Compounded Sterile Preparations Pharmacy

Compounded Sterile Preparations Pharmacy Specialty Certification (BCSCP)

Target Population: Pharmacists who are responsible for ensuring that sterile preparations meet the clinical needs of patients according to quality, safety, and environmental control requirements, regulations, and standards in all phases of preparation, storage, transportation, and administration.

Program Purpose: To validate that the pharmacist has the advanced knowledge and experience to ensure quality patient care and improve  therapeutic outcomes and safety for  medications that require sterile compounding.

Currently, there are more than 1,350 BPS Board-Certified Sterile Compounding Pharmacists.

Important Notice for Applicants:

USP approved and published updated versions of chapters <795> Pharmaceutical Compounding – Nonsterile Compounding and <797> Pharmaceutical Compounding – Sterile Preparations on November 1, 2022, and they are scheduled to become effective on November 1, 2023.

Recent updates to USP chapters <795> and <797> will be reflected on examination materials starting with the August/September 2023 examination window. 

Chapter <800> became official on December 1, 2019, however, chapter <800> is considered informational by USP and not compendially applicable.

This information is offered by BPS to help reduce confusion regarding USP Chapters <795>, <797>, and <800>. There are other standards and regulations applicable to the Compounding Sterile Preparations Pharmacy examination. For the content outline for the BPS Compounded Sterile Preparations Pharmacy examination, click here.

For updates and timelines on the status of revisions to USP Chapters, click here: https://www.usp.org/compounding.

Compounded Sterile Preparations Pharmacy Specialty Council Members

The purpose of the BPS Specialty Councils is to develop standards and eligibility requirements for board certification, develop examinations and passing standards for certification, and review and approve professional development programs for recertification of board-certified pharmacists. Specialty council members are at the heart of the peer-reviewed and peer-developed nature of BPS Board Certification.

Barbara Knightly
Barbara A. Knightly, [Chair]PharmD, RPh

Knightly brings over 25 years of pharmacy regulatory leadership, including sterile compounding, long-term care consulting, and home infusion experience. She completed her BS in Pharmacy from Philadelphia College of Pharmacy and Sciences and received her Doctorate of Pharmacy from the University of Kansas. Prior to joining Leiters, an FDA registered 503B outsourcing provider overseeing Regulatory Affairs and Pharmacy Operations, she has held various leadership positions focused on sterile compounding expertise. Her experiences included Pentec Health, InfuCare Rx, Walgreens (Option Care) Home Infusion and Christiana Care Infusion Services as well as Cardiac Solutions, a national company specializing in disease management programs. She was also the recipient of SmartCEO’s Executive Management Award in 2015.

 

Kathleen J. Kane, [Vice Chair]PharmD, BCSCP, DPLA

Over the past thirteen years, Dr. Kane focused her career on compounding pharmacy. While working in community, institutional, and industry settings she developed extensive expertise on the evolving compounding regulation standards. Prior to beginning pharmacy school, Dr. Kane was laboratory manager for an independent community compounding pharmacy. Dr. Kane graduated from Chicago State University-College of Pharmacy with a PharmD degree in 2014. During her time there she focused her studies on improving the focus on compounding within the curriculum. She led the creation of compounding training videos and establishing CSU-COP as a competitor in the regional and national SPCC- Student Pharmacist Compounding Competition. After graduation, Dr. Kane expanded her knowledge by working on Phase 1 and Phase 2 clinical trials with a local drug manufacturer. Currently at University of Chicago, she is working on designing and constructing cleanroom spaces that meet the new cGMP and USP standards.

Nicholas D. Baker, MPH, PharmD, BCPS, BCSCP

Nicholas D. Baker, MPH, PharmD, BCPS, BCSCP is a Regional Director for Pharmacy Operations in northern California for Kaiser Permanente. He earned his Master of Public Health from San Jose State and his Doctor of Pharmacy degree from the University of the Pacific. His post graduate managed care residency training was completed at Kaiser Permanente in the central valley of California. He oversees pharmacy operations including budgeting, workflow design and implementation, policy development, regional training programs, complex supply chain logistics, business continuity planning, technology implementation, and resource planning for the ambulatory care infusion pharmacies in the region.

