AN OVERVIEW OF NONSTERILE COMPOUNDING REGULATIONS, STANDARDS, AND GUIDELINES
Faculty:
Liz Fredrickson, PharmD, BCPS
Liz Fredrickson, PharmD, BCPS, 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, PharmD, BS, 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. Pamâs career spans many years in retail, clinics, hospitals, long-term care, Veterans Affairs, and managed health care responsibilities across a broad range of therapeutic classes and disease states.
Abstract
Compounded nonsterile medications play a critical role in meeting patient-specific therapeutic needs. However, these processes also introduce risks related to contamination, dosing variability, and preparation quality. Such risks have led to the development of a complex regulatory framework involving federal and state agencies, as well as standardized guidance from organizations such as the United States Pharmacopeia (USP). This continuing education activity provides an overview of the key legislation, regulatory bodies, and standards governing nonsterile compounding, including the Federal Food, Drug, and Cosmetic Act, the Drug Quality and Security Act, and USP Chapters <795> and <800>. It also reviews the roles of oversight organizations, including state boards of pharmacy, the FDA, OSHA, and NIOSH. Understanding these regulations and standards is essential to ensure compliance, minimize compounding-related risks, and promote patient safety in nonsterile compounding practice.
Accreditation Statements
In support of improving patient care, RxCe.com LLC is jointly accredited by the Accreditation CouncilTM for Continuing Medical Education (ACCMEÂź), the Accreditation Council for Pharmacy Education (ACPEÂź), and the American Nurses Credentialing Center (ANCCÂź), 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: JA4008424-0000-26-070-H07-P
Pharmacy Technicians: JA4008424-0000-26-070-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 19, 2026 Expiration Date: May 19, 2029
Target Audience: This educational activity is for Pharmacists and Pharmacy Technicians
How to Earn Credit: From May 19, 2026, through May 19, 2029, participants must:
Read the âlearning objectivesâ and âauthor and planning team disclosures;â
Take the âEducational Activity Pre-Test;â
Study the section entitled âEducational Activity;â 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 MonitorÂź for pharmacists and pharmacy technicians. Physicians may receive AMA PRA Category 1 Creditâąïž and use 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 boardâs specific requirements and eligibility criteria.
Statement of Need
Nonsterile compounding is governed by a complex and evolving framework of federal and state regulations, as well as USP standards. Gaps in understanding these requirements can lead to noncompliance, increased risk of compounding errors, and potential patient harm. Pharmacy personnel may have limited formal training in the historical and regulatory context of compounding, including distinctions between 503A and 503B facilities, oversight responsibilities, and applicable USP standards. This activity addresses these gaps by providing a clear, practical overview of key legislation, regulatory bodies, and standards to support safe, compliant compounding practices.
Learning Objectives: Upon completion of this educational activity, participants should be able to:
Recall key terminology and regulatory concepts in nonsterile compounding
Describe major legislation governing compounding
Discuss regulatory oversight and the roles of governing organizations in nonsterile compounding processes
Describe the roles of pharmacy staff in nonsterile compounding
Disclosures
The following individuals were involved in planning, developing, and/or authoring this activity: Liz Fredrickson, PharmD, BCPS, and Pamela Sardo, PharmD, BS. None of the individuals involved in developing this activity has a conflict of interest or financial relationships related to the subject matter. There are no financial relationships or commercial or financial support relevant to this activity to report or disclose by RxCe.com or any of the individuals involved in the development of this activity.
© 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 best describes the relationship between BUD (beyond-use date) and stability data in nonsterile compounding?
BUD is always equal to the manufacturerâs expiration date
BUD is determined solely by the pharmacistâs clinical judgment
BUD is assigned based on available stability data or, if unavailable, default USP guidelines
BUD is only required for sterile compounded preparation
Which of the following pieces of legislation created the distinction between 503A compounding pharmacies and 503B outsourcing facilities?
