RAC (US) Practice Exam 2015 Questions
and Correct Revised Answers and
Explanations 100% Guaranteed Pass
Which of the following is a requirement for a sponsor to advertise that a prescription
drug is safer or more effective than another prescription drug?
A. The representation must have been approved as part of the labeling in an initial new
drug application or biologic license
B. The representation is supported by substantial evidence derived from adequate and
well-controlled studies as defined by applicable regulation
C. The requirement for adequate and well-controlled studies is waived by regulation
D. Peer-reviewed scientific literature in support of the claim must be submitted in a
preapproval supplement - Answer- B. The representation is supported by substantial
evidence derived from adequate and well-controlled studies as defined by applicable
regulation
Regulatory Reference
21 CFR 202.1
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=202.1
(http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=202.1)
Question Feedback
Peer-reviewed scientific literature in support of the claim is not required to be submitted
in a preapproval supplement but should be supplied to the Food and Drug
Administration, if requested.
Sec. 202.1 Prescription-drug advertisements.
(6) An advertisement for a prescription drug is false, lacking in fair balance, or otherwise
misleading, or otherwise violative of section 502(n) of the act, among other reasons,
if it:
(i) Contains a representation or suggestion, not approved or permitted for use in the
labeling, that a drug is better, more effective, useful in a broader range of conditions or
patients (as used in this section patients means humans and in the case of veterinary
drugs, other animals), safer, has fewer, or less incidence of, or less serious side
effects or contraindications than has been demonstrated by substantial evidence or
substantial clinical experience (as described in paragraphs (e)(4)(ii) (b) and (c) of this
section) whether or not such representations are made by comparison with other drugs
or treatments, and whether or not such a representation or suggestion is made
directly or through use of published or unpublished literature, quotations, or other
references
,In most cases, the manufacturer of biological products should retain samples for a
minimum of what amount of time beyond the expiration date?
A. 10 Days
B. 30 Days
C. 6 Months
D. 12 Months - Answer- C. 6 Months
Regulatory Reference
21 CFR 600.13
Question Feedback
Manufacturers shall retain for a period of at least six months after the expiration date,
unless a different time period is specified in additional standards, a quantity of
representative material of each lot of each product, sufficient for examination and
testing for safety and potency, except Whole Blood, Cryoprecipitated AHF, Platelets,
Red Blood Cells, Plasma, and Source Plasma and Allergenic Products prepared to a
physician's prescription.
A blood center has discovered a unit of packed red blood cells for commercial use
previously shipped to a local hospital was stored inappropriately for four days during the
manufacturing process. The blood center should:
A. Recall the blood product and initiate a blood product deviation report to CBER within
45 calendar days of discovery of the deviation.
B. Recall the blood product and initiate a blood product deviation report to CDRH within
45 calendar days of discovery of the deviation.
C. Recall the blood product and initiate a blood product deviation report to CBER within
15 calendar days of discovery of the deviation.
D. Recall the blood product and initiate a blood product deviation report to CDRH within
15 calendar days of discovery of the deviation. - Answer- A. Recall the blood product
and initiate a blood product deviation report to CBER within 45 calendar days of
discovery of the deviation.
Regulatory Reference
FDA Guidance for Industry :Biological Product Deviation Reporting for Blood and
Plasma Establishments
21 CFR Part 606.171 (c)
Question Feedback:
The appropriate FDA branch handling biologic products is CBER and the appropriate
reporting period is 45 days from discovery of the manufacturing deviation.
Under 21 CFR 606.171, a manufacturer is required to report certain events associated
with the manufacturing, to include testing, processing, packing, labeling or storage, or
with the holding or distribution of blood or a blood component, which may affect the
safety, purity or potency of a distributed product. Safety, purity and potency are defined
in 21 CFR 600.3(p), (r) and (s).
Under 21 CFR 606.171(c), a manufacturer should submit reports as soon as possible,
but is required to submit reports at a date not to exceed 45 calendar days from the
date of discovery of information reasonably suggesting a reportable event has occurred.
