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 Class II Which device Class requires premarket approval? Class III Medical Device Class: pacemakers Class III Medical Device Class: replacement heart valves Class III Medical Device Class: Soft contact lenses Class III All new devices automatically fall into this class unless FDA determines that they are substantially equivalent to other classes? Class III What types of devices require an Rx due to the potential harm and need for collateral measures to ensure their proper use? Restricted devices What are some examples of restricted devices? Contact lenses and diaphragms What is currently the only banned device? Prosthetic hair fibers What type of devices are excluded from the US market? Banned devices Which of the following does the FDA NOT have the authority to mandate a recall? A. Devices B. Drugs C. Foods D. Biological products B - Drugs - they can only be voluntarily issued by the manufacturer What kind of action can the FDA take if they believe a drug should be recalled, but the manufacturer is unwilling to issue the recall? Seizure or injunction action Who is responsible for notifying consumers of recalls? The sellers Who is responsible for notifying sellers about a recall? The manufacturers Recall Class: Missing batch # on medication bottle Class III Recall Class: Valsartan contains NMDA Class I Recall Class: microbial contamination of a personal lubricant Class II Recall Class: microbial contamination of non-injectable, non-ophthalmic sterile product that can cause medical issue Class II Recall Class: insecure or incorrect closures for medicines such as cytotoxics Class II