Chapter A Flashcards
(20 cards)
Dispensing a prescription without authorization
Misbranded
Misfilling an Rx with the wrong drug, strength, or directions for use
Misbranded
Misfilled Rx involves wrong strength of the drug prescribed
Adulterated
Drug subject to REMS and it is prescribed or dispensed without meeting the requirements of the REMS
Misbranded
Advertising or promotion of a compounded drug that is false or misleading
Misbranding
Expired drug product in a manufacturer’s bottle
Adulterated (due to strength not being assured after the expiration date)
Rx is filled using an expired product
Misbranded (also if the pharmacist placed a beyond-use-date that is after the expiration date of the drug)
If a pharmacist counts a medication on a tray that has residue from another medication
Adulterated
Pharmacist stores inventory in a room or refrigerator where the temperature is not adequately controlled
Adulterated
Pharmacist stores a specific product incorrectly, such as stocking a medication on a pharmacy shelf instead of in the refrigerator as required
Adulterated
Pharmacist fails to dispense a medication in a child-resistant container when required
Misbranding
Failure to provide a PPI for oral contraceptives, estrogen-containing products, or to hospitalized/institutionalized patients (1st administration & every 30 days thereafter)
Misbranded
Failure to provide a MedGuide when dispensing a drug that requires one
Misbranded
If a dietary supplement or medical device has an NDC number on its label
Misbranded
Any product that implies it is an FDA-approved drug and it is not
Misbranded
Drug products in identical dosage forms and routes of administration that contain identical amounts of the identical active drug ingredient
Pharmaceutical equivalents
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
Therapeutic equivalents (means drug is bioequivalent to reference drug product)
Deemed to be low risk and are therefore subject to the least regulatory controls
Class I FDA Medical Devices (ex: dental floss, needles, scissors, stethoscopes, toothbrushes, tongue depressors, ice bags and eye pads)
Higher risk and require greater regulatory controls
Class II FDA Medical Devices (ex: syringes, thermometers, diagnostic reagents, tampons, blood pressure gauges, electric heating pads)
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
Class III FDA Medical Devices (ex: replacement heart valves, pacemakers, intraocular lenses, insulin pumps, breast implants)
