Cosmetic act of 1938 - Study guides, Class notes & Summaries

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...

Who pass law (legislative body) that govern pharmacy practice in VA? - correct answer U.S congress and VA general assembly Who regulate (regulative body) pharmacy practice in VA? - correct answer FDA, DEA, and VA Board of Pharmacy What is the Pure Food and Drug Act of 1906? - correct answer Prohibits the shipment of adulterated or misbranded drugs in interstate commerce -have to meet quality and purity standards What is the Food, Drug, and Cosmetic Act of 1938? - correct answer Law tha...

The nursing process - correct answer The nursing process is a system that guides the nurse's work in a logical way The 9 RIGHT'S of medication administration - correct answer Right patient Right time Right drug Right route Right dose Right to refuse Right documentation Right reason Right response Federal Food, Drug, and Cosmetic Act of 1938 - correct answer A. The act is an update of the Food and Drug Act first passed in 1906. B. It designates United States Pharmacopeia ...

Food, Drug, and Cosmetic Act of 1938 correct answers Due to sulfanilamide elixir deaths New drugs must be SAFE before marketing Established the FDA Durham-Humphrey Amendment of 1951 correct answers Created OTC vs. Legend drugs Verbal prescriptions Prescription refills Kefauver-Harris Amendment of 1962 correct answers "Drug Efficacy Amendment" New drugs must be SAFE and EFFICACIOUS Established GMPs FDA oversees prescription drug advertising Prescription Drug Market...

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...

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...

WGU COURSE D398 INTRO TO PHARMACOLOGY EXAM QUESTIONS AND ANSWERS LATEST GUIDE 2024/2025 GRADED A+. 2 / 13 1. Drug Standards: rules set to assure that consumers get what they pay for, thatall preparations by the same drug name must be of uniform strength, quality, and purity 2. 1906 Pure Food and Drug Act: Prohibits the sale and transport of adulteratedor mislabeled food, drinks and drugs. Prohibits the mislabeling and misbranding of products. 3. 1938 Food, Drug, and Cosmetic Act: creat...

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...

CSA correct answers Controlled Substances Act (enforced by the DEA) Poison Prevention Packaging Act correct answers Sets child-resistant drug packaging requirements, under US Consumer Product Safety Commission HIPAA correct answers set by the department of health and human services CMEA correct answers Control Methamphetamine Epidemic Act (CMEA)- pseudoephedrine containing product requirements Hatch-Waxman Act correct answers included the ANDA approval process for generic drugs in...

Maryland MPJE Questions and Answers Already Passed Pure Food and Drug Act of 1906 (Wiley Act) Prevents adulteration and misbranding Drugs met standard of strength/quality/purity according to USP/NF Food, Drug, and Cosmetic Act of 1938 Required manufacturer to prove drug safety prior to marketing it Also defined/regulated: adulteration, misbranding, interstate commerce Durham Humphrey Amendment of 1951 Divided medications into OTC and prescription (legend) drugs Kefauver-Harris Amendment of 1...