Best Practices Documentation Compounding Materials

OPTIMIZING OUTCOMES: BEST PRACTICES IN DOCUMENTATION FOR STERILE AND NONSTERILE COMPOUNDING

Liz Fredrickson, PharmD, BCPS

Liz Fredrickson is an Associate Professor of Pharmacy Practice and Pharmaceutical Sciences at the Northeast Ohio Medical University College of Pharmacy. She serves as Director of Instructional Labs and is course director for the Basic Pharmaceutics Lab and Parenteral Products and Parenteral Products Lab courses.

Topic Overview

Documentation is vital to the compounding process. Proper documentation has implications for patient safety, legal compliance, and quality assurance, and meticulous record-keeping is crucial in promoting optimal outcomes. Pharmacists and pharmacy technicians involved in compounding should be well-versed in managing various types of records, including Master Formulation Records and Compounding Records. With a firm grounding in standards and best practices related to documentation and record-keeping, compounding personnel will be better equipped to ensure quality and consistency in compounded preparations. This monograph will describe various types of records, discuss best practices for documentation, and detail common errors that can occur in the documentation processes, with related strategies to prevent and mitigate such errors.

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  0669-0000-23-130-H07-P

Pharmacy Technician  0669-0000-23-131-H07-T

Credits: 1 hour of continuing education credit

Type of Activity: Knowledge

Media: Internet Fee Information: $4.99

Estimated time to complete activity: 1 hour, including Course Test and course evaluation

Release Date: August 19, 2023 Expiration Date: August 19, 2026

Target Audience: This educational activity is for pharmacists.

How to Earn Credit: From August 19, 2023, through August 19, 2026, 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:

Explain the role of documentation in the compounding process and its impact on patient safety, legal compliance, and quality assurance

Describe best practices in maintaining and managing various types of documentation involved in the compounding process, including Standard Operating Procedures, Master Formulation Records, and Compounding Records

Identify common errors that can occur in the documentation process of sterile and nonsterile compounding

Identify strategies to prevent and mitigate documentation errors

Disclosures

The following individuals were involved in developing this activity: Liz Fredrickson, PharmD, BCPS, and Pamela Sardo, PharmD, BS. Pamela Sardo was an employee of Rhythm Pharmaceuticals until March 2022 and has no conflicts of interest or relationships regarding the subject matter discussed. 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.

©RxCe.com LLC 2023: All rights reserved. No reproduction of all or part of any content herein is allowed without the prior, written permission of RxCe.com LLC.

Introduction

Documentation is vital to the compounding process. Proper documentation has implications for patient safety, legal compliance, and quality assurance, and meticulous record-keeping is crucial in promoting optimal outcomes. Pharmacists and pharmacy technicians involved in compounding should be well-versed in managing various types of records, including Master Formulation Records and Compounding Records. With a firm grounding in standards and best practices related to documentation and record-keeping, compounding personnel will be better equipped to ensure quality and consistency in compounded preparations. This monograph will describe various types of records, discuss best practices for documentation, and detail common errors that can occur in the documentation processes, with related strategies to prevent and mitigate such errors.

Definitions of Compounding Records

Sterile and nonsterile compounding involves the creation of medications tailored to address unique and specific patient needs that cannot be met by commercially available products.1 Pharmaceutical compounding requires compliance with standards and regulations, and proper documentation is essential to ensure the safety, efficiency, and legality of these processes. Documentation can be broadly defined as a record of activities, and it serves crucial roles in helping compounding facilities demonstrate compliance with regulations, assure the quality and consistency of preparations, provide a means by which to audit preparations and track recalls, mitigate potential legal issues, and track inventory.2,3

Good documentation and record-keeping policies provide facilities with a system to correctly compound preparations, wherein they can determine what preparations were made, how they were made, when they were made, and who made them.2,3 These details are important from both a legal and quality control perspective. Compounding facilities need to keep accurate records to ensure a well-run pharmacy and comply with the laws and regulations of their local jurisdiction(s).2 A number of different records need

to be maintained, including certificates of analysis, compounding records, master formulation records, safety data sheets, and standard operating procedures. These are defined in Table 1.