Mike Carroll, BSPharm, RPh, BCSCP

Carroll is the Senior Director of Pharmacy for Option Care Health, the nation’s largest independent provider for home infusion therapy. He has national responsibility for the companies 94 clean rooms as well as all sterile compounding related practices. Carroll has over 20 years in pharmacy leadership in both the home infusion and health system fields. He specializes and clean room and facility design as well as compliance with compounding and regulatory standards. Mike is a graduate of the University of Rhode Island where he received a Bachelor of Science degree. He sits on the Vermont Board of Pharmacy where he served as Vice Chair for 2021.

Jessica Hawkins, PharmD, BCSCP, BCPS

Hawkins is the Sterile Compounding Pharmacy Program Manager at the Lexington VA Health Care System in Lexington, KY. She coordinates and oversees compounding activities for the medical facility’s main hospital and long-term care center, as well as a variety of outpatient specialty clinics including urology, ophthalmology, infusion, dermatology, and chemotherapy. She earned her PharmD from Ohio Northern University and completed a Pharmacy Practice residency at Baptist Health Lexington.

Sarrah Hein, PharmD, BCPPS

I am currently a pharmacy manager at Akron Children’s Hospital- Mahoning Valley Campus. I also act as the clinical specialist for our level 3 Neonatal Intensive Care Unit. I graduated from Ohio Northern University, received my PGY1 residency from Shands at the University of Florida, and my PGY2 from John Hopkins All Children’s Hospital. I am working toward my Masters in Business Administration. I live in Northeast Ohio with my husband and two teenage children. I look forward to working on the committee.

Jon M. Hicks, PharmD, BCSCP

Dr. Hicks is a Director and Pharmacist in Charge at STAQ Pharma, an FDA registered Outsourcing Facility, where he is responsible for all compounding and manufacturing processes. Hicks specializes in cleanroom and facility design, automation and technology, and regulatory compliance. He received his Doctor of Pharmacy from the University of Toledo and spent 11 years in hospital and health-system pharmacy leadership before transitioning to industry. He enjoys the challenges of working in a highly regulated industry and believes the profession can both learn from and elevate pharmacy compounding towards cGMP.

Kenneth “Chip” Lazenby, PharmD, BCPS, BCSCP

Lazenby currently serves as Pharmacy Operations Manager at Howard University Hospital in Washington, DC. Previously he worked at The Queen’s Medical Center in Honolulu, Hawaii where he oversaw sterile compounding and chemotherapy operations and managed the related personnel for the state’s largest hospital and only Level 1 Trauma Center. Prior to the management post, he served as QMC’s Coordinator of Sterile Compounding and Hazardous Drug Operations and has been involved in multiple sterile compounding facility redesign projects. He earned his PharmD from West Virginia University.

David Melton, PharmD, BCSCP

Melton is an Adjunct Clinical Professor at the University of Michigan College of Pharmacy. He also works as a pharmacy specialist on the Compounding Compliance Team serving as a facilities management lead for over 20 sterile and non-sterile locations. He received his Doctorate of Pharmacy and Bachelors in Pharmaceutical Sciences from the University of Toledo.

Binh Nguyen, PharmD, MSRegSci, BCSCP

Dr. Nguyen is a Senior Director at Lachman Consultants providing consulting services in FDA Compliance and CGMP audits for Bio and Pharmaceutical Industries. He has served on the Board of Pharmacy Sterile Compounding Specialty since 2021. He is also a per diem clinical pharmacist at Fountain Valley Hospital since 2002. He has 20+ years of FDA bio/pharmaceutical inspection, compliance, and assessment experience (Level III Certified Pharmaceutical Inspectorate, Level II Drug Auditor, drug branch chief, director regulatory review officer, pharmaceutical educator) in biotech, sterile injectable, sterile compounding, positron emission tomography, and other dosage forms. He completed his Doctorate in pharmacy, a Master in regulatory science, Board Certified in Sterile Compounding Pharmacy, and Certified in Health Profession Education.

