Board Certified Sterile Compounding Pharmacist (BCSCP) Practice Test

These questions are part of the practice quiz. Start practicing

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