Misbranding - Study guides, Class notes & Summaries

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?

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

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...

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...

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?:

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...

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

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...

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 ...

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...