Eligibility Requirements for BCSCP

An applicant for board certification in Compounded Sterile Preparations Pharmacy must demonstrate all of the eligibility requirements listed below prior to sitting for the initial certification examination. Once all of the requirements below are met, an applicant will be deemed eligible to sit for the Compounded Sterile Preparations Pharmacy specialty certification examination. If an applicant achieves a passing score on the Compounded Sterile Preparations Pharmacy certification examination, they may use the designation Board-Certified Sterile Compounding Pharmacist, or BCSCP.
  • Graduation from a pharmacy program accredited by the Accreditation Council for Pharmacy Education (ACPE) or a program outside the U.S. that qualifies the individual to practice in the jurisdiction.
  • A current, active license/registration to practice pharmacy in the U.S. or another jurisdiction.
  • Demonstration of practice experience through 4,000 hours of post-licensure or post-registration practice experience1 in Compounded Sterile Preparations Pharmacy. The 4,000 hours may be earned in a variety of settings, such as accredited Compounded Sterile Preparations Pharmacy residency programs2. Practice hours in the activities listed in the Compounded Sterile Preparations Pharmacy Content Outline will be accepted as practice experience on an hour-for-hour basis.

1All practice experience must be completed post-licensure/registration as a pharmacist. All applicants intending to demonstrate eligibility for any BPS certification examination utilizing the practice experience pathway must provide an attestation from their employer, on company letterhead, that verifies this experience accurately represents at least 50% of time spent in some or all of the activities defined by the applicable certification content outline. In addition, this practice experience must have occurred within the seven years immediately preceding the application. For more information, click here. A sample employer verification letter is available here.

2American Society of Health-System Pharmacists (ASHP)-accredited/candidate status PGY1 pharmacy residency, residencies accredited under the ASHP Accreditation Standard for International Pharmacy Practice Residency Programs, or Canadian Pharmacy Residency Board (CPRB)-accredited Year 1 pharmacy residency.

The rationale for the appropriateness of the requirements for BPS certification programs are based upon the following:

  • BPS recognizes individuals who graduate from a recognized school or college of pharmacy within the candidate’s jurisdiction. Those jurisdictions recognize and evaluate programs on the extent to which it accomplishes its stated goals and is consistent with the concept that pharmacy is a unique, personal service profession in the health science field. In the United States, the responsibility for recognizing schools and colleges of pharmacy falls to the Accreditation Council for Pharmacy Education (ACPE).
  • The rationale for requiring licensure or registration of pharmacists within their jurisdiction is based upon the fact that for public protection, all pharmacists must be licensed or registered. This is considered a baseline requirement to be a pharmacist specialist. In the United States, BPS recognizes the licensure process administered by the National Association of Boards of Pharmacy (NABP). The National Association of Boards of Pharmacy (NABP) aims to ensure the public’s health and safety through its pharmacist license transfer and pharmacist competence assessment programs. NABP’s member boards of pharmacy are grouped into eight districts that include all 50 United States, the District of Columbia, Guam, Puerto Rico, the Virgin Islands, Bahamas, and all 10 Canadian provinces.
  • The experiential component is required to help assure practical application of components of the specialty knowledge being certified. There are multiple pathways to meet the practice experience requirement. The faster eligibility pathways recognize accredited residencies through the American Society of Health System Pharmacists (ASHP). The ASHP residency accreditation program identifies and grants public recognition to practice sites having pharmacy residency training programs that have been evaluated and found to meet the qualifications of one of the ASHP’s residency accreditations standards. Thus, accreditation of a pharmacy residency program provides a means of assurance to residency applicants that a program meets certain basic requirements and is, therefore, an acceptable site for postgraduate training in pharmacy practice in organized health care.
  • Passing the BPS pharmacy specialty examination helps assure knowledge consistent with the validated content outline for the BPS specialty.

The appropriateness of the BPS program requirements are consistent with the Council on Credentialing in Pharmacy’s Resource Paper titled: Scope of Contemporary Pharmacy Practice: Roles, Responsibilities, and Functions of Pharmacists and Pharmacy Technicians.

Upcoming Deadlines for Certification Examinations

Individuals who meet the eligibility requirements for the BCSCP examination can find more information about examination dates and fees for certification examinations here.

Candidate's Guide

The Candidate’s Guide is intended for use by pharmacists who are interested in becoming certified as specialists by BPS in any of the BPS-recognized specialty practice areas. To review critical information for BPS Certification Examinations, visit this page.

Content Outline for BCSCP Examinations

For the Fall 2023 Examination, refer to the Compounded Sterile Preparations Pharmacy Content Outline found in the BCSCP Examination Specifications document for details.

