Pharmacy Law Unite 1 Ver4

Which of the following would be correct regarding ephedra products? [A] They are properly on the market as drugs [B] They are properly on the market as dietary supplements [C] They are no longer on the market [D] A & B

C

Pursuant to the Prescription Drug Marketing Act, a prescriber can receive samples from a manufacturer by which of the following procedures: [A] Execute a written request on a proper form each time the prescriber wants samples [B] Execute a standing written request for samples [C] Request the samples orally from the manufacturer's representative [D] The manufacturer can supply the samples without request [E] A, B or C are acceptable procedures

A

Which of the following about US Courts of Appeals is INCORRECT? A. They are referred to as "circuit courts" B. When a panel of 3 US Court of Appeals judges hear a case, it is an "en banc" proceeding C. They decide whether the trial court applied the correct law to the facts D. There are 13 federal Courts of Appeals

B

A Florida pharmacist is NOT legally permitted to dispense a drug written by an out-of-state practitioner. A. True B. False

B

Which of the following is NOT a sanction that can be handed down by the board of pharmacy? A. Fines B. Jail time C. License Revocation D. Probation E. None - all of the above can be handed down by the board

B

A drug is defined as a "new drug" under the FDCA if: [A] It has not been generally recognized by experts as safe and effective for the use recommended in the labeling [B] It has not been used to a material extent or for a material time under the conditions recommended in the labeling [C] It was marketed after 1906 [D] A & B [E] A, B & C

D

A product contains a Category X pregnancy warning. This means: [A] The drug may not be dispensed to pregnant women [B] There is no demonstrated risk to the fetus as determined from studies in pregnant women [C] There is no demonstrated risk to the fetus as determined from animal studies and no adequate studies in pregnant women [D] There is a demonstrated risk to the fetus as determined in studies of animals or humans

D

Judge-made law is referred to as: A. Civil law B. Stare decisis C. Dictum D. Rules E. Common law

E

Pursuant to the Poison Prevention Packaging Act a community pharmacy may [A] Reuse a child-resistant container if it is glass or threaded plastic [B] Dispense a non-child-resistant container upon a patient's request, but only if the request is in writing [C] Dispense a non-child-resistant container if in the pharmacist's professional judgment it is appropriate. [D] A & B [E] A, B & C

A

Tax-free alcohol may be used: [A] By hospital pharmacies for compounding medications for inpatients [B] By hospital pharmacies for compounding medications for outpatients [C] By community pharmacies for compounding medications [D] A & B [E] A, B & C

A

Terfiline, the established drug name, is manufactured by 3 companies in a 10mg strength. One of the 3 products is OTC and the other 2 are RX only. They all have identical labels. Which of the following statements is correct? I. The OTC product was likely switched via an SNDA. II. FDA likely added an OTC monograph for the switch. III. A pharmacist may legally sell the RX only products as OTC. A. I only B. II only C. III only D. I & III only E. II & III only

A

The sulfanilamide elixer tragedy of 1937 resulted in the government passing the Food, Drug and Cosmetic Act (FDCA) of 1938 that specified which one of the following: [A] That new drugs must have FDA approval prior to marketing [B] That all new drugs must be proven safe and effective [C] That the FDCA did not apply to pharmacist dispensing [D] That drugs marketed before 1938 and after 1938 are considered new drugs

A

Which of the following would be correct regarding Medication Guides (MedGuides)? [A] Failure by a pharmacy to dispense a MedGuide when required violates the FDCA [B] MedGuides replaced PPIs [C] CMI can be dispensed in place of a MedGuide [D] A & B [E] A & C

A

A generic drug manufacturer applying for an ANDA filed a paragraph IV patent certification alleging that the patent owner's drug product is invalid. Which of the following would be correct? [A] If the patent owner does not sue and the ANDA is approved, the generic manufacturer will receive 180 days of marketing exclusivity [B] If the patent owner sues, the FDA cannot rule on the ANDA for 30 months, unless a court issues a final ruling that the patent is invalid before then. [C] If the patent owner sues and a court issues a final ruling in favor of the patent holder, the generic manufacturer can still file the ANDA after 30 months. [D] A & B [E] B & C

D

A pharmacist received vials of an injectable drug. The solution containing the drug has always been clear, but the vials the pharmacist received contained a pink tinted solution. Even though the pharmacist has dispensed hundreds of vials in the past he did not notice the color difference and dispensed the vial for injection. The drug was contaminated and the patient was harmed. The FDA investigated. Which of the following would be the best answer pursuant to the FDCA? [A] The pharmacist could only violate the Act if he was negligent [B] The pharmacist violated the Act [C] The pharmacist violated the Act, but probably acted in good faith [D] The pharmacist violated the Act and probably did not act in good faith.