Food, Drug, and Cosmetic Act (FDCA)
Food and Drug Administration Modernization Act (FDAMA)
Drug Quality and Security Act (DQSA)
Occupational Safety and Health Act (OSHA)
Which of the following best describes the role of the United States Pharmacopeia (USP) in nonsterile compounding?
It enforces federal compounding laws
It conducts inspections of compounding pharmacies
It provides standards and guidelines that many regulators adopt and enforce
It licenses pharmacists and pharmacy technicians
Educational Activity
An Overview of Nonsterile Compounding Regulations, Standards, and Guidelines
Highlights Compounding personnel should understand the distinction between compounding and manufacturing, including patient-specific preparation vs large-scale production Facilities must differentiate between 503A and 503B compounding categories, which determine regulatory requirements and oversight State boards of pharmacy oversee traditional 503A compounding, while the FDA regulates 503B outsourcing facilities Compounding personnel should recognize the roles of key regulatory organizations, including the FDA, OSHA, NIOSH, EPA, and state boards Workplace safety requirements are governed by OSHA and informed by NIOSH hazardous drug guidance Compliance with compounding standards helps reduce risks such as contamination, dosing variability, and patient harm |
Introduction
Compounded nonsterile medications play a critical role in meeting patient-specific therapeutic needs. Despite progress in developing these medications, they carry notable risks, including contamination by bacteria, fungi, or other agents. Additionally, errors in the drug concentration during production can also cause unintended over- or under-dosing. This continuing education activity provides an overview of the key legislation, regulatory bodies, and standards governing nonsterile compounding. It also reviews the roles of oversight organizations, including state boards of pharmacy, the FDA, OSHA, and NIOSH. Understanding these regulations and standards is essential to ensure compliance, minimize compounding-related risks, and promote patient safety in nonsterile compounding practice.
A Brief History of Compounding
Compounding has been described as far back as 2000 BC.1 Early compounding practices relied on empiric remedies with variable safety and effectiveness. Many promoters of these products made outlandish claims, and the products themselves were often toxic. For example, reportedly taking âblue mass syrupâ for melancholy, Abraham Lincoln subsequently experienced severe mood swings and tremors.2 Several historical recipes for âblue mass syrupâ exist, all including mercury, which is a neurotoxin that potentially produces emotional changes and tremors.3 Interestingly, Lincolnâs symptoms resolved after he stopped taking the product in 1861.2
In the 1930s, 75% of all written prescriptions were for compounded medications.1 Over the following decades, as the availability of manufactured drugs increased, the use of compounding gradually declined.
By the mid-1970s, compounded medications accounted for only 1% of all written prescriptions.1 The number of compounded medication prescriptions increased again in the late 20th century. Pain management in home healthcare, total parenteral nutrition, and hospice care contributed to this rise. Additionally, manufacturers streamlined their offerings, reducing the number of available dosage forms.4
Figure 1 shows actual prescriptions from a Connecticut pharmacy in the 1920s.
