2022/2023 Practice RAC Exam Questions
and Answers (100% Pass)
A new chemical isintroduced into a manufacturing
facility. The regulatory affizirs practitioner must ensure
thatwhich ofthe fOllowing documents are availablefOr
the chemical?
A DOT manifest
B. MSDS
e. Interstate Bill of Lading
D. USP monograph - Answer-B. MSDS
A This document is not usually required by the manufacturer B.
B. The information contained in the MSDS must be disseminated as mandated by
OSHA regulations 29 CFR 1900.1200 (Hazard Communication) and various state
"employee right to know" laws. Failure to comply may expose the company to legal risk.
C. This document is not usually required by the manufacturer.
D. This may contain useful information about certain chemicaJs, but there is no
statutory mandate that they be available.
When assembling an NDA, all of the following FDA
guidelines are used EXCEPT:
A. environmental assessment of human drugs and
biologics application.
B. preparation of an IND product.
C. format and content of an application summary.
D. format and content of clinical and statistical
sections. - Answer-B. preparation of an IND product.
A. This is a guidance document that will help the regulatory professional assemble an
NDA
B. This guidance is useful in describing how to assemble an IND, the phase of drug
development that precedes an NDA
C.This is a guidance document that will help the regulatory professional assemble an
NDA
D.This is a guidance document that will help the regulatory professional assemble an
NDA
Under the IDE regulation, all of the following must be
reported to the sponsor within 5 days EXCEPT:
A. a deviation from the investigational plan.
,B. withdrawal of IRB approval.
C. an unanticipated adverse device effect.
D. use of a device without informed consent. - Answer-C. an unanticipated adverse
device effect.
A. The investigator should notify the sponsor within 5 days.
B. Withdrawal of IRB approval is reponed within 5 days.
C. The investigator notifies the sponsor and IRB within 10 days of notification of any
unanticipated adverse effect. 21 CFR 812.150
D. The investigator reports to the sponsor and IRB within 5 days after this occurs.
In reviewing a single-dose protocol for an oral dosage in vivo bioequivalence study on
48 subjects, the regulatory
affairs practitioner would make which of the following
recommendations?
A. Three different batches of both the drug and reference
products should be used, each on 8 patients.
B. A laboratory batch of at least 5,000 tablets may
be used if it meets all final product specifications.
C. The study should be crossover in design and should provide for a drug elimination
period.
D. The study should be conducted in 3 separate
locations to minimize demographic differences. - Answer-C. The study should be
crossover in design and should provide for a drug elimination period.
A This has too many parameters, too few patients per lot and no crossover control.
B. Size of the laboratory batch is irrelevant to study design.
C. Crossover uses patients as their own controls and the elimination phase prevents
carryover effect from previous dose. 21 CFR 320.26 ·
D. This has too many unnecessary parameters and has no crossover control.
Recall status reports are usually provided to FDA every
two to four weeks during the time period of a recall.
Submission of these reports may cease when which of the following occurs?
A. FDA terminates the recall.
B. Most of the affected products have been
recovered.
e. All of the product consignees have been notified.
D. The problem which caused the recall has been
corrected. - Answer-A. FDA terminates the recall.
A. Only FDA can officially terminate a recall. 21 CFR 7.53
B. This is not acceptable.
C. The affected product may still be unrecovered or unaccounted for.
D. See explanation C.
,In preparing the list of components of a drug product to
include in an NDA, the regulatory affairs practitioner
should submit which of the following?
A. the list of all active ingredients, antimicrobial preservatives and antioxidants, with
their pharmaceutical
grades and the names of the suppliers
B. Drug Master File referral letters from each supplier of active ingredients, antimicrobial
preservatives and antioxidants
C. GMP Certifications from the suppliers of all active ingredients excipients
D. the lis tof all components used in the manufacture of the drug product, regardless of
whether theyappearin the drug product - Answer-D. the list of all components used in
the manufacture of the drug product, regardless of whether they appear in the drug
product
A. This is an incomplete answer according to the regulation.
B. See explanation A
C. See explanation A
D. All information required in the regulation is provided. 21 CFR 314.50(d)(l)(ii)
To avoid the potential for cross-contamination, FDA
requires the manufacture of penicillin products to be:
A. in a building separated from other manufacturing
buildings.
B. in plants that are inspected quarterly.
C. in a dedicated and validated isolation facility.
D. under laminar flow protection that is validated periodically. - Answer-C. in a dedicated
and validated isolation facility.