D

A drug manufacturer sent brochures about the drug to prescribers. Which of the following would be the most important determination as to whether the brochures are labeling? [A] Whether the brochures can be considered as accompanying the drug [B] Whether the brochures contain advertising [C] Whether the brochures include the label information [D] Whether the brochures contained false information

A

A drug's NDC number is 55555-4444-22. The first segment of numbers (i.e. "55555") represents the: A. Manufacturer. B. Dosage form. C. Strength. D. Package size. E. Drug type.

A

A manufacturer made a powder from corn stalks and compressed it into tablets for oral use. The manufacturer made no claims or representations about the product. This product could best be described as: [A] Dietary supplement [B] Food supplement [C] Food [D] Medical food

A

A manufacturer markets a drug in two different strengths. The lower strength is OTC and the higher strength is prescription. The best reason for this difference is likely: [A] The two products have different indications [B] The lower strength product is less toxic [C] The lower strength drug is being illegally marketed [D] The manufacturer chose to sell the two products in this manner for marketing purposes

A

A pharmacist dispensing a prescription drug would violate the FDCA labeling laws if: [A] The label stated the name of a drug not in the container [B] The label did not contain the identification of the dispensing pharmacist [C] The label did not contain the expiration date of the drug [D] The label did not contain the patient's address

A

A physician wishes to treat a patient with an IND drug currently in Phase II. Which one of the following would be correct? [A] This might be possible but only if the patient has a serious or immediately life threatening disease or condition [B] The law does not allow IND drugs to be used for treatment purposes [C] The law allows a physician to treat any patient with an IND drug without restriction

A

Assume that the FDA just issued a proposed regulation to set new labeling requirements for prescription drugs. This proposed regulation would be published in: A. The Federal Register B. The Code of Federal Regulations C. Both the Federal Register and the Code of Federal Regulations

A

Congress enacts which of the following: A. Laws B. Ordinances C. Regulations D. Laws and Regulations E. Laws, Ordinances and Regulations

A

For the purposes of DESI, the FDA created which of the following as a means for generic drugs marketed between 1938 and 1962 to obtain approval: [A] The ANDA [B] The SNDA [C] The Paper NDA [D] B & C [E] A, B & C

A

Which of the following accurately describe(s) whether a pharmacy-compounded drug is a new drug for the purposes of the FDCA? [A] Pursuant to FDA interpretation it is a new drug [B] Pursuant to FDA interpretation it is not a new drug [C] The U.S. Supreme Court has ruled it is not a new drug [D] A & C [E] B & C

A

Which of the following statements about generic substitution in FL is CORRECT? A. Pharmacists must substitute brand drugs with less-expensive generics (should they exist) unless the words "Medically Necessary" appear on the faces of presented RXs. B. All pharmacies must establish a formulary of generic & brand-name drugs which, if selected as the drug of choice, would not pose a threat to the health & safety of patients receiving them. C. All pharmacies must establish a formulary of generic & brand name drugs that are determined to demonstrate clinically significant biological or therapeutic inequivalence & which, if substituted, would pose a threat to the health & safety of patients receiving them. D. All of the above E. A & B only

A

Which of the following was NOT one of the goals of the FDA Safety & Innovation Act of 2012? A. Establish ingredient-labeling requirements for inactive ingredients contained in OTC products B. Establish provisions to reduce drug counterfeiting C. Block the import of adulterated products D. Enhance the exchange of RX diversion information across state lines E. Give FDA the authority to regularly inspect drug manufacturers' production sites located outside the US

A

Which one of the following would be the best answer as to whether a pharmacy that compounds a commercially available product pursuant to a prescription is manufacturing? [A] It could be considered as manufacturing unless the pharmacy compounds only small quantities and there is a patient medical need to do so. [B] It would always be considered as manufacturing. [C] It could not be considered as manufacturing if the pharmacy does not profit from the prescription [D] It could not be considered as manufacturing.

