BCSCP 2026 || A+ Certified.
Which is the scientific non-profit organization that sets standards for the identity, strength,
quality, and purity of medicines, food ingredients, and dietary supplements? correct answers
USP
Which of the following USP chapters is federally-enforceable? correct answers <797>
Which USP standard's purpose is to ensure safe handling of hazardous drugs to minimize the risk
of exposure to healthcare personnel, patients, and the environment? correct answers USP <800>
Which USP standard's purpose is to reduce risk of patient harm from contamination, infection, or
incorrect dosing of compounded sterile preparations? correct answers USP <797>
Choose the option that lists USP requirements in order from most specific to least specific.
correct answers Monograph, General Chapter, General Notice
Which guideline for sterile compounding is focused on preventing patient harm due to
medication errors and provides best practice guidelines to ensure the safe preparation of
compounded sterile preparations by pharmacies? correct answers ISMP Guidelines for Safe
Preparation of Compounded Sterile Preparations
Which guidelines have the purpose of preventing transmission of infectious agents from
inappropriate sharing or reuse of needles, syringes, single-dose and multiple-dose vials? correct
answers CDC Safe Injection Practices
Which guidance document created a list of hazardous drugs which is recognized by USP <800>?
correct answers NIOSH Alert: Preventing Occupational Exposure to Antineoplastic and Other
Hazardous Drugs in Healthcare Settings
Which of the following is established by a standard and not by best practices or guidelines?
correct answers Minimum requirements
Which body of USP addresses specific standards? correct answers USP Expert Committees
Traditional drug compounding falls under what section of the Federal Food, Drug, & Cosmetic
Act (FDCA)? correct answers 503(A)
Which of the following sections of the Federal Food, Drug & Cosmetic Act (FDCA) requires
certain compounders to register with the FDA? correct answers 503(B)
A key difference between a compounder operating under section 503B vs 503A is that the
compounder is subject to __________________. correct answers cGMP
Which federal agency oversees regulations related to personnel protective equipment (PPE),
respiratory protection, and the hazard communication standard (HCS)? correct answers OSHA
,In general, compounders operating under section 503(a) of the Federal Food, Drug, and
Cosmetic Act (FDCA) are subject to regulation and inspection by which entity? correct answers
State Board of Pharmacy
According to a 2016 GAO report, what percentage of states have regulations specific to
compounding by non-pharmacists (e.g. physicians)? correct answers < 20%
Which of the following guidance documents, if and when finalized, has the potential to most
dramatically impact compounding practice at large health systems operating under 503A? correct
answers Hospital and Health System Compounding under Section 503A of the FDCA
Which document is issued at the end of an FDA inspection? correct answers FDA Form 483
Which of the following insanitary conditions would apply to both sterile and nonsterile
compounding facilities? correct answers Handling highly potent drugs with inadequate controls
If there are findings after an FDA inspection of a sterile compounding facility, which of the
following is expected to be implemented? correct answers CAPA
In the Fairview Compounding Pharmacy 483, which of the following was a response to the FDA
finding that the "personnel did not disinfect and change gloves frequently enough to prevent
contamination"? correct answers Required staff to complete training
Which provision of the FDCA applies to those compounding sterile preparations under section
503(A)? correct answers Insanitary conditions requirement
Which of the following is an insanitary condition from a source of non-microbial contamination?
correct answers Rust
Open processing of which medication would create an insanitary condition based on the FDA
draft guidance document? correct answers Beta-lactam antibiotics
Enforceable chapters of USP correct answers Below 1000
USP Standards Structure correct answers General Notices < General Chapters < Monographs
Qualified healthcare personnel may repackage medication from an unopened single-dose vial
into multiple single-use dosages, under what conditions during a shortage? correct answers Must
be done in ISO 5 environment, following USP <797> standards (i.e. in a pharmacy)
Which of the following documents are standards which apply to sterile compounding?
