Misbranded drug - Study guides, Class notes & Summaries
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FL CDR Sample questions module 9-15 already passed
- Exam (elaborations) • 31 pages • 2023
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FL CDR Sample questions module 9-15 already passed 
A quarantine area at Prescription drug wholesale distributor is used to store: A) Expired drugs 
B) Damaged drugs 
C) Misbranded drugs 
D) Adulterated drugs E) All of the above* 
Upon receipt of a prescription drug, prior to accepting the permittees inventory, a prescription drug wholesale distributor must perform which of the following tasks? A) Visually examine each outside shipping container for identity and to prevent accepting contaminated...
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Florida MPJE: June 2023 Questions and Answers 100% correct
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Florida MPJE: June 2023 Questions and Answers 100% correct 
Food, Drug, and Cosmetic Act of 1938 
Due to sulfanilamide elixir deaths 
 
New drugs must be SAFE before marketing 
 
Established the FDA 
 
 
 
Durham-Humphrey Amendment of 1951 
Created OTC vs. Legend drugs 
 
Verbal prescriptions 
 
Prescription refills 
 
 
 
Kefauver-Harris Amendment of 1962 
"Drug Efficacy Amendment" 
 
New drugs must be SAFE and EFFICACIOUS 
 
Established GMPs 
 
FDA oversees prescription drug advertising 
 
 ...
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PHCY 722 - Law Exam #2 Questions with Correct Answers
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Prescription Drug Marketing Act of 1987 
- What 2 things does it regulate? Correct Answer-1) Regulates drug samples - prohibits sale/purchase/trade of samples 
2) Bars re-importation of drugs 
 
Drug sample regulations Correct Answer-Samples can never be sold, purchased, nor traded 
- Samples may be distributed to practitioners that prescribe or to pharmacies at hospitals/clinics (on behalf of prescriber), but NOT to retail pharmacies 
- Samples must be stored appropriately and maintain receipt ...
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MPJE – Michigan Questions and Answers Graded A+
- Exam (elaborations) • 75 pages • 2023
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MPJE – Michigan Questions and Answers Graded A+ Misbranding Drugs which are sold, dispensed or distributed in violation of labeling requirements of FDCA 
Adulterated or Misbranded?: 
False/misleading labeling Misbranded 
Adulterated or Misbranded?: 
Packaging fails to identify name & address of manufacturer, packager of distributor, and quantity of drug Misbranded 
Adulterated or Misbranded?: 
Any word or statement required on label is not prominent, conspicuous and readable Misbranded 
Adulte...
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ILLINOIS MPJE EXAM 2024 WITH 100% CORRECT ANSWERS
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Form to send to DEA for destroying controls - correct answer DEA Form 41 
 
Controlled substance theft/loss form? - correct answer DEA Form 106. Must also be sent to DPR. Doesn't define what you have to report; err on the side of caution! 
 
How long to send in theft/loss form? - correct answer 1 business day 
 
Do you need to report pseudophedrine as stolen? - correct answer Yes, but since it is not listed as a controlled substance under federal law, you do not fill out Form 106. Instead, you ...
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(Updated) EXCPT Pharmacy Technician Exam Study Guide with complete solutions |Latest 2024/2025
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(Updated) EXCPT Pharmacy Technician Exam Study Guide with complete solutions |Latest 2024/2025 
1. Pure Food and 
Drug Act (1906) 
Prohibits interstate commerce of misbranded and adulterated drugs and foods. 
2. Misbranded a drug product is misbranded if its labeling is inaccurate, 
incomplete, or misleading 
3. Adulterated a drug product that fails to meet quality, strength, or purity 
standards 
4. Federal Food, 
Drug, and CosRequires drug manufacturers to provide the FDA with 
evidence of saf...
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NJ MPJE QUESTIONS AND ANSWERS ALREADY PASSED
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NJ MPJE QUESTIONS AND ANSWERS 
 
ALREADY PASSED 
 
Neither _____ nor _____ are required by an *ANDA*. -pre-clinical animal studies 
 
-clinical studies 
 
*bioequivalence only 
 
Prescription drug advertising is regulated by the _____, while OTC drug advertising is regulated 
by the _____. -FDA 
 
-FTC (Federal Trade Commission) 
 
Any false or misleading statements in a drug advertisement could be considered _____. - 
misbranding 
 
Pure Food and Drug Act (1906) description -mandated accurate p...
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ILLINOIS MPJE EXAM 2024 WITH 100% CORRECT ANSWERS
- Exam (elaborations) • 33 pages • 2024
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Form to send to DEA for destroying controls - correct answer DEA Form 41 
 
Controlled substance theft/loss form? - correct answer DEA Form 106. Must also be sent to DPR. Doesn't define what you have to report; err on the side of caution! 
 
How long to send in theft/loss form? - correct answer 1 business day 
 
Do you need to report pseudophedrine as stolen? - correct answer No, it is a C5 under state law but not controlled under federal law 
 
Difference between detox and maintenance treatmen...
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MPJE – Michigan Questions and Answers with Certified Solutions
- Exam (elaborations) • 75 pages • 2024
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Misbranding Drugs which are sold, dispensed or distributed in violation of labeling 
requirements of FDCA 
Adulterated or Misbranded?: 
False/misleading labeling Misbranded 
Adulterated or Misbranded?: 
Packaging fails to identify name & address of manufacturer, packager of distributor, and quantity 
of drug Misbranded 
Adulterated or Misbranded?: 
Any word or statement required on label is not prominent, conspicuous and readable 
Misbranded 
Adulterated or Misbranded?:
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PTCE Exam 2024 with 100% correct answers
- Exam (elaborations) • 19 pages • 2023
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Pure Food and Drug Act - correct answer Prevents the manufacturing, sale/transportation of misbranded or adulturated drugs, poisoned or contaminated drugs 
 
Adultered drugs - correct answer Any drug that is not pure 
 
misbranded drug - correct answer Not labeled correctly 
 
FDCA (Federal Food, Drug, and Cosmetic act) - correct 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 
 
FDA...
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