CUCO Certification Review

Certified USP 800 Compliance Officer (CUCO) Review

A Review Guide for the Certified USP 800 Compliance Officer (CUCO) Exam

Block 1: Foundations & Scope

ACPH: Air Changes Per Hour

AoR: Assessment of Risk

API: Active Pharmaceutical Ingredient

BSC: Biological Safety Cabinet

BUD: Beyond-Use Date

CACI: Compounding Aseptic Containment Isolator

C-PEC: Containment Primary Engineering Control

C-SCA: Containment Segregated Compounding Area

C-SEC: Containment Secondary Engineering Control

CSTD: Closed System Drug-Transfer Device

CVE: Containment Ventilated Enclosure

HD: Hazardous Drug

HEPA: High-Efficiency Particulate Air

NIOSH: National Institute for Occupational Safety and Health

OSHA: Occupational Safety and Health Administration

PAPR: Powered Air-Purifying Respirator

PPE: Personal Protective Equipment

SOP: Standard Operating Procedure

SDS: Safety Data Sheet

USP: United States Pharmacopeia

  • USP General Chapter <800> provides standards for the safe handling of hazardous drugs (HDs).
  • The primary purpose is to protect personnel, patients, and the environment from exposure to HDs.
  • It applies to all healthcare settings where HDs are handled, including pharmacies, hospitals, clinics, and veterinary practices.
  • The chapter covers the entire lifecycle of an HD, from receipt to disposal.
  • It establishes standards for engineering controls, personal protective equipment (PPE), and safe work practices.
  • Compliance with USP <800> is often enforced by state boards of pharmacy and other accrediting bodies like The Joint Commission.
  • The chapter is built on the principle of containment to minimize exposure at every step.
  • It recognizes that all personnel who handle HDs are at risk of exposure.
  • A CUCO must understand that USP <800> sets the minimum acceptable standards for safety.
  • The ultimate goal is to foster a culture of safety and awareness regarding the risks of HDs.
  • USP <800> requires each entity to designate a qualified and trained individual to be responsible for the HD handling program.
  • This designated person is often a pharmacist, and the CUCO role fulfills this requirement.
  • They are responsible for developing and implementing all policies and procedures for HD handling.
  • They must ensure competency of all personnel who handle HDs.
  • They are responsible for ensuring that the facility and engineering controls are appropriate and functioning correctly.
  • They oversee the monitoring of the program, such as environmental wipe sampling.
  • They must ensure compliance with all documentation and recordkeeping requirements.
  • They are responsible for overseeing the Assessment of Risk (AoR) process.
  • This individual must have a thorough understanding of the rationale and requirements of USP <800>.
  • The designated person has the ultimate accountability for the safety of the HD handling program.
  • USP <800> applies to all drugs on the current NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings.
  • The NIOSH list is the foundational document for determining which drugs require special handling.
  • Each entity must create its own specific list of HDs that it handles.
  • This list must be reviewed and updated at least every 12 months.
  • The CUCO is responsible for maintaining this entity-specific list.
  • The process involves cross-referencing the pharmacy's formulary against the NIOSH list.
  • The entity must also have a process to review new drugs against the NIOSH criteria for hazardousness.
  • This ensures that new drugs are promptly identified and handled appropriately.
  • The entity's HD list dictates which drugs are subject to the full containment requirements of USP <800>.
  • This list serves as the starting point for all other aspects of the compliance program.
  • The AoR is a provision in USP <800> that allows an entity to develop alternative containment strategies for certain HDs.
  • It can only be performed for HDs on the NIOSH list that are in their final, intact dosage form (e.g., tablets, capsules).
  • An AoR cannot be performed for any antineoplastic HD that requires manipulation (e.g., crushing).
  • It also cannot be performed for any active pharmaceutical ingredient (API).
  • The purpose of the AoR is to document the alternative strategies that will be used to protect staff.
  • For example, an AoR for a specific tablet might allow it to be counted with dedicated equipment in the general pharmacy area instead of a negative pressure room.
  • The AoR must be documented and reviewed at least every 12 months.
  • The designated person (CUCO) is responsible for developing and overseeing the AoR process.
  • If an AoR is not performed for an eligible drug, it must be handled with all of the full containment strategies of USP <800>.
  • This is a critical area that requires expert professional judgment.