Figure 1
Prescriptions from the 1920s
Important Acronyms and Definitions
Many acronyms are used throughout this activity. Table 1 lists common acronyms and definitions for reference.5-7
Table 1
Acronyms Relevant to Nonsterile Compounding
| Acronym | Definition |
| BUD | Beyond Use Date |
| CDC | Centers for Disease Control and Prevention |
| cGMP | Current Good Manufacturing Practice |
| CNSP | Compounded nonsterile preparation |
| C-PEC | Containment Primary Engineering Control |
| CQA | Compounding Quality Act |
| C-SEC | Containment Secondary Engineering Control |
| DQSA | Drug Quality and Security Act |
| EPA | Environmental Protection Agency |
| FDA | Food and Drug Administration |
| FDAMA | Food and Drug Administration Modernization Act |
| FDCA | Federal Food, Drug, And Cosmetic Act |
| HD | Hazardous Drug |
| MFR | Master Formulation Record |
| NECC | New England Compounding Center |
| NIOSH | National Institute for Occupational Safety and Health |
| OSHA | Occupational Safety and Health Administration |
| PPE | Personal Protective Equipment |
| SOP | Standard Operating Procedure |
| USP | United States Pharmacopeia |
In practice, compounding is the art and science of preparing individualized medications when commercially available products are not suitable. The United States Pharmacopeia (USP) defines nonsterile compounding as the process of combining, admixing, diluting, or otherwise altering a drug product or bulk substance to create a medication.8 The FDA similarly defines compounding as the preparation of customized medications to meet patient-specific needs.9
Pharmacy personnel should be able to distinguish compounding from manufacturing. Manufacturing is defined as the mass production of drug products and is regulated under FDA approval and cGMP standards, whereas traditional compounding under section 503A is exempt from certain FDA requirements when specific conditions are met. Under state and federal law, FDA-approved products are sold to authorized pharmacies, healthcare practitioners, and wholesalers. This contrasts with compounding, in which the final preparation is dispensed directly to the patient.11 It is important to note that compounded medications are not FDA-approved. Poorly compounded medications have led to life-long patient harm and even death.5
Compounded medications are important for patients with unmet clinical needs for which available FDA-approved products are not effective. For example, patients may have an allergy to a dye or excipient that can be removed from a compounded preparation. Additionally, vulnerable populations such as elderly or pediatric patients may need a liquid dosage form if they cannot swallow a tablet or capsule. Drug shortages and discontinuations of doses contribute to the need for compounded medications. Sometimes, available products are not medically appropriate for patients, also necessitating a compounded medication.9 With these specific needs in mind, compounding facilities offer multiple personalized options for the unique needs of a diverse patient population.
Sterile vs. Nonsterile Compounding
Compounded drugs can be prepared as either sterile or nonsterile formulations. Sterile compounding involves preparing custom medications in a sterile environment to prevent contamination and ensure patient safety. It requires a cleanroom and aseptic techniques to produce microorganism-free preparations. It is primarily used for injectable, implant, and ophthalmic preparations.5
In nonsterile compounding, drug formulations do not require the same level of sterility. They are prepared in a clean environment but without the aseptic techniques required in sterile compounding. However, attention to technique is still vital during the preparation of these medications. Nonsterile compounding includes oral and topical formulations, such as capsules, solutions, suspensions, ointments, creams, and suppositories.12
Hazardous vs. Non-Hazardous Compounding
A hazardous compound contains ingredients that have the potential to cause harm to an individual. This includes any ingredient or mixture that poses a physical or health hazard. Health hazards include chemicals that may cause cancer, affect reproductive abilities, or damage the lungs, skin, eyes, or mucus membranes.13 In comparison, non-hazardous compounds do not carry these risks.
Relevant Legislation
To understand pharmaceutical compounding more fully, it is essential to review relevant historical legislation.
Food, Drug, and Cosmetic Act (FDCA)
The Food, Drug, and Cosmetic Act (FDCA), passed in 1938, gave the FDA authority to oversee the safety of food, drugs, medical devices, and cosmetics, including the manufacture of pharmaceuticals. Due to the small-scale and individualized nature of compounding at the time, regulatory oversight remained with individual state boards of pharmacy.5,12 Over time, pharmacy compounding (both sterile and nonsterile) grew to accommodate emerging needs for home infusion therapy, total parenteral nutrition, and hospice care.4,5
Food and Drug Administration Modernization Act
In 1997, Congress passed the Food and Drug Administration Modernization Act (FDAMA) to clarify the FDAâs role in regulating drug preparations from compounding pharmacies. Section 503A outlines conditions that exempt compounded drugs from certain aspects of the FDCA if the conditions are met.12 Specifically, compounders must follow drug safety requirements and cannot advertise their product.5
This advertising restriction sparked litigation challenging the FDAMA. A group of pharmacies claimed the FDAMA violated commercial speech rights under the First Amendment.12 The ensuing case, Thompson v. Western States, resulted in the US Supreme Court ruling the advertising prohibition as unconstitutional. This created confusion over the FDAâs regulatory role in overseeing compounding pharmacies.5,12
Drug Quality and Security Act
In 2012, an outbreak of fungal meningitis brought into stark reality the need for more regulatory oversight of compounded medications.5 Resulting in 64 deaths, the outbreak reached 20 states and affected more than 750 people.5 The outbreakâs source was traced back to a single compounding pharmacy, New England Compounding Center (NECC), in Framingham, MA. NECC produced a preservative-free methylprednisolone epidural injection and distributed the product nationwide.5 Although the NECC tragedy involved sterile compounding, the resulting regulatory changes impacted both sterile and nonsterile compounding processes.
