BEST PRACTICES FOR NONSTERILE COMPOUNDING DOCUMENTATION
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, where she is course director of the Parenteral Products and Basic Pharmaceutics Lab courses.
Pamela Sardo, PharmD, BS
Pamela Sardo is a freelance medical writer and licensed pharmacist. She is the founder and principal at Sardo Solutions in Texas. Pam received her BS from the University of Connecticut and her PharmD from the University of Rhode Island. Pam’s career spans many years in retail, clinics, hospitals, long-term care, and Veterans Affairs, as well as in managed health care, with responsibilities across a broad range of therapeutic classes and disease states.
Abstract
Documentation is vital to the nonsterile compounding process. Proper documentation has implications for patient safety, legal compliance, and quality assurance. Meticulous record-keeping is crucial in promoting optimal outcomes. Pharmacists and pharmacy technicians involved in nonsterile compounding should be well-versed in managing various record types, 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 continuing education activity will describe various types of records, discuss best practices for documentation, and detail common documentation errors and strategies to prevent and mitigate them.
Accreditation Statements
In support of improving patient care, RxCe.com LLC is jointly accredited by the Accreditation CouncilTM 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.
Joint Universal Activity Number: The Joint Accreditation Universal Activity Numbers assigned to this activity are as follows:
Pharmacists: JA4008424-0000-26-079-H07-P
Pharmacy Technicians: JA4008424-0000-26-079-H07-T
Credits: 2 contact hour(s) (0.2 CEU(s)) of continuing education credit.
Credit Types:
Pharmacy - 2 Credits
Type of Activity: Knowledge
Media: Computer-Based Training (i.e., online courses)
Estimated time to complete activity: 2 contact hour(s) (0.2 CEU(s)), including Activity Pre-Test, Post-Test, and Activity Evaluation.
Release Date: May 31, 2026 Expiration Date: May 31, 2029
Target Audience: This educational activity is for Pharmacists and Pharmacy Technicians
How to Earn Credit: From May 31, 2026, through May 31, 2029, participants must:
Read the “learning objectives” and “author and planning team disclosures;”
Take the “Educational Activity Pre-Test;”
Study the section entitled “Educational Activity;” and
Complete the Educational Activity Post-Test and Activity Evaluation. The Educational Activity Post-Test will be graded automatically. Following successful completion of the Educational Activity Post-Test with a score of 70% or higher, a statement of participation will be made available immediately. (No partial credit will be given.)
CE and CME Credits: Credits for this course will be uploaded to CPE Monitor® for pharmacists and pharmacy technicians. Physicians may receive AMA PRA Category 1 Credit™️ and apply these credits toward Maintenance of Certification (MOC) requirements. Physician Assistants may earn AAPA Category 1 CME credits, reportable through PA Portfolio. All learners shall verify their individual licensing board’s specific requirements and eligibility criteria.
Statement of Need
Accurate and complete documentation is a foundational component of safe and compliant nonsterile compounding practice. Documentation errors, including incomplete compounding records, missing beyond-use dates (BUD), illegible entries, and failure to record lot numbers, can compromise patient safety, prevent traceability during recalls, and increase both legal and regulatory risk. Updated USP <795> standards emphasize the importance of maintaining detailed records for compounding procedures, personnel training, quality assurance, and equipment maintenance. Pharmacists and pharmacy technicians involved in nonsterile compounding must understand the purpose and proper use of key documents, including Master Formulation Records (MFRs), Compounding Records (CRs), Certificates of Analysis (CoAs), and Standard Operating Procedures (SOPs).
Learning Objectives: Upon completion of this educational activity, participants should be able to:
Describe records, reports, and documents used within the process of compounding nonsterile preparations
Describe best practices in maintaining and managing various types of documentation involved in the compounding process
Identify common errors that can occur in the nonsterile compounding documentation process
Identify strategies to prevent and mitigate documentation errors
Disclosures
The following individuals were involved in planning, developing, and/or authoring this activity: Liz Fredrickson, PharmD; Jennifer Salvon, RPh; 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.