Block 2: Facilities & Engineering Controls

  • HDs must be handled in areas that are separate from non-HDs.
  • Signage must be in place to identify areas where HDs are handled.
  • Access to these areas must be restricted to authorized personnel.
  • HDs must be stored separately from non-HDs in a manner that prevents contamination and personnel exposure.
  • They cannot be stored on the floor.
  • Storage areas must be externally vented and be under negative pressure relative to surrounding areas.
  • This applies to both sterile and non-sterile HDs.
  • Refrigerated HDs must be stored in a dedicated refrigerator within this negative pressure storage area.
  • The CUCO must ensure that all storage areas are designed and maintained to meet these requirements.
  • Proper storage is a key step in preventing the spread of contamination.
  • A C-PEC is a ventilated device designed to minimize exposure during HD handling.
  • All manipulation of HDs (e.g., compounding, crushing) must occur within a C-PEC.
  • The C-PEC must be externally vented to move contaminants outside the building.
  • It can also have redundant HEPA filtration in series.
  • For non-sterile compounding, a Containment Ventilated Enclosure (CVE) or a Class I Biological Safety Cabinet (BSC) can be used.
  • For sterile compounding, a Class II or III BSC or a Compounding Aseptic Containment Isolator (CACI) must be used.
  • The C-PEC must be located in an appropriate secondary engineering control (C-SEC).
  • It must operate continuously if it supplies some or all of the negative pressure in the C-SEC.
  • A CUCO must ensure the correct type of C-PEC is used for each activity.
  • Proper use and maintenance of the C-PEC is a cornerstone of HD safety.
  • The C-SEC is the room in which the C-PEC is placed.
  • It provides a second layer of containment.
  • The C-SEC must be externally vented.
  • It must be physically separated from other areas.
  • It must have negative pressure between 0.01 and 0.03 inches of water column relative to adjacent areas.
  • This ensures that air flows into the HD handling area, not out of it.
  • The room must have a specific number of Air Changes Per Hour (ACPH).
  • The C-SEC used for sterile compounding must meet at least ISO Class 7 standards.
  • A pressure gauge must be present to monitor the negative pressure continuously.
  • The CUCO must work with facilities management to ensure the C-SEC is designed and certified correctly.
  • USP <800> recognizes that activities other than compounding can pose an exposure risk.
  • For example, handling HD APIs for non-compounding tasks (e.g., in a research setting).
  • These activities must be performed in a C-PEC, such as a powder containment hood.
  • This C-PEC does not need to be located in a C-SEC.
  • However, the exhaust from this C-PEC must be externally vented.
  • This ensures that any generated powders or aerosols are removed from the general work area.
  • This is a specific requirement for handling raw HD materials.
  • The CUCO must ensure that all areas where HD APIs are handled meet these requirements.
  • Appropriate PPE must still be worn during these activities.
  • This highlights the chapter's focus on containment for all potential exposure sources.
  • All containment engineering controls (C-PECs and C-SECs) must be certified.
  • This certification must be performed by a qualified professional.
  • Certification must occur upon installation and at least every six months thereafter.
  • It must also be done whenever the device is moved or serviced.
  • The certification report must be reviewed by the CUCO to ensure all parameters meet USP standards.
  • Environmental monitoring includes both non-viable and viable air sampling for sterile compounding areas.
  • This is a requirement of USP <797> to ensure the sterility of the environment.
  • For HDs, USP <800> also requires environmental wipe sampling for surface contamination.
  • This wipe sampling should be performed routinely (e.g., every six months).
  • The CUCO is responsible for overseeing the entire certification and environmental monitoring program.