In 2013, Congress responded to this tragedy by passing the Drug Quality and Security Act (DQSA).5 Within the DQSA, the Compounding Quality Act (CQA) specifically addressed compounding and defined two distinct categories of compounding pharmacies: 503A and 503B.5 encompassing traditional compounding pharmacies. The 503A pharmacies can compound preparations based on individual prescriptions. The second category, 503B, refers to âoutsourcing facilities.â These facilities are allowed to compound non-patient-specific medications in large quantities.5,14 State boards of pharmacy have oversight responsibility of 503A facilities, while the FDA regulates 503B facilities. Table 2 outlines additional differences between the facilities.
Table 2
Differences between 503A and 503B Compounding Facilities5,14,15
| Guidance | 503A | 503B |
| Type of Facility | Compounding Pharmacy | Outsourcing Facility |
| Compounding Purpose | Must have a valid prescription for a specific patient | May compound nonpatient-specific preparations in bulk, with or without a prescription, for office use only |
| Advance compounding | Yes, limited quantities, under the expected receipt of patient-specific prescriptions | Yes, no limitations |
| Distribution | Only to other pharmacy-owned entities located within a 1-mile radius | May ship across state lines |
| Limitations | Maximum 30-day supply | Large batches |
| Regulation Oversight | State boards of pharmacy | FDA |
| Standards or Regulations | USP ,795>, <797>, <800>, etc | *cGMP, 21 CFR Parts 210, 211 |
| Adverse event reporting to the FDA | No, may voluntarily report to FDA | Yes |
| Production of the currently manufactured, available drug | No | No |
*cGMP = current Good Manufacturing Processes
The cGMP regulations establish minimum requirements to ensure the quality of manufactured or compounded drugs. The detailed guidelines include quality standards for facilities, equipment, production processes, quality controls, and packaging.16 The 503B pharmacies are required to follow cGMP, while 503A pharmacies are not.9,16 Regardless of where compounding occurs, whether in a pharmacy, outsourcing facility, or physicianâs office, other federal requirements still apply. This includes the requirement that drugs must not be prepared, packed, or held under unsanitary conditions.9
Occupational Safety and Health Act
The Occupational Safety and Health Act of 1970 is important legislation for prescription compounding.17 Congress passed this act to ensure worker and workplace safety. It aims to ensure that employers provide their workers with a place of employment free from recognized hazards to safety and health. These hazards include exposure to toxic chemicals, excessive noise levels, mechanical dangers, heat or cold stress, and unsanitary conditions.17
The act established the Occupational Safety and Health Administration (OSHA), a division of the U.S. Department of Labor that oversees the Act's administration and enforces standards in all 50 states.17 It also created the National Institute for Occupational Safety and Health (NIOSH) to establish workplace health and safety standards. NIOSH is the research institution for the Occupational Safety and Health Administration (OSHA).17
Compounded prescriptions are also subject to marketing regulations.14 The FDA is responsible for the information provided on compounded labeling, and the Federal Trade Commission monitors advertising for compounded pharmacies to ensure that advertisements are truthful, substantiated, and not misleading.14
Oversight of Pharmaceutical Compounding
After the separation of pharmacies into 503A and 503B categories, one would expect greater clarity in oversight. Unfortunately, that is not the case. Pharmaceutical compounding oversight is complex: it involves state, federal, and independent organizations. Each entity regularly reviews and updates its regulations, underscoring the importance of staying current with the latest revisions.