Table 1. Documentation Defintions3-6

Qualities of Good Documentation

Personnel responsible for compounding sterile and/or nonsterile preparations must demonstrate competency in documenting the compounding process.3,4,7 How documentation is constructed is as important as what is documented.2 Records that are incomplete or illegible are not useful during audits or reviews of documents.2,3 They also need to be stored so they can be

readily retrieved and so they will not be destroyed or lost.3,4,7 The following are characteristics of good documentation8:

Correct, accurate, legible, exact, and free of unnecessary information

Captures the original observations that are critical to preparation quality

Provides enough of the right information to stand on its own

Allows tracing of a preparation

Serves as a control for quality and final preparation evaluation

How and When to Document

There is no specific length or necessary format that pertains to compounding documentation.2 In fact, documentation can be any length given the necessary facts are all presented.2 The use of a structured, formalized process, whether this involves worksheets, forms, or computer systems, is the more important consideration, as it assists with keeping documents and records uniform and avoiding errors.2 Electronic health records, in particular, are helpful for keeping documentation in a structured format.2 Documentation should be conducted in a manner that is quick, precise, and consistent while ensuring sufficient detail to determine what was done.2 It should always occur either during a process or immediately after the process is completed and should be done in the same location (i.e., facility) where the work occurred.8

What to Do About Errors

Errors in the documentation process have the potential to negatively impact facility operations and cause patient harm.8 Addressing errors quickly assists in preventing or minimizing harm to patients.8 The best way to avoid errors is through prevention strategies that involve stringent procedures and thorough training.3 Facilities should also plan to review documentation processes regularly.3 Finally, compounding personnel should be encouraged to report errors rather than be fearful of potential repercussions associated with making errors.8

Because documentation errors may happen, compounding personnel and facilities should have policies and procedures in place for how to remedy such occurrences.10 When mistakes are made, correction fluids and scratch- outs should not be used on records.8 Rather, a neat line should be drawn through the mistake, and the individual who made the mistake should place their initials by the error.8 Examples of potential documentation errors are detailed in Table 2. Table 3 summarizes tips for the documentation process.8

Table 2. Types of Documentation Errors8

Table 3. Documentation Tips8

Types of Records

Logbooks

A logbook is defined as a collection of logs and documentation forms that constitute a chronological record of activities that reflect the operation of a pharmacy.9 Information within a logbook can be recorded manually or electronically daily, or information can be recorded on documentation sheets throughout the day and then compiled.9 Logbooks should include columns for the data, columns for data to be documented, and a column for signatures.9 Table 4 provides recommended types of documentation logbooks.

Table 4. Examples of Documentation Logbooks9

Standard Operating Procedures

Standard operating procedures (SOPs) are living documents that detail written instructions describing specific steps to follow in all activities under defined conditions.6 The purpose of an SOP is to carry out the operations correctly and always in the same manner and that assures staff perform all

tasks uniformly.8 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 to activity.8 SOPs assist compounding facilities with ensuring practices are uniform, accurate, safe, and quality and that involved personnel have accountability for those procedures.3 They should focus on procedure adherence, preventing and detecting errors, and investigating corrective actions.10 USP Chapters 795 and 797 require compounding facilities to have formal, written SOPs.4,7 Any procedure that is considered significant should be covered by a facility’s SOP and documented.3 All SOPs should be numbered, and the last revision should be dated to avoid mixups.3,8

SOPs include many different components. These include the title of the SOP, which identifies the task.8 The SOP number is an internal number that is assigned to the SOP in order to identify it.8 In some cases, the numbering system of an SOP is elaborate.8 The SOP should also include a written purpose.8 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.8 The SOP procedure should be presented in a detailed, step-by-step manner, and references used to create the SOP should be included.8 The designated person (or persons) responsible for creating and approving the SOP should be listed with the date of the most recent revision.4,7 Components of SOPs are summarized in Table 5.

Table 5. Components of Standard Operating Procedures8

SOPs encompass many areas of compounding, including personnel, facilities, equipment, and preparing and packaging the compounded preparations.3 For compounding equipment, records of maintenance ensure all equipment is tested and maintained regularly.3 Examples include calibration of balances and checking refrigerator thermometers.3 Examples of types of SOPs are listed in Table 6.3

Table 6. Types of Standard Operating Procedures for Compounding Pharmacies3

By documenting these procedures well, facilities are able to track and evaluate the procedures completed.

Ingredient Records

Any time a compounding facility purchases ingredients, records of these ingredients need to be kept.3 Important documentation includes the safety data sheet and certificate of analysis.3 These types of records can be stored as originals or photocopies, and they can also be stored electronically.3 Compounding personnel should understand where and how to locate these types of records.3

A safety data sheet is a document that details information and procedures for handling and working with chemicals; it is kept for any drug substance or bulk chemical.3 An SDS will detail important information pertaining to the ingredient, including physiochemical, toxicity, and handling instructions.3 Understanding this information keeps compounding personnel safe. SDS can be found on many websites of chemical wholesalers, and these can be bookmarked for reference.8 The following sections are standardized within an SDS. However, specific content can vary depending on the product and local regulatory requirements.5

Identification: Includes product identifier; manufacturer or distributor name, address, phone number; emergency phone number; recommended use; restrictions on use. Hazard(s) Identification: Includes all hazards regarding the chemical and required label elements:

Composition/Information on Ingredients: Includes information on chemical ingredients; trade secret claims.

First-Aid Measures: Includes important symptoms/effects, acute and delayed; required treatment.

Fire-Fighting Measures: Lists suitable extinguishing techniques, equipment; chemical hazards from fire.

Accidental Release Measures: Lists emergency procedures; protective equipment; proper methods of containment and cleanup.

Handling and Storage: Lists precautions for safe handling and storage, including incompatibilities.

Exposure Controls/Personal Protection: Lists OSHA's Permissible Exposure Limits (PELs); Threshold Limit Values (TLVs); appropriate engineering controls; personal protective equipment (PPE).

Physical and Chemical Properties: Lists the chemical's characteristics.

Stability and Reactivity: Lists chemical stability and possibility of hazardous reactions.

Toxicological Information: Includes routes of exposure; related symptoms; acute and chronic effects; numerical measures of toxicity.

Ecological Information: This section provides information on the environmental impact if the chemical is released into the environment.

Disposal Considerations: Provides guidance on proper disposal practices, recycling or reclamation of the chemical or its container, and safe handling practices.

Transport Information: Includes guidance on classification information for shipping and transporting hazardous chemical(s) by road, air, rail, or sea.

Regulatory Information: Identifies the safety, health, and environmental regulations specific to the product that is not indicated anywhere else on the SDS.

Other Information: Includes the date of preparation or last revision and where to find further information.

Certificate of Analysis

A certificate of analysis (COA) is a document issued by the manufacturer or supplier of a product that confirms that a regulated product meets its product specification.3 All official ingredients used in compounding preparations need to meet the requirements of USP compendial monographs.3 USP 795 and USP 797 states all active pharmaceutical ingredients (API) must have a COA that includes specifications and test results for the component that show the API meets expected quality.4 Additionally, other components

should be accompanied by a COA that verifies that the component meets the criteria in the USP–NF monograph, if one exists, and any additional specifications for the component.4

Nonsterile Compounding Documentation

Per USP 795, all facilities where nonsterile preparations are made must have and maintain written or electronic documentation to demonstrate compliance with chapter requirements.4 This documentation must include, but is not limited to, the following:

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

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

COAs and all documentation required for components not conventionally manufactured

Receipt of components

SOPs, MFRs, and CRs

Release inspection and testing records

Information related to complaints and adverse events including corrective actions taken

Results of investigations and corrective actions

Records of cleaning and sanitizing the designated compounding area

Temperature logs

Accommodations to personnel compounding CNSPs

Any required routine review (e.g., a yearly review of QA and QC programs, a yearly review of chemical hazard and disposal information)

Two important documents must be completed during the nonsterile compounding process: master formulation and compounding records. These are discussed in detail below.

