Pure food and drugs act 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...

What legislation was created for the provisions for the fast track review of some NDA submissions to expedite approval of new drugs used to treat life-threatening conditions? - Food and Drug Administration (FDA) Modernization Act 1997 What legislation encouraged manufacturers to conduct research for new uses of drugs and to submit SNDAs for these uses? - FDA modernization act 1997 What act reduced the cose of orphan drugs? - Orphan drug act 1983 What act prohibited the adulteration or misb...

Pure Food and Drug Act (1906) aka Wiley Law Prohibits adulteration and misbranding Food, Drug and Cosmetic Act (1938) -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) -Established prescription and OTC drug categories -Allowed for oral prescriptions -Allowed for refills

What legistation was created for the provisions for the fast track review of some NDA submissions to expedite approval of new drugs used to treat life-threatening conditions? - ️️Food and Drug Administration (FDA) Modernization Act 1997 What legistation encouraged manufacturers to conduct research for new uses of drugs and to submit SNDAs for these uses? - ️️FDA modernization act 1997 What act reduced the cose of orphan drugs? - ️️Orphan drug act 1983 What act prohibited the...

NJ MPJE QUESTIONS AND ANSWERS ALREADY PASSED Neither _____ nor _____ are required by an *ANDA*. -pre-clinical animal studies -clinical studies *bioequivalence only Prescription drug advertising is regulated by the _____, while OTC drug advertising is regulated by the _____. -FDA -FTC (Federal Trade Commission) Any false or misleading statements in a drug advertisement could be considered _____. - misbranding Pure Food and Drug Act (1906) description -mandated accurate p...

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...

Behavioral Cues of Intoxication - Correct Answer-inhibitions impaired judgement slowed reactions loss of coordination inhibitions - Correct Answer-relaxed and talkative + could display mood swings. Judegement - Correct Answer-overly friendly, dancing or singing reactions - Correct Answer-thinking process has been affected. glassy/unfocused eyes. slurred speech . lost their train of thought coordination - Correct Answer-spill drinks, stumble, stagger. may have a difficult time handling t...

Virginia MPJE Questions and Answers Already Passed Legislative bodies that enact laws governing pharm practice in VA US congress and va general assembly primary regulatory bodies Federal Food & Drug Administration (FDA) federal drug enforcement *administration* (DEA) and the VA BOP majority are governed by DEA and VA BOP The Pure Food and Drug Act of ____ 1906 - Forbade the manufacture or sale of *-*mislabeled* or *adulterated* food or drugs, it gave the government broad powers to ensure the ...

(Updated) EXCPT Pharmacy Technician Exam Study Guide with complete solutions |Latest 2024/2025 1. Pure Food and Drug Act (1906) Prohibits interstate commerce of misbranded and adulterated drugs and foods. 2. Misbranded a drug product is misbranded if its labeling is inaccurate, incomplete, or misleading 3. Adulterated a drug product that fails to meet quality, strength, or purity standards 4. Federal Food, Drug, and CosRequires drug manufacturers to provide the FDA with evidence of saf...

EHST 2110 Final Exam Study Guide with Complete SolutionsEHST 2110 Final Exam Study Guide with Complete SolutionsEHST 2110 Final Exam Study Guide with Complete SolutionsEHST 2110 Final Exam Study Guide with Complete Solutions The deliberate addition of inferior or cheaper materials to a pure food product in order to stretch out supplies and increase profits is referred to as: - ANSWER - adulteration As a result of adulteration, Congress passed the _________________. One of the first federal l...