A

Which of the following statements about members of the FL board of pharmacy is INCORRECT? A. One member must be 65 y/o or older. B. Five members are pharmacists practicing in any pharmacy setting. C. All pharmacist members must have been practicing pharmacy for at least 4 yrs. D. One member must practice in a community pharmacy. E. Two members are non-pharmacists with no pharmacy affiliations.

A (60 years old)

A dietary supplement manufacturer contracted with a pharmacy to include the pharmacy's name on television ads for the product as a place where the product may be purchased. Unknown to the pharmacy, the ads contained false and misleading statements. The FTC sued the manufacturer and the pharmacy. Which of the following would be correct? [A] The manufacturer would be liable for false advertising, but not the pharmacy [B] Both the manufacturer and the pharmacy would be liable for false advertising [C] Neither the manufacturer or the pharmacy would be liable for false advertising

B

A hospital has excess inventory of drug products. Local community pharmacies would like to purchase the excess inventory since they can buy the products for less from the hospital than from the wholesaler. Which of the following would be the best answer: [A] The hospital could sell inventory to the pharmacies provided it charged the same amount as the wholesaler [B] The hospital could sell inventory to the pharmacies for emergency reasons to alleviate a temporary shortage [C] The hospital could sell inventory to the pharmacies without restriction [D] The hospital could not sell inventory to the pharmacies

B

A manufacturer made a health claim for its dietary supplement product that has never been approved by the FDA by regulation or through the significant scientific agreement test. Evidence does exist, however, to support the claim. Which of the following would be correct as a result of the Pearson decision? [A] The FDA would always allow the claim [B] The FDA would not allow the claim [C] The FDA would likely allow the claim without being qualified

B

A patient sued a pharmacist for failing to warn her of the interaction of two drugs she was taking which resulted in her injury. The pharmacist filed a motion prior to trial agreeing that the pharmacist did not warn the patient, but contended a pharmacist has no legal duty to do so. This motion would be called: [A] A motion for a summary judgment [B] A motion for a directed verdict [C] A motion for a judgment notwithstanding the facts [D] A motion for voir doir

B

A pharmacist counsels patients that certain dietary supplements might be effective for particular diseases even though there is little to no proof of their efficacy in those diseases. Which of the following would be correct? [A] The pharmacist is likely violating the FDCA [B] The pharmacist is not violating the FDCA, provided he is counseling and not promoting [C] The pharmacist is not likely violating the FDCA regardless whether he is promoting or counseling.

B

A pharmacist dispensed the wrong drug that caused injury to a patient. The patient sued both the pharmacy and pharmacist. This action would be deemed: [A] An administrative action [B] A civil action [C] A criminal action [D] A & B [E]A, B & C

B

A plaintiff sued a pharmacist for dispensing the wrong drug that caused her injury. The pharmacist contended she did not dispense the wrong drug and the case went to trial. The jury decided that the pharmacist did dispense the wrong drug. If the pharmacist wanted to appeal on the basis that she did not dispense the wrong drug, which of the following would be the most likely result: [A] The appeal would be granted since a losing party has the right to appeal [B] The appeal would not be granted since this is a question of fact [C] The appeal would be granted since this is a question of fact [D] The appeal would not be granted since this is a question of law [E] The appeal would be granted since this is a question of law

B

Adequate information for use in a drug's labeling means: [A] That the directions are adequate for a patient to take the drug safely and for the purposes intended [B] That the directions are adequate for a health care professional, not the patient [C] That the information in the labeling is adequate, but could be better [D] That the drug in an OTC drug

B

Assume in the above example that the manufacturer made no claim or representation about its product for the use in eczema, but rather a consumer accidently found it effective for treating eczema and advertised this result on the Internet. Which would be correct? [A] The FDA would likely regard the product as a drug [B] The FDA would not likely regard the product as a drug

B

Assume that the Supreme Court of Arizona issued an opinion that pharmacists have a legal duty to warn the prescriber and the patient if a prescription is written for a dangerously high dosage. Which one of the following would be correct? A This is merely an opinion and carries no authority B This opinion would be binding on all lower courts in Arizona C This opinion would be considered by lower courts in Arizona but is not binding D This opinion would be binding on all courts in the country

