Hatch waxman act of 1984 - Study guides, Class notes & Summaries
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PTU FINAL EXAM
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PTU FINAL EXAM 
 
Food, Drug, and Cosmetic Act of 1938 
purity, strength, and safety 
Pure Food and Drug Act of 1906 
forbade the manufacture or transport or sale of mislabeled or adulterated food or drugs and poisonous patent medicines. 
Durham-Humphrey Amendment of 1951 
• Created a distinction between "OTC" and "Legend Drugs". 
Patient Package Insert (PPI) 
Manufacturer's patient product information included with the product package. 
Hatch-Waxman Act of 1984 
promoted the manufacturin...
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PTU Final Exam Questions And Answers
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PTU Final Exam Questions And Answers 
 
Food, Drug, and Cosmetic Act of 1938 - ANS purity, strength, and safety 
 
Pure Food and Drug Act of 1906 - ANS forbade the manufacture or transport or sale of mislabeled or adulterated food or drugs and poisonous patent medicines. 
 
Durham-Humphrey Amendment of 1951 - ANS • Created a distinction between "OTC" and "Legend Drugs". 
 
Patient Package Insert (PPI) - ANS Manufacturer's patient product information included with the product ...
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PTU Study Guide Questions with 100% Correct Answers Graded A+
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PTU Study Guide Questions with 100% Correct Answers Graded A+ 
According to HIPAA, which is considered protected health information? 
 
- Co-pay amount 
- Prescriber's phone number 
- Patient's prescription record 
- Product's NDC number 
Patient's prescription record 
 
 
Which law requires the pharmacist to consult about new prescriptions with patients? 
 
- DSHEA 
- Hatch-Waxman Act 
- HIPPA 
- OBRA '90 
OBRA '90 
 
 
Which act requires putting a child-resistant cap on Mr. Dunn's Neur...
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PTU Final Exam 2024 Questions and Answers
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PTU Final Exam 2024 Questions and Answers 
Food, Drug, and Cosmetic Act of 1938 -Answer-purity, strength, and safety 
Pure Food and Drug Act of 1906 -Answer-forbade the manufacture or transport or sale of 
mislabeled or adulterated food or drugs and poisonous patent medicines. 
Durham-Humphrey Amendment of 1951 -Answer-• Created a distinction between "OTC" and 
"Legend Drugs". 
Patient Package Insert (PPI) -Answer-Manufacturer's patient product information included with 
the product packa...
-
PTU Final Exam questions with correct answers
- Exam (elaborations) • 19 pages • 2023
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Food, Drug, and Cosmetic Act of 1938 - Answer purity, strength, and safety 
 
Pure Food and Drug Act of 1906 - Answer forbade the manufacture or transport or sale of mislabeled or adulterated food or drugs and poisonous patent medicines. 
 
Durham-Humphrey Amendment of 1951 - Answer • Created a distinction between "OTC" and "Legend Drugs". 
 
Patient Package Insert (PPI) - Answer Manufacturer's patient product information included with the product package. 
 
Hatch-Waxman Act of 1...
And that's how you make extra money
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MPJE (Michigan Law) Latest Update Graded A
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MPJE (Michigan Law) Latest Update Graded A Hatch-Waxman Act In 1984 this allowed greater access for companies to dispense generic drugs. 
Drugs companies must submit this for a generic drug: Abbreviated New Drug Application (ANDA) 
ANDA process Does not require companies to repeat animal and clinical research on ingredients. 
ANDA Process applies to drugs made after: 1962 
Generic drug has to match with the following: Identity, Strength, Purity and Quality (ISPQ) 
If a drug has an NDC does it gu...
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PTU FINAL EXAM
- Exam (elaborations) • 11 pages • 2023
- Available in package deal
-
- $12.49
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PTU FINAL EXAM 
 
Food, Drug, and Cosmetic Act of 1938 
purity, strength, and safety 
Pure Food and Drug Act of 1906 
forbade the manufacture or transport or sale of mislabeled or adulterated food or drugs and poisonous patent medicines. 
Durham-Humphrey Amendment of 1951 
• Created a distinction between "OTC" and "Legend Drugs". 
Patient Package Insert (PPI) 
Manufacturer's patient product information included with the product package. 
Hatch-Waxman Act of 1984 
promoted the manufacturin...
-
PTU FINAL EXAM
- Exam (elaborations) • 11 pages • 2024
-
- $9.99
- + learn more
PTU FINAL EXAM 
 
Food, Drug, and Cosmetic Act of 1938 
purity, strength, and safety 
Pure Food and Drug Act of 1906 
forbade the manufacture or transport or sale of mislabeled or adulterated food or drugs and poisonous patent medicines. 
Durham-Humphrey Amendment of 1951 
• Created a distinction between "OTC" and "Legend Drugs". 
Patient Package Insert (PPI) 
Manufacturer's patient product information included with the product package. 
Hatch-Waxman Act of 1984 
promoted the manufacturin...
-
PTU Rite Aid Final Exam 2023-2024 Questions and Answers 100% Verified!
- Exam (elaborations) • 11 pages • 2024
- Available in package deal
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Food, Drug, and Cosmetic Act of 1938 - ANSWER-purity, strength, and safety 
 
Pure Food and Drug Act of 1906 - ANSWER-forbade the manufacture or transport or sale of mislabeled or adulterated food or drugs and poisonous patent medicines. 
 
Durham-Humphrey Amendment of 1951 - ANSWER-• Created a distinction between "OTC" and "Legend Drugs". 
 
Patient Package Insert (PPI) - ANSWER-Manufacturer's patient product information included with the product package. 
 
Hatch-Waxman Act of 1984 - AN...
-
PTU FINAL EXAM
- Exam (elaborations) • 11 pages • 2024
-
- $10.49
- + learn more
PTU FINAL EXAM 
 
Food, Drug, and Cosmetic Act of 1938 
purity, strength, and safety 
Pure Food and Drug Act of 1906 
forbade the manufacture or transport or sale of mislabeled or adulterated food or drugs and poisonous patent medicines. 
Durham-Humphrey Amendment of 1951 
• Created a distinction between "OTC" and "Legend Drugs". 
Patient Package Insert (PPI) 
Manufacturer's patient product information included with the product package. 
Hatch-Waxman Act of 1984 
promoted the manufacturin...
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