BCSCP QUESTIONS & ANSWERS
Which is the scientific non-profit organization that sets standards for the identity,
strength, quality, and purity of medicines, food ingredients, and dietary supplements? -
ANSWER USP
Which of the following USP chapters is federally-enforceable? - ANSWER <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? -
ANSWER USP <800>
Which USP standard's purpose is to reduce risk of patient harm from contamination,
infection, or incorrect dosing of compounded sterile preparations? - ANSWER USP
<797>
Choose the option that lists USP requirements in order from most specific to least
specific. - ANSWER 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? - ANSWER 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? - ANSWER CDC Safe Injection Practices
Which guidance document created a list of hazardous drugs which is recognized by
USP <800>? - ANSWER 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? - ANSWER Minimum requirements
Which body of USP addresses specific standards? - ANSWER USP Expert Committees
Traditional drug compounding falls under what section of the Federal Food, Drug, &
Cosmetic Act (FDCA)? - ANSWER 503(A)
Which of the following sections of the Federal Food, Drug & Cosmetic Act (FDCA)
requires certain compounders to register with the FDA? - ANSWER 503(B)
A key difference between a compounder operating under section 503B vs 503A is that
the compounder is subject to __________________. - ANSWER cGMP
,Which federal agency oversees regulations related to personnel protective equipment
(PPE), respiratory protection, and the hazard communication standard (HCS)? -
ANSWER 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? -
ANSWER 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)? - ANSWER < 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? - ANSWER Hospital and Health System Compounding under Section 503A of
the FDCA
Which document is issued at the end of an FDA inspection? - ANSWER FDA Form 483
Which of the following insanitary conditions would apply to both sterile and nonsterile
compounding facilities? - ANSWER 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? - ANSWER 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"? - ANSWER Required staff to complete training
Which provision of the FDCA applies to those compounding sterile preparations under
section 503(A)? - ANSWER Insanitary conditions requirement
Which of the following is an insanitary condition from a source of non-microbial
contamination? - ANSWER Rust
Open processing of which medication would create an insanitary condition based on the
FDA draft guidance document? - ANSWER Beta-lactam antibiotics
Enforceable chapters of USP - ANSWER Below 1000
USP Standards Structure - ANSWER 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? -
,ANSWER 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 - ANSWER 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. - ANSWER ASHP, ISMP, ASPEN, and others
_______________ may apply to sterile compounding or administration in healthcare
settings where USP <797> standards are not followed. - ANSWER 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? - ANSWER If he gets patient-specific prescriptions, he is fully compliant
with compounding under his license
FEDERAL REGULATIONS IMPACTING STERILE COMPOUNDING - FDCA -
ANSWER Section503A & Section503B
FEDERAL REGULATIONS IMPACTING STERILE COMPOUNDING - OSHA -
ANSWER 29 CFR 1910.1020: Access to employee medical and exposure records & 29
CFR 1910.1200: Hazard communication standard
FEDERAL REGULATIONS IMPACTING STERILE COMPOUNDING - EPA - ANSWER
RCRA of 1976
503A: Who may compound - ANSWER Licensed pharmacist in a state-licensed
pharmacy or federal facility, or licensed physician.
503A: Type of drugs compounded - ANSWER May compound nonsterile or sterile
drugs.
503A: Prescriptions - ANSWER Compounding must be based on receipt of valid
prescription for identified individual patient.
503A: Registration with the FDA - ANSWER No registration requirement.
, 503A: Inspections - ANSWER 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 - ANSWER 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 - ANSWER Licensed pharmacist or individual under the
direct supervision of a licensed pharmacist in an outsourcing facility.
503B: Type of drugs compounded - ANSWER Must compound sterile drugs and may
also compound nonsterile drugs.
503B: Prescriptions - ANSWER Compounding may or may not be based on receipt of
prescriptions for identified individual patients.
503B: Inspections - ANSWER Inspected by FDA according to a risk-based schedule,
based on the known safety risks of such outsourcing facilities.
