Fdca amendment - Study guides, Class notes & Summaries
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PTU STUDY GUIDE QUESTIONS AND ANSWERS
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PTU STUDY GUIDE QUESTIONS AND ANSWERS 
 
Generic for Effexor? 
venlafaxine 
1 tsp>>ml 
5ml 
1 tbsp>>ml, tsp 
15ml, 3tsp 
1oz>>ml 
30ml 
1pt >>ml, oz 
480 ml , 16oz 
1gal>>ml 
3785 ml 
1kg>lbs 
2.2lbs 
1lb>>gm, oz 
454gm, 16oz 
65mg>>grain 
1 grain 
Federal Food and Drug Act of 1906 
• Known as the Pure Food and Drug Act. 
• Provided authority for federal inspection of meat products and prohibited the sale of adulterated foods. 
• Required that ...
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NYSDEC Pesticide Applicators Exam | Questions & 100% Correct Answers (Verified) | Latest Update | Grade A+
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How long must you keep pesticide records in NYS? 
: 3 Years 
What is the 3 tier system? 
: Certified Applicator, Technician, Apprentice 
EPA 
: Environmental Protection Agency 
NYSDEC 
: New York State Department of Environmental Conservation (Lead Agency in 
NY) 
ESA 
: Endangered Species Act 
FIFRA 
2 | P a g e 
: Federal Insecticide, Fungicide, and Rodenticide Act 
SARA Title III 
: Superfund Amendment and Reauthorization Act (1986). Federal mandate. 
Requires MSDS - material data safety s...
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PTCE Exam Questions and Answers 100% Pass
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PTCE Exam Questions and Answers 100% Pass 
Pure Food and Drug Act - Answer- Prevents the manufacturing, sale/transportation of 
misbranded or adulturated drugs, poisoned or contaminated drugs 
Adultered drugs - Answer- Any drug that is not pure 
misbranded drug - Answer- Not labeled correctly 
FDCA (Federal Food, Drug, and Cosmetic act) - Answer- drugs must comply with 
standards of safety and efficacy, more modern act than Pure Food and Drug Act. 
Oversees safety of food, drugs and cosmetics 
F...
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Florida MPJE 2023 (100% verified with complete answers)
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Food, Drug, and Cosmetic Act of 1938 correct answers Due to sulfanilamide elixir deaths 
 
New drugs must be SAFE before marketing 
 
Established the FDA 
 
Durham-Humphrey Amendment of 1951 correct answers Created OTC vs. Legend drugs 
 
Verbal prescriptions 
 
Prescription refills 
 
Kefauver-Harris Amendment of 1962 correct answers "Drug Efficacy Amendment" 
 
New drugs must be SAFE and EFFICACIOUS 
 
Established GMPs 
 
FDA oversees prescription drug advertising 
 
Prescription Drug Market...
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PTCE Exam Questions and Answers 100% Pass
- Exam (elaborations) • 19 pages • 2024
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PTCE Exam Questions and Answers 100% Pass 
Pure Food and Drug Act - Answer- Prevents the manufacturing, sale/transportation of 
misbranded or adulturated drugs, poisoned or contaminated drugs 
Adultered drugs - Answer- Any drug that is not pure 
misbranded drug - Answer- Not labeled correctly 
FDCA (Federal Food, Drug, and Cosmetic act) - Answer- drugs must comply with 
standards of safety and efficacy, more modern act than Pure Food and Drug Act. 
Oversees safety of food, drugs and cosmetics 
F...
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KANSAS - Pharmacy Law Practice Exam 2023 with 100% complete solutions
- Exam (elaborations) • 33 pages • 2023
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Which FDCA amendment exempted certain drugs from the "adequate directions for use" labeling requirement if they bear "Rx only" on their labels? 
a. Durham Humphrey 
b. Kefauver-Harris 
c. Prescription Drug Marketing 
d. Waxman-Hatch correct answersa. Durham Humphrey 
 
The FDCA defines a "new drug" as a previously approved drug entity with a new: 
a. route of administration. 
b. indication for use. 
c. combination of ingredients. 
d. a and b 
e. a, b and c. correct answerse. route of admin...
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PTU STUDY GUIDE QUESTIONS AND ANSWERS
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PTU STUDY GUIDE QUESTIONS AND ANSWERS 
 
Generic for Effexor? 
venlafaxine 
1 tsp>>ml 
5ml 
1 tbsp>>ml, tsp 
15ml, 3tsp 
1oz>>ml 
30ml 
1pt >>ml, oz 
480 ml , 16oz 
1gal>>ml 
3785 ml 
1kg>lbs 
2.2lbs 
1lb>>gm, oz 
454gm, 16oz 
65mg>>grain 
1 grain 
Federal Food and Drug Act of 1906 
• Known as the Pure Food and Drug Act. 
• Provided authority for federal inspection of meat products and prohibited the sale of adulterated foods. 
• Required that ...
-
Pharmacy Law Practice Exam 2023 with 100% correct answers
- Exam (elaborations) • 24 pages • 2023
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Available in package deal
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- $17.49
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Which FDCA amendment exempted certain drugs from the "adequate directions for use" labeling requirement if they bear "Rx only" on their labels? 
a. Durham Humphrey 
b. Kefauver-Harris 
c. Prescription Drug Marketing 
d. Waxman-Hatch - correct answer -a. Durham Humphrey 
 
The FDCA defines a "new drug" as a previously approved drug entity with a new: 
a. route of administration. 
b. indication for use. 
c. combination of ingredients. 
d. a and b 
e. a, b and c. - correct answer -e. route of...
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Federal MPJE (2022/2023) Graded A+
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What did the FDCA of 1938 accomplish? 
Food, Drug, and Cosmetic Act 
1) Drugs must be safe prior to marketing 
2) Established the FDA - Food, Drug, Cosmetic, Medical device safety 
Durham-Humphrey Amendment of 1951 
• Created a distinction between "OTC" and "Legend Drugs/Prescription". 
• Authorized verbal prescriptions/refills 
• Required Legend Drugs to carry the statement: 
"Caution: Federal law prohibits dispensing without a prescription.". 
Kefauver-Harris Amendment of 1962 
1) ...
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PTU STUDY GUIDE 2024 QUESTIONS AND ANSWERS
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PTU STUDY GUIDE 2024 QUESTIONS AND ANSWERS 
Generic for Effexor? -Answer-venlafaxine 
1 tsp>>ml -Answer-5ml 
1 tbsp>>ml, tsp -Answer-15ml, 3tsp 
1oz>>ml -Answer-30ml 
1pt >>ml, oz -Answer-480 ml , 16oz 
1gal>>ml -Answer-3785 ml 
1kg>lbs -Answer-2.2lbs 
1lb>>gm, oz -Answer-454gm, 16oz 
65mg>>grain -Answer-1 grain 
Federal Food and Drug Act of 1906 -Answer-• Known as the Pure Food and Drug Act. 
• Provided authority for federal inspection of meat pr...
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