And cosmetic act of 1938 Study guides, Class notes & Summaries

Test Bank For Abrams’ Clinical Drug Therapy Rationales for Nursing Practice 12th Edition (Geralyn Frandsen, 2024) All Chapters 1-56 , Latest Guide A+. Chapter 1 : The Foundation of Pharmacology: Quality and Safety : 1.A woman diagnosed with obsessive–compulsive disorder has been prescribed oral paroxetine hydrochloride. What is the expected effect for this prescription? A. Curative effect on symptoms B. Systemic effect on symptoms C. Local effect on symptoms D. Parenteral effect on sy...

Ohio MPJE 2024 Questions and Answers Graded A+ Federal Food, Drug, and Cosmetic Act of 1938 The "Pillar of Pharmacy Law"; gave authority to FDA to oversee safety of food, drugs, and cosmetics Adulteration Contains any poisonous or deleterious substance which may render it injurious to users when used as directed Misbranded Drug that's labeling or packaging is false or misleading; contains incorrect drug, pt name, prescriber name, or directions Durham-Humphrey Amendment of 19...

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...

1. Pure Food and Drug Act of 1906 (Wiley Act) ANS Prevents adulteration and mis- branding Drugs met standard of strength/quality/purity according to USP/NF 2. Food, Drug, and Cosmetic Act of 1938 ANS Required manufacturer to prove drug safety prior to marketing it Also defined/regulated ANS adulteration, misbranding, interstate commerce 3. Durham Humphrey Amendment of 1951 ANS Divided medications into OTC and prescription (legend) drugs 4. Kefauver-Harris Amendment of 1962 ANS Manufact...

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...

MPJE Michigan, Questions and answers, 100% proven pass rate. 2022/2023. Document Content and Description Below MPJE Michigan, Questions and answers, 100% proven pass rate. 2022/2023. Which prescription type is good for 12 months - Noncontrolled and schedule 5 Which prescription type is good for 6 months - Schedule 3-4 Which prescription type is good for 90 days - Schedule 2 Max refills for non control - 11 Max refills for schedule 5 - 11 Max refills for schedule 3-4 - 5 Max refills for schedul...

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...

Medication Aide medical terminologyAnatomy - correct answer Structure of body parts Assay - correct answer Identifying and measuring the ingredients of a drug in a laboratory Bioassay - correct answer Identifying the amount of a specific drug that is needed to produce a certain effect in a patient Chemical name - correct answer Given by the chemist, which describes the chemical structure Controlled substance - correct answer Potentially dangerous drug, tne sale and use of the drug is...

Virginia MPJE Exam Questions and Answers 100% CorrectVirginia MPJE Exam Questions and Answers 100% CorrectVirginia MPJE Exam Questions and Answers 100% CorrectVirginia MPJE Exam Questions and Answers 100% Correct Who pass law (legislative body) that govern pharmacy practice in VA? - ANSWER-U.S congress and VA general assembly Who regulate (regulative body) pharmacy practice in VA? - ANSWER-FDA, DEA, and VA Board of Pharmacy What is the Pure Food and Drug Act of 1906? - ANSWER-Prohibits th...

PTU Quiz Questions, (0%-50%) with correct Answers Which act governs patient privacy and the sharing of patient information? A. The Drug Privacy Act of 1972 B. The Food, Drug, and Cosmetic Act of 1938 C. The Omnibus Budget Reconciliation Act of 1990 D. The Health Insurance Portability and Accountability Act of 1996 (HIPAA) - Ans ️️ -D According to HIPAA, when you use and disclose only the amount of protected patient information you need, it is known as: A. Abbreviated information rule...