© RxCe.com LLC 2026: 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 Pre-Test
Which of the following documents provides the standardized formula and detailed instructions used to prepare a compounded nonsterile preparation (CNSP)?
Compounding Record (CR)
Safety Data Sheet (SDS)
Certificate of Analysis (CoA)
Master Formulation Record (MFR)
Which of the following is considered a best practice for nonsterile compounding documentation?
Completing documentation at the end of the week
Using correction fluid to fix documentation errors
Recording information during or immediately after the compounding process
Omitting lot numbers if ingredients come from the same supplier
Failure to document the lot number of an active pharmaceutical ingredient (API) primarily creates which of the following risks?
Increased medication cost
Inability to perform effective recalls and trace affected preparations
Reduced pharmacy workflow efficiency
Incorrect storage temperature monitoring
Educational Activity
Best Practices for Nonsterile Compounding Documentation
Highlights Good documentation and record-keeping policies provide facilities with a system for compounding preparations correctly and for determining which preparations were made, how they were made, when they were made, and who made them “If it wasn’t documented, it wasn’t done.” This principle underscores the importance of compliance with legal and regulatory requirements in compounding practice, and the impact accurate and complete documentation has on patient safety. In clinical practice, incomplete or inaccurate documentation can result in dosing errors, contamination risks, and the inability to trace or recall affected preparations. Because documentation errors may occur, compounding personnel and facilities should have policies and procedures in place to address them. |
Introduction
Documentation is foundational to the nonsterile compounding process and directly impacts patient safety, regulatory compliance, and quality assurance. Accurate, complete records are essential to ensure consistency, traceability, and optimal patient outcomes. Pharmacy technicians involved in nonsterile compounding should be well-versed in managing various records, including Master Formulation Records (MFR) and Compounding Records (CR). With a firm grounding in documentation standards and best practices, personnel will be better equipped to ensure quality and consistency in prepared medications.
Per USP <795>, all facilities where nonsterile preparations are made must have and maintain written or electronic documentation to demonstrate compliance with chapter requirements.1 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 (calibration, verification, and maintenance reports)
Certificates of analysis and all documentation required for components not conventionally manufactured
Receipt of components
Standard operating procedures, 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, such as a yearly review of quality assurance and quality control programs, a yearly review of chemical hazard and disposal information
In clinical practice, incomplete or inaccurate documentation can result in dosing errors, contamination risks, and the inability to trace or recall affected preparations. These failures may lead to patient harm, regulatory action, or legal liability. Therefore, robust documentation is not only a technical requirement but a critical patient safety function. This continuing education activity will describe various types of records, discuss best practices for documentation, and detail common errors that can occur in the documentation process, along with related strategies to prevent and mitigate them.
Definitions of Compounding Records
Nonsterile compounding involves creating medications tailored to address unique patient needs that cannot be met by commercially available products.2 Pharmaceutical compounding requires compliance with regulatory standards, and accurate documentation supports safety, efficiency, and legal accountability. Documentation can be broadly defined as a record of activities, and it serves crucial roles in helping compounding facilities demonstrate compliance with regulations, ensure the quality and consistency of preparations, provide a means to audit preparations and track recalls, mitigate potential legal issues, and track inventory.3
Good documentation and record-keeping policies provide facilities with a system for compounding preparations correctly and for determining which preparations were made, how they were made, when they were made, and who made them.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).1 Several records and reports must 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 Defintions1,3,4,5
| Name | Abbreviation | Definition |
| Certificate of analysis | CoA | A report from the supplier of a component, container, or closure that accompanies the supplier’s material and contains the specifications and results of all analyses and a description of the material |
| Compounding record | CR | The worksheet for preparing an individual formulation |
| Master formulation record | MFR | A detailed record of procedures that describes how the compound is to be prepared |
| Safety data sheets | SDS | A document that details information and procedures for handling and working with chemicals |
| Standard operating procedures | SOP | Living documents that detail written instructions describing specific steps to follow in all activities under defined conditions. |
Qualities of Good Documentation
Personnel responsible for compounding nonsterile preparations must demonstrate competency in documenting the compounding process.1,3 It is crucial that every step of the compounding process is documented.6 It is recommended that pharmacy personnel keep four different records within the compounding area. These include the following:6
Compounding formulas and procedures
A log of all compounded items (including batch labels)
Equipment and maintenance records
Records of purchased ingredients
Documentation Pearl
“If it wasn’t documented, it wasn’t done.” This principle underscores the importance of compliance with legal and regulatory requirements in compounding practice, and the impact accurate and complete documentation has on patient safety.