For the 2024 Examinations and forward, refer to the Compounded Sterile Preparations Pharmacy Content Outline found here for details.

Important Resources

Preparatory Courses for BCSCP Examinations
Certification is a significant differentiator, and the rigorous exam process requires concentrated study. Successful candidates are well prepared, and a number of available resources can assist pre-qualified applicants. Suggested preparation for the examination might include:
  • The study of journal articles, textbooks or other publications related to the Content Outline.
  • Attendance at continuing education programs and courses in specialized pharmacy practice.
  • Participation in study groups and examination preparation courses.
  • Reviewing the sample examination items provided in order for candidates to familiarize themselves with the various item formats which are presented on the exam. Sample question performance should not be interpreted as an indicator of exam performance.
To maintain its strict, independent standards for certification, BPS does NOT provide review information, preparatory courses, or study guides. However, such materials are available from outside organizations, state or local professional associations and colleges of pharmacy. Potential applicants may contact the professional associations noted below for additional study resources. The Board of Pharmacy Specialties provides the following program listing for informational purposes. This list is not an exhaustive list of options available for examination preparation. BPS does not endorse or provide preparatory courses for Board Certification Examinations.
Compounded Sterile Preparations Pharmacy

BPS partners with Prometric to provide the examination. BPS does not have any other partnerships for the certification or recertification application process. BPS partners with professional development program (PDP) providers to provide continuing education (CE) for recertification and the relationship is noted here. Any organization claiming a relationship with BPS for the application process or providing CE labeled ‘BPS-approved’ outside of the organizations listed should be reported to BPS immediately.

Certification for Applicants Outside the U.S.

BPS would like to offer some helpful tips to candidates outside of the United States in order to make their application experience easier. To learn more about applying for board certification as a pharmacist outside of the U.S., visit this page

Apply for ADA Accomodations 

BPS complies with the relevant provisions of the Americans with Disabilities Act (ADA). For applicants looking to request special accommodations in their application process, more instructions can be found on this page.

Frequently Asked Questions

After review of the BPS Candidates Guide and specialty certification page, some applicants may still have questions. Visit this page to see frequently asked questions from pharmacists pursuing board certification like you!

Sample Examination Items

Sample Items for BCSCP Examinations

The sample examination items for BCSCP examinations are made available by BPS for the purposes of familiarizing certification candidates and other stakeholders with the structure and format of BPS certification examinations. This is not meant for use as a self-assessment. Performance on any of these items does not correlate with performance on the actual examination.

The content of these examples is meant to be illustrative of actual examination items, but these items do not appear on the certification examination and are not meant to identify the scope of the examination. For a more comprehensive indication of the scope of the certification examination, please refer to the BCSCP Exam Content Outline.

Examination items are in multiple-choice format. The great majority of examination items are multiple-choice with a single response from among four options. Some examinations may include a small percentage of items that require selection of multiple (three or four) responses from among a larger set of available (up to eight) options. Examinations items may also be supplemented by an image.

View the examination items down below.

A 503A compounding pharmacy at a health-system centralized compounding facility was inspected by the Food and Drug Administration (FDA) following a complaint. A FDA form 483 was issued to the pharmacy. What is the correct response from the pharmacy?

The findings do not need to be addressed since the FDA's Insanitary Conditions document is just guidance.
The findings do not need to be addressed since the pharmacy is considered a 503A compounder.
The findings must be addressed using a corrective and preventative action plan (CAPA).
The findings should be addressed using a failure mode and effects analysis (FMEA).

Correct!

Incorrect!

A hospital pharmacy received a shipment of antineoplastic hazardous drugs. Where should the shipment be unpacked?

A designated area within the pharmacy department with positive pressure relative to the surrounding areas
A designated area within the pharmacy department with neutral or negative pressure relative to the surrounding areas
An area on the delivery truck by the loading dock before transporting to the pharmacy department
An area within the sterile compounding clean room

Correct!

Incorrect!

Which organization regulates disinfectants by evaluating and registering manufacturer data submitted for microbiocidal activity, stability, toxicity, and contact time for labeling indicated uses?

Centers For Disease Control and Prevention (CDC)
Environmental Protection Agency (EPA)
Food and Drug Administration (FDA)
Occupational Health and Safety Administration (OSHA)

Correct!

