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RAC US Exam Questions

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 safetyrisks 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



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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 thecompany's approved prescription drug products. Which of the following should be included in the advertisement to be in compliance with regulations?

A. Full prescribing informationB. A brief summary of the prescribing informationC. All the available names of the drug product and the established name of each of the active ingredients in the drug productD. A complete listing of adverse events

Answer: C






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 SaleB. Customs Tax StampsC. No clearance requiredD. FDA receipt for sample Form-484

Answer: C






Question No 4:

Which of the following activities is regulated by FDA?

A. Advertising of an OTC drugB. Advertising of a toothpaste that does not contain fluorideC. Refuse entry of an imported drug into USD. Placement of substances on a Class IV narcotic drug schedule

Answer: D






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 lastB. Establish written procedures describing the distribution of drug productsC. Establish a system whereby the oldest approved stock of a drug is distributed firstD. Establish a system by which the distribution of each lot can readily be tracked and thelot recalled if necessary

Answer: A






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 envelopesB. Use appropriate language on the outside of the mailing envelope that indicates thenature of the alertC. Notify FDA of its action prior to disseminating the dispensing alert notificationD. Include its name and address in the upper left hand corner of the envelope

Answer: C






Question No 7:

The Freedom of Information Act allows a manufacturer to:

A. Make claims about a product already commercially availableB. Obtain QC methods on a competitor's productC. Obtain the Drug/Device Master File of a competitor's productD. Obtain public documents on another manufacturer's product

Answer: D






Question No 8

Removal of a distributed product for a reason NOT subject to legal action by FDA is known as:

A. Product recallB. Stock recoveryC. Market withdrawalD. Corrective action

Answer: C






Question No 9:

The difference between advertising and professional labeling is:

A. Advertising can be directed only to consumers and professional labeling can bedirected only to professionals.B. Advertising must be accompanied by a PI while professional labeling must beaccompanied 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






Question No 10:

Distribution records for drug products must reference or contain all of the following EXCEPT:

A. Name and address of the consigneeB. Name and strength of the product and description of the dosage formC. Lot or control number and date and quantity shippedD. Purchase order number and date ordered

Answer: D








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