How to Document
How documentation is constructed is as important as what is documented.1,3,4 Incomplete or illegible records are not useful during audits or reviews of documents.1,3,4 They also need to be stored so they can be readily retrieved and not destroyed or lost.1,3 The following are characteristics of good documentation:7
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
There is no specific length or required format for compounding documentation.1,3 In fact, documentation can be of any length, given that the necessary facts are all presented.1,3 The use of a structured, formalized process, whether it involves worksheets, forms, or computer systems, is the more important consideration, as it assists with keeping documents and records uniform and avoiding errors.1,3 Electronic health records, in particular, help keep documentation in a structured format.1,3 Documentation should be conducted in a manner that is quick, precise, and consistent while ensuring sufficient detail to determine what was done.1,3 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.7
What to Do About Errors
Documentation errors can negatively impact operations and lead to patient harm.7 For example, failure to document a beyond-use date (BUD) may result in a patient receiving a degraded or contaminated preparation. Similarly, omitting lot numbers prevents effective recall if a component is later found defective. Addressing errors quickly assists in preventing or minimizing harm to patients.7 Prevention strategies involving stringent procedures and thorough training are the best way to avoid errors.1,3 Facilities should plan to review documentation processes regularly.1,3 Finally, compounding personnel should be encouraged to report errors rather than be fearful of potential repercussions associated with making errors.7
Because documentation errors may occur, compounding personnel and facilities should have policies and procedures in place to address them.8 When mistakes are made, correction fluids and scratch-outs should not be used on records.7 Rather, a neat line should be drawn through the mistake, and the individual who made the mistake should place their initials by the error.7 Examples of potential documentation errors are detailed in Table 2. Table 3 summarizes tips for the documentation process.7
Common Pitfalls in Compounding Documentation include the following:
Missing or incorrect BUDs
Illegible handwriting or unclear entries
Incomplete CR fields
Use of unapproved or ambiguous abbreviations
Failure to document lot numbers or expiration dates of components
Delayed documentation instead of real-time recording
Table 2
Types of Documentation Errors7
| Type of Error |
| Using unapproved or undefined abbreviations to save time and space on documentation |
| Failing to include the beyond-use date of compounded medications |
| Not documenting the names of personnel involved in the compounding process |
Table 3
Documentation Tips7
| Compounding logs can be brief or detailed as long as all important facts are included |
| Preprinted forms, worksheets, and software can assist in prompting compounding personnel to document required information |
| Documentation should be done when and where the work is completed |
| Equipment documentation should be kept with the piece of equipment in a notebook or folder |
| Documentation logs should be kept in areas where tasks occur |
| Observations made by compounding personnel are considered original data and documented immediately |
| Correction fluid should never be used on records to avoid a “cover-up” appearance |
Types of Records
Logbooks
A logbook is a collection of logs and documentation forms that chronologically record activities reflecting the operation of a pharmacy.9 Information in a logbook can be recorded daily, either manually or electronically, or 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
| Title | Purpose | Frequency of Use | Integral data |
| Adverse Event/Complaint Log | Document any unexpected occurrences for compounded medications | Any time of any occurrence of adverse events or complaints from a patient | Details on adverse events/complaints Date of adverse event/complaint
Name and contact information of the patient Details on how the adverse event/complaint was handled and how the preparation was disposed of
Signature of the employee who handled the documentation |
| Compounding Equipment Log | Record specific information on each piece of equipment used in the pharmacy | Upon purchase of the equipment | Purchase receipt Maintenance details Repair details Calibration details Signature of the employee who handled the documentation |
| Computer Log | Record computer and software purchases and related information | As computers and related software and equipment are purchased, they are replaced, or maintained | Each computer should have a separate log Receipt of purchase Details of routine maintenance Details of repairs