A. USP General Chapter <795>
B. USP General Chapter <800>
C. USP General Chapter <797>
D. All of the above
,E. B and C correct answers E. B and C
Examples of organizations create guidelines which provide additional detail and focus on
particular aspects of sterile compounding practice not otherwise covered in the USP standards.
correct answers ASHP, ISMP, ASPEN, and others
_______________ may apply to sterile compounding or administration in healthcare settings
where USP <797> standards are not followed. correct answers CDC Safe Injection Practices
A pharmacist has been compounding sterile preparations for the last 15 years without incident
under his state-issued pharmacy license. He is thinking about expanding his business to provide
compounded sterile Trimix to a local urologist for in-clinic use.
Which of the following actions should the pharmacist take to ensure regulatory compliance?
correct answers If he gets patient-specific prescriptions, he is fully compliant with compounding
under his license
FEDERAL REGULATIONS IMPACTING STERILE COMPOUNDING - FDCA correct
answers Section503A & Section503B
FEDERAL REGULATIONS IMPACTING STERILE COMPOUNDING - OSHA correct
answers 29 CFR 1910.1020: Access to employee medical and exposure records & 29 CFR
1910.1200: Hazard communication standard
FEDERAL REGULATIONS IMPACTING STERILE COMPOUNDING - EPA correct answers
RCRA of 1976
503A: Who may compound correct answers Licensed pharmacist in a state-licensed pharmacy or
federal facility, or licensed physician.
503A: Type of drugs compounded correct answers May compound nonsterile or sterile drugs.
503A: Prescriptions correct answers Compounding must be based on receipt of valid prescription
for identified individual patient.
503A: Registration with the FDA correct answers No registration requirement.
503A: Inspections correct answers No requirement for FDA to inspect; while FDA may choose
to inspect, a pharmacy's or physician's records may be exempt from inspection in certain cases.
503A: Quality standards correct answers Exempt from cGMP requirements, but not from other
quality requirements, such as the prohibition on preparing, packing, or holding drugs under
insanitary conditions.
503B: Who may compound correct answers Licensed pharmacist or individual under the direct
supervision of a licensed pharmacist in an outsourcing facility.
, 503B: Type of drugs compounded correct answers Must compound sterile drugs and may also
compound nonsterile drugs.
503B: Prescriptions correct answers Compounding may or may not be based on receipt of
prescriptions for identified individual patients.
503B: Inspections correct answers Inspected by FDA according to a risk-based schedule, based
on the known safety risks of such outsourcing facilities.
503B: Quality standards correct answers Must comply with cGMP requirements, in addition to
other quality requirements, such as the prohibition on preparing, packing, or holding drugs under
insanitary conditions.
OSHA Regulations correct answers 29 CFR 1910.132: Personal Protective Equipment- Requires
appropriate PPE available and used by employees
29 CFR 1910.133: Eye and Face Protection Standard- Requires eye and face protection as HDs
may splash in the eyes, nose, or
mouth
29 CFR 1910.134: Respiratory Protection Standard
- Provides requirements for respirator selection, medical evaluation, fit testing and training
29 CFR 1910.1020: Access to employee exposure and medical records - Includes exposure
assessment of all employees who have worked
with HDs
29 CFR 1910.1200: Hazard Communication Standard
- Many HDs are classified as workplace hazards and fall under this standard - Employers must
develop a written hazardous drug safety and health plan
• Protect employees from health hazards associated with HDs
• Keep exposures as low as reasonably achievable (ALARA)
- Plan available and accessible to all employees, including temporary employees, contractors,
and trainees
RCRA correct answers Promulgated in the Resource Conservation and Recovery Act of 1976
(RCRA): Designates P-listed, and U-listed pharmaceutical hazardous wastes and
characteristic hazardous waste
Federal vs. State: Greater focus on cGMPs correct answers Federal
Federal vs. State: Direct oversight of 503B compounding facilities correct answers Federal
Federal vs. State: Direct oversight of 503A
professionals compounding correct answers State
Federal vs. State: Requires licensing correct answers State
Federal vs. State: Requires registration correct answers Federal
Which is the scientific non-profit organization that sets standards for the identity, strength,
quality, and purity of medicines, food ingredients, and dietary supplements? correct answers
USP
Which of the following USP chapters is federally-enforceable? correct answers <797>
Which USP standard's purpose is to ensure safe handling of hazardous drugs to minimize the risk
of exposure to healthcare personnel, patients, and the environment? correct answers USP <800>
Which USP standard's purpose is to reduce risk of patient harm from contamination, infection, or
incorrect dosing of compounded sterile preparations? correct answers USP <797>
Choose the option that lists USP requirements in order from most specific to least specific.
