which of the following best promotes a culture of transparency and accountability in adverse event reporting?

Strict penalties for errors

Training staff on error prevention only

Implementing a non-punitive reporting approach

Increasing regulatory oversight

Which step is not part of the adverse event reporting process?

Propose penalties for staff who were the cause of the adverse event

Documentation of contributing factors

Implementation of corrective actions

Identification of the event

References

General Chapter: USP. Pharmaceutical Compounding-Sterile Preparations <797>. In: USP-NF. Rockville, MD: USP; September 2023.

General Chapter: USP. Quality Assurance in Pharmaceutical Compounding <1163>. In: USP-NF. Rockville, MD: USP; December 2020.

Akers MJ. Quality Assurance and Quality Control, Part 1. Int J Pharm Compd. 2015 Mar-Apr;19(2):121-4. PMID: 26685493.

Allen L. The Art, Science, and Technology of Pharmaceutical Compounding. APhA. 2016.

Hazard Communication Standard: Safety Data Sheets. OSH Brief. https://www.osha.gov/sites/default/files/publications/OSHA3514.pdf. Accessed August 10, 2023.

What are standard operating procedures? Compoundingtoday.com. https://compoundingtoday.com/SOP/#:~:text=What%20are%20Stand ard%20Operating%20Procedures,performance%20and%20quality%20p roducts%2Fpreparations. Accessed April 2025.

McElhiney LF Pharmd Rph. Records and record-keeping for the hospital compounding pharmacist. Int J Pharm Compd. 2007;11(2):136-141.

Hawkins J. Quality Assurance: Compounding Record Audits for Error Prevention. Int J Pharm Compd. 2023;27(3):211-217.

Lambert A. USP <797>: Translating low, medium, and high-risk compounding into categories. Wolters Kluwer. July 19, 2023. Accessed April 16, 2025. https://www.wolterskluwer.com/en/expert-insights/usp- 797-translating-low-medium-and-high-risk-compounding-into- categories

General Chapter: USP. Sterility Tests<71>. In: USP-NF. Rockville, MD: USP; 2013.

General Chapter: USP. Bacterial Endotoxin Tests <85>. In: USP-NF. Rockville, MD: USP; 2018.

General Chapter: USP. Antimicrobial Effectiveness Testing <51> In: USP-NF. Rockville, MD: USP; 2018.

McAlister, Jessica Pressley. Center of Excellence. Understanding the Form FDA 483 Process and Timeline. https://www.fda.gov/media/162162/download . Published October 6, 2022. Accessed April, 14, 2025

Form FDA 483 (09/08) Inspectional Observations. U.S. Food and Drug Administration. March 20, 2013. Accessed April 13, 2025. https://www.fda.gov/media/85788/download

The Joint Commission. Medication Compounding (Sterile and Non- Sterile): Standards FAQ Details. The Joint Commission; 2023. Accessed April 16, 2025. https://www.jointcommission.org/standards/standard-

faqs/hospital-and-hospital-clinics/medication-compounding-sterile-and- nonsterile/

The Joint Commission. Framework for Conducting a Root Cause Analysis and Action Plan. The Joint Commission; 2015. Accessed April 16, 2025. https://www.jointcommission.org/resources/patient-safety- topics/sentinel-event/root-cause-analysis/

Institute for Safe Medication Practices. ISMP Guidelines for Safe Medication Practices: Creating a Culture of Safety. ISMP; 2021. Accessed April 16, 2025. https://www.ismp.org

DISCLAIMER

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 is constantly changing. 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.

© RxCe.com LLC 2025: All rights reserved. No reproduction of all or part of any content herein is allowed without the prior, written permission of RxCe.com LLC.