State boards of pharmacy are primarily responsible for the day-to-day oversight of 503A pharmacies. They mandate the quality standards that pharmacies must follow. Most pharmacies must adhere to USP standards and conduct regular inspections to ensure compliance.9
Facilities that register with the FDA as outsourcing facilities under section 503B must adhere to the USP standards and the cGMP. The FDA oversees these facilities, conducting regular inspections and issuing warning letters when warranted.
In some instances, a state inspection may identify a pharmacy engaged in larger-scale compounding or poor compounding practices. The FDA and the states must work together to identify and take appropriate action against compounding facilities whose practices present the greatest risk to public health.9
The Occupational Safety and Health Administration (OSHA) writes and enforces workplace safety and health regulations. Compounding pharmacies must comply with OSHA regulations to protect employees from job-related injuries or illnesses. Non-sterile compounding includes using proper personal protective equipment (PPE), protecting against inhalation of hazardous materials, and handling and storing hazardous drugs.6
The NIOSH published List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings is a crucial resource for pharmaceutical compounding. This list classifies hazardous drugs (HDs) into three tables:6
Antineoplastic drugs
Hazardous drugs that are not antineoplastic
Drugs that pose a risk to individuals of reproductive capacity
NIOSH uses a set of six criteria to determine the hazardous nature of a drug: carcinogenicity; teratogenicity or other developmental toxicity; reproductive toxicity in humans; organ toxicity at low doses in humans or animals; genotoxicity; and new drugs that mimic existing HDs in structure or toxicity.6 The most recent NIOSH list was published in 2016. In 2020, NIOSH proposed changes to the list that still need to be finalized. USP <800> requires compliance with the most recent list, and compounding pharmacies are responsible for assessing the potential hazards of new drugs.6
The Environmental Protection Agency (EPA) develops and enforces regulations to protect the environment and human health. EPA regulations related to compounding involve the generation, treatment, and disposal of hazardous waste.6
The Drug Enforcement Administration (DEA) oversees the use of controlled substances in the preparation of compounded medications.
Guidelines for Nonsterile Compounding
The United States Pharmacopeia (USP), established in 1820 by a group of physicians, plays a central role in enhancing the quality of medications. Today, it is an independent, non-profit organization with a mission to elevate the quality of drugs, including compounded preparations. USPâs compounding standards, encompassing the compounding process, facilities, equipment, documentation, quality controls, and personnel training, are pivotal in ensuring drug safety.18 While USP lacks regulatory authority to enforce these standards, it is important to note that the federal government has adopted them. Several USP standards pertain to drug compounding:19
795 Pharmaceutical Compounding - Nonsterile Preparation
797 Pharmaceutical Compounding - Sterile Preparation
800 Hazardous Drugs - Handling in Healthcare Settings
825 Radiopharmaceuticals - Preparation, Compounding, Dispensing, and Repackaging
1160 Pharmaceutical Calculations in Pharmacy Practice
1163 Quality Assurance in Pharmaceutical Compounding
1176 Prescription Balances and Volumetric Apparatus Used in Compounding
USP 795: Pharmaceutical Compounding â Nonsterile Preparation
The aim of USP General Chapter <795> is to guide the preparation of nonsterile compounds. First released in 2000, the latest revision was finalized in 2022 and made official in November 2023. USP 795 covers all aspects of nonsterile compounding, divided into the following 14 sections:
Introduction and scope
Personnel training and evaluation
Personal hygiene and garbing
Buildings and facilities
Cleaning and sanitizing
Equipment and components
Master formulation and compounding records
Release inspections and testing
Labeling
Establishing beyond-use dates
Standard operating procedures
Quality assurance and quality control
CSNP packaging and transporting
Documentation
Below is a brief discussion of each section of the USP General Chapter <795>. Several sections will be covered in more detail in subsequent modules.7
Introduction and Scope
