NU 578 ADVANCED PHARM UNIT 1
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📋 DOCUMENT OVERVIEW 72 Qs
This document, "NU 578 Advanced Pharm Unit 1," covers specific topics such as the history of
pharmaceutical regulation, drug excretion, the effects of poor nutrition on excretion, and
pharmacological concepts like parasympathetic antagonists and sympathetic and parasympathetic
systems. The document provides 72 questions with correct answers, allowing students to review and
understand key concepts. By studying and reviewing these questions, students can solidify their
knowledge and prepare for exams, making this document a valuable resource for advanced
pharmaceutical education.
✓ Verified Answers ✓ Exam Ready ✓ Study Guide
Trusted by thousands of students and professionals worldwide
EXAM QUESTIONS
QUESTION 1
1906
CORRECT ANSWER
1. Pure food and Drug Act (1906)
2. FDA may enforce drug STRENGTH and PURITY
3. Prohibits MISLABELING or ADULTERATION
4. Basis for DRUG RECALLS
QUESTION 2
1914
CORRECT ANSWER
1. Harrison Narcotic Act
2. Regulated opium, cocaine, MJ
3. Later replaced by controlled substance act (1970)
QUESTION 3
1938
CORRECT ANSWER
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, -Food, drug, cosmetic act (1938)
-Mandated SAFETY, not effectiveness
-Enforced by FDA through registration of all parties involves in manufacture, sale, distribution of drugs
QUESTION 4
(1952)
CORRECT ANSWER
Durham Humphrey Amendments
Seperated who prescribed vs dispensed. OTC vs prescription.
QUESTION 5
1962
CORRECT ANSWER
Kefaurer-Harris Amendments (1962)
1. Proof of EFFICACY and safety before interstate commerce
2. Guidelines for clinical trials
3. Established DESI (drug efficacy, study, implementation
QUESTION 6
1970
CORRECT ANSWER
Comprehensive Drug Abuse prevention and control act of 1970
-Established rehab programs for drug users
-Established DEA
-Regulated export/import of controlled substances
QUESTION 7
G. Poison Prevention Packaging Act (1970)
CORRECT ANSWER
1. regulates certain "household substances" and requires that they be packaged for consumer use in a
manner that will make them significantly difficult for children < 5 yr to open
2. patient may request noncomplying container
3. child-resistant container applies to:
a. all controlled drugs
b. all legend drugs except
i. sublingual nitroglycerin
ii. oral contraceptives in dispenser packs
c. aspirin or aspirin-containing preparations; some exceptions, e.g., effervescent tablets
d. iron-containing drugs and dietary supplements; some exceptions
QUESTION 8
Food and Drug Administration Modernization Act (FDAMA) 1997
CORRECT ANSWER
-Allows for fast-tracking of drugs for serious illnesses to market
-Drug manufacturers have to give patients 6 months notice before they discontinue making a drug
-Established a clinical trial database for drugs for critical illnesses
Trusted by thousands of students and professionals worldwide Page 2 of 17
, -Informs of "off-label" uses
-Incentives for pediatric drug research
QUESTION 9
•Best Pharmaceuticals for Children Act (BPCA) 2002
•Pediatric Research Equity Act 2003
CORRECT ANSWER
-Both promote drug studies in children
-See how existing drugs work in children and determine safety
-Set up pediatric drug trials
QUESTION 10
•FDA Amendments Act 2007
CORRECT ANSWER
•Drug safety legislation designed to monitor drugs once they are on the market
•Post-marketing safety, risk surveillance mandated to include 100 million patients
-Black Box Warnings—high risk!!
-Risk Evaluation Mitigation Strategies
-Dear Prescriber Letters
-Removal of unsafe drugs from the market quickly
QUESTION 11
New Drug Laws
CORRECT ANSWER
•Drug laws are dynamic!
•More than 120 new laws regarding the opioid crisis
•Good Samaritan Laws
-Defibrillators
-Narcan (Naloxone) administration
QUESTION 12
What is a controlled substance?
CORRECT ANSWER
•Prescription
•Potentially addictive
-Reinforcing
-Physically addicting
-Psychologically addicting
•Use is controlled by the Federal Government and monitored by both Federal and State Governments
QUESTION 13
Controlled substances classifications: Schedule I
CORRECT ANSWER
Schedule I - high abuse potential and no accepted medical use in U.S.
