Chapter A

Question 1

Dispensing a prescription without authorization

Answer 1

Misbranded

Question 2

Misfilling an Rx with the wrong drug, strength, or directions for use

Answer 2

Misbranded

Question 3

Misfilled Rx involves wrong strength of the drug prescribed

Answer 3

Adulterated

Question 4

Drug subject to REMS and it is prescribed or dispensed without meeting the requirements of the REMS

Answer 4

Misbranded

Question 5

Advertising or promotion of a compounded drug that is false or misleading

Answer 5

Misbranding

Question 6

Expired drug product in a manufacturer’s bottle

Answer 6

Adulterated (due to strength not being assured after the expiration date)

Question 7

Rx is filled using an expired product

Answer 7

Misbranded (also if the pharmacist placed a beyond-use-date that is after the expiration date of the drug)

Question 8

If a pharmacist counts a medication on a tray that has residue from another medication

Answer 8

Adulterated

Question 9

Pharmacist stores inventory in a room or refrigerator where the temperature is not adequately controlled

Answer 9

Adulterated

Question 10

Pharmacist stores a specific product incorrectly, such as stocking a medication on a pharmacy shelf instead of in the refrigerator as required

Answer 10

Adulterated

Question 11

Pharmacist fails to dispense a medication in a child-resistant container when required

Answer 11

Misbranding

Question 12

Failure to provide a PPI for oral contraceptives, estrogen-containing products, or to hospitalized/institutionalized patients (1st administration & every 30 days thereafter)

Answer 12

Misbranded

Question 13

Failure to provide a MedGuide when dispensing a drug that requires one

Answer 13

Misbranded

Question 14

If a dietary supplement or medical device has an NDC number on its label

Answer 14

Misbranded

Question 15

Any product that implies it is an FDA-approved drug and it is not

Answer 15

Misbranded

Question 16

Drug products in identical dosage forms and routes of administration that contain identical amounts of the identical active drug ingredient

Answer 16

Pharmaceutical equivalents

Question 17

Approved drug products that are pharmaceutical equivalents for which bioequivalence has been demonstrated; expected to have same clinical effect and safety profile when administered to patients under conditions specified in labeling

Answer 17

Therapeutic equivalents (means drug is bioequivalent to reference drug product)

Question 18

Deemed to be low risk and are therefore subject to the least regulatory controls

Answer 18

Class I FDA Medical Devices (ex: dental floss, needles, scissors, stethoscopes, toothbrushes, tongue depressors, ice bags and eye pads)

Question 19

Higher risk and require greater regulatory controls

Answer 19

Class II FDA Medical Devices (ex: syringes, thermometers, diagnostic reagents, tampons, blood pressure gauges, electric heating pads)

Question 20

Highest risk devices and are subject to the highest level of regulatory control; pose a significant risk of illness or injury require premarket approval by the FDA

Answer 20

Class III FDA Medical Devices (ex: replacement heart valves, pacemakers, intraocular lenses, insulin pumps, breast implants)