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Exam (elaborations)

Federal MPJE Practice Questions and Answers Latest 2023

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Federal MPJE Practice Questions and Answers Latest 2023 Which of the following ingredients has special labeling requirements if it is included in a product? A. Gelatin B. FD&C Yellow No. 5 C. High fructose corn syrup D. Sorbitol E. Xanthan gum - B. FD&C Yellow No. 5 Several ingredients such as FD&C Yellow No. 5, aspartame, wintergreen oil, mineral oil, salicylates, sulfites, Ipecac syrup, and alcohol have special labeling requirements under federal regulations. The presence of FD&C Yellow No. 5 must be disclosed and the product must include a warning in the "precautions" section about the potential for allergic reaction in certain susceptible patients. A pharmacy dispenses and distributes a total of 50,000 doses of controlled substances in a 12 month period. How many doses is the pharmacy able to transfer to another pharmacy without registering as a distributor? A. 500 doses B. 1,000 doses C. 2,500 doses D. 5,000 doses E. 10,000 doses - C. 2,500 doses The 5% rule states that a pharmacy does not have to register with the DEA as a distributor if the total quantity of controlled substances distributed during a 12-month period does not exceed 5% of the total quantity of all controlled substances dispensed and distributed during that period. Over-the-counter (OTC) drug advertising is regulated by: A. Federal Trade Commission B. Food and Drug Administration C. Drug Quality and Security Commission D. Consumer Product Safety Commission E. None of the above - A. Federal Trade Commission OTC drug advertising is regulated by the Federal Trade Commission (FTC). Prescription drug advertising is regulated by the Food and Drug Administration (FDA). Which law first required new drugs to be proven safe and effective for their claimed use? A. Food, Drug, and Cosmetic Act B. Durham-Humphrey Amendment C. Kefauver-Harris Amendment D. Prescription Drug Marketing Act E. Drug Quality and Security Act - C. Kefauver-Harris Amendment The Kefauver-Harris Amendment of 1962 required new drugs to be proven safe and effective for their claimed use. It also established good manufacturing practices for manufacturing of drugs, and gave FDA jurisdiction over prescription drug advertising. A patient is admitted to a hospital and does not remember the names of the medications that she takes at home. The hospital pharmacist calls the patient's outpatient pharmacy to obtain a list of medications. Which of the following is true? A. This is a HIPPA violation unless the patient has given signed consent for the information to be given to the hospital pharmacy B. This is a HIPAA violation unless the patient has given verbal consent for the information to be given to the hospital pharmacy C. This is a HIPAA violation unless the patient has given written and verbal consent for the information to be given to the hospital pharmacy D. This is not a HIPAA violation because HIPAA does not apply to patients being treated in a hospital setting E. This is not a HIPAA violation because the information is being given to the hospital pharmacy for treatment purposes - E. This is not a HIPAA violation because the information is being given to the hospital pharmacy for treatment purposes. HIPAA permits the use of protected health information (PHI) for treatment purposes. This information can be given to anyone involved in the patient's care, and does not require written or verbal consent.

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Uploaded on
August 29, 2023
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