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A pharmacist supervising a chemotherapy infusion suite reviews USP <800> applicability. Which activity DOES require USP <800> controls?

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2026 Statistics

Key Facts: BCSCP Exam

30%

Largest Domain Weight

Compounded Sterile Preparations

500

Passing Scaled Score

Range 200-800

$600

Initial Exam Fee

BPS

USP <797>

Core Standard

2023 Revision

USP <800>

HD Standard

NIOSH 2024 list

BPS

Specialty Body

Compounded Sterile Preparations Pharmacy

The BCSCP (Board Certified Sterile Compounding Pharmacist) exam is administered by BPS for the Compounded Sterile Preparations Pharmacy specialty. The exam has a passing scaled score of 500 (range 200-800). The fee is $600 initial / $300 retake. Compounded Sterile Preparations is the largest domain at 30%, followed by Facilities/Equipment/Environmental Control (20%) and Quality Management (20%). Mastery of USP <797> 2023, USP <800>, and the NIOSH 2024 hazardous drug list is essential.

Sample BCSCP Practice Questions

Try these sample questions to test your BCSCP exam readiness. Each question includes a detailed explanation. Start the interactive quiz above for the full 100+ question experience with AI tutoring.

1Which USP chapter establishes minimum standards for compounding sterile preparations (CSPs) in healthcare settings?
A.USP <795>
B.USP <797>
C.USP <800>
D.USP <71>
Explanation: USP General Chapter <797> Pharmaceutical Compounding—Sterile Preparations establishes the minimum standards for compounding sterile preparations to minimize harm including death from microbial contamination, excessive bacterial endotoxins, variability from intended strength, unintended chemical and physical contaminants, and ingredients of inappropriate quality. The 2023 revision is the current enforceable version.
2Per USP <797> 2023, what is the maximum beyond-use date (BUD) for a Category 1 CSP stored at controlled room temperature?
A.6 hours
B.12 hours
C.24 hours
D.4 days
Explanation: Category 1 CSPs are compounded in less stringent environments (such as a Segregated Compounding Area) and have a maximum BUD of 12 hours at controlled room temperature or 24 hours refrigerated. The shorter BUD reflects the reduced environmental controls compared to a full ISO 7 buffer area.
3What is the maximum BUD for a Category 2 CSP prepared aseptically from sterile-to-sterile components, refrigerated, without sterility testing?
A.4 days
B.10 days
C.30 days
D.45 days
Explanation: Per USP <797> 2023 Table 11, an aseptically processed Category 2 CSP prepared exclusively from sterile starting components and not subjected to sterility testing has a maximum BUD of 4 days at controlled room temperature, 10 days refrigerated, and 45 days frozen. Without sterility testing, refrigerated storage tops out at 10 days.
4Which ISO classification applies to the air inside a primary engineering control (PEC) such as a laminar airflow workbench used for CSP compounding?
A.ISO Class 5
B.ISO Class 7
C.ISO Class 8
D.ISO Class 9
Explanation: The PEC (LAFW, BSC, CACI, CAI) must provide ISO Class 5 air or better during dynamic operating conditions. ISO 5 allows no more than 3,520 particles ≥0.5 µm per cubic meter, providing the critical direct compounding area where the CSP is exposed.
5Per USP <797>, hand hygiene with soap and water during garbing is performed AFTER which step?
A.Donning sterile gloves
B.Donning the gown
C.Applying sterile alcohol-based hand antiseptic
D.Donning the face mask and head/facial hair covers
Explanation: USP <797> 2023 specifies the garbing order from dirtiest to cleanest: shoe covers, head/facial hair covers, face mask, then hand hygiene with soap and water (washing hands and forearms to elbows for at least 30 seconds), followed by gowning, then sterile alcohol-based hand antiseptic, and finally sterile gloves. Hand hygiene comes after the head/face covers and mask.
6How frequently must compounding personnel performing Category 1 and 2 CSPs successfully complete gloved fingertip and thumb sampling after initial qualification?
A.Every month
B.Every 3 months
C.Every 6 months
D.Every 12 months
Explanation: After initial qualification (3 successful gloved fingertip/thumb samples after garbing without alcohol contact), personnel compounding Category 1 or Category 2 CSPs must successfully complete gloved fingertip sampling at least every 6 months. Category 3 personnel must do so at least every 3 months.
7A pharmacy compounds an antineoplastic IV in a biological safety cabinet. According to USP <800>, the buffer area must maintain what pressure relationship to adjacent areas?
A.Positive pressure of 0.02 to 0.05 inches water column
B.Negative pressure of 0.01 to 0.03 inches water column
C.Neutral pressure
D.Positive pressure greater than 0.05 inches water column
Explanation: USP <800> requires that hazardous drug (HD) compounding occur in a C-PEC located in a C-SEC that is externally vented, has at least 12 ACPH, and maintains negative pressure between 0.01 and 0.03 inches water column relative to all adjacent areas. Negative pressure prevents HD aerosols from escaping the room.
8Which document defines the ingredients, equipment, procedures, and quality control needed to compound a specific CSP and is required before any compounding occurs?
A.Compounding record (CR)
B.Master formulation record (MFR)
C.Standard operating procedure (SOP)
D.Certificate of analysis (CoA)
Explanation: A Master Formulation Record (MFR) is required for any CSP prepared from a non-sterile starting component or for batch CSPs and serves as the recipe for the preparation. It includes the name/strength/dosage form, identities and amounts of all ingredients, container closure systems, equipment, procedures, BUD, storage, QC procedures, and reference sources.
9How often must the primary and secondary engineering controls be recertified by a qualified individual per USP <797>?
A.Every 3 months
B.Every 6 months
C.Every 12 months
D.Every 24 months
Explanation: USP <797> requires certification of the PEC, SEC (buffer and ante-areas), and any SCA at least every 6 months and whenever the equipment or facility is moved, modified, or repaired. Certification includes airflow, HEPA filter integrity, smoke pattern, total particle counts, and pressure differentials per CETA CAG-003 and ISO 14644.
10Which test, performed per USP <85>, detects bacterial endotoxins in CSPs intended for parenteral administration?
A.Sterility test
B.Limulus amebocyte lysate (LAL) test
C.Membrane filtration test
D.Container closure integrity test
Explanation: USP <85> Bacterial Endotoxins Test uses Limulus Amebocyte Lysate (LAL) reagent—gel-clot, turbidimetric, or chromogenic methods—to detect Gram-negative bacterial endotoxins. CSPs prepared from non-sterile starting components or with extended BUDs require BET to ensure pyrogen safety.