A. This is not sufficient to assure no cross-contamination.
B. See explanation A
C. GMP requires dedicated facilities for penicillin manufacture. 21 CFR 211.42(d),
211.46(d)
D. See explanation A
Which of the following is true regarding FDA's MDR
program?
A. It is not a mandatory program for hospitals.
B. It requires the manufacturer to report deaths and serious injuries.
C. It does not require the report of serious injury due to malfunction.
D. It requires physicians to alert FDA of device malfunctions in their personal practice. -
Answer-B. It requires the manufacturer to report deaths and serious injuries
, A. This is required by the MDR regulation. 21 CFR 803.30
B. Tills is the primary requirement of MDR 21 CFR 803.50
C. An MDR does require reporting to FDA of serious injuries resulting from
malfunctions. 21 CFR 803.50
D. An MDR does not require physicians to report device malfunctions in their personal
practice.
A personal deodorant manufacturer is required to do all
of the following EXCEPT:
A. comply with GMP
B. state the place of business on the label.
C. list the quantity of contents on the label.
D. comply with export regulations when exporting
product. - Answer-A. comply with GMP
A. Compliance to GMP is recommended, but not required for cosmetics. FD&C Act,
Section 602(b)
B. This is required by the regulations. Fair Packaging and Labeling Act, Section 4(a)
C. An accurate statement of the quantity is required. Fair Packaging and Labeling Act,
Section 4(a)
D. The export regulations govern drug, devices and cosmetics. FD&C Act, Section 801
(c)
During an FDA post-submission meeting, the regulatory
affairs practitioner should attempt to accomplish all of
the following EXCEPT:
A identify the individual with primary responsibility for the review.
B. attempt to reach agreement on acceptability of data.
C. limit the amount of additional study required.
D. provide testimonials from investigators. - Answer-D. provide testimonials from
investigators.
A. Knowing the reviewer will help expedite responses to any inquiries for additional
information.
B. If more studies are needed, can expedite to provide data required.
C. If more studies are needed, have FDA agree on the minimum number.
D. FDA makes its approval decision on basis of adequate and well controlled studies,
not anecdotal statements. 21 CFR 314.126
The regulatory affairs practitioner's company manufacturers a product which requires a
power source. All of the following US associations could assist in obtaining the
information necessary for compliance with European standards EXCEPT the:
A. Advanced Medical Technology Association.
and Answers (100% Pass)
A new chemical isintroduced into a manufacturing
facility. The regulatory affizirs practitioner must ensure
thatwhich ofthe fOllowing documents are availablefOr
the chemical?
A DOT manifest
B. MSDS
e. Interstate Bill of Lading
D. USP monograph - Answer-B. MSDS
A This document is not usually required by the manufacturer B.
B. The information contained in the MSDS must be disseminated as mandated by
OSHA regulations 29 CFR 1900.1200 (Hazard Communication) and various state
"employee right to know" laws. Failure to comply may expose the company to legal risk.
C. This document is not usually required by the manufacturer.
D. This may contain useful information about certain chemicaJs, but there is no
statutory mandate that they be available.
When assembling an NDA, all of the following FDA
guidelines are used EXCEPT:
A. environmental assessment of human drugs and
biologics application.
B. preparation of an IND product.
C. format and content of an application summary.
D. format and content of clinical and statistical
sections. - Answer-B. preparation of an IND product.
A. This is a guidance document that will help the regulatory professional assemble an
NDA
B. This guidance is useful in describing how to assemble an IND, the phase of drug
development that precedes an NDA
C.This is a guidance document that will help the regulatory professional assemble an
NDA
D.This is a guidance document that will help the regulatory professional assemble an
NDA
Under the IDE regulation, all of the following must be
reported to the sponsor within 5 days EXCEPT:
A. a deviation from the investigational plan.
,B. withdrawal of IRB approval.
C. an unanticipated adverse device effect.
D. use of a device without informed consent. - Answer-C. an unanticipated adverse
device effect.
A. The investigator should notify the sponsor within 5 days.
B. Withdrawal of IRB approval is reponed within 5 days.
C. The investigator notifies the sponsor and IRB within 10 days of notification of any
unanticipated adverse effect. 21 CFR 812.150
D. The investigator reports to the sponsor and IRB within 5 days after this occurs.
In reviewing a single-dose protocol for an oral dosage in vivo bioequivalence study on
48 subjects, the regulatory
affairs practitioner would make which of the following
recommendations?
A. Three different batches of both the drug and reference
products should be used, each on 8 patients.
B. A laboratory batch of at least 5,000 tablets may
be used if it meets all final product specifications.
