Misbranding - Study guides, Class notes & Summaries
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Culinary Arts; Questions and Answers 100% Correct
- Exam (elaborations) • 12 pages • 2024
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Culinary Arts; Questions and Answers 100% 
Correct 
USDA Prime Correct answer-You are responsible for purchasing steak for a five-star, highend restaurant which serves only the best. Which of the following quality grades of beef would 
you purchase for the restaurant? 
Meat Inspection Act Correct answer-In 1906, which act was passed to prevent 
adulteration and misbranding and misbranding of meat products?
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NJ MPJE Questions and Answers 100% Solved
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NJ MPJE Questions and Answers 100% 
Solved 
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 product labeling a...
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Alabama MPJE | Questions and answers with 100% correct solutions | Graded A+
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Pure Food and Drug Act (1906) aka Wiley Law Prohibits adulteration and misbranding 
Food, Drug and Cosmetic Act (1938) -New drug could not be marketed unless safe 
-Required manufacturer label to have directions for use and warnings about habit forming drugs 
Durham-Humphrey Amendment (1951) -Established prescription and OTC drug categories 
-Allowed for oral prescriptions 
-Allowed for refills
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Florida MPJE Latest Version Already Passed
- Exam (elaborations) • 72 pages • 2024
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Florida MPJE Latest Version Already Passed Durham-Humphrey Amendment Created 2 classes of drugs: OTC and Rx 
Kefauver-Harris Amendment This requires drug manufacturers to provide proof of safety and efficacy. 
Drug Importation Florida allows drug importation from Canada, but no plan has been approved yet by the HHS 
Drug Quality and Security Act - DSQA distinguishes compounding from manufacturing 
503A vs 503B facilities 503A: may only compound persuant to a prescription and are regulated by sta...
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MPJE – Michigan Questions and Answers with Certified Solutions
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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?:
Too much month left at the end of the money?
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WGU Course D398 Intro to Pharmacology CORRECT 100%
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Drug Standards - ANSWER rules set to assure that consumers get what they pay for, that all preparations by the same drug name must be of uniform strength, quality, and purity 
 
1906 Pure Food and Drug Act - ANSWER Prohibits the sale and transport of adulterated or mislabeled food, drinks and drugs. 
Prohibits the mislabeling and misbranding of products. 
 
1938 Food, Drug, and Cosmetic Act - ANSWER created to enforce rules such as labeling, drug approval before release, and warning labels (such...
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NJ MPJE Questions and Answers Already Passed
- Exam (elaborations) • 159 pages • 2024
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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
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Multistate Pharmacy Jurisprudence Exam (MPJE) Review (FEDERAL LAW)
- Exam (elaborations) • 24 pages • 2022
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Food and Drug Administration Correct Answer: a federal agency in the Department of Health and Human Services established to regulate the release of new foods and health-related products 
 
(P)FDA Correct Answer: Pure Food and Drug Act of 1906 
 
Federal Food, Drug, and Cosmetic Act of 1938 (6/25/38) Correct Answer: FDCA 
 
Poison Prevention Packaging Act of 1970 Correct Answer: PPPA 
 
Controlled Substance of 1970 Correct Answer: CSA 
 
Controlled Substance Act of 1970 Correct Answer: What...
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Florida MPJE: June 2023 Questions and Answers 100% correct
- Exam (elaborations) • 25 pages • 2023
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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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TX MPJE LATEST UPDATE GRADED A+
- Exam (elaborations) • 75 pages • 2024
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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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