About the BCSCP Exam

BPS specialty certification for pharmacists practicing in Compounded Sterile Preparations Pharmacy. The BCSCP validates expertise across USP <797> 2023 (Categories 1/2/3 with category-specific BUDs), USP <800> hazardous drug handling (NIOSH 2024 list, CSTDs, negative-pressure cleanrooms), USP <795>, cleanroom design and certification (ISO 5/7/8), aseptic technique and garbing, environmental monitoring, end-product testing (sterility USP <71>, endotoxin USP <85>), and the regulatory framework (FDA 503A vs 503B, state boards). NOTE: This credential covers Sterile Compounding Pharmacy — NOT Solid Organ Transplant. The Solid Organ Transplantation Pharmacy credential is BCTXP.

Questions

100 scored questions

Time Limit

Per BPS scheduling

Passing Score

Scaled 500 (200-800)

Exam Fee

$600 initial / $300 retake (BPS)

BCSCP Exam Content Outline

15%

Standards, Regulations, Best Practices

USP <797>/<800>/<795>, FDA 503A/503B, state board, NIOSH 2024

20%

Facilities, Equipment, Environmental Control

Cleanroom ISO 5/7/8, PEC types, environmental monitoring, certification

30%

Compounded Sterile Preparations

Categories 1/2/3, BUDs, aseptic technique, garbing, HD compounding, CSTDs

15%

Patient Care

Therapy assessment, stability, compatibility, monitoring CSPs (TPN, oncology), labeling

20%

Quality Management

End-product testing (USP <71>/<85>), personnel competency (GFT/media-fill), SOPs, RCA

