Board Certified Sterile Compounding Pharmacist (BCSCP) Practice Test

These questions are part of the practice quiz. Start practicing

• Are sterile and non-sterile HD compounding allowed in the same room?
• How can a CSTD be chemically incompatible with a HD?
• What is the HEPA filter efficiency for capturing 0.3 micron particles?
• Sterile HD compounding must be performed in which containment?
• Is product verification a DSCSA requirement?
• What does API stand for?
• Which item is not typically recommended PPE for HD drug receipt?
• What are the requirements for a CACI located outside ISO7 used for hazardous drugs?
• Which testing information category would include concentration and strength measurements?
• In situ Gels are liquid preparations intended for injection into specific therapeutic targets. Typically they consist of polymers in organic solvents, and upon injection the solvents migrate away from the site, leaving a gelled mass.
• Under what condition can a positive-pressure C-SEC be used for NIOSH Table 2 or 3 HDs if an AOR is performed?
• What incubation time is used for bacteria on Soybean-Casein Digest Medium?
• What is recommended regarding field certification labeling on a BSC?
• Which statement accurately describes USP 800's scope?
• Can NIOSH listed Table 2 or 3 HDs be compounded in a positive pressure C-SEC, and if so, what labeling requirements?
• Which administration activity has potential exposure to HDs?
• For Low Risk CSPs, what is the maximum BUD when stored at room temperature (20-25°C)?
• Regarding Group 1, 2, or 3 assessment of risk, which statement is true?
• Which statement best lists those who may be exposed to HDs?
• Which dosage form consists of drug substances and other components as dry-formulation ingredients to ensure the chemical and physical stability of the presentation within a final use container?
• For high-risk by filtration, what pore size must the filter have?
• Microparticles are injectable, resorbable microparicles for extended release generally range from 20 to 100 µm in diameter. They consist of drug substances embedded with a biocompatible, bioresorable polymeric excipient.
• What type of C-PEC is required for aseptic HD prep?
• Dry Heat Sterilization is performed how?
• Which dosage form is defined as a clear, homogeneous liquid dose form that contains one or more chemical substances dissolved in a solvent or a mixture of mutually miscible solvents?
• Which of the following is NOT a technique used for bacterial endotoxin testing?
• Gowns may be removed and retained in the compounding area and re-donned during the same work shift only if they are not visibly soiled.
• Under which circumstances are Class II A2 or B1 allowed for aseptic HD prep?
• Sterile Powders for Suspension: Consists of drug substances and other components as dry-formulation ingredients to ensure the chemical and physical stability of the presentation within final use container.
• For pre-sterilization procedures such as weighing and mixing, the C-PEC must be:
• Which element is NOT part of the baseline data collection for medical surveillance?
• Which of the following is a parenteral route of administration?
• For high-risk CSPs, endotoxin content must not exceed what measure?
• Arsenic trioxide disposal category under RCRA?
• Which term describes quantitative testing information?
• Qualitative testing information includes which of the following?
• Compounding documentation should include which records?
• Which statement about AOR documentation is true?
• Does a prefilled syringe with a self-contained system of reconstitution need to be manipulated inside a C-PEC?
• Which statement describes a requirement for HD storage?
• Are PPE and Environmental controls specified in Table 5 of NIOSH required?
• A prefilled syringe with a self-contained system of reconstitution may be considered a final dosage form. This means manipulation inside a C-PEC is not always required.
• Which color containers are used for trace waste?
• Liposomes are aqueous dispersions of amphiphilic lipids organized as lipid bilayer vesicles enclosing an internal aqueous compartment. Which description best matches liposomes?
• What is the BUD for addEASE devices assembled in ISO 5 for 50 and 100 mL bags?
• PPE chemo gown material: which provides better protection and should be disposed after each use?
• Subcutaneous, local ocular delivery or surgically implanted—these are delivery routes for which dosage form?
• Which flooring description correctly describes SEC floors in a sterile compounding environment?
• Under entity policy, which storage allowance is correct?
• Which of the following is a designated person requirement?
• What does OEL stand for?
• What is the rate of squamous cell shedding from the human body per hour?