USP General Chapter <795> outlines the minimum standards for compounded nonsterile preparations (CNSPs) for humans and animals. This includes combining, admixing, diluting, pooling, reconstituting (other than as listed on the manufacturer's labeling), or altering a drug product or bulk drug substance to create a nonsterile preparation.7 These requirements do not apply to repackaging manufactured products, breaking or cutting a tablet into smaller portions, or reconstituting a commercially available nonsterile product under the approved labeling directions.7 It includes various dosage forms, including solid and liquid oral, rectal, vaginal, topical, nasal, and otic preparations.7
This chapter applies to all individuals and locations involved in preparing CNSPs. A new aspect of the standards is the designation of one or more people with oversight and full responsibility for the facility's performance and operations, as well as for personnel. Several responsibilities are specified, including training, selecting ingredients for compounding, labeling, and cleaning.7
Personnel Training and Evaluation
Previously, the standards noted vague training requirements, stating that the compounder must be proficient in compounding, pursue knowledge of compounding, and be familiar with Chapter 795. More defined and structured training requirements now exist.7 The organizationâs designated person(s) is responsible for designing the training program, which must include a detailed description of the training, the training frequency, and the competency evaluation process. Training frequency involves initial training and then retraining every 12 months.7
Training programs must include the following topics:7
Hand hygiene
Garbing
Cleaning and sanitizing
Handling and transporting CNSPs and their components
Measuring and mixing
Proper use of equipment
Compounding process documentation
Knowledge of Chapter 795
Safety data sheet knowledge and interpretation
Procedures related to compounding duties
Personal Hygiene and Garbing
Personnel engaged in compounding must maintain appropriate personal hygiene.7 Individuals with rashes, recent tattoos, oozing sores, conjunctivitis, or active respiratory infections may contaminate the CNSP. The designated individual should assess whether people need to be excluded from compounding activities until their condition has been resolved.7
Gloves are required for all compounding activities.7 It is important to ensure that gloves are free of holes, punctures, or tears. Depending on the type of CNSP being prepared, additional garbing requirements, such as shoe covers, face masks, and gowns, may be necessary.7 When leaving the compounding area, all garb must be removed and discarded.7
Buildings and Facilities
The pharmacy must have an area designated for nonsterile compounding.7 The area must be well-lit, clean, sanitary, and in good repair. No other activities may occur in this area while compounding is in progress. Carpet is not allowed in the area.7
Equipment and supplies must be stored in an orderly fashion to prevent mix-ups.7 Temperatures must be monitored in the storage area, either manually once a day when the facility is open or continuously using an automatic temperature-recording device. A sink with hot and cold water must be available.7
Cleaning and Sanitizing
Surfaces must be cleaned and sanitized regularly.7 Compounding area surfaces should also be resistant to damage by cleaning agents. The selection of compounding agents should prioritize effectiveness and minimize the potential for residue formation. Table 3 provides the guidelines for the frequency of cleaning the nonsterile compounding area.7
Table 3
Guidelines for Frequency of Cleaning Nonsterile Compounding Areas7
| Location | Cleaning Frequency |
| Work Surfaces | Start and end of each shift on days when compounding occurs After spills or surface contamination Between compounding different CNSPs |
| Floors | Start and end of each shift on days when compounding occurs After spills or surface contamination |
| Walls | When soiled After spills or surface contamination |
| Ceilings | When soiled After surface contamination |
| Storage Shelving | Every 3 months After spills or surface contamination |
Equipment and Components
Equipment used in compounding CNSPs must be suitable for the type of compounding being performed. USP 795 outlines specifics for equipment surfaces, storage, and cleaning. The selection of components for CNSP must be detailed in written standard operating procedures (SOPs) that are readily accessible to all personnel involved in the compounding process. Module 5 covers buildings and facilities and provides detailed guidelines for equipment and components.7
Master Formulation and Compounding Records
Master formulation records (MFRs) are recipes for compounding a CNSP and include detailed procedures for preparing it. Each unique CNSP must have an MFR. Compounding records document that each CNSP must be created for all preparations.
