RAC US Exam Questions

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7. Question No 1: Which of the following is NOT TRUE regarding post-approval pharmacovigilance for a drug? A. It is intended to detect all medically important adverse effects and uncommon safety risks in the "real world" of clinical practice. B. Health professionals report all adverse drug reactions associated with the use of a marketed drug. C. Adverse effects from products in the same pharmacologic class as the marketed drug must be considered along with those for the marketed drug. D. Serious and unexpected adverse drug reactions in patients treated with the product outside the United States need to be reported within 15 days after initial notification. Answer: B https://www.exams4sure.net/raps/rac-us-exam-questions-dumps.html

8. Question No 2: The marketing department has designed a journal advertisement that mentions leadership in a particular therapeutic area and includes only the name of the company's approved prescription drug products. Which of the following should be included in the advertisement to be in compliance with regulations? A. Full prescribing information B. A brief summary of the prescribing information C. All the available names of the drug product and the established name of each of the active ingredients in the drug product D. A complete listing of adverse events Answer: C https://www.exams4sure.net/raps/rac-us-exam-questions-dumps.html

9. Question No 3: What additional FDA clearances are required to export a drug approved by FDA when the drug will be used for its approved use? A. Certificate of Free Sale B. Customs Tax Stamps C. No clearance required D. FDA receipt for sample Form-484 Answer: C https://www.exams4sure.net/raps/rac-us-exam-questions-dumps.html

10. Question No 4: Which of the following activities is regulated by FDA? A. Advertising of an OTC drug B. Advertising of a toothpaste that does not contain fluoride C. Refuse entry of an imported drug into US D. Placement of substances on a Class IV narcotic drug schedule Answer: D https://www.exams4sure.net/raps/rac-us-exam-questions-dumps.html

11. Question No 5: With respect to drug product distribution procedures, a distributor is required to do all of the following EXCEPT: A. Establish a system whereby the oldest approved stock of a drug is distributed last B. Establish written procedures describing the distribution of drug products C. Establish a system whereby the oldest approved stock of a drug is distributed first D. Establish a system by which the distribution of each lot can readily be tracked and the lot recalled if necessary Answer: A https://www.exams4sure.net/raps/rac-us-exam-questions-dumps.html

12. Question No 6: Because of reported dispensing errors due to the similarity of proprietary drug names, one of the companies involved has decided to quickly and voluntarily notify physicians and others responsible for providing patient care about the issue via a "Dispensing Error Alert". In this approach, the company is NOT required to: A. Use first class mail and number 10 white envelopes B. Use appropriate language on the outside of the mailing envelope that indicates the nature of the alert C. Notify FDA of its action prior to disseminating the dispensing alert notification D. Include its name and address in the upper left hand corner of the envelope Answer: C https://www.exams4sure.net/raps/rac-us-exam-questions-dumps.html

13. Question No 7: The Freedom of Information Act allows a manufacturer to: A. Make claims about a product already commercially available B. Obtain QC methods on a competitor's product C. Obtain the Drug/Device Master File of a competitor's product D. Obtain public documents on another manufacturer's product Answer: D https://www.exams4sure.net/raps/rac-us-exam-questions-dumps.html

14. Question No 8 Removal of a distributed product for a reason NOT subject to legal action by FDA is known as: A. Product recall B. Stock recovery C. Market withdrawal D. Corrective action Answer: C https://www.exams4sure.net/raps/rac-us-exam-questions-dumps.html

15. Question No 9: The difference between advertising and professional labeling is: A. Advertising can be directed only to consumers and professional labeling can be directed only to professionals. B. Advertising must be accompanied by a PI while professional labeling must be accompanied by a brief summary. C. Advertising can be directed to either consumers or professionals while professional labeling can be directed only to consumers. D. Advertising must be accompanied by a brief summary and professional labeling must be accompanied by a PI. Answer: D https://www.exams4sure.net/raps/rac-us-exam-questions-dumps.html

16. Question No 10: Distribution records for drug products must reference or contain all of the following EXCEPT: A. Name and address of the consignee B. Name and strength of the product and description of the dosage form C. Lot or control number and date and quantity shipped D. Purchase order number and date ordered Answer: D https://www.exams4sure.net/raps/rac-us-exam-questions-dumps.html

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