Fdca amendment - Study guides, Class notes & Summaries

Florida MPJE 2024 Verified Answers Food, Drug, and Cosmetic Act (FDCA) of 1938 Due to sulfanilamide elixir deaths New drugs must be SAFE before marketing Established the FDA Durham-Humphrey Amendment of 1951 Created OTC vs. Legend drugs Verbal prescriptions Prescription refills Kefauver-Harris Amendment of 1962 "Drug Efficacy Amendment" New drugs must be SAFE AND EFFICACIOUS Established GMPs FDA oversees prescription drug advertising Prescription Drug Marketing Act...

Federal MPJE (2022/2023) Graded A+ What did the FDCA of 1938 accomplish? Food, Drug, and Cosmetic Act 1) Drugs must be safe prior to marketing 2) 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 prescription.". Ke...

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

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...

KANSAS - Pharmacy Law Practice Exam Questions (2024/2025) Already Graded A Which FDCA amendment exempted certain drugs from the "adequate directions for use" labeling requirement if they bear "Rx only" on their labels? a. Durham Humphrey b. Kefauver-Harris c. Prescription Drug Marketing d. Waxman-Hatch a. Durham Humphrey The FDCA defines a "new drug" as a previously approved drug entity with a new: a. route of administration. b. indication for use. c. combination of ingredients. d...

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...

TX MPJE LATEST UPDATE GRADED A+ Food Drug and Cosmetic Act of 1938 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 Established Rx and OTC drug class; authorized verbal prescriptions and prescription refills Kefauver-Harris Amendment of 1962 Required new drugs to be SAFE and EFFECTIVE; increased safety requirements for drugs and est...

NYSDEC Pesticide Applicators Exam Study Guide Latest Update Graded A+ How long must you keep pesticide records in NYS? 3 Years What is the 3 tier system? Certified Applicator, Technician, Apprentice EPA Environmental Protection Agency NYSDEC New York State Department of Environmental Conservation (Lead Agency in NY) ESA Endangered Species Act FIFRA Federal Insecticide, Fungicide, and Rodenticide Act SARA Title III Superfund Amendment and Reauthorization Act (1986). Federal...

What are the four Elements of Negligence? - Answer Duty Breach of Duty Causation Damages What are pharmacists legal duties? - Answer Mechanical (Dispensing): Duty of Accuracy Intellectual (Cognitive) Factors that determine a pharmacist Duty to Not Fill: - Answer (1) The relationship between parties (2) Foreseeability of the harm (3) Public policy issues Risk Assessment - Answer Required for choice of drug decisions, requires patient-specific medical knowledge; Pr...

Pest Control Technician Exam Latest Update Graded A+ Cholinesterase enzyme produced in the liver how do carbamates and organophosphates affect Cholinesterase? - organophosphate insecticides inhibit cholinesterase activity - carbamate insecticides inhibit cholinesterase activity Cultural Control Control of agricultural pests through environmental techniques, such as crop rotation and maintenance of native vegetation Biological Control the control of a pest by the introduction ...