B

Black Box" warnings are: (I) Used widespread. (II) Prominently placed in the PI. (III) Extremely effective. A. I only B. II only C. III only D. I & II only E. I, II, & III

B

Comparing criminal cases to civil cases, which one of the following would be correct. [A] The burden of proof is much higher in a civil case [B] Defendants have more rights in a criminal trial [C] Defendants can plead "nolo contendere" in either civil or criminal cases [D] A grand jury can serve indictments in civil or criminal cases

B

Discovery is the process in a civil lawsuit where: [A] The defendant discovers who is suing him or her [B] Each side finds out the other side's facts, evidence and witnesses [C] Jury members are selected [D] The proper court is determined

B

In order for a live educational program for pharmacists to be considered independent and objective and thus not subject to the advertising and labeling laws of the FDCA, the program cannot: [A] Accept any funding from a drug manufacturer [B] Allow the drug manufacturer to influence the content [C] Provide free meals to pharmacist attendees [D] A & B [E] A, B & C

B

Overuse of an antibiotic is an example of which type of market failure? A. Public goods B. Externalities C. Natural monopolies D. Information asymmetry

B

Part C of the drug definition excludes food from articles intended to affect the function or structure of the body. Congress likely intended which of the following by this exclusion: [A] That foods cannot affect the function or structure of the body [B] That foods are only excluded when used for their ordinary purpose as foods [C] That foods under no circumstances can be considered drugs [D] That foods are really drugs

B

The FDA rated a new drug as P2 for the purposes of the NDA process. This could mean: [A] The drug is a new salt or ester form and offers only minor improvements over existing drugs [B] The drug is a new salt or ester form and has important advantages to other drugs on the market [C] The drug is a new dosage form or formulation and has important advantages to other drugs on the market [D] The drug is a new combination of products and has important advantages to other drugs on the market

B

The USP beyond-use date is the same as the manufacturer's expiration date. [A] True [B] False

B

The requirements in order for a pharmacist to substitute a generic drug for the prescribed drug are established by: [A] The FDCA [B] State law [C] The Orange Book [D] Professional judgment

B

Which of the following acts must be reported to the FL Department of Health pursuant to the state's prescription drug monitoring program? a. An MD directly administering a controlled substance medication to a patient in the ER b. A pharmacist dispensing a 30-day supply of a CIII drug to an adult patient c. A certified optometrist administering a controlled substance medication to a child d. A physician administering a controlled substance medication to a nursing home resident e. A dentist administering a controlled substance medication to a prisoner

B

Which of the following would be correct regarding consumer medication information (CMI)? [A] Federal law mandates that it be dispensed to patients [B] About 71% of CMI is deemed "useful" [C] About 50% of patients actually receive CMI [D] A & B [E] B & C

B

Which one of the following would be the best answer regarding direct-to-consumer (DTC) advertising? [A] The FDCA specifically exempts it from the advertising requirements of the Act Off-label uses may be promoted provided they are accompanied with a statement the use is not approved by the FDA [B] A manufacturer may avoid compliance with the advertising requirements of the Act by meeting the "adequate provision requirements [C] The FDA can screen DTC broadcast ads before they run and enjoin them if necessary

B

A dentist issued a prescription to a patient for an oral contraceptive and for the purpose of preventing contraception. This prescription would likely be (best answer): [A] Valid since a dentist has prescriptive authority under state law [B] Valid since a dentist has prescriptive authority under federal law [C] Invalid since the dentist has exceeded the scope of his practice under state law [D] Invalid since the dentist has exceeded the scope of his practice under federal law

C

A drug in which of the following pregnancy category contains the following statement in its labeling, "Drug should be used in pregnancy if the potential benefits justifies the potential risk to the fetus?" A. A B. B C. C D. D E. X

C

A manufacturer initiated a Class I recall of its product. This means: [A] The product may cause temporary or reversible adverse health consequences. [B] The product is not likely to cause adverse health consequences [C] The product has a reasonable probability of causing serious adverse health consequences or death [D] The product may continue to be dispensed.