List of authorized users Details on hardware and software purchases Computer virus details Signature of the employee who handled the documentation |
| Controlled Drugs Disposal Log | Record disposition of controlled drugs | Each time-controlled drug is disposed of | Name of drug Quantity of the drug Date of disposal Time of disposal Method of disposal Signature of the employee who handled the disposal |
| Deviation from Standards Log | Document any activity (e.g., omissions of daily monitoring, incomplete cleaning procedures, failure to document) or compounded preparation (e.g., out of specification) that does not conform to standards established by the pharmacy or other resources | When an activity or compounded preparation does not conform to established pharmacy standards (e.g., 100 capsules were compounded outside the ±10% weight variation limit as established for non-pharmacopeial items in USP Chapter <795>) | Date of occurrence Time of occurrence Specified activity involved
List of employee names involved in the incident Details on corrective action taken Signature of an employee who handled documentation |
Standard Operating Procedures
Standard operating procedures are living documents that provide written instructions detailing specific steps to follow for all activities under defined conditions.5 The purpose of an SOP is to carry out the operations correctly and always in the same manner, so that staff perform all tasks uniformly.7 These procedures are step-by-step instructions on how to do a task and include using a log sheet to document the activity.7
Standard operating procedures ensure that practices are uniform, accurate, safe, and of consistent quality.1,3 They should focus on procedure adherence, preventing and detecting errors, and investigating corrective actions.8 USP Chapter <795> 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.3 All SOPs should be numbered, and the last revision should be dated to avoid mixups.3,7
Standard operating procedures include many different components. These include the SOP title, 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.8 The designated person (or persons) responsible for creating and approving the SOP should be listed with the most recent revision date.1 Components of SOPs are summarized in Table 5.
Table 5
Components of Standard Operating Procedures7
| Title |
| Standard Operating Procedure number |
| Author |
| Date effective |
| Authorization signature |
| Purpose of the procedure |
| Procedure |
| References |
| Documentation forms or logs |
Standard operating procedures encompass many areas, including personnel, facilities, equipment, and the preparation and packaging of compounded preparations.3 For compounding equipment, maintenance records 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
| Administrative |
| Training |
| Safety |
| Facility (Environment and Monitoring) |
| Facility (Cleaning) |
| Equipment |
| Personnel |
| Compounding Procedures |
| Quality Assurance |
| Inventory Control |
By documenting these procedures well, facilities can track and evaluate completed procedures.
Ingredient Records
Any time a compounding facility purchases ingredients, records of these ingredients must 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 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 A safety data sheet (SDS) will detail important information pertaining to the ingredient, including physicochemical, toxicity, and handling instructions.3 Understanding this information keeps compounding personnel safe. Safety data sheets are available on many chemical wholesalers' websites and 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: This includes the product identifier, manufacturer or distributor name, address, phone number, emergency phone number, recommended use, and 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 and trade secret claims.
First-Aid Measures: Includes important symptoms/effects, acute and delayed; required treatment.
Fire-Fighting Measures: Lists suitable extinguishing techniques, equipment, and chemical hazards from fire.
Accidental Release Measures: Lists emergency procedures, protective equipment, and 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, and personal protective equipment (PPE).
Physical and Chemical Properties: Lists the chemical's characteristics.
Stability and Reactivity: Lists chemical stability and the potential for hazardous reactions.
Toxicological Information: Includes routes of exposure, related symptoms, acute and chronic effects, and numerical measures of toxicity.
Ecological Information: This section provides information on the environmental impact if the chemical is released into the environment.