Block 3: Personal Protective Equipment (PPE)

  • Gloves: Two pairs of chemotherapy gloves are required.
  • The outer glove must be sterile for sterile compounding.
  • Gloves must be changed every 30 minutes or when contaminated.
  • Gowns: Must be disposable, impermeable to HDs, and close in the back.
  • Shoe Covers: Two pairs of shoe covers are required for sterile compounding.
  • Head and Hair Covers: Required for all compounding. Beard covers are needed if applicable.
  • Eye and Face Protection: Must be worn when there is a risk of splashes, such as outside of an isolator.
  • Sleeves: When compounding in a BSC, the inner glove goes under the cuff of the gown and the outer glove goes over the cuff.
  • All PPE used in compounding is considered contaminated.
  • The CUCO must ensure an adequate supply of appropriate PPE is always available.
  • The PPE required for administration depends on the dosage form of the HD.
  • For injectable antineoplastic HDs, two pairs of chemotherapy gloves and a chemotherapy gown are required.
  • A Closed System Drug-Transfer Device (CSTD) should be used for administration.
  • For oral solid dosage forms (tablets/capsules) that are not manipulated, a single pair of gloves may be sufficient.
  • If tablets are crushed or capsules opened, full compounding PPE is required.
  • Eye protection is needed if there is a risk of splashing.
  • The CUCO must collaborate with nursing leadership to develop clear PPE policies for administration.
  • This ensures that protection extends beyond the pharmacy to the point of patient care.
  • Training for nurses on proper PPE use is a critical part of the program.
  • These requirements protect nurses from exposure during direct patient care.
  • PPE is required even for non-compounding, non-administration tasks.
  • During receiving and unpacking, at least one pair of chemotherapy gloves must be worn.
  • An elastomeric half-mask with a P100 cartridge should be used if unpacking HDs not contained in plastic.
  • When handling HDs in the storage area, appropriate gloves should be worn.
  • During transport, the HD should be in a sealed, labeled container.
  • No additional PPE is required for transporting a properly contained HD.
  • However, the person transporting the drug should be trained on what to do in case of a spill.
  • The CUCO must ensure that PPE is available in all areas where HDs are handled, including the receiving area.
  • This protects staff at the very first point of contact with the HDs.
  • These requirements are often overlooked but are a key part of the standard.
  • Full HD handling PPE is required for the four-step cleaning process.
  • This includes double gloves, an impermeable gown, and shoe covers.
  • Eye protection and a face shield are required if splashing is likely.
  • Respiratory protection may be needed depending on the agents used and the activity.
  • Staff performing cleaning tasks are at high risk of exposure to residual contamination.
  • This includes both pharmacy and environmental services staff.
  • The CUCO must ensure that all staff involved in cleaning are properly trained and equipped.
  • The PPE used for cleaning must be disposed of as hazardous waste.
  • This is a critical step in protecting the cleaning staff.
  • This requirement applies to routine daily cleaning as well as terminal cleaning.