• Which of the following is an example of a finished dosage form?
• Which analytical techniques are most reliable for determining stability when published literature is not available?
• During media fill testing, incubation temperatures include which range?
• What is a primary criterion in selecting a sterilization method for CSPs?
• Substance identification is part of which testing information category?
• BLA stands for which regulatory document?
• If CSP has been exposed to temps warmer than labeled limit or to temperatures above 40°C for more than 4 hours, what should be done?
• Which of the following best defines the drug-eluting stent?
• How long should calibration, annual maintenance reports, and routine maintenance records be kept?
• Soybean-Casein Digest Medium is incubated at which temperature range?
• Environmental sampling for HD is conducted at what frequency?
• Quality Assurance is a mechanism for monitoring, evaluating, correcting, and improving activities and processes. How often is QA reassessed?
• What is the official date associated with the second USP Supplement publication?
• RCRA stands for?
• Medium Risk CSP is characterized by which description?
• In ISO 5 (Class 100) environments, how many 5 µm and larger particulates are allowed per cubic meter?
• What factors are considered in the risk assessment for hazardous drugs?
• High Risk CSP Prep includes a prefiltration pore size of what?
• Which formula converts Fahrenheit to Celsius?
• Growth must be identified to which taxonomic level?
• Approximately how many US healthcare workers are exposed to hazardous drugs each year?
• What does REL stand for?
• What is the typical steam sterilization parameter for terminally sterilizing aqueous preparations?
• The term 'About' on labeling indicates what?
• What testing data should gown manufacturers provide to prove permeability resistance for HD handling?
• Oil-in-water or water-in-oil emulsions typically entrap the drug substance. This describes which dosage form?
• If ceiling panels are inlaid, what treatment is required to render them impervious and secure?
• May a CACI, isolator, robotic device etc be used to compound a sterile HD outside a C-SEC?
• C-SEC external ventilation must be:
• Which HDs were detected in the urine of healthcare workers?
• What elements are included in the initial baseline assessment for medical surveillance?
• Which statement is true about the location of a Low Risk CSP area relative to other spaces?
• Under USP guidelines, which arrangement is specified for low- and medium-risk hazardous drug compounding with fixed walls?
• Which dosage form is a liquid dose form that contains solid particles in a state of uniform dispersion?
• What is the minimum PPE requirement when unpacking hazardous drugs?
• In preps with volumes exceeding 5 mL, which additive is limited to a maximum of 0.2%?
• Which of the following is a route of administration for parenteral drug products?
• Gloved fingertip sampling plates are incubated at what temperature and duration?
• What is the initial competency requirement for gloved fingertip sampling?
• Which agents are commonly monitored in environmental sampling for HD?
• Which element must be included in an occupational safety plan for hazardous drugs?
• Allergen extracts are administered by which routes?
• Adverse events and defects must be reported to which programs?
• Which characteristic describes 800-C-SEC for HD compounding?
• Small volume injections are defined as volumes of how many milliliters or less?
• What is the BUD for ADD-Vantage devices assembled in ISO 5?
• DSCSA stands for which act?
• What describes the limits of open architecture in sterile compounding?
• If an AOR is not performed, what must be done with HDs?
• Which of the following is a factor that affects exposure to hazardous drugs (HDs)?
• Implants for extended release consist of a matrix of drug substance and polymeric excipient that may or may not have an outer rate-controlling membrane. The polymeric excipient must be biocompatible but may or may not be bioresorable. They are used for subcutaneous, local ocular delivery or surgically implanted.
• In preps with volumes exceeding 5 mL, which additive is limited to a maximum of 0.5%?
• What does ACGIH stand for?
• The 351(k) pathway is used for which products?
• C-PECs used for manipulation of sterile HDs must be:
• What is the required ACPH for 800-low & med-risk HD C-SCA?
• Which statement about hazardous drug sign posting is true?
• Which are possible health effects of HD exposure?
• Does OSHA hazard communication standard mandate evaluation of every marketed drug?
• Are suppliers required to ship HDs in impervious plastic?
• Which is a compounding exposure activity?
