Misbranded drug - Study guides, Class notes & Summaries
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Arizona MPJE exam 2023 with 100% correct answers
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Pure Food and Drug Act - correct answer 1906 - Forbade the manufacture or sale of mislabeled or adulterated food or drugs, it gave the government broad powers to ensure the safety and efficacy of drugs in order to abolish the "patent" drug trade. Still in existence as the FDA. 
 
The Food Drug and Comestic Act of 1938 - correct answer Established the Food and Drug Administration (FDA). Primarily regulates drug development, manufacturing, and marketing- focus on quality. Only safe and properl...
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Indiana MPJE Exam Review Questions 2022/2023 | Consisting Of 111 Questions With Verified Answers From Experts
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Indiana MPJE Exam Review Questions 2022/2023 | Consisting Of 111 Questions With Verified Answers From Experts 
 
Which federal act discusses adulteration and misbranding of drugs? 
Food Drug and Cosmetic Act 
T/F Adulteration/Misbranding can occur with both a drug and a device. 
True 
T/F A drug must be contaminated to be considered adulterated. 
F - if held under unsanitary conditions where it MAYA have been contaminated 
A container that contains a drug is made of poisonous or harmful material...
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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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TX MPJE LATEST UPDATE GRADED A+
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TX MPJE LATEST UPDATE GRADED A+ 
 
Food Drug and Cosmetic Act of 1938 Followed deaths by sulfanalimide elixier; required 
new drugs to be SAFE; established FDA as primary federal law dealing with food, drug, 
costmetic, and medical device safety 
 
Durham-Humphrey Act of 1951 Established Rx and OTC drug class; authorized verbal 
prescriptions and prescription refills 
 
Kefauver-Harris Amendment of 1962 Required new drugs to be SAFE and EFFECTIVE; 
increased safety requirements for drugs and est...
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NJ MPJE EXAM | QUESTIONS & ANSWERS (VERIFIED) | LATEST UPDATE | GRADED A+
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NJ MPJE EXAM | QUESTIONS & ANSWERS 
(VERIFIED) | LATEST UPDATE | GRADED 
A+ 
Neither _____ nor _____ are required by an *ANDA*. 
Correct Answer: -pre-clinical animal studies 
-clinical studies 
*bioequivalence only 
Prescription drug advertising is regulated by the _____, while OTC drug advertising is 
regulated by the _____. 
Correct Answer: -FDA 
-FTC (Federal Trade Commission) 
Any false or misleading statements in a drug advertisement could be considered _____. 
Correct Answer: -misbrand...
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Oberon's RAC Drugs Exam Questions With Complete Answers!!
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TEA process - 21 CFR 330-14 
add established ingredient to existing OTC monograph 
Request for Designation (RFD) - ask FDA if it is a drug, biological, device, combo 
HDE humanitarian device excempt - no effectiveness data required 
misbranded device - not cleared through 510k process (but needs one) 
adultered device - does not have PMA but needs one 
design input for device - requirements that must be met 
IDE (Investigational Device Exemption) - report within 5 working days: emergencies, use ...
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RAC Exam 2023/2024 with 100% correct answers
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Which division has primary jurisdiction over a vascular graft with an antibiotic based on primary mode of action? 
 
A. CDER 
B. CBER 
C. CDRH 
D. OCP - correct answer C. CDRH 
 
In this combination of a device and a drug, the primary mode of action is that of the vascular graft (device). The antibiotic is supportive in this case. 
 
A company wants to modify its legally marketed device such that the modification does not affect the intended use or alter the fundamental scientific technology o...
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Indiana MPJE Questions and Answers Already Passed
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Indiana MPJE Questions and Answers Already Passed Adulteration Something wrong with the preparation, strength, or purity of a product - making the product less pure 
Expired products - adulteration or misbranding? Adulteration 
Contaminated drug packaging - adulteration or misbranding? Adulteration 
Not meeting current good manufacturing practices (cGMP) - adulteration or misbranding? Adulteration 
Using an unsafe coloring agent - adulteration or misbranding? Adulteration 
Not meeting USP standa...
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NY MPJE || All Questions Answered Correctly.
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CSA correct answers Controlled Substances Act (enforced by the DEA) 
 
Poison Prevention Packaging Act correct answers Sets child-resistant drug packaging requirements, under US Consumer Product Safety Commission 
 
HIPAA correct answers set by the department of health and human services 
 
CMEA correct answers Control Methamphetamine Epidemic Act (CMEA)- pseudoephedrine containing product requirements 
 
Hatch-Waxman Act correct answers included the ANDA approval process for generic drugs 
 
in...
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KS MPJE Review Latest Update Graded A+
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KS MPJE Review Latest Update Graded A+ Pure Food and Drug Act of 1906 Focused on Purity and Quality Prohibited the interstate transfer of adulterated or misbranded drugs Recognized USP/NF Standards 
Food, Drug, and Cosmetic Act of 1938 Focused on Safety New drug cannot be marketed until proven safe (drugs prior to 1938 were exempt) Power given to Congress via authority over interstate commerce 
Durham-Humphrey Amendment of 1951 Established 2 classes of drugs: Rx and OTC Established provisions fo...
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