503B: Quality standards - ANSWER 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 - ANSWER 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 - ANSWER Promulgated in the Resource Conservation and Recovery Act of
1976 (RCRA): Designates P-listed, and U-listed pharmaceutical hazardous wastes and
characteristic hazardous waste
Which is the scientific non-profit organization that sets standards for the identity,
strength, quality, and purity of medicines, food ingredients, and dietary supplements? -
ANSWER USP
Which of the following USP chapters is federally-enforceable? - ANSWER <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? -
ANSWER USP <800>
Which USP standard's purpose is to reduce risk of patient harm from contamination,
infection, or incorrect dosing of compounded sterile preparations? - ANSWER USP
<797>
Choose the option that lists USP requirements in order from most specific to least
specific. - ANSWER 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? - ANSWER 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? - ANSWER CDC Safe Injection Practices
Which guidance document created a list of hazardous drugs which is recognized by
USP <800>? - ANSWER 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? - ANSWER Minimum requirements
Which body of USP addresses specific standards? - ANSWER USP Expert Committees
Traditional drug compounding falls under what section of the Federal Food, Drug, &
Cosmetic Act (FDCA)? - ANSWER 503(A)
Which of the following sections of the Federal Food, Drug & Cosmetic Act (FDCA)
requires certain compounders to register with the FDA? - ANSWER 503(B)
A key difference between a compounder operating under section 503B vs 503A is that
the compounder is subject to __________________. - ANSWER cGMP
,Which federal agency oversees regulations related to personnel protective equipment
(PPE), respiratory protection, and the hazard communication standard (HCS)? -
ANSWER 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? -
ANSWER 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)? - ANSWER < 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? - ANSWER Hospital and Health System Compounding under Section 503A of
the FDCA
Which document is issued at the end of an FDA inspection? - ANSWER FDA Form 483
Which of the following insanitary conditions would apply to both sterile and nonsterile
compounding facilities? - ANSWER 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? - ANSWER 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"? - ANSWER Required staff to complete training
Which provision of the FDCA applies to those compounding sterile preparations under
section 503(A)? - ANSWER Insanitary conditions requirement
Which of the following is an insanitary condition from a source of non-microbial
contamination? - ANSWER Rust
Open processing of which medication would create an insanitary condition based on the
FDA draft guidance document? - ANSWER Beta-lactam antibiotics
Enforceable chapters of USP - ANSWER Below 1000
USP Standards Structure - ANSWER 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? -
,ANSWER 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 - ANSWER 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. - ANSWER ASHP, ISMP, ASPEN, and others
_______________ may apply to sterile compounding or administration in healthcare
settings where USP <797> standards are not followed. - ANSWER 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? - ANSWER If he gets patient-specific prescriptions, he is fully compliant
with compounding under his license
FEDERAL REGULATIONS IMPACTING STERILE COMPOUNDING - FDCA -
ANSWER Section503A & Section503B
FEDERAL REGULATIONS IMPACTING STERILE COMPOUNDING - OSHA -
ANSWER 29 CFR 1910.1020: Access to employee medical and exposure records & 29
CFR 1910.1200: Hazard communication standard
FEDERAL REGULATIONS IMPACTING STERILE COMPOUNDING - EPA - ANSWER
RCRA of 1976
503A: Who may compound - ANSWER Licensed pharmacist in a state-licensed
pharmacy or federal facility, or licensed physician.
503A: Type of drugs compounded - ANSWER May compound nonsterile or sterile
drugs.
503A: Prescriptions - ANSWER Compounding must be based on receipt of valid
prescription for identified individual patient.
503A: Registration with the FDA - ANSWER No registration requirement.
, 503A: Inspections - ANSWER 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 - ANSWER 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 - ANSWER Licensed pharmacist or individual under the
direct supervision of a licensed pharmacist in an outsourcing facility.
503B: Type of drugs compounded - ANSWER Must compound sterile drugs and may
also compound nonsterile drugs.
503B: Prescriptions - ANSWER Compounding may or may not be based on receipt of
prescriptions for identified individual patients.
503B: Inspections - ANSWER Inspected by FDA according to a risk-based schedule,
based on the known safety risks of such outsourcing facilities.
503B: Quality standards - ANSWER 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 - ANSWER 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 - ANSWER Promulgated in the Resource Conservation and Recovery Act of
1976 (RCRA): Designates P-listed, and U-listed pharmaceutical hazardous wastes and
characteristic hazardous waste
