Fdca amendment - Study guides, Class notes & Summaries

What did the Federal Controlled Substances Act do? Why was it implemented? - correct 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? - correct answer -Prohibited the adulteration and misbranding of...

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 2 | P a g e : Federal Insecticide, Fungicide, and Rodenticide Act SARA Title III : Superfund Amendment and Reauthorization Act (1986). Federal mandate. Requires MSDS - material data safety s...

PTCE Exam Questions and Answers 100% Pass Pure Food and Drug Act - Answer- Prevents the manufacturing, sale/transportation of misbranded or adulturated drugs, poisoned or contaminated drugs Adultered drugs - Answer- Any drug that is not pure misbranded drug - Answer- Not labeled correctly FDCA (Federal Food, Drug, and Cosmetic act) - Answer- drugs must comply with standards of safety and efficacy, more modern act than Pure Food and Drug Act. Oversees safety of food, drugs and cosmetics F...

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...

PTCE Exam Questions and Answers 100% Pass Pure Food and Drug Act - Answer- Prevents the manufacturing, sale/transportation of misbranded or adulturated drugs, poisoned or contaminated drugs Adultered drugs - Answer- Any drug that is not pure misbranded drug - Answer- Not labeled correctly FDCA (Federal Food, Drug, and Cosmetic act) - Answer- drugs must comply with standards of safety and efficacy, more modern act than Pure Food and Drug Act. Oversees safety of food, drugs and cosmetics F...

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 correct answersa. 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. a and b e. a, b and c. correct answerse. route of admin...

PTU STUDY GUIDE QUESTIONS AND ANSWERS Generic for Effexor? venlafaxine 1 tsp>>ml 5ml 1 tbsp>>ml, tsp 15ml, 3tsp 1oz>>ml 30ml 1pt >>ml, oz 480 ml , 16oz 1gal>>ml 3785 ml 1kg>lbs 2.2lbs 1lb>>gm, oz 454gm, 16oz 65mg>>grain 1 grain Federal Food and Drug Act of 1906 • Known as the Pure Food and Drug Act. • Provided authority for federal inspection of meat products and prohibited the sale of adulterated foods. • Required that ...

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 - correct answer -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. a and b e. a, b and c. - correct answer -e. route of...

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.". Kefauver-Harris Amendment of 1962 1) ...

PTU STUDY GUIDE 2024 QUESTIONS AND ANSWERS Generic for Effexor? -Answer-venlafaxine 1 tsp>>ml -Answer-5ml 1 tbsp>>ml, tsp -Answer-15ml, 3tsp 1oz>>ml -Answer-30ml 1pt >>ml, oz -Answer-480 ml , 16oz 1gal>>ml -Answer-3785 ml 1kg>lbs -Answer-2.2lbs 1lb>>gm, oz -Answer-454gm, 16oz 65mg>>grain -Answer-1 grain Federal Food and Drug Act of 1906 -Answer-• Known as the Pure Food and Drug Act. • Provided authority for federal inspection of meat pr...