Release Inspections and Testing
Release inspections refer to the process of checking the CNSP to ensure quality. Before dispensing the final preparation, it must be visually inspected to confirm the CSPâs physical appearance is as expected. This inspection includes an evaluation of the container and closure. If the CNSP is released on a day after preparation, the visual inspection must be conducted directly before the release. In case of observed defects, the CNSP must be rejected and isolated to prevent use.7
Labeling
Labeling refers to all written information included with the CNSP, including the labeled product and any accompanying informational materials. The information must be legible and include the following details:7
Individual identification number
Active ingredients
Storage conditions
Beyond-use dating
Dose form
Route of administration
Indicate the product is compounded
Special handling requirements
Warning statements
Compounding facility information
Establishing Beyond-Use Dates
Beyond-use dates (BUDs) are the dates or times after which a compounded preparation must not be used. BUDs decrease the risk of patient exposure to product contamination or degradation. Compounding pharmacies are responsible for establishing BUDs in accordance with USP 795. If a compounding pharmacy follows a USP-NF monograph, the BUD must not exceed the limits specified in the monograph. If no other stability information is available, the USP standards guide determines the BUD of a CSNP.7
Quality Assurance and Quality Control
Quality assurance is a system that ensures that the compounding process meets quality standards. Quality control involves taking samples and testing products to ensure they meet quality specifications.7
CNSP Packaging and Transporting
If the CSNP needs to be delivered, the facilityâs SOPs must describe the packaging process. This process must maintain the integrity and stability of the CNSP and protect it from potential damage or contamination. SOPs outline the necessary mode of transportation and any special handling.7
Documentation
Written or electronic documentation is required to demonstrate compliance with these guidelines. The documentation must be legible and stored in a safe, readily available location. The required elements are extensive.
USP 800: Hazardous Drugs â Handling in Healthcare Settings
USP <800> provides guidance on handling hazardous drugs (HDs) to minimize exposure to patients, healthcare workers, and the environment.20 Like USP 795, the chapter is broken down into sections covering similar topics. Reviewing every section is beyond the scope of this activity. We will focus on the sections most relevant to CNSPs.
Consistent with USP 795, one or more people must be designated to oversee and be responsible for the pharmacy's operations and personnel. Usually, the same person oversees the entire program, including compliance with USP 795 and 800.20
As defined earlier, an HD is any drug identified by NIOSH as hazardous or potentially hazardous. These drugs are listed in the current NIOSH list of antineoplastic and other hazardous drugs used in healthcare settings.21 The most current NIOSH list is the 2016 List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings, available on the NIOSH website.22
Compounding facility staff must review the NIOSH list to identify the HDs they might handle, maintain a list of these HDs, and review the list every 12 months. When a new HD enters the market following the most recent version of the list, the compounding facility must assess it using the criteria provided by NIOSH. Some drug formulations, such as tablets and capsules, may not pose significant risks. This risk assessment considers the type of HD, dosage form, risk of exposure, packaging, and manipulation.20 Exposure to an HD may occur during any activity related to the compounding process. This includes receipt, dispensing, compounding, spills, transport, and waste. USP 800 defines requirements for handling HDs during these activities.20
Within the compounding facility, areas designated for handling and compounding HDs must be clearly marked and restricted to trained, authorized personnel. There are specific requirements for receiving, storing, and compounding HDs. A containment primary engineering control (C-PEC) is a ventilated device designed to minimize exposure to personnel and the environment. A containment secondary engineering control (C-SEC) is the room in which the C-PEC is located. Preparation of a CNSP containing an HD must be performed in a C-PEC.20
Compounding nonsterile hazardous drugs (HDs) also requires wearing gowns, head covers, hair covers, shoe covers, and two pairs of gloves. In some cases, eye, face, and respiratory protection may be necessary. All PPE worn while compounding an HD must be properly disposed of in accordance with local, state, and federal regulations.20
Compounding facilities must ensure that all personnel involved in compounding HDs receive proper training and education on HDs and the associated exposure risks. SOPs are necessary for receiving, labeling, packaging, and transporting HDs. They should also outline processes to be followed in the event of a spill, including decontamination, cleaning, and disinfection.20
Regulation Compliance
Given the many regulations and guidelines surrounding pharmaceutical compounding, maintaining compliance may seem daunting. Many resources exist to aid in compounding compliance. One avenue is to undergo a compounding accreditation process. Eight pharmacy organizations formed the Pharmacy Compounding Accreditation Board (PCAB) to create compounding quality and safety standards and establish an accreditation program for compounding pharmacies. Today, the Accreditation Commission for Healthcare (ACHC) administers the PCAB accreditation process. Accreditation through PCAB is voluntary and involves reviewing compounding policies and procedures and conducting on-site inspections. PCAB Non-Sterile Pharmacy Compounding Accreditation references USP <795> and measures a specific set of process standards that concentrate on the quality and consistency of compounded preparations.23
Compounding Reference Information
Daily access to compounding references supports and maintains quality compounding. Table 6 lists compounding references containing up-to-date information.