Block 4: The HD Handling Lifecycle

  • HDs must be delivered directly to a designated receiving area.
  • They must not be delivered to general pharmacy or patient care areas.
  • The receiving area must be neutral or negative pressure.
  • HDs must be unpacked by trained personnel wearing appropriate PPE.
  • A spill kit must be readily available.
  • Upon receipt, shipping containers should be inspected for any signs of damage or leakage.
  • Damaged containers must be treated as a spill.
  • The outer container is removed, and the inner container is wiped down before being transported to the storage area.
  • This initial step is crucial for preventing the introduction of contamination into the facility.
  • The CUCO should audit the receiving process to ensure compliance.
  • HDs must be transported in containers that are designed to minimize the risk of breakage or leakage.
  • These containers must be labeled with a clear hazardous drug warning.
  • Pneumatic tube systems should not be used for liquid or antineoplastic HDs due to the risk of breakage and system contamination.
  • If a pneumatic tube system is used for any HD (e.g., intact tablets), there must be a formal SOP for decontamination in case of a leak.
  • Personnel who transport HDs must be trained on what to do in case of a spill.
  • A spill kit should be accessible along the transport route.
  • The goal is to maintain containment from the moment the drug leaves the pharmacy until it reaches its destination.
  • The CUCO must ensure these transport policies are in place and are followed.
  • This applies to transport within the facility as well as to outside locations.
  • This is another area where collaboration with other departments is key.
  • The person administering the HD must wear appropriate PPE.
  • For injectable antineoplastics, this includes two pairs of chemotherapy gloves and a chemotherapy gown.
  • USP <800> requires the use of a Closed System Drug-Transfer Device (CSTD) for the administration of antineoplastic HDs when the dosage form allows.
  • This helps to prevent the release of aerosols and droplets during connection and disconnection.
  • "Spiking" an IV bag of HD should be done with care to prevent leaks.
  • Crushing tablets or opening capsules should be avoided; if necessary, it should be done in a plastic pouch.
  • All materials used for administration are considered contaminated and must be disposed of as HD waste.
  • Patients and caregivers must be educated on how to handle any excreted body fluids, which may contain the drug or its active metabolites.
  • The CUCO must work with nursing to ensure these practices are implemented at the bedside.
  • This is the final, and one of the most critical, points of potential exposure.
  • This four-step process is required for all surfaces and equipment that may be contaminated with HDs.
  • Step 1 - Deactivation: Renders the HD inert. Typically done with an EPA-registered oxidizer like peroxide or sodium hypochlorite.
  • Step 2 - Decontamination: Removes the inactivated HD residue. Typically done with alcohol or sterile water.
  • Step 3 - Cleaning: Removes organic matter. Done with a germicidal detergent.
  • Step 4 - Disinfection: Destroys microorganisms. Done with an EPA-registered disinfectant and required for sterile areas.
  • The CUCO is responsible for selecting the appropriate agents and validating the process.
  • There must be a written SOP detailing the entire procedure, including contact times.
  • All staff performing these tasks must be trained and wear appropriate PPE.
  • This process applies to C-PECs, work surfaces, floors, and patient care areas where HDs are administered.
  • It is a cornerstone of preventing the accumulation and spread of surface contamination.
  • All items contaminated with HDs must be disposed of as hazardous waste.
  • This includes used PPE, compounding supplies, and administration supplies.
  • Waste must be segregated into different containers based on its type and level of contamination.
  • Trace-contaminated waste (e.g., empty vials, used gloves) is typically placed in yellow containers.
  • Bulk-contaminated waste (e.g., partially used IV bags of certain chemotherapy drugs) may be classified as RCRA hazardous waste.
  • RCRA waste must be placed in black containers and managed by a licensed hazardous waste hauler.
  • Sharps contaminated with HDs must be placed in puncture-resistant containers that are clearly labeled as hazardous.
  • The CUCO must develop policies that comply with federal (EPA), state, and local waste regulations.
  • All staff must be trained on proper waste segregation.
  • This is a critical step for protecting environmental services staff and the environment.
  • A formal spill management policy is a requirement of USP <800>.
  • Spill kits must be readily accessible in all areas where HDs are handled.
  • The contents of the spill kit should be appropriate for the type and quantity of HDs handled.
  • All personnel who handle HDs must be trained on how to manage a spill.
  • The first step is to restrict access to the spill area.
  • The individual cleaning the spill must don full HD handling PPE, including respiratory protection for large spills.
  • The spill should be cleaned using the materials in the kit, working from the outside in.
  • All cleanup materials must be disposed of as hazardous waste.
  • The area must be decontaminated and cleaned after the initial cleanup.
  • Every spill, no matter how small, must be documented.
  • A CSTD is a device that mechanically prohibits the transfer of environmental contaminants into the system and the escape of hazardous drug or vapor concentrations outside the system.
  • USP <800> requires that CSTDs be used for the administration of antineoplastic HDs when the dosage form allows.
  • It recommends that CSTDs be used during the compounding of antineoplastic HDs.
  • CSTDs are not a substitute for a C-PEC; they must be used inside a ventilated cabinet during compounding.
  • They provide an additional layer of protection for both pharmacists and nurses.
  • Studies have shown that CSTDs can significantly reduce surface contamination.
  • There are several different types of CSTDs on the market with different mechanisms.
  • The CUCO should be involved in the selection and evaluation of CSTDs.
  • All staff must be trained on the proper use of the specific CSTD system implemented by the facility.
  • This is a key technology for enhancing HD safety.

