BCSCP EXAM QUESTIONS WITH COMPLETE
SOLUTIONS
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 ANSWER✔✔-USP | | |
Which of the following USP chapters is federally-enforceable? - CORRECT
| | | | | | | | | |
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? - CORRECT 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? - CORRECT ANSWER✔✔-USP <797> | | | |
Choose the option that lists USP requirements in order from most specific to least
| | | | | | | | | | | | |
specific. - CORRECT 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? - CORRECT
| | | | | | | | |
,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? - CORRECT ANSWER✔✔-CDC Safe Injection Practices
| | | | | | |
Which guidance document created a list of hazardous drugs which is recognized
| | | | | | | | | | | |
by USP <800>? - CORRECT 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? - CORRECT ANSWER✔✔-Minimum requirements
| | | |
Which body of USP addresses specific standards? - CORRECT ANSWER✔✔-USP
| | | | | | | | | |
Expert Committees|
Traditional drug compounding falls under what section of the Federal Food, Drug,
| | | | | | | | | | | |
& Cosmetic Act (FDCA)? - CORRECT ANSWER✔✔-503(A)
| | | | | |
Which of the following sections of the Federal Food, Drug & Cosmetic Act (FDCA)
| | | | | | | | | | | | | |
requires certain compounders to register with the FDA? - CORRECT ANSWER✔✔-
| | | | | | | | | |
503(B)
A key difference between a compounder operating under section 503B vs 503A is
| | | | | | | | | | | | |
that the compounder is subject to __________________. - CORRECT
| | | | | | | | |
ANSWER✔✔-cGMP
,Which federal agency oversees regulations related to personnel protective
| | | | | | | | |
equipment (PPE), respiratory protection, and the hazard communication standard
| | | | | | | |
(HCS)? - CORRECT 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? - CORRECT 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)? - CORRECT
| | | | | | | | |
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? - CORRECT ANSWER✔✔-Hospital and Health
| | | | | | | | |
System Compounding under Section 503A of the FDCA
| | | | | | |
Which document is issued at the end of an FDA inspection? - CORRECT
| | | | | | | | | | | | |
ANSWER✔✔-FDA Form 483 | |
Which of the following insanitary conditions would apply to both sterile and
| | | | | | | | | | | |
nonsterile compounding facilities? - CORRECT 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? - CORRECT 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"? - CORRECT ANSWER✔✔-
| | | | | | | |
Required staff to complete training | | | |
Which provision of the FDCA applies to those compounding sterile preparations
| | | | | | | | | | |
under section 503(A)? - CORRECT ANSWER✔✔-Insanitary conditions requirement
| | | | | | |
Which of the following is an insanitary condition from a source of non-microbial
| | | | | | | | | | | | |
contamination? - CORRECT ANSWER✔✔-Rust | | |
Open processing of which medication would create an insanitary condition based
| | | | | | | | | | |
on the FDA draft guidance document? - CORRECT ANSWER✔✔-Beta-lactam
| | | | | | | | |
antibiotics
Enforceable chapters of USP - CORRECT ANSWER✔✔-Below 1000
| | | | | | |
USP Standards Structure - CORRECT 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
| | | | | | | | | | |
SOLUTIONS
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 ANSWER✔✔-USP | | |
Which of the following USP chapters is federally-enforceable? - CORRECT
| | | | | | | | | |
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? - CORRECT 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? - CORRECT ANSWER✔✔-USP <797> | | | |
Choose the option that lists USP requirements in order from most specific to least
| | | | | | | | | | | | |
specific. - CORRECT 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? - CORRECT
| | | | | | | | |
,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? - CORRECT ANSWER✔✔-CDC Safe Injection Practices
| | | | | | |
Which guidance document created a list of hazardous drugs which is recognized
| | | | | | | | | | | |
by USP <800>? - CORRECT 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? - CORRECT ANSWER✔✔-Minimum requirements
| | | |
Which body of USP addresses specific standards? - CORRECT ANSWER✔✔-USP
| | | | | | | | | |
Expert Committees|
Traditional drug compounding falls under what section of the Federal Food, Drug,
| | | | | | | | | | | |
& Cosmetic Act (FDCA)? - CORRECT ANSWER✔✔-503(A)
| | | | | |
Which of the following sections of the Federal Food, Drug & Cosmetic Act (FDCA)
| | | | | | | | | | | | | |
requires certain compounders to register with the FDA? - CORRECT ANSWER✔✔-
| | | | | | | | | |
503(B)
A key difference between a compounder operating under section 503B vs 503A is
| | | | | | | | | | | | |
that the compounder is subject to __________________. - CORRECT
| | | | | | | | |
ANSWER✔✔-cGMP
,Which federal agency oversees regulations related to personnel protective
| | | | | | | | |
equipment (PPE), respiratory protection, and the hazard communication standard
| | | | | | | |
(HCS)? - CORRECT 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? - CORRECT 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)? - CORRECT
| | | | | | | | |
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? - CORRECT ANSWER✔✔-Hospital and Health
| | | | | | | | |
System Compounding under Section 503A of the FDCA
| | | | | | |
Which document is issued at the end of an FDA inspection? - CORRECT
| | | | | | | | | | | | |
ANSWER✔✔-FDA Form 483 | |
Which of the following insanitary conditions would apply to both sterile and
| | | | | | | | | | | |
nonsterile compounding facilities? - CORRECT 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? - CORRECT 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"? - CORRECT ANSWER✔✔-
| | | | | | | |
Required staff to complete training | | | |
Which provision of the FDCA applies to those compounding sterile preparations
| | | | | | | | | | |
under section 503(A)? - CORRECT ANSWER✔✔-Insanitary conditions requirement
| | | | | | |
Which of the following is an insanitary condition from a source of non-microbial
| | | | | | | | | | | | |
contamination? - CORRECT ANSWER✔✔-Rust | | |
Open processing of which medication would create an insanitary condition based
| | | | | | | | | | |
on the FDA draft guidance document? - CORRECT ANSWER✔✔-Beta-lactam
| | | | | | | | |
antibiotics
Enforceable chapters of USP - CORRECT ANSWER✔✔-Below 1000
| | | | | | |
USP Standards Structure - CORRECT 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
| | | | | | | | | | |