C

A manufacturer made a powder from corn stalks and compressed it into tablets for oral use.The manufacturer promoted the product for the purpose of improving gastric motility. This claim would likely mean that the product would be considered: [A] A drug [B] A food [C] A dietary supplement [D] A & C [E] A, B & C

C

A pharmacist received a bottle of cephalosporin capsules. Unknown to the pharmacist, the [capsule] also contained small amounts of penicillin. The pharmacist dispensed the capsule to a patient who is allergic to penicillin and who then suffered an anaphylactic shock. Which of the following best describes this scenario? I. The drug was misbranded. II. The drug was adulterated. III. The pharmacist has violated the FDCA. IV. The pharmacist will face sanction by FDA. A. II only B. I & II only C. I, II, & III only D. II, III & IV only E. I, II, III, & IV

C

An Oregon pharmacist dispensed a prescription drug to an Oregon patient requiring the accompaniment of a Medication Guide under federal law, but did not include the Medication Guide. Which of the following would be correct: [A] The federal government has no jurisdiction to charge the pharmacist because of the Tenth Amendment [B] The federal government has jurisdiction to charge the pharmacist because of the Tenth Amendment [C] The federal government has jurisdiction to charge the pharmacist because the transaction would be considered in interstate commerce [D] The federal government has no jurisdiction to charge the pharmacist since the transaction was not in interstate commerce

C

Class III medical devices include: [A] Stethoscopes [B] Infusion pumps [C] Pacemakers [D] A & C [E] B & C

C

Drug product P is the original patented drug product. X, Y and Z are generic drug products to P. The Orange Book classifies X as A rated to P, and Y and Z as B rated to P. Which of the following would be correct? [A] X, Y & Z are considered therapeutically equivalent to P [B] Y & Z are considered therapeutically equivalent to one another [C] P and X are considered therapeutically equivalent to one another [D] B & C

C

Emergency contraception (Plan B) may be sold over-the-counter: [A] From any retail business that sells OTC drugs [B] Only to a female purchaser over 16 years of age [C] To a purchaser over 16 years of age [D] A & B [E] A & C

C

FL University Hospital applies to the FL board of pharmacy for a pharmacy permit in order to open an outpatient pharmacy that will dispense drugs to patients being discharged, as well as to employees of the University. Assuming no complications, what pharmacy permit will the board grant? A. Class I institutional pharmacy B. Modified Class II institutional pharmacy C. Community pharmacy D. Class II institutional pharmacy E. None of the above

C

Infant formulas best fit under the definition of: [A] Dietary supplement [B] Food supplement [C] Special dietary food [D] Medical food [E] Drug

C

Pursuant to the Drug Price Competition and Patent Term Restoration Act of 1984 for a generic drug to be approved under an ANDA the manufacturer must prove: [A] Safety [B] Efficacy [C] Bioequivalence [D] A & B [E] A, B & C

C

The U.S. Supreme Court has jurisdiction over: [A] All cases [B] Only cases brought on appeal [C] Any case where a state is a party [D] Administrative decisions from state agencies [E] B, C & D

C

The term "authorized generic" best means: [A] A generic drug approved by the FDA by means of an ANDA [B] A generic drug approved by the FDA by means of an NDA [C] A generic version of the brand name drug made by the innovator manufacturer [D] The brand name drug after its patent expires.

C

Which of the following always requires FDA approval before implementation by the manufacturer? I. Changes to strengthen the warnings II. Changes in the container size III. Changes to the way the drug is synthesized A. I only B. II only C. III only D. I & II only E. I, II, & III

C

Which of the following best describes laws that are related to pharmacy practice? A. They are a substitute for good professional judgment B. They are sufficient to achieve professional success if followed C. They describe the best general approach to specific practice situations D. They prescribe behavior for every situation a pharmacist will encounter

C

Which of the following is directly enacted by state legislatures: I) Ordinances; II) Regulations; III) State constitutions? A. I only B. II only C. III only D. I & II only E. I, II, & III only

C

Which of the following statements about controlled substances (CS), when inserted into the blank makes the next sentence TRUE? A Florida pharmacist must never dispense_______: a. CS listed in Schedule II unless she has a signed RX issued by the prescriber. b. More than a 30-day supply of a CS listed in Schedule IV upon an oral RX. c. More than 5 refills of CIIIs & CIVs in 6 months without practitioner renewal. d. All the above e. A & C only

C

Which of the following would be correct regarding "black box warnings"? [A] They are required on both OTC and prescription drugs [B] The manufacturer determines whether such a warning should be on the label [C] The warning applies only to those drugs that may lead to death or serious injury [D] A & C [E] B & C

C

Which of the following would be correct regarding phase IV studies? [A] They are performed at the discretion of the manufacturer and the FDA has no authority to mandate them. [B] The FDA may require them for any drug [C] The FDA may require them to assess serious risks when adverse event reporting or active surveillance would not be sufficient [D] They are required of drugs marketed after 1997

C

Which of the following would be correct regarding secondary wholesalers? [A] They are essentially black market distributors and illegal under the FDCA [B] They are currently required to receive and distribute a pedigree with each product they buy and sell [C] They are legal and exist in far greater numbers than primary wholesalers [D] B & C

C

Drug product A is identical to drug product B, each made by a different manufacturer. Drug A is a prescription drug and Drug B is an OTC drug. This could be explained by: [A] A has different indications in the labeling than B [B] The FDA switched the active ingredient in the drugs to OTC by monograph [C] The manufacturer of B switched from prescription to OTC via an SNDA [D] Either A or C [E] Either A, B or C

D

How many internship hours must a person desiring to be a licensed pharmacist complete? A. 500 B. 1100 C. 1750 D. 2080 E. 3200

D

OTC drug labeling must contain which of the following: [A] The pharmacological category or intended action of the drug after its name [B] A "Drugs Facts" panel [C] Other OTC drugs in the pharmacological category the patient might want to try [D] A & B [E] A & C

D

Patient package inserts (PPIs) are required for: (I) Any drug posing serious and significant concerns; (II) Estrogen contain drugs; (III) All OTC drugs; (IV) All drugs required to have a REMS [A] I only [B] I & II [C] I, II & III [D] II only [E] II & IV

D

Presuming a written protocol is in place, which of the following products is a licensed Florida pharmacist legally permitted to administer to her patients? a. Pneumococcal vaccine b. Shingles vaccine c. Epinephrine via an autoinjector delivery system d. All of the above e. A & B only

D

The FDA's Orange Book rates pharmaceutically equivalent drugs on the basis of therapeutic equivalence. Pharmaceutical equivalence means: [A] The drugs have the same active ingredients [B] The drugs are identical in strength [C] The drugs are bioequivalent [D] A & B [E] A, B & C

D

Under the drug approval process of the FDCA, which of the following would be correct? [A] A drug must pass through three phases of clinical testing before approval [B] A manufacturer whose drug shows outstanding safety and efficacy in an early phase of testing can skip subsequent phases of testing [C] The FDA may terminate testing of the drug at anytime [D] A & C [E] B & C

D

Which of the following about MedGuides is CORRECT? A. They need not be approved by FDA before distributing. B. They are written in technical, scientific language. C. Private sector (& not FDA) oversees their distribution. D. They are required for drugs posing serious & significant concerns. E. They are dispensed with about 95% of marketed prescription drugs.

D

Which of the following accurately describe(s) the FDA today? [A] The commissioner is appointed by the secretary of DHHS [B] The agency regularly relies on advice from outside experts [C] The agency is housed under DHHS [D] B & C [E] A, B & C

D

Which of the following accurately describe(s) why the FDA has acted to regulate compounding by pharmacies starting in 1992? [A] Concerns that some pharmacies were actually engaging in manufacturing [B] Concerns that some pharmacy compounding jeopardized public health [C] Belief that the FDCA does not exempt compounding pharmacies from registering as manufacturers [D] A & B [E] B & C

D

Which of the following best defines the role of a Congressional committee during the process of a bill in Congress? [A] The sponsor of the bill can choose to skip the committee and ask for a direct vote by the House or Senate [B] Committees are important in the House, but not the Senate [C] If a committee fails to pass a bill, the majority leadership of the House or Senate can override the committee decision [D] The committee stage of a bill's life is the most important step to its success or failure

D

Which of the following statements about nonresident pharmacies is CORRECT? A. Nonresident pharmacies must never advertise their pharmacy services in Florida. B. Nonresident pharmacies must provide services to FL residents 7 days a week. C. Nonresident pharmacies must include a toll-free number on every RX label. D. All of the above E. A & C only

D

A U.S. federal court can hear cases involving: [A] One state suing another state [B] A citizen of a state alleging that the state violated his constitutional rights [C] A U.S. attorney suing a citizen of a state for violating a federal law [D] B & C [E] All the above