Block 5: Program Management & Oversight

  • This is a requirement of OSHA.
  • The program must ensure that all employees are informed of the chemical hazards in their workplace.
  • For HDs, this includes developing and maintaining a written hazard communication plan.
  • It requires maintaining a list of all hazardous chemicals, including HDs.
  • Safety Data Sheets (SDSs) for all HDs must be readily accessible to employees.
  • All containers of HDs must be properly labeled with a hazard warning.
  • Employees must be trained on the hazards of the drugs they handle and the protective measures to be taken.
  • This training must occur upon initial assignment and whenever a new hazard is introduced.
  • The CUCO is responsible for ensuring the hazard communication program is fully implemented for HDs.
  • This program is foundational to worker safety and right-to-know principles.
  • USP <800> requires job-specific training for all personnel who handle HDs.
  • Training must cover the entity's list of HDs, all SOPs, proper use of PPE, and spill management.
  • The effectiveness of this training must be demonstrated through a formal competency assessment.
  • Competency must be reassessed at least every 12 months.
  • All training and competency assessments must be documented.
  • This documentation is a critical record for regulatory inspections.
  • Personnel of reproductive capability must sign a written acknowledgement that they understand the risks of handling HDs.
  • This acknowledgement should be part of the initial training process.
  • The CUCO is responsible for developing, implementing, and documenting the entire training and competency program.
  • A well-trained workforce is the most important component of a safe handling program.
  • USP <800> requires that a medical surveillance program be made available to workers who routinely handle HDs.
  • The purpose is to monitor for potential health effects from exposure and to detect any issues early.
  • The program should include a baseline assessment before the employee begins handling HDs.
  • Periodic follow-up assessments should be offered to track health status over time.
  • The program should include a mechanism for workers to report any potential exposures or health concerns.
  • An exit examination should be offered when a worker's employment ends.
  • The CUCO collaborates with the occupational health department to design and implement this program.
  • Participation in the program is voluntary for employees.
  • The results of the surveillance program should be used to evaluate the effectiveness of the overall safety program.
  • This is a key component of protecting the long-term health of healthcare workers.
  • USP <800> requires written Standard Operating Procedures (SOPs) for every aspect of HD handling.
  • SOPs are detailed, step-by-step instructions that ensure tasks are performed consistently and safely.
  • There must be SOPs for receiving, storage, compounding, transport, administration, and disposal.
  • There must also be SOPs for spill management, cleaning, and personnel training.
  • The CUCO is responsible for developing, reviewing, and approving all HD-related SOPs.
  • SOPs must be readily available to all staff who handle HDs.
  • They must be reviewed and updated at least every 12 months.
  • All personnel must be trained on the SOPs relevant to their job functions.
  • SOPs are the backbone of the administrative controls for the HD safety program.
  • They are a primary focus of any regulatory or accreditation inspection.
  • Meticulous documentation is a central theme of USP <800>.
  • The principle is: "If it wasn't documented, it wasn't done."
  • The entity must maintain records of its HD list and all Assessments of Risk.
  • All personnel training and competency assessments must be documented.
  • Certification reports for all engineering controls must be kept on file.
  • Environmental monitoring results, including air and surface sampling, must be documented.
  • All spill events must have a formal, documented report.
  • Medical surveillance records must be maintained by occupational health.
  • All SOPs must be formally documented and version-controlled.
  • The CUCO is responsible for ensuring that all of these records are maintained and are readily retrievable for inspection.
  • A quality assurance (QA) program is required to ensure that the HD safety program is effective.
  • This involves continuous monitoring of key processes and metrics.
  • The CUCO is responsible for overseeing this QA program.
  • Key components include reviewing environmental monitoring results (e.g., wipe samples).
  • It also includes reviewing data from the medical surveillance program.
  • Regular audits of staff compliance with SOPs (e.g., proper PPE use) are part of QA.
  • The QA program should also track and trend any spills or exposure events.
  • The findings from the QA program should be reported to a multidisciplinary safety committee.
  • This data is used to identify weaknesses in the program and to drive continuous improvement.
  • This is how a facility ensures that its HD safety program is not just a paper-based plan but a living, effective system.

