PIL A, B LEGISLATION EXAM QUESTIONS WITH 100% VERIFIED ANSWERS!! 2026/2027 2026/2027 | Page 1 | Passing Score: 75%
PIL EXAMINATION BOARD
PIL A, B LEGISLATION EXAM QUESTIONS
WITH 100% VERIFIED ANSWERS!! 2026/2027
LEGISLATION EXAM -- Official Exam 2026/2027
100 75% CERTIFIED
QUESTIONS PASSING SCORE RECERTIFICATION
TABLE OF CONTENTS
Section 1 Drug Regulation and FDA Laws Q1-25
Section 2 Pharmacy Practice and Professional Regulation Q26-50
Section 3 Dangerous Drugs and Controlled Substances Q51-70
Section 4 Consumer Protection and Health Product Laws Q71-85
Section 5 Institutional and International Pharmacy Law Q86-100
Instructions: Select the single best answer for each question. This exam is designed for PIL A, B Legislation examination
preparation. Passing score: 75% (75 questions correct).
PIL A, B LEGISLATION EXAM QUESTIONS WITH 100% VERIFIED ANSWERS!! 2026/2027 -- 2026/2027 | Passing Score: 75% | Page 1
, SECTION 1 QUESTIONS
| DRUG REGULATION
WITH 100%
AND
VERIFIED
FDA LAWS
ANSWERS!!
| Q1-Q252026/2027
| PIL A, B 2026/2027
LEGISLATION EXAM
PIL A, B LEGISLATION EXAM QUESTIONS WITH 100% VERIFIED ANSWERS!! 2026/2027 -- 2026/2027 | Passing Score: 75% | Page 2
, Q1 Question 1 of 100
Q1. A pharmaceutical company submits a new drug application to the Food and Drug Administration
for a novel cardiovascular medication. Under Republic Act 3720, the FDA has the authority to
evaluate the safety, efficacy, and quality of the drug before granting market authorization. The
regulatory review process requires which type of application for a new chemical entity seeking initial
marketing approval?
A. Abbreviated New Drug Application demonstrating bioequivalence to an existing product
B. Over-the-Counter Drug Application demonstrating consumer self-medication capability
C. New Drug Application containing complete clinical and preclinical data demonstrating safety and
efficacy
D. Generic Drug Application demonstrating pharmaceutical equivalence only
Correct Answer: C
Rationale:
A New Drug Application (NDA) requires complete clinical and preclinical data to demonstrate safety and efficacy for
a new chemical entity. An Abbreviated NDA is used for generic drugs, which only need to demonstrate
bioequivalence to a reference listed drug, not original safety and efficacy data.
Q2 Question 2 of 100
Q2. A drug manufacturer is found to be distributing a batch of antibiotics that fails to meet the quality
standards set by the FDA. Under the provisions of Republic Act 9711 (FDA Act of 2009), the
regulatory agency may issue an order to remove the product from the market. This regulatory action
is formally known as which type of order?
A. Voluntary recall initiated by the manufacturer without regulatory involvement
B. Product seizure conducted exclusively by law enforcement agencies
C. Mandatory recall ordered by the FDA when a product poses imminent danger to public health
D. Market withdrawal initiated through consumer complaints only
Correct Answer: C
Rationale:
Under RA 9711, the FDA has the authority to issue mandatory recalls when a health product poses imminent danger
to public health. A voluntary recall is initiated by the manufacturer, not ordered by the FDA. Product seizure is a
separate enforcement action. Market withdrawal is a less formal action that does not address imminent health
dangers.
PIL A, B LEGISLATION EXAM QUESTIONS WITH 100% VERIFIED ANSWERS!! 2026/2027 -- 2026/2027 | Passing Score: 75% | Page 3
, Q3 Question 3 of 100
Q3. A community pharmacist receives a shipment of prescription medications and discovers that the
products lack the required Batch Identification Number on their packaging. According to current FDA
regulations, the Batch Identification Number serves which primary regulatory purpose?
A. It provides marketing information for consumer brand recognition and product differentiation
B. It certifies that the product has been approved for over-the-counter distribution
C. It indicates the retail price ceiling established by the Department of Health
D. It enables complete traceability of the product through the manufacturing and distribution chain for recall
purposes
Correct Answer: D
Rationale:
The Batch Identification Number enables complete traceability of the product through the manufacturing and
distribution chain, which is critical for conducting effective product recalls. It is not related to marketing, pricing, or
distribution classification. Without batch traceability, targeted recalls become impossible, posing significant public
health risks.
Q4 Question 4 of 100
Q4. During a routine inspection of a pharmaceutical manufacturing facility, FDA inspectors discover
significant deviations from Current Good Manufacturing Practice (cGMP) standards. The inspectors
document findings including inadequate quality control procedures and insufficient documentation of
production processes. Under RA 9711, the FDA may take which immediate regulatory action against
the facility?
A. Issue a warning letter requiring corrective action within 15 working days while allowing continued
production
B. Permanently revoke the facility's business permit through the Department of Trade and Industry
C. Suspend the facility's License to Operate until compliance with cGMP standards is demonstrated
D. Impose a monetary fine only, without requiring any changes to manufacturing processes
Correct Answer: C
Rationale:
Under RA 9711, the FDA may suspend a facility's License to Operate when significant cGMP violations are found
that could compromise product quality and public safety. A warning letter is used for minor violations. Business
permit revocation is handled by DTI, not FDA. Monetary fines alone do not address the underlying safety concerns.
