Misbranded drug - Study guides, Class notes & Summaries

FL CDR Sample questions module 9-15 already passed A quarantine area at Prescription drug wholesale distributor is used to store: A) Expired drugs B) Damaged drugs C) Misbranded drugs D) Adulterated drugs E) All of the above* Upon receipt of a prescription drug, prior to accepting the permittees inventory, a prescription drug wholesale distributor must perform which of the following tasks? A) Visually examine each outside shipping container for identity and to prevent accepting contaminated...

Florida MPJE: June 2023 Questions and Answers 100% correct Food, Drug, and Cosmetic Act 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 of 1987 - What 2 things does it regulate? Correct Answer-1) Regulates drug samples - prohibits sale/purchase/trade of samples 2) Bars re-importation of drugs Drug sample regulations Correct Answer-Samples can never be sold, purchased, nor traded - Samples may be distributed to practitioners that prescribe or to pharmacies at hospitals/clinics (on behalf of prescriber), but NOT to retail pharmacies - Samples must be stored appropriately and maintain receipt ...

MPJE – Michigan Questions and Answers Graded A+ Misbranding Drugs which are sold, dispensed or distributed in violation of labeling requirements of FDCA Adulterated or Misbranded?: False/misleading labeling Misbranded Adulterated or Misbranded?: Packaging fails to identify name & address of manufacturer, packager of distributor, and quantity of drug Misbranded Adulterated or Misbranded?: Any word or statement required on label is not prominent, conspicuous and readable Misbranded Adulte...

Form to send to DEA for destroying controls - correct answer DEA Form 41 Controlled substance theft/loss form? - correct answer DEA Form 106. Must also be sent to DPR. Doesn't define what you have to report; err on the side of caution! How long to send in theft/loss form? - correct answer 1 business day Do you need to report pseudophedrine as stolen? - correct answer Yes, but since it is not listed as a controlled substance under federal law, you do not fill out Form 106. Instead, you ...

(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...

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...

Form to send to DEA for destroying controls - correct answer DEA Form 41 Controlled substance theft/loss form? - correct answer DEA Form 106. Must also be sent to DPR. Doesn't define what you have to report; err on the side of caution! How long to send in theft/loss form? - correct answer 1 business day Do you need to report pseudophedrine as stolen? - correct answer No, it is a C5 under state law but not controlled under federal law Difference between detox and maintenance treatmen...

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

Pure Food and Drug Act - correct answer Prevents the manufacturing, sale/transportation of misbranded or adulturated drugs, poisoned or contaminated drugs Adultered drugs - correct answer Any drug that is not pure misbranded drug - correct answer Not labeled correctly FDCA (Federal Food, Drug, and Cosmetic act) - correct 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 FDA...