Incorrect!

When preparing a horizontal laminar airflow workbench for compounding a sterile product, compounding personnel should:

clean and disinfect working surfaces 6 inches from the front and sides of the hood.
only use cleaning materials, such as wipers, sponges, or towels, that are non-shedding.
use povodine-iodine to wipe surfaces clean during heavy surface contamination.
use sterile gauze to wipe working surfaces to prevent damage of the surface areas

Correct!

Incorrect!

Compounding involving only transfer, measuring, and mixing manipulations using not more than three commercially manufactured sterile products and not more than two entries into any container describes what type of compounding risk level?

Low-Risk Level
Medium-Risk Level
High-Risk Level
Immediate Use

Correct!

Incorrect!

Which ingredient is incompatible and must not be added to a 3-in-1 parenteral nutrition admixture?

Iron
Phytonadione
Selenium
Zinc

Correct!

Incorrect!

What is the most appropriate delivery route for a parenteral nutrition formulation with an osmolarity of 1,230 mOsm/L?

Central venous catheter
Midline catheter
Peripheral catheter
Subcutaneous catheter

Correct!

Incorrect!

An emergency department nurse administered pancuronium instead of influenza vaccine to a patient. The patient experienced some respiratory depression but not permanent injuries. After a root cause analysis (RCA), the team determined the causes to be similar size and labels on the vials. Additionally, the look alike vials had been stored adjacent to each other in the refrigerator. What was the most appropriate action plan that resulted from the RCA?

Neuromuscular blockers are segregated from all other medications in a separate lidded, labeled container.
Place a sign on the refrigerator that neuromuscular blockers are placed in the refrigerator to alert all staff.
Purchase a different brand of influenza vaccine so the vials do not appear similar.
Train and educate the staff regarding the significance and dangers of neuromuscular blockers.

Correct!

Incorrect!

How often must non-high risk compounding personnel demonstrate proficiency through hands-on testing/evaluation?

Every 3 months
Every 6 months
Every 12 months
Every 18 months

Correct!

Incorrect!

How often should personnel pass written and media-fill testing of aseptic work skills when working with sterile ingredients?

Initially and monthly
Initially and annually
Initially and every 2 years
Initially and every 3 years

Correct!

Incorrect!

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Recertification Requirements for BCSCP

Pharmacists who earn the designation Board-Certified Sterile Compounding Pharmacist® (BCSCP) are required to maintain their certification over a seven-year period by completing one of the following recertification pathways:

Option One: Recertification Examination

  • For BCSCP with certification beginning January 1, 2023 or earlier: Achieve a passing score on the recertification examination administered by BPS.
  • For BCSCP with certification beginning January 1, 2024 or later: Achieve a passing score on the recertification examination administered by BPS and self-report 20 units of completed continuing professional development (CPD) in MyBPS. For more information on CPD, review the FAQ. To maintain an active certification in good standing, a minimum of two units of assessed CPE from BPS-approved professional development programs
    or self-reported CPD must be reported each year.

OR

Option Two: Professional Development Program

  • For BCSCP with certification beginning January 1, 2023 or earlier: recertification via professional development program requires 100 units of assessed CPE from BPS-approved professional development programs offered by:
  • For BCSCP with certification beginning January 1, 2024 or later: recertification via professional development program requires 100 units, comprised of 80 units of BPS-approved, assessed CE provided by the professional development programs offered by:
    • The American Pharmacists Association (APhA), and/or
    • The American Society of Health-Systems Pharmacists (ASHP).
    • Additionally, 20 units of continuing professional development (CPD) must be completed and self-reported in MyBPS. For more information on CPD, review the FAQ. To maintain an active certification in good standing, a minimum of two units of assessed CPE from BPS-approved professional development programs or self-reported CPD must be reported each year.
    • BCSCP may participate in recertification from any BPS-approved BCSCP programs. The Compounded Sterile Preparations Pharmacy Preparatory Review and Recertification Course offered by any of the approved providers may only be completed for recertification credit up to two times, in nonconsecutive years, during the seven-year certification cycle.
Year certified/recertified

New cycle start

(begin earning recert units)

Cycle expiration

(deadline to meet recert reqs)

