Compounding I

Which organization sets the standards for compounding preparations?

What determines if a compounded drug is non-sterile or sterile?

What is the purpose of USP 800?

What distinguishes a traditional compounded drug from commercially available medications?

Which chapter of USP sets standards for non-sterile compounding?

What are the categories for non-sterile compounding based on the level of complexity involved?

Which organization do hospital pharmacists rely on for detailed guidance on implementing USP standards?

What is the purpose of non-sterile compounding?

What is the primary requirement for the physical space for non-sterile compounding?

What is the primary purpose of sterile compounding?

Which of the following is an example of a product prepared using sterile compounding?

What are BSC and CSTD examples of in USP standards?

What do terms like C-PEC, CACI, and C-SEC refer to in USP standards?

What is the primary requirement for facilities used in compounding?

What is the minimum air quality required in critical areas according to ISO standards?

What is the efficiency of High-efficiency particulate air (HEPA) filters in removing particles?

How often must the HEPA filter be recertified?

What type of air quality does the Primary Engineering Control (PEC) provide for sterile compounding?

What are the requirements for surfaces in the compounding area?

What contributes largely to contamination in sterile compounding?

What organization sets the standards for air quality?

What is the minimum air quality required in the buffer area according to ISO standards?

What type of compounding area requires an anteroom of at least ISO 8?

What is the air quality requirement for the anteroom in some types of compounding?

What are the types of sterile compounding areas mentioned in the text?

What is the recommended frequency for recertifying the HEPA filter?

What type of environment does the Primary Engineering Control (PEC) provide for sterile compounding?

What is the maximum beyond-use date (BUD) for IV drugs prepared under suboptimal conditions for sterility?

What type of air pressure does the PEC for non-hazardous sterile preparations have?

What does the Segregated Compounding Area (SCA) provide for low-risk CSPs without a buffer area or anteroom?

What is the purpose of the Secondary Engineering Control (SEC) in the sterile compounding environment?

What is the purpose of the Laminar Airflow Workbench (LAFW) in sterile compounding?

Where is the Compounding Aseptic Isolator (CAI) located in the sterile compounding environment?

What is the purpose of the Anteroom in the sterile compounding environment?

Which organization determines which drugs are hazardous?

What is the primary requirement for facilities used in compounding hazardous drugs?

What is the purpose of the National Institute for Occupational Safety and Health (NIOSH) list of hazardous drugs?

Which type of drug is considered hazardous if it is genotoxic?

What is the purpose of Safety Data Sheets (SDS) for hazardous drugs?

What is the primary responsibility of the designated individual in a compounding facility?

What is the minimum required frequency for reviewing the list of hazardous drugs stocked?

What must individuals with reproductive capability confirm prior to handling hazardous drugs?

What is the purpose of the Personal Protective Equipment (PPE) for hazardous drug handling?

What is the primary focus of the Hazard Communication Program for hazardous drug handling?

What is the purpose of the spill clean-up procedures for hazardous drugs?

What is the primary requirement for pharmacies regarding hazardous drugs?

Compounded drugs are always FDA-approved.

Non-sterile compounded drugs cannot be hazardous.

USP 795 sets the standards for sterile compounding.

USP 800 determines which drugs are hazardous.

Air will flow out of the SEC and into the adjacent anteroom when the door is opened.

The anteroom for non-hazardous drug compounding must be ISO 7 or 8.

Positive air pressure in the anteroom means the ISO 8 air will blow into the SEC and risk contaminating the CSPs.

The National Institute for Occupational Safety and Health (NIOSH) determines which drugs are hazardous.

NIOSH maintains a list of all hazardous drugs called the NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings.

Each hazardous drug has its own Safety Data Sheet (SDS) providing guidance on drug-specific safety information.

Facilities must maintain a list of all hazardous drugs stocked and review it every 12 months or whenever a new drug or dosage form is stocked or used.

Prior to handling any hazardous drugs, individuals with reproductive capability must confirm in writing that they understand the risks associated with handling hazardous drugs.

High-efficiency particulate air (HEPA) filters must be recertified every 6 months.

The Hazard Communication Program includes a written plan detailing the implementation of hazardous drug safety procedures and proper training of personnel.

The purpose of the spill clean-up procedures for hazardous drugs is to prevent contamination of the environment.

Personal protective equipment (PPE) is not required when handling hazardous drugs.

HEPA filters are 100% efficient in removing particles as small as 0.3 microns wide or larger.

The air quality in critical areas must be at least ISO 5, with no more than 3,520 particles per cubic meter.

