Kefauver harris amendment Study guides, Class notes & Summaries

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...

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...

Texas MPJE, Ultimate Texas MPJE 2024 Already Graded A Texas pharmacist can administer all vaccines True What age can pharmacist administer influenza 7 What is the min age for all other vaccines 14 How many hours for nuclear training 700 hours State board is made up of how many members 11 How many pharmacists are on the state board 7 How many techs are on the state board 1 How many public members are on the state board? 3 What are pharmacists requirements to be on th...

Which of the following was NOT a requirement of the original Food Drug and Cosmetic Act of 1938? a) Proof of efficacy b) Proof of safety c) Authorized standards of identify d) Safe tolerances for unavoidable poisonous substances(1:1) - correct answer A: Proof of efficacy Which amendments to the FD&C Act resulted from the thalidomide tragedy? a) Durham-Humphrey Amendments b) Hatch-Waxman Act c) Controlled Substances Act d) Kefauver-Harris Amendments (1:2) - correct answer D: Kefauver-Harri...

Federal MPJE (2022/2023) Graded A+ What did the FDCA of 1938 accomplish? Food, Drug, and Cosmetic Act 1) Drugs must be safe prior to marketing 2) 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 prescription.". Ke...

Food Drug and Cosmetic Act of 1938 - correct answer 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 - correct answer Established Rx and OTC drug class; authorized verbal prescriptions and prescription refills Kefauver-Harris Amendment of 1962 - correct answer Required new drugs to be SAFE and EFFECTIVE; increased safety requirements for d...

Yes or no, do self defense sprays contain mase? correct answers No, and not sold to anyone under 18 Who can request an easy open container? correct answers Patient can, a prescriber cannot request all of them (only the one they prescribe) How many registered techs in a community pharmacy? correct answers Zero how many unlicensed personnel can assist one pharmacist? correct answers 4 If have 2 pharmacists, how many unlicensed personnel can you have? correct answers 8 If pass a law ...

CPHT 2024 Exam Questions with Correct Answers Food and Drug Administration - Answer-Leading fed. enforcement agency for regulations concerning drug products Drug Enforcement Agency - Answer-controls the distribution of drugs that can be easily abused Food and Drug act of 1906 - Answer-Government pre approval of drugs 1938 Food, Drug, and Cosmetic Act - Answer-New drugs must be safe before marketing; in response to 107 poisonings 2 Requirements in 1951 Durham-Humphrey Amendment - An...

According to the Quality System Regulation, when an investigation of a complaint is conducted all of the following are requirements for inclusion in the record of the investigation EXCEPT: A. The dates and results of the investigation B. The nature and details of the complaint C. Changes in procedures correcting quality problems D. Any reply to the complainant - Answer-C. A regulatory affairs professional wants to schedule a pre-NDA meeting with FDA. He or she should: A. Write a letter to...

2. Which source contains information specific to nutritional supplements? a. USP Dictionary of USAN & International Drug Names b. Natural Medicines Comprehensive Database c. United States Pharmacopoeia/National Formulary (USP NF) d. Drug Interaction Facts ANS: C United States Pharmacopoeia/National Formulary contains information specific to nutritional supplements. USP Dictionary of USAN & International Drug Names is a compilation of drug names, pronunciation guide, and possible future FDA...