Disposal Considerations: This section 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 are 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 confirming that a regulated product meets its specifications.3 All official ingredients used in compounding preparations need to meet the requirements of USP compendial monographs.3 USP 795 states that all active pharmaceutical ingredients (APIs) must have a COA that includes specifications and test results for the component, demonstrating that 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
Master Formulation and Compounding Records
Master Formulation Records
USP 795 defines an 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.6 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 Any formula utilized from a published article should include a copy of the article attached to the written procedure.
Once an MFR is created, any subsequent changes or alterations must be approved and documented in accordance with the compounding facility’s SOP.1,3 It is best practice to have two pharmacists review initial and updated MFRs.3 The following components must be included within an MFR:1
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 a description of compounding steps
Physical description of the final CNSP
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 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 or temperature)
The name, strength, and dosage form serve as the MFR title.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 equipment required to compound the preparation should also be listed, as using different equipment may yield different results. If new equipment is being utilized, the MFR should be updated.3 Exact instructions should be detailed to ensure the preparation is properly mixed. This includes the mixing order, temperature, and mixing duration.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 Records
The difference between an MFR and a CR is that an MFR provides a reference for preparing the formulation. In contrast, the CR documents the ingredients used and the person who compounded the preparation.3 Compounding personnel should document the compounding process in enough detail to allow for replication and the tracing of every ingredient used. A CR is a worksheet used to prepare an individual CNSP and document the process.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 of when ingredients are 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 duplicating the MFR but leaving the fields blank.3 Per USP 795, the following must be included on the CR:1
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 those verifying the final CNSP
Name, vendor or manufacturer, lot number, and expiration date of each component
Weight or measurement of each component
The total quantity of the CNSP compounded
Assigned 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
Compounding records for nonsterile preparations must be reviewed before a CNSP is released.1,8 When an MFR is not used as the basis of the CR, a copy of a medication label or order can be included to capture some of that information.8 In many cases, compounding software can record the required information electronically.8 While this provides an easier and more efficient way of capturing information, it may be cost-prohibitive for some pharmacies to use this compounding software.8
Table 7
Summary of Master Formulation Records
and Compounding Records8
| Master formulation records | Both records | Compounding records |
Complete instructions for preparing the preparation, including equipment, supplies, a description of compounding steps, and any special precautions Type and size of the container closure system Beyond-use date or stability reference Labeling requirements for CNSPs | Name, strength or activity, and dosage form of the preparation Identities and amounts of all components and relative components, if required Physical description of the final preparation BUD and storage requirements Calculations when required Quality control procedures and results | Date and time of preparation Assigned internal identification number Identities of staff members involved in compounding and verifying the preparation Weight, volume, or measurement of each component Name, vendor, lot number, and expiration date of each component when required Physical description for CNSP MFR reference when required Results of quality control procedures |
Table 8
Summary of Important Documents
| Record Type | Purpose | Key Risk if Missing |
| MFR | Standardizes preparation | Inconsistent formulation |
| CR | Documents individual preparation | No traceability |
| SOP | Ensures consistency | Process variability |
| CoA | Verifies ingredient quality | Contaminated inputs |
Compounding Record Audits
Routinely auditing compounding records helps prevent and detect errors that may occur during compounding. Documentation is a means to assure the quality of a compounded preparation.8 If an issue related to a CNSP arises, documentation can be quickly checked as a part of a quality assurance investigation.8 This can assist facilities in identifying problems, taking appropriate steps to improve problem areas, and evaluating the effectiveness of any actions taken.9 Ideally, pharmacy personnel should follow up with patients to determine if their preparation had any stability-related issues or adverse reactions. This follow-up and any related findings should be documented.6
Various audits can be incorporated with a quality assurance program, depending on the information required to be included on a compounding record.8 For example, the name, strength, and/or concentration of ingredients utilized in a preparation can be cross-referenced against pharmacy purchasing data, determining the appropriateness of ingredients used.8 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.8 Further, checking the appropriateness of ingredients assists in determining staff competency levels.9 Another example of a QA audit is reviewing the assigned beyond-use dates of various preparations.8 Through this review, a pharmacy may find that different staff members assign different beyond-use dates to the same types of preparations.8
The auditing process may feel overwhelming for both small and large pharmacies. No matter the size, it is best practice for pharmacies to develop a method to review a sufficient number of compounding records efficiently.8 The designated person per USP can oversee the design and oversight of this review process. One way to do this is to review a set number of records at the end of each shift, day, or week.8 Records should be randomly selected, and the audit can be performed by a pharmacist, pharmacy intern, or pharmacy technician.8 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.8
The results from record audits should be compiled and included in quality assurance reports.8 These audit summaries can also be published and reviewed with pharmacy staff to increase accountability and prevent future errors.8 If errors are found, these can be addressed through increased pharmacist staff training, ideally in a group setting.8
Case Example
A compounding pharmacy prepared multiple batches of a topical medication but failed to document the lot numbers of the active pharmaceutical ingredient used. When the supplier later issued a recall due to contamination, the pharmacy was unable to identify which patients received affected preparations. As a result, all potentially exposed patients had to be notified, increasing patient risk, operational burden, and legal liability. This case highlights the critical importance of complete and accurate documentation for traceability and patient safety.
