Pure food and drug act - Study guides, Class notes & Summaries

Pure Food and Drug Act of 1906Answer - prohibited the adulteration and misbranding of foods and drugs in interstate commerce Food, Drug, and Cosmetic Act of 1938Answer - Core of today's drug laws. No new drug can be marketed/sold until proven safe and approved by FDA. Labels must contain adequate directions for use and warnings about their habit-forming properties Durham-Humphrey Amendment of 1951Answer - Established two classes of medications: Rx and OTC. Authorized oral prescriptions...

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 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...

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 (FDCA) - Answer This act requires that manufacture prove a new drug is safe for human consumption. Toxicological studies - done on animals. Clinical trials - done on humans. Gave rise to the Food and Drug Administration. Manufacturer must submit New Drug Application (NDA) to...

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...

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...

what law prohibits the distribution of food and drugs that are misbranded or adulterated? Pure Food and Drug Act What is the system that can be used as an electronic substitute for DEA Form 222 when ordering Schedule II controlled substances? Controlled Substance Ordering System (CSOS) What agency is responsible for the federal Controlled Substances Act (CSA)? the DEA A pharmacist wants to know if generic warfarin tablets are bioequivalent to brand name Coumadin tablets. Where can this inf...

Respiratory Therapy - Lindsey Jones/Clinical Simulations 459 Questions with Verified Answers Information Gathering - Emphysema: (Abnormal condition of the alveoli resulting destruction and loss of elasticity) - CORRECT ANSWER LEVEL I : Cyanosis, Barrel chest, increased A-P diameter, Accessory muscle use, Digital clubbing of the nail beds, Significant history of smoking and/or occupational exposure to smoke or other pulmonary irritant LEVEL II : Dyspnea, Wheezing breath sounds LEVEL III ...

drug actions - ️️Mechanism of action Therapeutic effect Side effects Adverse effects Mild to severe reactions (anaphylaxis-life threatening) Drug interactions Pharmacokinetics legislation and standards for non parental medication - ️️Pure Food and Drug Act 1906 U.S. Food and Drug Administration (FDA) Institutional policies Official government agency NPA medication - ️️substance administered for the diagnosis, cure, treatment, or relief of a symptom or for prevention of ...

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...