The buffer area must be at least ISO 6.

USP 795 sets standards for non-sterile compounding, while USP 797 sets standards for sterile compounding.

Compounding should be done in the cleanest air, which is the air coming directly out of the HEPA filter.

Non-sterile compounding is primarily used to prepare doses or formulations that are commercially available.

The PEC provides ISO 7 air quality for sterile compounding.

The revisions to USP 795 and 797 published in June 2019 are currently in effect and have replaced the 2014 and 2008 versions.

Surfaces in the compounding area must be rough, impervious, and free from cracks and crevices.

Sterile compounding is used to prepare intravenous drugs, intramuscular and subcutaneous drugs, radiopharmaceuticals, eye drops, and oral inhalations.

Compounding staff largely contribute to contamination through inadequate hand hygiene and garbing.

The types of sterile compounding areas include cleanroom suites and segregated compounding areas (SCA) with an ISO 6 PEC.

Non-sterile compounding is categorized into simple, moderate, and complex based on the level of sterility involved.

The HEPA filter must be recertified every 1 year and anytime a Primary Engineering Control (PEC) has been moved.

The physical space for non-sterile compounding should be well-organized and separated from the dispensing part of the pharmacy, but it does not need to be specifically designated.

Sterile compounding must be carried out using strict procedures to keep products free from contamination, particularly for drugs administered into certain body sites, but not necessarily for drugs injected into the blood.

The PEC provides ISO 6 air quality for sterile compounding.

The anteroom must be at least ISO 9.

Biological Safety Cabinet (BSC) and Closed System Transfer Device (CSTD) are not essential terms to understand for compliance with USP standards.

The air quality in critical areas must be at least ISO 4, with no more than 3,000 particles per cubic meter.

The terminology used by USP includes terms like C-PEC, CACI, CAI, C-SCA, C-SEC, CSPs, CSTD, CVE, LAFW, and lVP, each with specific meanings related to compounding.

Non-sterile compounding is not used to prepare specific ointment concentrations.

USP 795 and 797 standards for compounding apply only to hospital pharmacists, not to pharmacy staff, nurses, and physicians in various practice settings.

Sterile compounding is primarily used to prepare doses or formulations that are not commercially available.

Positive air pressure in PEC and SEC protects compounded sterile products (CSPs) from contamination

Emergency use of IV drugs prepared under suboptimal conditions for sterility has a very short beyond-use date (BUD) of 1 hour

Segregated Compounding Area (SCA) is an option for low-risk CSPs without a buffer area or anteroom, with a maximum BUD of 12 hours

Secondary Engineering Control (SEC) contains the PEC, providing a buffer of relatively clean air (ISO 7) around the PEC

Anteroom connects the pharmacy to the buffer room (SEC), facilitating garbing and preparation for compounding

Laminar airflow workbench (LAFW) is an open-front PEC that keeps cleaner air from mixing with dirtier air, maintaining ISO 5 environment

Compounding aseptic isolator (CAI) is a closed-front PEC located in a buffer room or segregated compounding area (SCA), keeping unclassified room air from mixing with clean air inside

SCA is useful for satellite pharmacies, infusion centers, clinics, and small hospitals

Types of PECs include horizontal laminar airflow workbench (LAFW) and compounding aseptic isolator (CAI)

First air into the direct compounding area (DCA) is the cleanest, and positive air pressure in the PEC and SEC protects CSPs from contamination

Positive air pressure in PEC and SEC prevents CSPs from contamination

Emergency use of IV drugs prepared under suboptimal conditions for sterility has a very short beyond-use date (BUD) of 1 hour

What is the primary difference between risk assessment in USP 797 and USP 800?

What is the purpose of an Assessment of Risk (AoR) for drugs with lower risk in USP 800?

What type of airflow does a Biological Safety Cabinet (BSC) have according to USP 800?

What is the primary requirement for facilities used in compounding hazardous drugs according to USP 800?

Which type of Biological Safety Cabinets (BSC) is used for sterile hazardous drug compounding?

What type of containment ventilated enclosures (CVEs) are used for non-sterile compounding?

Where are Compounding Aseptic Containment Isolators (CACIs) located?

What does a Compounding Aseptic Containment Isolator (CACI) for compounding hazardous drugs contain?

What is necessary for manipulation of low-risk hazardous drugs?

How often must the review of compounding documents occur?

Where are containment hoods and buffer rooms required for compounding hazardous drugs?