• Which activity has potential for HD exposure?
• The first USP Supplement was published in which month?
• Which statement defines Biological indicators (BI) in sterilization contexts?
• On each package of nonsterile bulk materials used for compounding CSPs, what information must be marked?
• Which statement about USP 800 requirements for NIOSH-listed drugs is correct?
• For low-volume HD compounding, what containment is required under 797 guidelines?
• Who does USP 800 apply to?
• What is the beyond-use date (BUD) for segregated compounding area CSP?
• NIOSH recommendations for HD receipt include which PPE?
• What should be done before removing HD drug prep from the C-PEC?
• Which individuals may potentially be exposed to HDs?
• Are there current standards or recommendations for HD exposure amounts?
• Which statement is true about Biological indicators (BI) in sterilization monitoring?
• What is the maximum number of packages and entries allowed for a Low Risk CSP?
• Which is the most common chemical degradation pathway for CSPs?
• Compounding documentation should be retained for the same period as prescriptions under state law. Which option reflects this retention?
• For soluble platinum salts, the OSHA PEL and ACGIH TLV are based on what?
• What is the preferred method of volumetric air sampling?
• For nonaqueous formulations, the BUD is not later than the earliest expiration day of any API or a maximum of how many months, whichever is earlier?
• Which ISO class corresponds to ISO Class 100 (Class 100) for room air?
• The second USP Supplement was published in which month?
• What incubation time is used for fungi on Soybean-Casein Digest Medium?
• What is USP 800's purpose?
• How often must the AOR review be documented?
• What is the BUD for Mini-Bag Plus 50 mL or 100 mL bags?
• Which policy is included for HD waste segregation and disposal?
• Which ISO classification is required for sterile HD compounding work areas?
• What activities are encompassed by handling HDs?
• Which PPE is required specifically when administering injectable antineoplastic HDs?
• What is the maximum beyond-use date for a sterile dose vial (SDV) when opened in air worse than ISO 5?
• An OSHA PEL and an ACGIH TLV have been established for which HD?
• What is a potential issue when using water-miscible alcohols with filtration?
• Which statement reflects Bendamustine incompatibility with CSTDs?
• Does USP certify or validate PPE or equipment for HD handling?
• Which option lists all three methods used for testing bacterial endotoxins?
• In a drug-eluting stent, where is the drug substance incorporated?
• Which microbiological medium is used for viable airborne sampling at 30-35°C for 48-72 hours?
• What constitutes trace waste?
• In precision of ACD, what does precision refer to?
• Do inorganic arsenic and arsenic trioxide have established standards?
• Within an ISO classified area, where should a hand-washing sink be located relative to the HD buffet room?
• In accuracy of ACD, what is the small-volume range?
• What does WEEL stand for?
• How should spill kits be disposed?
• In SEC ceilings, how should the junctures between ceiling and wall be treated to avoid cracks?
• Qualitative testing information would include presence/absence testing and sterility.
• CSTD requirements are described as follows:
• Where should HD APIs be handled prior to sterilization when compounding sterile HDs?
• Can the C-PEC be used to create 100% of the external venting for the C-SEC?
• After steam sterilization, CSP should be packaged in which way?
• Endotoxin reduction verification for depyrogenation uses endotoxin challenge vials to verify cycle achieving which log reduction?
• Large volume injections are defined as which of the following?
• Which item is explicitly included as part of the occupational safety plan?
• What has to be disposed of at RCRA permitted incinerator?
• TLV stands for what?
• How should bulk hazardous drugs (HD) be disposed?
• What is required to show that a gown will resist permeability by HDs?
• Open architecture relies on a specific airflow velocity. What is this velocity?
• Do inorganic arsenic compounds, including arsenic trioxide, have established standards such as PEL, REL, and TLV?
• Which dosage form comprises injectable, resorbable particles sized roughly 20 to 100 micrometers for extended release?
• Which item is NOT listed as a NIOSH criterion for hazardous drugs?
• If the C-PEC cannot maintain ISO 7 in the prep area, in what ISO environment should presterilization procedures be completed?
• Where must water sources and drains be located relative to the C-PEC?
