The fdca - Study guides, Class notes & Summaries

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 ...

Florida MPJE Study Guide 2024 Seamon Already Graded A Sherman Antitrust Act This act: Outlaws agreements that restrain trade. Prevent monopolies and mergers that lessen competition Federal Food Drug and Cosmetic Act This act states: No adulterated or misbranded drugs in interstate commerce Adulteration Gross - Think inside the capsule Misbranded Improperly labeled - think outside the bottle FDCA This act requires: ingredients are disclosed on bottle drug must be proven safe before marketing...

KANSAS - Pharmacy Law Practice Exam Questions (2024/2025) Already Graded A Which FDCA amendment exempted certain drugs from the "adequate directions for use" labeling requirement if they bear "Rx only" on their labels? a. Durham Humphrey b. Kefauver-Harris c. Prescription Drug Marketing d. Waxman-Hatch a. Durham Humphrey The FDCA defines a "new drug" as a previously approved drug entity with a new: a. route of administration. b. indication for use. c. combination of ingredients. d...

Florida MPJE 2023/2024 Latest Update Graded A+ Food, Drug, and Cosmetic Act (FDCA) 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 Prescription Drug Marketing Act of 1987 Prev...

Florida MPJE Exam Questions and Answers 100% Pass Sherman Antitrust Act - Correct Answer ️️ -This act: Outlaws agreements that restrain trade. Prevent monopolies and mergers that lessen competition Federal Food Drug and Cosmetic Act - Correct Answer ️️ -This act states: No adulterated or misbranded drugs in interstate commerce Adulteration - Correct Answer ️️ -Gross - Think inside the capsule Misbranded - Correct Answer ️️ -Improperly labeled - think outside the bottle F...

What year was FIFRA Enacted? A. 1936 B. 1947 C. 1978 D. 1988 : B. 1947 What are the required amounts for general liability insurance? A. 500,000/1,000,000 B. 400,000 C. 250,000/500,000 D. None required as of September 2003 : C. 250,000/500,000 Where are termite ideas mixed? A. Kitchen sink 2 | P a g e B. On job site C. At office D. At home : B. On job site Which agency oversees stored pesticides at facility? A. OSHA B. FDACS C. DEP D. FDCA : D. FDCA Where would you put v...

Federal MPJE (2024/2025) Exam Questions and Answers 100% Solved What did the FDCA of 1938 accomplish? Food, Drug, and Cosmetic Act Drugs must be safe prior to marketing Established the FDA - Food, Drug, Cosmetic, Medical device safety Durham-Humphrey Amendment of 1951 Created a distinction between "OTC" and "Legend Drugs/Prescription". Authorized verbal prescriptions/refills Required Legend Drugs to carry the statement: "Caution: Federal law prohibits dispensing without a presc...

What federal law established the FDA? - correct answer Federal Food Drug and Cosmetic Act (FDCA) What federal law separated OTCs from prescription medications? - correct answer Durham-Humphrey What federal law created Good Manufacturing Practices and required drugs proven 'safe and effective'? - correct answer Kefauver-Harris What is the required warning for salicylate use in children? - correct answer Reye's Syndrome What federal law established laws regarding samples? - correct ...

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...

KANSAS - Pharmacy Law Practice Exam Questions Already Graded A Which FDCA amendment exempted certain drugs from the "adequate directions for use" labeling requirement if they bear "Rx only" on their labels? a. Durham Humphrey b. Kefauver-Harris c. Prescription Drug Marketing d. Waxman-Hatch a. Durham Humphrey The FDCA defines a "new drug" as a previously approved drug entity with a new: a. route of administration. b. indication for use. c. combination of ingredients. ...