Master Formulation Records

USP 795 defines a master formulation record (MFR) as a detailed record of procedures that describe how the compounded nonsterile preparation (CNSP) is to be prepared, and an MFR should be used each time a CNSP is made.4 An MFR is analogous to a recipe in that it lists all the ingredients needed for the CNSP and instructions for making the preparation. These records can be developed using formulas available through resources such as the International Journal of Pharmaceutical Compounding (IJPC) or compoundingtoday.com.3 If a formula is not readily available, personnel may need to reference the primary literature.3 Once an MFR is created, if changes or alterations are later made, these must be approved and documented according to the compounding facility’s standard operating procedure (SOP).3,4 It is best practice to have two pharmacists review initial and updated MFRs.3 The following components must be included within an MFR:4

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

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

Container closure system(s)

Complete instructions for preparing the CNSP including equipment, supplies, and description of compounding steps

Physical description of the final CNSP

Beyond-use date (BUD) and storage requirements

Reference source to support the assigned BUD

If applicable, calculations to determine and verify quantities and/or concentrations of components and strength or activity of the API(s)

Labeling requirements (e.g., shake well)

Quality control (QC) procedures (e.g., pH testing, visual inspection) and expected results

Other information needed to describe the compounding process and ensure repeatability (e.g., adjusting pH, temperature)

The name, strength, and dosage form serve as the title of the MFR.3 The source of the formulation should also be listed.3 If compounding personnel created the MFR via primary literature, any relevant articles should be cited and included within the MFR.3 In terms of ingredients, all quantities should be listed.3 It can be helpful for future preparations to include a table of the required quantities of ingredients based on the total quantity of the preparation.3 For liquid ingredients, the specific gravity of the preparation should be included to assist with conversions.3

The exact equipment needed to compound the preparation should also be listed, as using different equipment may lead to different results. If new equipment is being utilized, the MFR should be updated.3 To ensure the preparation is properly mixed, exact instructions should be detailed. This includes the order of mixing, the temperature, and the duration of mixing.3 Additionally, the container needed should be listed.3 Selecting the correct container helps to ensure the stability of the preparation.3 Quality control allows pharmacists to verify that the preparation was made accurately and safely. Any necessary quality control procedures should be fully described.3

Compounding Record

The difference between an MFR and a compounding record (CR) is that an MFR provides a reference for preparing the formulation, whereas the CR documents the actual ingredients used and the person who compounded the preparation.3 A CR is the worksheet for preparing an individual CNSP.3 Every CNSP must have an associated CR and the verifying pharmacist must review the CR for completeness before releasing the CNSP.4 The CR is important for providing a record in cases when ingredients are either recalled or cause issues for the patient.3

To create a CR, compounding personnel can use the MFR as the basis for the CR.3 This would entail making a duplicate of the MFR but leaving the fields blank.3 Per USP 795, the following must be included on the CR:4

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

Date—or date and time—of preparation of the CNSP

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

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

Name, vendor or manufacturer, lot number, and expiration date of each component

Weight or measurement of each component

Total quantity of the CNSP compounded

Assigned beyond-use date (BUD) and storage requirements

If applicable, calculations to determine and verify quantities and/or concentrations of components and strength or activity of the API(s)

Physical description of the final CNSP

Results of quality control procedures (e.g., pH testing and visual inspection)

MFR reference for the CNSP

Unlike in USP 797, CRs for nonsterile preparations must be reviewed prior to releasing a CNSP.4,10 When an MFR is not used as the basis of the MFR, a copy of a medication label or order can be included within a CR to capture some of that information.10 In many cases, compounding software can be used to record the required information electronically.10 While this provides an easier and more efficient way of capturing information, it may be cost- prohibitive for some pharmacies to use this type of compounding software.10

Sterile Compounding Documentation

Documentation of processes within the sterile compounding environment is of paramount importance. USP 797 states all facilities that prepare CSPs must have and maintain written or electronic documentation of the following.7 This assists in demonstrating compliance within these areas.7

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

Master Formulation Record

Like with nonsterile compounding, master formulation records are also required for the sterile compounding process.7 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.7 The following are required components of MFRs for CSPs:7

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

BUD 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 methods, such as steam, dry heat, irradiation, or filter)

Compounding Record

Compounding records are used to document the process of compounding each CSP.7 A CR is required for all categories of CSPs, including Category 1, Category 2, and Category 3.7 If an immediate-use CSP is made for more than one patient, this also requires creation of a CR.7 In this case of CSPs, MFRs, prescription orders, medication orders, or a label may serve as the CR. CRs can be stored electronically as long as they are readily retrievable and contain all required components.7 The following are required components of CRs per USP:7