Documenting Training and Competence
USP <795> requires the designated person and/or assigned trainer to document that compounding personnel have been trained and completed competency assessments successfully.1 Further, if a facility has only one person performing compounding operations, that individual must document that they have obtained training and demonstrated competency.1 Specific competencies, such as garbing and gloving requirements, must be documented in the compounding facility’s SOP.1
Hazardous Drug Compounding
Documentation is also an important component within USP Chapter <800>, titled Hazardous Drugs (HD) Handling in Healthcare Settings.10 Per USP <800>, SOPs must be maintained to ensure the safe handling of HDs in all situations in which these HDs are used within a facility. These SOPs must be reviewed at least every 12 months by the designated person, and the review must be documented. Standard operating procedures for handling HDs should include the following:10
Hazardous drug communication program
Occupational safety program
Designation of HD areas
Receipt
Storage
Compounding
Use and maintenance of proper engineering controls (e.g., C-PECs, C-SECs, and CSTDs)
Hand hygiene and use of PPE based on activity (e.g., receipt, transport, compounding, administration, spill, and disposal)
Deactivation, decontamination, cleaning, and disinfection
Dispensing
Transport
Administering
Environmental monitoring (e.g., wipe sampling)
Disposal
Spill control
Medical surveillance
Legal and Regulatory Considerations
Documentation in nonsterile compounding is subject to oversight by multiple regulatory and accrediting bodies, each of which may review records for compliance, quality assurance, and safety. The maintenance of medication records should comply with the mandates of the local regulatory jurisdiction.2,3 Several different organizations will inspect records for 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.2,3 Documents and records are necessary for determining payments, granting licensure, and justifying the continued accreditation of a facility.2,3 Outside of USP, the Federal Food, Drug, and Cosmetic Act sections 503A and 503B detail the documentation requirements for traditional compounders (503A) and outsourcing facilities (503B).2,3 Further, if a patient decides to pursue litigation related to a CNSP, a facility’s records and documents may be subpoenaed.2,3
Summary
Nonsterile compounding involves creating medications tailored to meet unique patient needs that cannot be met by commercially available products. These processes require strict adherence to standards and regulations, with documentation serving as a central component of safety, efficiency, and legal compliance. The documentation process plays a crucial role in helping compounding facilities demonstrate regulatory compliance, ensure 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 compound preparations correctly, enabling them to determine which preparations were made, how they were made, when, and by whom. These details are important from legal and quality-control perspectives. All compounding facilities need to keep accurate records to ensure a well-run pharmacy and to comply with the laws and regulations of the local jurisdiction.
References
General Chapter: USP. Pharmaceutical Compounding-Nonsterile Preparations <795>. In: USP-NF. Rockville, MD: USP; 2023.
Compounding and the FDA Questions and Answers. United States Food and Drug Administration. Accessed March 20, 2026. https://www.fda.gov/drugs/human-drug-compounding/compounding-and-fda-questions-and-answers
Allen L. The Art, Science, and Technology of Pharmaceutical Compounding. APhA. 2020.
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