Misbranding - Study guides, Class notes & Summaries

Misbranding Correct Answer Drugs which are sold, dispensed or distributed in violation of labeling requirements of FDCA Adulterated or Misbranded?: False/misleading labeling Correct Answer Misbranded Adulterated or Misbranded?: Packaging fails to identify name & address of manufacturer, packager of distributor, and quantity of drug Correct Answer Misbranded Adulterated or Misbranded?: Any word or statement required on label is not prominent, conspicuous and readable Correct Answer Mi...

What is a statute? - correct answer -A law What is administrative law? - correct answer -Rules and regulations created by administrative agencies such as the FDA and Indiana Board of Pharmacy What was accomplished by the pure food and drug act of 1906? - correct answer -Prohibited adulteration and misbranding of foods and drugs in interstate commerce (does NOT include that misbranding includes false or misleading efficacy claims) What was accomplished by the food, drug, and cosmetic act...

Adulteration - ANSWERSSomething wrong with the preparation, strength, or purity of a product - making the product less pure Expired products - adulteration or misbranding? - ANSWERSAdulteration Contaminated drug packaging - adulteration or misbranding? - ANSWERSAdulteration Not meeting current good manufacturing practices (cGMP) - adulteration or misbranding? - ANSWERSAdulteration Using an unsafe coloring agent - adulteration or misbranding? - ANSWERSAdulteration Not meeting USP s...

Nevada MPJE Questions With Complete Solutions. True or false: "take as directed" does not fulfill the directions for use requirements for controlled substances. true. Controlled Rx must clearly specify dosage, frequency, and manner in which the drug is to be taken. How often must practitioners or other people who dispense controlled substances obtain registration from the DEA? every 2 years True or false: an agent or employee of a registered dispenser is not required to register with th...

Misbranding - Answer- Drugs which are sold, dispensed or distributed in violation of labeling requirements of FDCA Adulterated or Misbranded?: False/misleading labeling - Answer- Misbranded Adulterated or Misbranded?: Packaging fails to identify name & address of manufacturer, packager of distributor, and quantity of drug - Answer- Misbranded Adulterated or Misbranded?: Any word or statement required on label is not prominent, conspicuous and readable - Answer- Misbranded Adultera...

What did the Federal Controlled Substances Act do? Why was it implemented? 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? Prohibited the adulteration and misbranding of foods and drugs in interstate commerce; D...

Adulteration Something wrong with the preparation, strength, or purity of a product - making the product less pure Expired products - adulteration or misbranding? Adulteration Contaminated drug packaging - adulteration or misbranding? Adulteration Not meeting current good manufacturing practices (cGMP) - adulteration or misbranding? Adulteration Using an unsafe coloring agent - adulteration or misbranding? Adulteration Not meeting USP standards - adulterat...

Indiana MPJE Exam Review Questions Consisting Of 111 Questions With Verified Answers From Experts Which federal act discusses adulteration and misbranding of drugs? Food Drug and Cosmetic Act T/F Adulteration/Misbranding can occur with both a drug and a device. True T/F A drug must be contaminated to be considered adulterated. F - if held under unsanitary conditions where it MAYA have been contaminated A container that contains a drug is made of poisonous or harmful materials. However, ...

Administrative Procedure Act - correct answer federal law enacted in 1946, "notice and comment rulemaking" 1906: The Pure Food and Drug Act (PFDA) - correct answer interstate commerce labeling 1912 Pure Food and Drug Act - correct answer revised in 1912, stated that a drug was misbranded if its label contained a "false and fraudulent" statement regarding "curative or therapeutic effect." 1938 FD&C Act - correct answer • extended control to cosmetics and therapeutic de...

MISBRANDING definitions - Answer Labeling of a product that is false or misleading; label information must include directions for use; safe and/or unsafe dosages; manufacturer, packer, or distributor; quantity; and weight What does the FDA regulate? - Answer Food, drugs, cosmetics, Biologics, medical devices, Veterinary produccts, tobacco products. Does not regulate the practice of medicine or pharmacy.