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 individuals 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 the component

Unlike nonsterile compound CRs, sterile compound CRs do not require the inclusion of a vendor, lot number, and expiration date when a CSP is prepared for a single patient without using nonsterile ingredients.10 Despite this, compounding personnel should incorporate this information in order to have a thorough quality assurance program and procedures.10 Such information also aids in tracing compounds during times of recall.10

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.7 Laws and regulations may vary state to state and compounding personnel should also follow the more stringent timeline of either USP 797 or their local jurisdiction.7 A summary of MFRs and CRs is provided in Tables 7.10 Nonsterile and sterile compounding MFRs and CRs are compared in Tables 8 and 9.10

Table 7. Summary of Master Formulation Records and Compounding Records10

Table 8. Comparison of Master Formulation Record Requirements10

Table 9. Comparison of Compounding Record Requirements10

Compounding Record Audits

Routinely auditing compounding records provides a means by which to prevent and detect errors that may occur during the compounding process. Documentation is a means by which to assure the quality of a compounded preparation.10 If an issue related to a CSP or CNSP arises, documentation can be quickly checked as a part of a quality assurance investigation.10 This can assist facilities in identifying problems, taking appropriate steps to improve problem areas, and evaluating the effectiveness of any actions taken.10

Various audits can be incorporated with a quality assurance program, depending on the information required to be included on a compounding record.10 For example, the name, strength, and/or concentration of ingredients utilized in a preparation can be cross-referenced against pharmacy purchasing data, assisting in determining the appropriateness of ingredients used.10 If the ingredients used in one compound do not match those used in similar compounds made of the same type, this type of error is easily traceable through a QA procedure.10 Further, checking the appropriateness of ingredients assists in determining staff competency levels.10 Another example of a QA audit is reviewing the assigned beyond-use dates of various preparations.10 Through this type of review, a pharmacy may find different staff members assign different beyond-use dates to the same types of preparations.10

The process of auditing may feel overwhelming for small and large pharmacies alike. No matter the size, it is best practice for pharmacies to develop a method by which to review an acceptable number of compounding records in an efficient manner.10 The designated person per USP can oversee the design and oversight of this review process. One method to undergo this process is to review a defined number of records at the end of each shift, day, or week.10 Records should be randomly selected, and the audit can be performed by a pharmacist, pharmacy intern, or pharmacy technician.10 Records can also be reviewed every month and even virtually by pharmacy staff via a process that involves comparing a record of one preparation to another of the same preparation from a specified time and cross-referencing ingredients and other information.10

The results from record audits should be compiled and included within quality assurance reports.10 These audit summaries can also be published and reviewed with pharmacy staff to assist in increasing accountability and preventing future errors.10 If errors are found, these can be addressed through increased pharmacist staff training, ideally in a group setting.10

Legal and Regulatory Considerations

The maintenance of medication records should follow the mandate of the local regulatory jurisdiction.2 A number of different organizations will inspect records for both sterile and nonsterile compounding. These include state boards of pharmacy, the Joint Commission, the Food and Drug Administration (FDA), the Drug Enforcement Administration (DEA), and others.2 Third-party payers may also request documentation.2 Documents and records are necessary in determining payments, granting licensure, and justifying the continued accreditation of a facility.2 Outside of USP, the Federal Food Drug and Cosmetic Act sections 503A and 503B detail the requirements for documentation for both traditional compounders (503A) and outsourcing facilities (503B).2 Further, if a patient would decide to pursue litigation related to a CSP or CNSP, a facility’s records, and documents may be subpoenaed.2

Summary

Sterile and nonsterile compounding involves the creation of medications tailored to meet unique and specific patient needs that cannot be met by commercially available products. These processes are intricate and require compliance with standards and regulations, and proper documentation is an essential part of ensuring the safety, efficiency, and legality of the process. Documentation can be broadly defined as a record of activities. This process serves crucial roles in helping compounding facilities demonstrate compliance with regulations, assure the quality and consistency of preparations, provide a means to audit preparations and track recalls, mitigate potential legal issues, and track inventory. Good documentation and record-keeping policies provide facilities with a system to correctly compound preparations, wherein facilities can determine what preparations were made, how they were made when they were made, and who made them. These details are important from a legal and quality control perspective. All compounding facilities need to keep accurate records to ensure a well-run pharmacy and also comply with laws and regulations of the local jurisdiction.