• In radiopharmaceutical handling, which arrangement is correct?
• In Low Risk CSP, which category is associated with 12-hour BUD?
• Which method is the method of choice for sterility testing?
• For ISO 7 environments, what is the actionable surface cfu threshold?
• Which dosage form is a liquid preparation of drug substances dissolved or dispersed in a suitable emulsion medium, typically oil-in-water or water-in-oil?
• Which of the following is a factor affecting exposure to hazardous drugs?
• Media-Fill Testing: How often must it be performed?
• An AOR is performed for which purpose?
• Which of the following is recognized as a High Risk Condition?
• How often is viable airborne particle testing performed?
• Which statement best describes a compliant Working Environment in sterile compounding?
• For Soybean-Casein Digest Medium, how long should it be incubated for bacteria and for fungi respectively?
• Is compounding regulated by the FDA?
• Which statement about receiving hazardous drugs is correct?
• Which act is cited as part of the biosimilars regulatory context in the source?
• Under USP 800, which drugs do not have to follow USP 800 if an AOR is performed?
• What does PEL stand for?
• For Soybean-Casein Digest Medium, which of the following statements is accurate?
• What best describes a drug-eluting stent?
• Low-volume HD prep can be performed with which arrangement?
• Does NIOSH apply to workers in the drug manufacturing sector?
• Which product is covered by DSCSA Section 581(13)?
• In preps with volumes exceeding 5 mL, which additive is limited to a maximum of 0.01%?
• For ISO 5 air, what is the actionable CFU threshold?
• Is product identification a DSCSA requirement?
• For Low Risk CSP with 12-hour BUD, what containment is required?
• Which of the following is a requirement for the low risk area regarding windows/doors?
• What is the maximum beyond-use date for multidose vials (MDV) according to standard sterile compounding guidelines?
• What documentation is necessary for AOR?
• Which of the following is a component of the occupational safety plan?
• The open architecture limits are described as applicable to which risk categories?
• Which dosage form requires a biocompatible polymeric excipient and may be bioresorbable for extended release?
• If nonHD prep is performed in the same C-PEC as an HD prep, which procedure is required?
• Packages lacking supplier expiration dates cannot be used after how long unless inspection or testing indicates purity?
• Which statement is NOT true about High Risk CSP Prep?
• Cyclophosphamide surface contamination above which threshold has been associated with human uptake?
• Which is an example of an alternative containment strategy under AOR?
• Which statement best describes the HD exposure standards regarding RELs, PELs, and TLVs?
• Which dosage form is described as unique drug products that can be either solutions or suspensions, and are aqueous dispersions of amphiphilic lipids organized as bilayer vesicles enclosing an internal aqueous compartment?
• DSCSA requires an enhanced system to trace products at package level by 2023. Is this statement true?
• Which medium is used for airborne fungi in a high-risk compounded environment at 26-30°C for 5-7 days?
• Who is responsible for enforcing USP standards?
• For water-containing topical and mucosal liquids, the BUD is not later than how many days?
• What is the HEPA filter efficiency for particles as small as 0.3 micron (MPPS)?
• If a CACI or isolator is used for preparation of HDs and is later used for non-HD prep, what labeling requirement applies to the non-HD prep?
• Which statement about AOR documentation is true?
• DSCSA requires packaging level tracing by which year?
• What does TLV stand for in occupational exposure terms?
• For water-containing oral formulations, the BUD is not later than how many days when stored at controlled cold temperature?
• The NIOSH list is based on what?
• Endotoxin tolerance levels are typically assessed in which category of testing information?
• Which statement about actionable organisms in airborne sampling is true?
• Segregated compounding area is designed to minimize cross-contamination during sterile compounding.
• When should BSC be field certified?
• Which ability should personnel trained to operate equipment possess?
• Which statement reflects a DSCSA requirement that includes multiple components?
• Is there a single biological marker that is a good indicator of HD exposure?
• Depyrogenation by dry heat uses what temperature and time?
• USP 800 defines API as which of the following?
• Which of the following is NOT listed as a cause of viable air sample failure?
• Semiquantitative testing information refers to which of the following?