Units required 

(PDP = professional development program)

20161/1/201712/31/2023100 units assessed CPE via BPS-approved PDP
20171/1/201812/31/2024100 units assessed CPE via BPS-approved PDP
20181/1/201912/31/2025100 units assessed CPE via BPS-approved PDP
20191/1/202012/31/2026100 units assessed CPE via BPS-approved PDP
20201/1/202112/31/2027100 units assessed CPE via BPS-approved PDP
20211/1/202212/31/2028100 units assessed CPE via BPS-approved PDP
20221/1/202312/31/2029100 units assessed CPE via BPS-approved PDP
20231/1/202412/31/2030100 units (80 units assessed CPE via BPS-approved PDP + 20 units CPD)
2024 onward1/1/2025 onward12/31/2031 onward100 units (80 units assessed CPE via BPS-approved PDP + 20 units CPD)

For full details regarding recertification, please refer to the BPS Recertification Guide.

Board-Certified Sterile Compounding Pharmacists® are required to pay the BPS Annual Certification Maintenance fee of $125 each year for years one through six and the $400 recertification fee in year seven. Individuals with more than one BPS certification are assessed one BPS Annual Certification Maintenance Fee each year.

Upcoming Deadlines for Recertification

Candidates are required to recertify every 7 years. Certificants must submit their recertification application no later than the deadline of August 4. BPS encourages candidates to submit their recertification application as early as January 1 of their recertification year.

Candidates who intend to recertify via examination should note the availability of the recertification examination and related application deadlines. Candidates recertifying their BCSCP credential by examination can find more information about examination dates and fees for here

Candidates who intend to recertify via continuing education (CE) MUST submit their recertification application by the deadline date of August 4 even if they have not completed their CE requirements.

The deadline to complete the required CE for recertification is December 31 for all specialties. The board-certified pharmacist is responsible for submitting an application that is completely and accurately filled out. Incomplete and/or unpaid applications will not be processed. 

Recertification Guide

The Recertification Guide is intended for use by candidates renewing their certification. To review critical information for recertifying with the Board of Pharmacy Specialties, visit this page.

CPE Providers

BCSCP with certification beginning January 1, 2023 or earlier: recertification via professional development program requires 100 units of assessed CPE from BPS-approved professional development programs offered by:

BCSCP may participate in recertification from any BPS-approved BCSCP programs. The Compounded Sterile Preparations Pharmacy Preparatory Review and Recertification Course offered by any of the approved providers may only be completed for recertification credit up to two times, in nonconsecutive years, during the seven-year certification cycle.

BCSCP with certification beginning January 1, 2024 or later: recertification via professional development program requires 100 units, comprised of 80 units of assessed CPE from BPS-approved professional development programs offered by:

Additionally, 20 units of continuing professional development (CPD) must be completed and self-reported in MyBPS. For more information on CPD, review the FAQ. To maintain an active certification in good standing, a minimum of two units of assessed CPE from BPS-approved professional development programs or self-reported CPD must be reported each year.

BCSCP may participate in recertification from any BPS-approved BCSCP programs. The Compounded Sterile Preparations Pharmacy Preparatory Review and Recertification Course offered by any of the approved providers may only be completed for recertification credit up to two times, in nonconsecutive years, during the seven-year certification cycle.

Content Outline for BCSCP Examinations

For the Fall 2023 Examination, refer to the Compounded Sterile Preparations Pharmacy Content Outline found in the BCSCP Examination Specifications document for details.

For the 2024 Examinations and forward, refer to the Compounded Sterile Preparations Pharmacy Content Outline found here for details.

Important Resources

Apply for ADA Accomodations 

BPS complies with the relevant provisions of the Americans with Disabilities Act (ADA). For applicants looking to request special accommodations in their application process, more instructions can be found on this page.

Frequently Asked Questions

After review of the BPS Recertification Guide and specialty page, some applicants may still have questions. Visit this page to see frequently asked questions from pharmacists renewing their board certification like you!

Important Resources

Sample Items for BCSCP Examinations

The sample examination items for BCSCP examinations are made available by BPS for the purposes of familiarizing certification candidates and other stakeholders with the structure and format of BPS certification examinations. This is not meant for use as a self-assessment. Performance on any of these items does not correlate with performance on the actual examination.

The content of these examples is meant to be illustrative of actual examination items, but these items do not appear on the certification examination and are not meant to identify the scope of the examination. For a more comprehensive indication of the scope of the certification examination, please refer to the BCSCP Exam Content Outline.

Examination items are in multiple-choice format. The great majority of examination items are multiple-choice with a single response from among four options. Some examinations may include a small percentage of items that require selection of multiple (three or four) responses from among a larger set of available (up to eight) options. Examinations items may also be supplemented by an image.

View the examination items down below. 

A 503A compounding pharmacy at a health-system centralized compounding facility was inspected by the Food and Drug Administration (FDA) following a complaint. A FDA form 483 was issued to the pharmacy. What is the correct response from the pharmacy?

The findings do not need to be addressed since the FDA's Insanitary Conditions document is just guidance.
The findings do not need to be addressed since the pharmacy is considered a 503A compounder.
The findings must be addressed using a corrective and preventative action plan (CAPA).
The findings should be addressed using a failure mode and effects analysis (FMEA).

Correct!

Incorrect!

A hospital pharmacy received a shipment of antineoplastic hazardous drugs. Where should the shipment be unpacked?

A designated area within the pharmacy department with positive pressure relative to the surrounding areas
A designated area within the pharmacy department with neutral or negative pressure relative to the surrounding areas
An area on the delivery truck by the loading dock before transporting to the pharmacy department
An area within the sterile compounding clean room

Correct!

Incorrect!

Which organization regulates disinfectants by evaluating and registering manufacturer data submitted for microbiocidal activity, stability, toxicity, and contact time for labeling indicated uses?

Centers For Disease Control and Prevention (CDC)
Environmental Protection Agency (EPA)
Food and Drug Administration (FDA)
Occupational Health and Safety Administration (OSHA)

Correct!

Incorrect!

When preparing a horizontal laminar airflow workbench for compounding a sterile product, compounding personnel should:

clean and disinfect working surfaces 6 inches from the front and sides of the hood.
only use cleaning materials, such as wipers, sponges, or towels, that are non-shedding.
use povodine-iodine to wipe surfaces clean during heavy surface contamination.
use sterile gauze to wipe working surfaces to prevent damage of the surface areas

Correct!

Incorrect!

Compounding involving only transfer, measuring, and mixing manipulations using not more than three commercially manufactured sterile products and not more than two entries into any container describes what type of compounding risk level?

Low-Risk Level
Medium-Risk Level
High-Risk Level
Immediate Use

Correct!

Incorrect!

Which ingredient is incompatible and must not be added to a 3-in-1 parenteral nutrition admixture?

Iron
Phytonadione
Selenium
Zinc

Correct!

Incorrect!

What is the most appropriate delivery route for a parenteral nutrition formulation with an osmolarity of 1,230 mOsm/L?

Central venous catheter
Midline catheter
Peripheral catheter
Subcutaneous catheter

Correct!

Incorrect!

An emergency department nurse administered pancuronium instead of influenza vaccine to a patient. The patient experienced some respiratory depression but not permanent injuries. After a root cause analysis (RCA), the team determined the causes to be similar size and labels on the vials. Additionally, the look alike vials had been stored adjacent to each other in the refrigerator. What was the most appropriate action plan that resulted from the RCA?

Neuromuscular blockers are segregated from all other medications in a separate lidded, labeled container.
Place a sign on the refrigerator that neuromuscular blockers are placed in the refrigerator to alert all staff.
Purchase a different brand of influenza vaccine so the vials do not appear similar.
Train and educate the staff regarding the significance and dangers of neuromuscular blockers.

Correct!

Incorrect!

How often must non-high risk compounding personnel demonstrate proficiency through hands-on testing/evaluation?

Every 3 months
Every 6 months
Every 12 months
Every 18 months

Correct!

Incorrect!

How often should personnel pass written and media-fill testing of aseptic work skills when working with sterile ingredients?

Initially and monthly
Initially and annually
Initially and every 2 years
Initially and every 3 years

Correct!

Incorrect!

Share the quiz to show your results !

Subscribe to see your results

Compounded Sterile Preparations Pharmacy Sample Questions

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Certification Verification

BPS offers the ability to search and verify a Board-Certified Pharmacist by name or credential number.