C. The study should be crossover in design and should provide for a drug elimination
period.
D. The study should be conducted in 3 separate
locations to minimize demographic differences. - Answer-C. The study should be
crossover in design and should provide for a drug elimination period.
A This has too many parameters, too few patients per lot and no crossover control.
B. Size of the laboratory batch is irrelevant to study design.
C. Crossover uses patients as their own controls and the elimination phase prevents
carryover effect from previous dose. 21 CFR 320.26 ·
D. This has too many unnecessary parameters and has no crossover control.
Recall status reports are usually provided to FDA every
two to four weeks during the time period of a recall.
Submission of these reports may cease when which of the following occurs?
A. FDA terminates the recall.
B. Most of the affected products have been
recovered.
e. All of the product consignees have been notified.
D. The problem which caused the recall has been
corrected. - Answer-A. FDA terminates the recall.
A. Only FDA can officially terminate a recall. 21 CFR 7.53
B. This is not acceptable.
C. The affected product may still be unrecovered or unaccounted for.
D. See explanation C.
,In preparing the list of components of a drug product to
include in an NDA, the regulatory affairs practitioner
should submit which of the following?
A. the list of all active ingredients, antimicrobial preservatives and antioxidants, with
their pharmaceutical
grades and the names of the suppliers
B. Drug Master File referral letters from each supplier of active ingredients, antimicrobial
preservatives and antioxidants
C. GMP Certifications from the suppliers of all active ingredients excipients
D. the lis tof all components used in the manufacture of the drug product, regardless of
whether theyappearin the drug product - Answer-D. the list of all components used in
the manufacture of the drug product, regardless of whether they appear in the drug
product
A. This is an incomplete answer according to the regulation.
B. See explanation A
C. See explanation A
D. All information required in the regulation is provided. 21 CFR 314.50(d)(l)(ii)
To avoid the potential for cross-contamination, FDA
requires the manufacture of penicillin products to be:
A. in a building separated from other manufacturing
buildings.
B. in plants that are inspected quarterly.
C. in a dedicated and validated isolation facility.
D. under laminar flow protection that is validated periodically. - Answer-C. in a dedicated
and validated isolation facility.
A. This is not sufficient to assure no cross-contamination.
B. See explanation A
C. GMP requires dedicated facilities for penicillin manufacture. 21 CFR 211.42(d),
211.46(d)
D. See explanation A
Which of the following is true regarding FDA's MDR
program?
A. It is not a mandatory program for hospitals.
B. It requires the manufacturer to report deaths and serious injuries.
C. It does not require the report of serious injury due to malfunction.
D. It requires physicians to alert FDA of device malfunctions in their personal practice. -
Answer-B. It requires the manufacturer to report deaths and serious injuries
, A. This is required by the MDR regulation. 21 CFR 803.30
B. Tills is the primary requirement of MDR 21 CFR 803.50
C. An MDR does require reporting to FDA of serious injuries resulting from
malfunctions. 21 CFR 803.50
D. An MDR does not require physicians to report device malfunctions in their personal
practice.
A personal deodorant manufacturer is required to do all
of the following EXCEPT:
A. comply with GMP
B. state the place of business on the label.
C. list the quantity of contents on the label.
D. comply with export regulations when exporting
product. - Answer-A. comply with GMP
A. Compliance to GMP is recommended, but not required for cosmetics. FD&C Act,
Section 602(b)
B. This is required by the regulations. Fair Packaging and Labeling Act, Section 4(a)
C. An accurate statement of the quantity is required. Fair Packaging and Labeling Act,
Section 4(a)
D. The export regulations govern drug, devices and cosmetics. FD&C Act, Section 801
(c)
During an FDA post-submission meeting, the regulatory
affairs practitioner should attempt to accomplish all of
the following EXCEPT:
A identify the individual with primary responsibility for the review.
B. attempt to reach agreement on acceptability of data.
C. limit the amount of additional study required.
D. provide testimonials from investigators. - Answer-D. provide testimonials from
investigators.
A. Knowing the reviewer will help expedite responses to any inquiries for additional
information.
B. If more studies are needed, can expedite to provide data required.
C. If more studies are needed, have FDA agree on the minimum number.
D. FDA makes its approval decision on basis of adequate and well controlled studies,
not anecdotal statements. 21 CFR 314.126
The regulatory affairs practitioner's company manufacturers a product which requires a
power source. All of the following US associations could assist in obtaining the
information necessary for compliance with European standards EXCEPT the:
A. Advanced Medical Technology Association.