How to Pass the BCSCP Exam

What You Need to Know

  • Passing score: Scaled 500 (200-800)
  • Exam length: 100 questions
  • Time limit: Per BPS scheduling
  • Exam fee: $600 initial / $300 retake

Keys to Passing

  • Complete 500+ practice questions
  • Score 80%+ consistently before scheduling
  • Focus on highest-weighted sections
  • Use our AI tutor for tough concepts

BCSCP Study Tips from Top Performers

1Master USP <797> 2023 Category 2 default BUDs (no sterility test): aseptically processed sterile-to-sterile = 4 days room temp / 10 days refrigerated / 45 days frozen; non-sterile starting components = 24 hours room temp / 4 days refrigerated. With passing sterility testing: 30/45/60 days
2Know the garbing sequence (dirtiest to cleanest into the clean area): shoe covers → hair cover → face mask → beard cover → hand hygiene with soap and water → gown → into clean area → alcohol-based hand antisep → sterile gloves
3Memorize personnel competency: gloved fingertip and thumb sampling — 3 successful trials initially, then every 6 months Cat 1/2 or every 3 months Cat 3. Media-fill testing — initially + every 6 months Cat 1/2 or every 3 months Cat 3
4Understand cleanroom hierarchy: ISO 5 PEC (DCA) inside ISO 7 buffer area inside ISO 8 ante-area. Or alternative: ISO 5 PEC inside a Segregated Compounding Area (SCA) for Category 1 only
5Distinguish 503A (patient-specific compounding pharmacy, state-board-regulated) from 503B (FDA-registered outsourcing facility, cGMP-compliant, can ship without patient-specific Rx)

Frequently Asked Questions

What does BCSCP actually stand for?

BCSCP = Board Certified Sterile Compounding Pharmacist. The credential covers BPS's Compounded Sterile Preparations Pharmacy specialty. It is sometimes confused with Solid Organ Transplant — that is a separate specialty (BCTXP). BCSCP focuses entirely on sterile compounding under USP <797>/<800> standards.

What is the most heavily weighted BCSCP domain?

Compounded Sterile Preparations is the largest domain at 30%. This domain emphasizes USP <797> 2023 Categories 1/2/3 distinctions and BUDs (default Cat 2: 4d room temp / 10d refrigerated / 45d frozen for sterile-to-sterile without sterility testing), aseptic technique, the garbing sequence (dirtiest-to-cleanest into the clean area), hazardous drug compounding under USP <800> with CSTD use, and patient-specific products like TPN and oncology preparations.

What changed in the USP <797> 2023 revision?

USP <797> 2023 reorganized CSP categories into Category 1 (≤12 hour BUD, segregated compounding area), Category 2 (cleanroom suite with category-specific BUDs based on storage temperature and sterility testing), and Category 3 (extended BUDs up to 60d/90d/120d with additional controls including released sterility testing). The revision also tightened gloved fingertip and thumb sampling requirements (initial 3 successful trials, then every 6 months for Cat 1/2 or 3 months for Cat 3) and media-fill cadence.

How does USP <800> apply to sterile compounding?

USP <800> governs hazardous drug (HD) handling for any drug on the NIOSH HD list (2024 update — Group 1 anti-neoplastic, Group 2 non-anti-neoplastic, Group 3 reproductive risk). HD compounding requires negative-pressure rooms, BSC or CACI inside the negative-pressure space, mandatory CSTD use during administration of antineoplastic agents, chemo-rated PPE (double chemo-rated gloves, chemo gowns, eye/face protection for spills), and a documented Assessment of Risk for any HD not compounded as listed.

How should I study for the BCSCP exam?

Plan 60-100 hours over 8-12 weeks. Focus 30%+ of your time on Compounded Sterile Preparations and another 40% on Facilities/Equipment/Environmental Control + Quality Management. Memorize USP <797> 2023 Category 1/2/3 distinctions, default BUD tables, garbing sequence, gloved fingertip and media-fill cadence, environmental monitoring frequencies, and USP <800> HD handling requirements with the 2024 NIOSH list categories.