,The supplier of the active drug substance for a company's OTC monograph drug
product informs the company that it will be moving its production of the drug substance
from the current plant to a new manufacturing plant in another state in six months. The
supplier states that all manufacturing processes will remain the same and the
specifications will not change. The company intends to qualify the change suitably. How
should the company report the change to FDA?
A. The change only needs to be reported in an Annual Report because the company will
qualify the change and the supplier said the process and specifications will not change
B. The change should be reported in a Pre-approval Supplement
C. The change would be reported during the annual drug listing process
D. An amendment to the OTC monograph should be filed - Answer- C. The change
would be reported during the annual drug listing process
Regulatory Reference
21 CFR 207
Guidance for Industry: Providing Regulatory Submissions in Electronic Format—Drug
Establishment Registration and Drug Listing
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guida
nces/ucm072339.pdf
(http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guid
ances/ucm072339.pdf)
Question Feedback
Monograph drugs are not subject to Annual Reports or Preapproval Supplements. Nor
is the supplier of an active drug substance prescribed by regulation (so a change to
the monograph is not warranted). However, because the manufacturing API Drug
Establishment number will change, this must be updated with FDA as part of the annual
drug listing process.
Advertising and promotional materials are required to be submitted to FDA at the time of
initial dissemination or publication for all products EXCEPT:
A. Prescription Drugs
B. Biologics
C. Non-restricted devices and OTC drugs
D. None, all products require submission of advertising and promotional material. -
Answer- C. Non-restricted devices and OTC drugs
Regulatory Reference
21 CFR 314.81(b)(3)(i); 21 CFR 601.12(f)(4); FD&C Act Sections 502(q) and 502(r)
Question Feedback
Non-restricted medical device and OTC drug advertising is regulated by the Federal
Trade Commission (FTC) under the FTC Act.
A manufacturer is closing its current facility for manufacturing an approved drug
product. The manufacturer has two other facilities, and has asked regulatory to examine
the
, two locations and develop an appropriate regulatory strategy. Facility A: A large facility
being built near the existing facility will have state-of-the-art electronics to monitor the
manufacturing process, all new isolated manufacturing areas and all new equipment.
The new facility will open one month before the current facility is scheduled to close.
This manufacturing process will be the first process moved to this new building. Facility
B: A smaller facility 100 miles away from the existing facility has been manufacturing
several approved drug products for the same therapeutic purpose for the past 15 years
Which is the most accurate analysis/recommendation?
A. The transfer of the manufacturing process to Facility A is considered a minor chan -
Answer- D. Facility B has been manufacturing approved drug products for the same
therapeutic purpose for the past 15 years and has been inspected by FDA. The move of
the manufacturing process to Facility B would be a moderate change and could be filed
in a CBE 30.
Regulatory Reference
Guidance for Industry: Changes to an Approved NDA or ANDA
Question Feedback
The transfer of a drug product manufacturing process to a new facility requires
notification of FDA of the change to the process. In reviewing Facilities A and B, the
regulatory professional would recognize that Facility A, although new and state-of-the-
art, has not been inspected by FDA and would result in a major change to the
approved NDA. This major change would require a prior approval before drug product
manufactured in this location could be placed onto the market. Reporting of this
manufacturing change in an Annual Report would be incorrect.
The transfer of the manufacturing process to Facility B, however, would be a moderate
change as FDA has inspected it for the other drug products it currently manufactures.
This is considered a moderate change and would result in a Changes Being Effected
(CBE) 30 notification to FDA prior to placing the drug product manufactured on the
market.
FDA's Office of Generic Drugs (OGD) remains committed to the "first-in, first-reviewed"
review order for original Abbreviated New Drug Applications (ANDAs), amendments and
supplements unless there is specific reason to expedite an application. Which of the
following is NOT specific reason to grant expedited review?
A. Products to respond to current and anticipated public health emergencies
B. Products that show evidence of safety and effectiveness in a new subpopulation
C. Products for which a nationwide shortage has been identified
D. First generic products for which there are no blocking patents or exclusivities on the
Reference Listed Drug (RLD) - Answer- B. Products that show evidence of safety and
effectiveness in a new subpopulation
Regulatory Reference
MAPP 5240.3 Review Order of Original ANDAs, Amendments, and Supplements page
Definition of ANDA/Generic drug:
