Indiana MPJE Exam Review Questions 2022/2023 | Consisting Of 111 Questions With Verified Answers From Experts

Indiana MPJE Exam Review Questions 2022/2023 | Consisting Of 111 Questions With Verified Answers From Experts Which federal act discusses adulteration and misbranding of drugs? Food Drug and Cosmetic Act T/F Adulteration/Misbranding can occur with both a drug and a device. True T/F A drug must be contaminated to be considered adulterated. F - if held under unsanitary conditions where it MAYA have been contaminated A container that contains a drug is made of poisonous or harmful materials. However, there is no harm to the drugs inside the container. Is the drug considered adulterated? Yes T/F: If a product does not meet standards of USP, but plainly states on it's label "Not USP" it is not considered adulterated. True - can deviate from USP standards if it says on package plainly "Not USP" T/F If quality or purity falls above the stated amount on the bottle it is considered adulterated. False - no only considered adulterated if it falls below purity/quality stated T/F If a strength of a drug does not match what is stated on the bottle, it is both adulterated and misbranded. True T/F: Providing a drug product other than the one that is written on the bottle is considered misbranding only. False - Misbranding and Adulteration An Rx product dispensed directly to a patient is misbranding when it does not contain name and place of business of the manufacturer, packer, and/or distributor. False - commercial products must contain this, but not Rx products dispensed to a patient do not have to have this A commercial product must accurately contain the quantity listed on the bottle, but an Rx dispensed directly to a patient does not have to have this information on it. True - considered misbranding if a commercial product does not have an accurate quantity listed on it On a commercial product, generic names but be _______ the height of the brand name. Half If a legend drug is dispensed without a prescription or drug order, it is considered misbranding. True If a drug may decompose, it must state this on the label or it is considered misbranding. True A drug dispensed after the written Rx has expired is considered adulteration. False - this is misbranding cGMP applies to who? Manufacturers Manufacturers must go through the inspection process every ____ years. Once every 2 years Moving a drug manufacturer facility oversees exempts a manufacturer from cGMP. False - cGMP applies to facilities in the US and making products for use in the US What 3 things constitute pharmacy compounding? 1. For an individual patient 2. Based on receipt of valid Rx or drug order from licensed practitioner 3. Compounded by a licensed pharmacist or physician If something meets criteria for pharmacy compounding, it is exempt from what 3 regulations? cGMP Misbranding New drug requirements T/F Pharmacists may compound something before the receipt of an Rx? True If a location does not meet requirements of pharmacy compounding, what are they considered? An outsourcing facility Which medical device is the simplest device? Class I Medical Device Class: Stethoscope Class I Medical Device Class: Scissors Class I Medical Device Class: Toothbrushes Class I Medical Device Class: Syringes Class II Medical Device Class: Tampons Class II Medical Device Class: Condoms Class II Medical Device Class: Hgb A1c Assays Class II Which device class requires special controls to assure safety and effectiveness of the device such as performance standards, postmarket surveillance, patient registries, etc