The NIOSH List of Hazardous Drugs

The foundational assessment tool. It is the primary resource used to identify which drugs in an organization's formulary must be handled according to USP <800> standards. The CUCO uses this list to create and maintain the entity-specific list of HDs.

Assessment of Risk (AoR) Template

A structured document used to formally evaluate the risk of specific HD dosage forms (e.g., intact tablets) and to define alternative containment strategies. It typically includes the drug name, dosage form, potential for exposure, and the specific alternative procedures to be followed.

USP <800> Compliance Checklist

A detailed checklist, often provided by consulting groups or professional organizations like ASHP, that breaks down every requirement of USP <800>. The CUCO uses this tool to conduct a thorough gap analysis of the organization's practices against the standard's requirements.

Air Changes Per Hour (ACPH)

A critical metric for C-SEC ventilation. It measures how many times the entire volume of air in a room is replaced in one hour. It is calculated from the room's volume and the airflow rate supplied by the HVAC system.

ACPH=(Total Airflow in CFM × 60 min/hr) / Room Volume (ft³)

Interpreting Wipe Sample Results

This is not a formula but a data interpretation skill. The lab report for a wipe sample will provide a result in mass per unit of area (e.g., nanograms/cm²). The CUCO compares this result to the organization's established action level to determine if cleaning procedures are effective or if further investigation is needed.

  • Containment is the Cornerstone. Every rule in USP <800> can be traced back to the fundamental principle of containing the hazardous drug to prevent it from escaping and exposing workers.
  • The Hierarchy of Controls Governs All Decisions. A CUCO must always prioritize higher-level controls. Engineering controls (the facility) are always more reliable than administrative controls (SOPs), which are more reliable than PPE.
  • A Culture of Safety is Your Strongest Control. A truly compliant organization is one where every single employee understands the risks of HDs and is empowered and committed to following safe handling procedures at all times.
  • You Are the Subject Matter Expert. The CUCO is the designated person with the ultimate responsibility and authority. You must be the most knowledgeable person in the facility on the requirements and rationale of USP <800>.
  • The Standard Applies to a Lifecycle, Not Just a Room. Compliance is not just about the compounding cleanroom. It encompasses every single point where an HD is handled, from the receiving dock to the waste stream.
  • Collaboration is Not Optional. It is impossible to implement USP <800> alone. A successful CUCO builds strong partnerships with nursing, environmental services, facilities management, and occupational health.
  • Documentation is the Language of Compliance. From SOPs to training records to certification reports, meticulous and readily retrievable documentation is the only way to prove compliance to a regulator or accreditor.
  • Risk Assessment is a Continuous Process. The Assessment of Risk is not a one-time task. The CUCO must continuously assess risks as new drugs, equipment, and processes are introduced.
  • Training is the Foundation of Safe Practice. Staff cannot follow procedures they do not know or understand. A robust, ongoing training and competency program is essential for success.
  • Your Mission is to Protect Your Colleagues. At its heart, the role of the CUCO is about protecting your fellow healthcare workers from the insidious, long-term health risks associated with occupational exposure to hazardous drugs.
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