1. investigational drugs
2. opiates: heroin, many synthetic derivatives
Trusted by thousands of students and professionals worldwide
Page 3 of 17
70+ (Latest 2026 Edition) 100% Verified Q&A + Answer Key Solutions
100% Guarantee Pass
📋 DOCUMENT OVERVIEW 72 Qs
This document, "NU 578 Advanced Pharm Unit 1," covers specific topics such as the history of
pharmaceutical regulation, drug excretion, the effects of poor nutrition on excretion, and
pharmacological concepts like parasympathetic antagonists and sympathetic and parasympathetic
systems. The document provides 72 questions with correct answers, allowing students to review and
understand key concepts. By studying and reviewing these questions, students can solidify their
knowledge and prepare for exams, making this document a valuable resource for advanced
pharmaceutical education.
✓ Verified Answers ✓ Exam Ready ✓ Study Guide
Trusted by thousands of students and professionals worldwide
EXAM QUESTIONS
QUESTION 1
1906
CORRECT ANSWER
1. Pure food and Drug Act (1906)
2. FDA may enforce drug STRENGTH and PURITY
3. Prohibits MISLABELING or ADULTERATION
4. Basis for DRUG RECALLS
QUESTION 2
1914
CORRECT ANSWER
1. Harrison Narcotic Act
2. Regulated opium, cocaine, MJ
3. Later replaced by controlled substance act (1970)
QUESTION 3
1938
CORRECT ANSWER
Trusted by thousands of students and professionals worldwide Page 1 of 17
, -Food, drug, cosmetic act (1938)
-Mandated SAFETY, not effectiveness
-Enforced by FDA through registration of all parties involves in manufacture, sale, distribution of drugs
QUESTION 4
(1952)
CORRECT ANSWER
Durham Humphrey Amendments
Seperated who prescribed vs dispensed. OTC vs prescription.
QUESTION 5
1962
CORRECT ANSWER
Kefaurer-Harris Amendments (1962)
1. Proof of EFFICACY and safety before interstate commerce
2. Guidelines for clinical trials
3. Established DESI (drug efficacy, study, implementation
QUESTION 6
1970
CORRECT ANSWER
Comprehensive Drug Abuse prevention and control act of 1970
-Established rehab programs for drug users
-Established DEA
-Regulated export/import of controlled substances
QUESTION 7
G. Poison Prevention Packaging Act (1970)
CORRECT ANSWER
1. regulates certain "household substances" and requires that they be packaged for consumer use in a
manner that will make them significantly difficult for children < 5 yr to open
2. patient may request noncomplying container
3. child-resistant container applies to:
a. all controlled drugs
b. all legend drugs except
i. sublingual nitroglycerin
ii. oral contraceptives in dispenser packs
c. aspirin or aspirin-containing preparations; some exceptions, e.g., effervescent tablets
d. iron-containing drugs and dietary supplements; some exceptions
QUESTION 8
Food and Drug Administration Modernization Act (FDAMA) 1997
CORRECT ANSWER
-Allows for fast-tracking of drugs for serious illnesses to market
-Drug manufacturers have to give patients 6 months notice before they discontinue making a drug
-Established a clinical trial database for drugs for critical illnesses
Trusted by thousands of students and professionals worldwide Page 2 of 17
, -Informs of "off-label" uses
-Incentives for pediatric drug research
QUESTION 9
•Best Pharmaceuticals for Children Act (BPCA) 2002
•Pediatric Research Equity Act 2003
CORRECT ANSWER
-Both promote drug studies in children
-See how existing drugs work in children and determine safety
-Set up pediatric drug trials
QUESTION 10
•FDA Amendments Act 2007
CORRECT ANSWER
•Drug safety legislation designed to monitor drugs once they are on the market
•Post-marketing safety, risk surveillance mandated to include 100 million patients
-Black Box Warnings—high risk!!
-Risk Evaluation Mitigation Strategies
-Dear Prescriber Letters
-Removal of unsafe drugs from the market quickly
QUESTION 11
New Drug Laws
CORRECT ANSWER
•Drug laws are dynamic!
•More than 120 new laws regarding the opioid crisis
•Good Samaritan Laws
-Defibrillators
-Narcan (Naloxone) administration
QUESTION 12
What is a controlled substance?
CORRECT ANSWER
•Prescription
•Potentially addictive
-Reinforcing
-Physically addicting
-Psychologically addicting
•Use is controlled by the Federal Government and monitored by both Federal and State Governments
QUESTION 13
Controlled substances classifications: Schedule I
CORRECT ANSWER
Schedule I - high abuse potential and no accepted medical use in U.S.
1. investigational drugs
2. opiates: heroin, many synthetic derivatives
Trusted by thousands of students and professionals worldwide
Page 3 of 17