correct answers Monograph, General Chapter, General Notice
Which guideline for sterile compounding is focused on preventing patient harm due to
medication errors and provides best practice guidelines to ensure the safe preparation of
compounded sterile preparations by pharmacies? correct answers ISMP Guidelines for Safe
Preparation of Compounded Sterile Preparations
Which guidelines have the purpose of preventing transmission of infectious agents from
inappropriate sharing or reuse of needles, syringes, single-dose and multiple-dose vials? correct
answers CDC Safe Injection Practices
Which guidance document created a list of hazardous drugs which is recognized by USP <800>?
correct answers NIOSH Alert: Preventing Occupational Exposure to Antineoplastic and Other
Hazardous Drugs in Healthcare Settings
Which of the following is established by a standard and not by best practices or guidelines?
correct answers Minimum requirements
Which body of USP addresses specific standards? correct answers USP Expert Committees
Traditional drug compounding falls under what section of the Federal Food, Drug, & Cosmetic
Act (FDCA)? correct answers 503(A)
Which of the following sections of the Federal Food, Drug & Cosmetic Act (FDCA) requires
certain compounders to register with the FDA? correct answers 503(B)
A key difference between a compounder operating under section 503B vs 503A is that the
compounder is subject to __________________. correct answers cGMP
Which federal agency oversees regulations related to personnel protective equipment (PPE),
respiratory protection, and the hazard communication standard (HCS)? correct answers OSHA
,In general, compounders operating under section 503(a) of the Federal Food, Drug, and
Cosmetic Act (FDCA) are subject to regulation and inspection by which entity? correct answers
State Board of Pharmacy
According to a 2016 GAO report, what percentage of states have regulations specific to
compounding by non-pharmacists (e.g. physicians)? correct answers < 20%
Which of the following guidance documents, if and when finalized, has the potential to most
dramatically impact compounding practice at large health systems operating under 503A? correct
answers Hospital and Health System Compounding under Section 503A of the FDCA
Which document is issued at the end of an FDA inspection? correct answers FDA Form 483
Which of the following insanitary conditions would apply to both sterile and nonsterile
compounding facilities? correct answers Handling highly potent drugs with inadequate controls
If there are findings after an FDA inspection of a sterile compounding facility, which of the
following is expected to be implemented? correct answers CAPA
In the Fairview Compounding Pharmacy 483, which of the following was a response to the FDA
finding that the "personnel did not disinfect and change gloves frequently enough to prevent
contamination"? correct answers Required staff to complete training
Which provision of the FDCA applies to those compounding sterile preparations under section
503(A)? correct answers Insanitary conditions requirement
Which of the following is an insanitary condition from a source of non-microbial contamination?
correct answers Rust
Open processing of which medication would create an insanitary condition based on the FDA
draft guidance document? correct answers Beta-lactam antibiotics
Enforceable chapters of USP correct answers Below 1000
USP Standards Structure correct answers General Notices < General Chapters < Monographs
Qualified healthcare personnel may repackage medication from an unopened single-dose vial
into multiple single-use dosages, under what conditions during a shortage? correct answers Must
be done in ISO 5 environment, following USP <797> standards (i.e. in a pharmacy)
Which of the following documents are standards which apply to sterile compounding?