PIL A, B LEGISLATION EXAM QUESTIONS WITH 100% VERIFIED ANSWERS!! 2026/2027 -- 2026/2027 | Passing Score: 75% | Page 4
PIL EXAMINATION BOARD
PIL A, B LEGISLATION EXAM QUESTIONS
WITH 100% VERIFIED ANSWERS!! 2026/2027
LEGISLATION EXAM -- Official Exam 2026/2027
100 75% CERTIFIED
QUESTIONS PASSING SCORE RECERTIFICATION
TABLE OF CONTENTS
Section 1 Drug Regulation and FDA Laws Q1-25
Section 2 Pharmacy Practice and Professional Regulation Q26-50
Section 3 Dangerous Drugs and Controlled Substances Q51-70
Section 4 Consumer Protection and Health Product Laws Q71-85
Section 5 Institutional and International Pharmacy Law Q86-100
Instructions: Select the single best answer for each question. This exam is designed for PIL A, B Legislation examination
preparation. Passing score: 75% (75 questions correct).
PIL A, B LEGISLATION EXAM QUESTIONS WITH 100% VERIFIED ANSWERS!! 2026/2027 -- 2026/2027 | Passing Score: 75% | Page 1
, SECTION 1 QUESTIONS
| DRUG REGULATION
WITH 100%
AND
VERIFIED
FDA LAWS
ANSWERS!!
| Q1-Q252026/2027
| PIL A, B 2026/2027
LEGISLATION EXAM
PIL A, B LEGISLATION EXAM QUESTIONS WITH 100% VERIFIED ANSWERS!! 2026/2027 -- 2026/2027 | Passing Score: 75% | Page 2
, Q1 Question 1 of 100
Q1. A pharmaceutical company submits a new drug application to the Food and Drug Administration
for a novel cardiovascular medication. Under Republic Act 3720, the FDA has the authority to
evaluate the safety, efficacy, and quality of the drug before granting market authorization. The
regulatory review process requires which type of application for a new chemical entity seeking initial
marketing approval?
A. Abbreviated New Drug Application demonstrating bioequivalence to an existing product
B. Over-the-Counter Drug Application demonstrating consumer self-medication capability
C. New Drug Application containing complete clinical and preclinical data demonstrating safety and
efficacy
D. Generic Drug Application demonstrating pharmaceutical equivalence only
Correct Answer: C
Rationale:
A New Drug Application (NDA) requires complete clinical and preclinical data to demonstrate safety and efficacy for
a new chemical entity. An Abbreviated NDA is used for generic drugs, which only need to demonstrate
bioequivalence to a reference listed drug, not original safety and efficacy data.
Q2 Question 2 of 100
Q2. A drug manufacturer is found to be distributing a batch of antibiotics that fails to meet the quality
standards set by the FDA. Under the provisions of Republic Act 9711 (FDA Act of 2009), the
regulatory agency may issue an order to remove the product from the market. This regulatory action
is formally known as which type of order?
A. Voluntary recall initiated by the manufacturer without regulatory involvement
B. Product seizure conducted exclusively by law enforcement agencies
C. Mandatory recall ordered by the FDA when a product poses imminent danger to public health
D. Market withdrawal initiated through consumer complaints only
Correct Answer: C
Rationale:
Under RA 9711, the FDA has the authority to issue mandatory recalls when a health product poses imminent danger
to public health. A voluntary recall is initiated by the manufacturer, not ordered by the FDA. Product seizure is a
separate enforcement action. Market withdrawal is a less formal action that does not address imminent health
dangers.
PIL A, B LEGISLATION EXAM QUESTIONS WITH 100% VERIFIED ANSWERS!! 2026/2027 -- 2026/2027 | Passing Score: 75% | Page 3
, Q3 Question 3 of 100
Q3. A community pharmacist receives a shipment of prescription medications and discovers that the
products lack the required Batch Identification Number on their packaging. According to current FDA
regulations, the Batch Identification Number serves which primary regulatory purpose?
A. It provides marketing information for consumer brand recognition and product differentiation
B. It certifies that the product has been approved for over-the-counter distribution
C. It indicates the retail price ceiling established by the Department of Health
D. It enables complete traceability of the product through the manufacturing and distribution chain for recall
purposes
Correct Answer: D
Rationale:
The Batch Identification Number enables complete traceability of the product through the manufacturing and
distribution chain, which is critical for conducting effective product recalls. It is not related to marketing, pricing, or
distribution classification. Without batch traceability, targeted recalls become impossible, posing significant public
health risks.
Q4 Question 4 of 100
Q4. During a routine inspection of a pharmaceutical manufacturing facility, FDA inspectors discover
significant deviations from Current Good Manufacturing Practice (cGMP) standards. The inspectors
document findings including inadequate quality control procedures and insufficient documentation of
production processes. Under RA 9711, the FDA may take which immediate regulatory action against
the facility?
A. Issue a warning letter requiring corrective action within 15 working days while allowing continued
production
B. Permanently revoke the facility's business permit through the Department of Trade and Industry
C. Suspend the facility's License to Operate until compliance with cGMP standards is demonstrated
D. Impose a monetary fine only, without requiring any changes to manufacturing processes
Correct Answer: C
Rationale:
Under RA 9711, the FDA may suspend a facility's License to Operate when significant cGMP violations are found
that could compromise product quality and public safety. A warning letter is used for minor violations. Business
permit revocation is handled by DTI, not FDA. Monetary fines alone do not address the underlying safety concerns.
PIL A, B LEGISLATION EXAM QUESTIONS WITH 100% VERIFIED ANSWERS!! 2026/2027 -- 2026/2027 | Passing Score: 75% | Page 4