Under what conditions can non-sterile and sterile hazardous drug compounding occur in the same space?

What is used for removing hazardous contaminants in non-sterile hazardous drug compounding?

What type of air pressure is essential in the C-PEC and C-SEC for removing hazardous contaminants?

What are the air changes per hour (ACPH) requirements for spaces used for hazardous drug compounding?

How must hazardous drugs be stored?

USP 800 risk categories are based on risk of contamination of the sterile product.

Biological safety cabinets (BSCs) have vertical laminar airflow and positive air pressure.

The anteroom for non-hazardous drug compounding must be ISO 7 or 8.

Non-sterile compounded drugs cannot be hazardous.

Class II or Class III Biological Safety Cabinets (BSC) are used for sterile hazardous drug compounding

Containment Ventilated Enclosures (CVEs) with HEPA-filtered air and negative air pressure are used for non-sterile compounding

Compounding Aseptic Containment Isolators (CACIs) are closed-front gloveboxes located in a buffer room (C-SEC) or a C-SCA

Compounding Aseptic Containment Isolator (CACI) for compounding HDs contains hazardous fumes/particles and is externally vented

Compliance with USP 800 requirements is necessary for manipulation of low-risk hazardous drugs

Review of compounding documents must occur at least every 12 months

Specific space requirements include containment hoods and buffer rooms for compounding hazardous drugs

Non-sterile and sterile hazardous drug compounding can occur in the same space under certain conditions

External exhaust or redundant HEPA filters are used for non-sterile hazardous drug compounding

Negative air pressure in the C-PEC and C-SEC is essential for removing hazardous contaminants

Air changes per hour (ACPH) requirements for spaces used for hazardous drug compounding

Hazardous drugs must be stored separately in a negatively pressurized room with specific air changes per hour (ACPH) requirements

What is the most urgent action to take when a staff member has a hazardous drug (HD) exposure?

What is the minimal action to take for an exposure to gloves or gown contaminated with a hazardous drug?

When is respiratory protection needed in hazardous drug (HD) compounding?

What is the recommended action for an eye exposure to a hazardous drug?

What is the primary purpose of the face mask when garbing for hazardous drug compounding?

What is the requirement for the Chemotherapy Gloves when handling hazardous drugs?

When should the alcohol-sanitized gloves be used during hazardous drug compounding?

What is the requirement for the Shoe Covers when compounding sterile hazardous drugs?

What is the primary purpose of the Chemical Cartridge-type Respirator when handling hazardous drugs?

What is the requirement for the Chemotherapy Gown when handling hazardous drugs?

What is the requirement for the Eye/Face Protection when working with hazardous drugs?

What is the requirement for the Chemotherapy Gloves when handling higher-risk non-sterile hazardous drugs?

What is the purpose of the Compounding Aseptic Containment Isolator (CACI) for compounding hazardous drugs?

What is the requirement for the Chemotherapy Gloves when handling low-risk non-sterile hazardous drugs?

What is the requirement for the Chemotherapy Gown when handling hazardous drugs?

What is the primary purpose of the Respirator when handling hazardous drugs?

What type of respiratory protection is necessary when there is a risk of respiratory exposure to hazardous drugs?

What is the primary purpose of using closed-system drug transfer devices (CSTDs) for drug administration?

What should be done immediately after hazardous drug spills are cleaned?

When should pregnant women leave the area in case of a hazardous drug spill?

What should be readily available in areas where hazardous drugs are handled?

What is the purpose of a powered air-purifying respirator (PAPR) when handling hazardous drugs?

What type of personal protective equipment (PPE) must be worn when administering hazardous drugs?

What is the primary purpose of using eye and face protection, including goggles and face shields, when handling hazardous drugs?

What is the purpose of immediate cleanup for hazardous drug spills?

What should be avoided for cleaning up hazardous drug spills?

What is the purpose of using elastomeric half-mask with a multi-gas cartridge and P100 filter when handling unpacked hazardous drugs?

What should be used for respiratory protection when there is a risk of respiratory exposure to hazardous drugs?

What should be done when manipulating tablets to handle hazardous drugs?

Where are outer chemotherapy gloves worn during compounding hazardous drugs discarded?

What is necessary when transporting hazardous drugs to minimize the risk of spillage or breakage?

What is required for compounding sterile hazardous drugs in terms of personal protective equipment (PPE)?

What is applied in the buffer area before compounding sterile hazardous drugs?

What must be done to reusable gowns before reuse when compounding hazardous drugs?

What is the alternative option for hand scrub when allergic reactions to chlorhexidine are a concern?

What type of gloves are required for compounding hazardous drugs?

Where are trace and bulk antineoplastic waste disposed for incineration?

What is considered contaminated with trace amounts when handling hazardous drugs?

What attire is necessary for compounding, depending on the type of compounding?

What is the color of the waste bin for discarding outer chemotherapy gloves during compounding?

Delaying treatment, even for a few seconds, may cause serious injury.

An N95 respirator is sufficient for most HD compounding, but does not provide adequate protection against gases, vapors or direct liquid splashes.

Respiratory protection is needed in situations with direct HD exposure including cleaning up spills that need more supplies to clean up than provided by a spill kit.

Disposal of PPE used when handling HDs, which will be contaminated with (minimally) trace amounts.

Face masks are not required when compounding with an isolator (glove box)

The gown can be taken off and kept on the clean side of the anteroom if it is visibly soiled

A full-facepiece respirator or a face shield with goggles should be used for unpacking HDs which are not wrapped in plastic

Chemotherapy gloves must meet the American Society for Testing and Materials (ASTM) standard D6978

Disposable sleeve covers made of coated materials can be used with higher-risk non-sterile HDs

Shoe covers are not required when compounding sterile HDs

Two pairs of gloves must be worn while compounding sterile HDs

Chemotherapy gown must be disposable and may be reused

Hand hygiene is not necessary when re-entering the compounding area

A fit-tested NIOSH-certified respirator is not required for sterile compounding

Two pairs of gloves are worn with a gown, one pair should go under the cuff of the gown

A powered air-purifying respirator (PAPR) should be worn for cleaning up large HD spills

Respiratory protection is necessary when there is a risk of respiratory exposure to hazardous drugs.

Eye and face protection, including goggles and face shields, must be worn when there is a risk of HD spills or splashes.

Elastomeric half-mask with a multi-gas cartridge and P100 filter should be worn when handling unpacked HDs until packaging integrity is ensured.

A powered air-purifying respirator (PAPR) can be used for respiratory protection, blowing air through a filter to the user.

Immediate cleanup is required for hazardous drug spills, with guidance from the Safety Data Sheet (SDS).

Spill kits containing protective gear, waste bags, and spill cleanup procedures must be readily available in areas where HDs are handled.

Pregnant women should not be involved in cleanup activities and should leave the area immediately in case of a spill.

Spill cleanup involves donning appropriate personal protective equipment (PPE), avoiding the use of brushes for cleanup, and decontaminating affected surfaces.

After the spill is cleaned, PPE should be removed, and hand hygiene should be performed.

Appropriate PPE, including chemotherapy gloves and gowns, must be worn when administering hazardous drugs.

Closed-system drug transfer devices (CSTDs) should be used for drug administration to contain HDs and prevent leaks and spills.

CSTDs have a built-in valve to equalize air pressure when adding or withdrawing fluid from the vial.

True or false: Outer chemotherapy gloves worn during compounding are discarded in a yellow trace chemotherapy waste bin located inside the containment primary engineering control (C-PEC).

True or false: FDA has issued a warning for serious allergic reactions to chlorhexidine, an alternative option for hand scrub is povidone-iodine (Betadine).

True or false: Compounding sterile hazardous drugs requires strict adherence to garbing procedures, including donning garb in the ante-area and performing hand hygiene with soap and warm water.

True or false: Reusable gowns must be laundered prior to reuse and two pairs of ASTM D6978 (chemotherapy)-rated gloves are required for compounding HDs.

True or false: An alcohol-based surgical hand scrub with persistent antimicrobial activity is applied in the buffer area before compounding sterile hazardous drugs.

True or false: Proper labeling and packaging are necessary when transporting HDs to minimize the risk of spillage or breakage.

True or false: Non-sterile hazardous drugs may require a single pair of gloves, while sterile hazardous drugs necessitate a more extensive PPE, including impermeable gowns and respirators.

True or false: All personal protective equipment (PPE) worn when handling hazardous drugs (HDs) is considered contaminated with trace amounts.

True or false: Liquid formulations of drugs should be used when available to avoid the need for manipulation.

True or false: Manipulation, such as crushing tablets, should be done in a plastic bag to contain any dust or particles.

True or false: Trace and bulk antineoplastic waste are disposed of in yellow and black containers, respectively, for incineration at a waste facility.

True or false: Garb attire for compounding includes hair covers, special shoes or shoe covers, gowns, gloves, face masks, eye shields, and aprons, depending on the type of compounding.