A. USP General Chapter <795>
B. USP General Chapter <800>
C. USP General Chapter <797>
D. All of the above
,E. B and C correct answers E. B and C
Examples of organizations create guidelines which provide additional detail and focus on
particular aspects of sterile compounding practice not otherwise covered in the USP standards.
correct answers ASHP, ISMP, ASPEN, and others
_______________ may apply to sterile compounding or administration in healthcare settings
where USP <797> standards are not followed. correct answers CDC Safe Injection Practices
A pharmacist has been compounding sterile preparations for the last 15 years without incident
under his state-issued pharmacy license. He is thinking about expanding his business to provide
compounded sterile Trimix to a local urologist for in-clinic use.
Which of the following actions should the pharmacist take to ensure regulatory compliance?
correct answers If he gets patient-specific prescriptions, he is fully compliant with compounding
under his license
FEDERAL REGULATIONS IMPACTING STERILE COMPOUNDING - FDCA correct
answers Section503A & Section503B
FEDERAL REGULATIONS IMPACTING STERILE COMPOUNDING - OSHA correct
answers 29 CFR 1910.1020: Access to employee medical and exposure records & 29 CFR
1910.1200: Hazard communication standard
FEDERAL REGULATIONS IMPACTING STERILE COMPOUNDING - EPA correct answers
RCRA of 1976
503A: Who may compound correct answers Licensed pharmacist in a state-licensed pharmacy or
federal facility, or licensed physician.
503A: Type of drugs compounded correct answers May compound nonsterile or sterile drugs.
503A: Prescriptions correct answers Compounding must be based on receipt of valid prescription
for identified individual patient.
503A: Registration with the FDA correct answers No registration requirement.
503A: Inspections correct answers No requirement for FDA to inspect; while FDA may choose
to inspect, a pharmacy's or physician's records may be exempt from inspection in certain cases.
503A: Quality standards correct answers Exempt from cGMP requirements, but not from other
quality requirements, such as the prohibition on preparing, packing, or holding drugs under
insanitary conditions.
503B: Who may compound correct answers Licensed pharmacist or individual under the direct
supervision of a licensed pharmacist in an outsourcing facility.
, 503B: Type of drugs compounded correct answers Must compound sterile drugs and may also
compound nonsterile drugs.
503B: Prescriptions correct answers Compounding may or may not be based on receipt of
prescriptions for identified individual patients.
503B: Inspections correct answers Inspected by FDA according to a risk-based schedule, based
on the known safety risks of such outsourcing facilities.
503B: Quality standards correct answers Must comply with cGMP requirements, in addition to
other quality requirements, such as the prohibition on preparing, packing, or holding drugs under
insanitary conditions.
OSHA Regulations correct answers 29 CFR 1910.132: Personal Protective Equipment- Requires
appropriate PPE available and used by employees
29 CFR 1910.133: Eye and Face Protection Standard- Requires eye and face protection as HDs
may splash in the eyes, nose, or
mouth
29 CFR 1910.134: Respiratory Protection Standard
- Provides requirements for respirator selection, medical evaluation, fit testing and training
29 CFR 1910.1020: Access to employee exposure and medical records - Includes exposure
assessment of all employees who have worked
with HDs
29 CFR 1910.1200: Hazard Communication Standard
- Many HDs are classified as workplace hazards and fall under this standard - Employers must
develop a written hazardous drug safety and health plan
• Protect employees from health hazards associated with HDs
• Keep exposures as low as reasonably achievable (ALARA)
- Plan available and accessible to all employees, including temporary employees, contractors,
and trainees
RCRA correct answers Promulgated in the Resource Conservation and Recovery Act of 1976
(RCRA): Designates P-listed, and U-listed pharmaceutical hazardous wastes and
characteristic hazardous waste
Federal vs. State: Greater focus on cGMPs correct answers Federal
Federal vs. State: Direct oversight of 503B compounding facilities correct answers Federal
Federal vs. State: Direct oversight of 503A
professionals compounding correct answers State
Federal vs. State: Requires licensing correct answers State
Federal vs. State: Requires registration correct answers Federal
