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

PA MPJE 2024 QUESTIONS AND ANSWERS GRADED A+ Generic drug companies can submit what two abbreviated drug applications? ANDA or 505(b)(2) application What is the key difference between an ANDA and 505(b)(2) application? Drugs submitted under ANDA must be bioequivalent and have same route of administration, strength, and formulation Drugs submitted under 505(b)(2) can have different strength or formulation What Act approved in March of 2020 includes OTC monograph reform? The CARES Ac...

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...

Pure Food and Drug Act (1906) aka Wiley Law - correct answer Prohibits adulteration and misbranding Food, Drug and Cosmetic Act (1938) - correct answer -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) - correct answer -Established prescription and OTC drug categories -Allowed for oral prescriptions -Allowed for refills Manufacturer label on Rx drugs after Durham-...

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...

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...

What did the Federal Controlled Substances Act do? Why was it implemented? - Answer Legislators very concerned in the 1960s about legal and illegal drugs being abused They were given the opportunity to design an act/law Created the DEA to promulgate and enforce the law Created a closed system between: manufacturer, distributors, prescriber, dispenser, and patient. What did the Pure Food and Drug Act of 1906 do? - Answer Prohibited the adulteration and misbranding of foods and ...

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...

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...

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

PTU Final Exam Guide Questions and CORRECT Answers Food, Drug, and Cosmetic Act of 1938 - Correct Answer- purity, strength, and safety Pure Food and Drug Act of 1906 - Correct Answer- forbade the manufacture or transport or sale of mislabeled or adulterated food or drugs and poisonous patent medicines.