E

A case citation of 466 F. Supp. 922 means: [A] The case can be found in volume 466 [B] The case can be found at page 922 of the volume [C] The opinion is from a federal district court [D] A & B [E] A, B & C

E

A manufacturer of an industrial solvent promoted that its product when applied to the skin would cure eczema, but specifically proclaimed that its product is a solvent, not a drug. The FDA is investigating whether the product should be considered as a drug. Which of the following would be the best answer regarding the claim to cure eczema. [A] The claim would not likely make the product a drug [B] The claim would not likely make the product a drug because of the proclamation. [C] The claim would not likely make the product a drug unless consumers actually used the product for that purpose [D] The claim would not make the product a drug if it was actually effective [E] The claim to cure eczema would likely make the product a drug and the proclamation is irrelevant

E

A physician has prescribed a drug for an indication not contained in the drug's labeling. Which of the following is correct? [A] The physician has not violated the FDCA [B] The pharmacy who dispenses the drug has not violated the FDCA [C] In most situations the pharmacist would have a professional duty to confirm the use with the prescriber [D] B & C [E] A, B & C

E

A product may be adulterated under which of the following condition(s). [A] Its strength differs from that on the label [B] It contains a decomposed substance [C] The manufacturing facility where it is made is contaminated [D] A & B [E] A, B & C

E

A state board of pharmacy passed a regulation that a pharmacy corporation could not invest funds in other companies unless those companies met certain requirements as determined by the board. No statute grants the board this authority. This regulation would likely be: A. Valid because the board has broad authority B. Invalid because the regulation exceeds the scope of the board's authority C. Invalid because no statute enables the board to regulate in this area D. Invalid because boards cannot enact regulations E. Either B or C

E

Assume that a state law provides that no health care entity can be sued for negligence after one year has passed from the time of injury. For all other entities, a plaintiff has two years to sue. A plaintiff is suing a pharmacy 14 months after the injury. The pharmacy contends it is a health care entity and thus the plaintiff is barred from suing it. The law does not define a health care entity. The most important factor to a court in determining whether a pharmacy is a health care entity would likely be: [A] The definition of health care entity in other states [B] The dictionary definition of health care entity [C] The social policy effect of including pharmacies in the definition [D] Whether including or excluding pharmacies would affect their due process rights [E] Determining the intent of the legislature

E

Flivasted has been marketed for 3 years. There is emerging evidence that the drug may have serious adverse health risks to users that were not identified premarket. The FDA ordered the manufacturer to implement a REMS. This means: [A] That the manufacturer must distribute a Medication Guide [B] That the manufacturer must require that prescribers have specialized training or experience [C] That the manufacturer must restrict distribution of the drug [D] That the manufacturer must do A and B [E] That the manufacturer may have to do one or all of the above

E

In order for a manufacturer's advertising to meet the "true statement" requirement of the law, the advertising must: [A] Provide fair balance between adverse effects and effectiveness [B] Reveal material facts [C] Not be false or misleading [D] B & C [E] A, B & C

E

Pursuant to the Durham Humphrey Amendment a drug is a prescription drug if it is unsafe for use except under the supervision of a practitioner because of: [A] Its toxicity [B] Its method of use [C] The collateral measures necessary to use the drug [D] A & B [E] A, B & C

E

Ramkin is a drug product being marketed today that has never been approved by the FDA. A reason for this could be: [A] The drug was marketed before 1938 [B] The drug was marketed between 1938 and 1968 and the FDA determined it was not a new drug at the time [C] The manufacturer has yet to remove the drug after DESI review determined it lacked evidence of efficacy. [D] A and C [E] A, B & C

E

Under the FDA compassionate use policy a consumer may import small amounts of a drug if: [A] It is not approved in the U.S. [B] It is used for the treatment of a serious condition for which no satisfactory treatment is available in this country. [C] The consumer provides the name of his/her treating physician [D] B & C [E] A, B & C

E

Which of the following would be correct regarding the complaint in a civil lawsuit? [A] Together with the summons they are called the pleadings of the case [B] The plaintiff must first deliver it personally to the defendant, and the defendant must then deliver it to the court [C] The complaint contains all material facts of the case and the remedy requested [D] A & B [E] A & C

E