Table 6
Compounding Resources
| Resource | Type Information |
| U.S. Food and Drug Administration10 | The FDA provides information on compounding laws and policies, oversees compounding, and enforces compliance. website: https://www.fda.gov/drugs/guidance-compliance-regulatory-information/human-drug-compounding |
/// Compounding Quality Center of Excellence | /// The Compounding Quality Center of Excellence is an FDA organization that provides seminars and webinars on compounding practice and laws. website: https://www.fda.gov/drugs/human-drug-compounding/compounding-quality-center-excellence |
| International Journal of Pharmaceutical Compounding (IJPC) | The IJPC is bi-monthly Journal that provides information on quality pharmaceutical compounding, hands-on, how-to compounding techniques, and up-to-date compounding information website: https://ijpc.com |
| Compounding Today | Compounding Today is an interactive website maintained by the International Journal of Pharmaceutical Compounding. It provides formulas, standard operating procedures, clinical information, and compliance information webpage: compoundingtoday.com |
| Alliance for Pharmacy Compounding (APC) | APC is a trade association that provides access to APCâs information services and professional development events webpage: https://a4pc.org |
| Professional Compounding Centers of America (PCCA) | The PCCA is a web-based member organization. It provides training and education, access to compounding formulas, and access to its Clinical Services team, which answers members' compounding questions via online support. website: https://www.pccarx.com |
| The Art, Science, and Technology of Pharmaceutical Compounding Book23 | This book covers all aspects of compounding, including regulatory, technology, and scientific information, example formulas for all dosage forms, instructions for preparation, compatibility considerations, and quality control |
The Role of the Pharmacy Technician
As essential members of the pharmacy team, pharmacy technicians play a critical role in nonsterile compounding. Nonsterile compounding occurs in many practice settings, including retail pharmacies, hospitals, and outpatient clinics. Pharmacy technician responsibilities are multifaceted and include many activities:
Selection of ingredients
CNSP preparation
Equipment maintenance and use
Documentation
Quality control
Compliance with regulations
Inventory management
Education and training
When permitted by state law and after training, pharmacy technicians may be key to ensuring that compounded medications are prepared accurately and safely, and in compliance with regulatory standards. Their work supports the pharmacy team and ultimately contributes to the health and well-being of patients requiring customized medication solutions.
Summary
Compounding is a critical aspect of pharmacy practice that involves preparing customized medications when commercially available products are unsuitable. NSC must be carried out with precision, care, and strict adherence to standards to ensure the safety and efficacy of medications. The compounding process is complicated and subject to many regulations and guidelines. These regulations and guidelines are necessary to minimize risks to patients, compounding personnel, and the environment. Pharmacy technicians are essential members of the compounding team and integral to the successful preparation of safe, accurate, and high-quality preparations.
References
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The information provided in this course is general in nature, and it is designed solely to provide participants with continuing education credit(s). This course and materials are not meant to substitute for the independent, professional judgment of any participant regarding that participantâs 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.
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