Course Test

Which of the following statements best describes the role of documentation in the compounding process?

Documentation is optional and does not significantly impact patient safety or legal compliance.

Documentation serves as a record of compounding activities and does not impact patient safety or quality assurance.

Documentation is essential for maintaining accountability, ensuring patient safety, legal compliance, and quality assurance.

Documentation is primarily required for billing purposes and does not affect patient safety or legal compliance.

Which of the following are types of documentation utilized in the compounding process?

Master Formulation Records, Sterilization Logs, and Inventory Checklists

Compounding Records, Safety Data Sheets, and Drug Monographs

Standard Operating Procedures, Quality Control Reports, and Prescription Records

Standard Operating Procedures, Master Formulation Records, and Compounding Records

Which of the following is considered a best practice for managing Standard Operating Procedures (SOPs) in the compounding process?

Keep SOPs outdated to avoid confusion among staff

Ensure SOPs are numbered and that the latest revision is dated to avoid mix-ups

Rely on verbal communication rather than written SOPs for efficiency

Always store SOPs electronically instead of using physical copies

What is the primary purpose of Master Formulation Records (MFRs) in the compounding process?

To document patient-specific instructions for compounding medications

To record the inventory of all drugs and chemicals in the compounding pharmacy

To provide guidelines for the training of new compounding personnel

To provide a detailed record of procedures for the compounding process, including ingredients and equipment needed

Which of the following statements about Compounding Records is true?

Compounding Records are not necessary for nonsterile compounding processes

Compounding Records are only required for investigational drugs, not commercially available medications

Compounding Records serve as a comprehensive record of each compounded medication's preparation

Compounding Records are mainly used for marketing purposes to track medication usage.

Which of the following is not an error that could occur during the compounding documentation process?

Using abbreviations to save time and space on documentation.

Failing to include the expiration date of compounded medications

Not documenting the names of personnel involved in the compounding process

Keeping detailed records of the compounding process to ensure accuracy.

Which of the following strategies can help prevent and mitigate documentation errors in the compounding process?

Using outdated Standard Operating Procedures to maintain consistency

Allowing multiple compounding personnel to use the same login credentials for documentation

Regularly reviewing and updating documentation practices based on best practices and regulations

Discouraging the use of electronic documentation to minimize the risk of data loss.

Which of the following is an important reason to address documentation errors promptly and accurately?

To prevent patient harm

To maintain the confidentiality of patient information

To minimize the need for staff training on proper documentation practices

To increase the efficiency of the compounding process without interruptions.

Which of the following best represents the potential consequences of inadequate documentation in the compounding process?

Improved patient outcomes and increased efficiency

Enhanced communication among compounding personnel

Compromised patient safety, legal non-compliance, and compromised quality assurance

Reduced need for regular audits and inspections.

How can compounding pharmacists ensure the accuracy and completeness of documentation for nonsterile compounding processes?

Only document the steps that have a direct impact on the final product's appearance

Rely on the memory of experienced personnel rather than written documentation

Review and verify all documentation related to the compounding process for accuracy

Exclude any information that may be considered redundant or repetitive to save time.

References

Compounding and the FDA Questions and Answers. United States Food and Drug Administration. June 29, 2022. https://www.fda.gov/drugs/human-drug-compounding/compounding- and-fda-questions-and-answers. Accessed August 10, 2023.

Forrey R. Documentation of Compounded Sterile Preparations in Compounding Sterile Preparations. ASHP. 2017.

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

General Chapter: USP. Pharmaceutical Compounding-Nonsterile Preparations <795>. In: USP-NF. Rockville, MD: USP; September 2020.

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 August 10, 2023.

General Chapter: USP. Pharmaceutical Compounding-Sterile Preparations <797>. In: USP-NF. Rockville, MD: USP; September 2020.

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

Allen J. Quality-control Analytical Methods: Logbooks and Documentation Forms. Int J Pharm Compd. 2007; 306-11.

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

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 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.

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