Page 1 of 95 1 NEVADA MPJE EXAM LATEST 2024 -2025 COMPLETE 3 VERSIONS WITH 400 QUESTIONS AND CORRECT DETAILED ANSWERS ALREADY GRADED A+ LATEST UPDATE J UST RELEASED NEVADA MPJE EXAM A True or false: a practitioner may prescribe or administer controlled substances (C2s) for himself, his spouse, or his children if it's in the usual course of his professional practice. - ANSWER -FALSE - only in cases of emergency. How long does a pharmacist have to notify the DEA and Board of Pharmacy of any loss or theft of controlled substances? - ANSWER -within 10 days after the date of discovery of the theft or loss. What items are required in the log book for the sale of precur sors to methamphetamines? - ANSWER -(1) name of the product sold, (2) quantity of the product sold, (3) name and address of the purchaser, (4) date and time of the sale How long must records for the sale of precursors to methamphetamine be maintained? - ANSWER -at least 2 years. What is the max of pseudoephedrine product that can be purchased in a single day? 30 days? - ANSWER -3.6 grams per day. 9 grams per 30 days. What are the elements of negligence? - ANSWER -duty owed, breach of duty, causation and dama ge. All four elements required to prove legal liability. What is the difference between a prescription drug and an OTC drug? - ANSWER -Prescription drugs are intended for human use, but are generally not safe unless taken under the supervision of a practit ioner. OTC medications are generally seen as safe, must be manufactured using current GMPs, and have adequate directions for use for the lay -person. Page 2 of 95 2 What is the difference between an NDA and an ANDA? - ANSWER -NDA is a new drug application. Typically reser ved for new chemical entities, or new indications/dosage forms/routes of administration, etc of already known chemical entities. These require safety and efficacy data for the FDA to give pre -marketing approval. And ANDA = abbreviated new drug application. These are used for generics of brand name medications who's patent just ran out. Safety/efficacy studies not generally required, but bioequivalency studies are needed. What is an SNDA? - ANSWER -Supplemental new drug application. An application process fo r previously FDA approved drug products that want to request a change to the production of the drug, manufacturing process, or to the labeling of the drug. What is an OTC monograph? - ANSWER -a regulation specifying the conditions (dosage, indications) und er which specific active ingredients and combinations may be formulated in OTC drug products without prior FDA approval . What is an NDC? - ANSWER -national drug code - it identifies all drug products, is required on all OTC and prescription drug labels. A drug with an NDC does not mean is has an approved NDA. First section = manufacturer. 2nd section = drug product. 3rd section = packaging. What is the difference between adulteration and misbranding? - ANSWER -Adulteration is concerned with the physical con ditions of drugs or devices and the environment of their manufacture. Misbranding is concerned with the representations made by the manufacturer concerning the drug or device. Misbranding or adulteration: does not bear generic name in type not less than ½ size of the trade or brand name? - ANSWER -misbranding Misbranding or adulteration: does not bear adequate directions for use. - ANSWER -misbranding Misbranding or adulteration: label fails to state name and place of business of manufacturer and accurate statement of quantity. - ANSWER -misbranding Page 3 of 95 3 Misbranding or adulteration: does not bear caution: warning, may be habit forming, if the substance is ha bit forming. - ANSWER -misbranding Misbranding or adulteration: prepared, packed, or held in unsanitary conditions - ANSWER -
adulteration Misbranding or adulteration: manufactured not in conformance with GMP. - ANSWER -
adulterated Misbranding or adulterati on: contains unsafe color additive. - ANSWER -adulteration Misbranding or adulteration: OTC drug not packaged in tamper -resistant packaging. - ANSWER -
Adulteration Misbranding or adulteration: subject to deterioration and label does not warn - ANSWER -
misbr anding Misbranding or adulteration: package or drug is misleading in the way ait is filled or formed or is imitative of another drug. - ANSWER -misbranding Misbranding or adulteration: health endangering if used in the manner suggested by the labeling. - ANSWER -misbranding What is the difference between consumer medication information (CMI) and MedGuides? - ANSWER -CMI - mandated that written information is provided to the patient for every drug every time a new prescription is dispensed (key information: how to take it, storage, etc). MedGuides - manufacturers are required to provide for drugs that pose a "serious and significant" concern to the public; requires FDA approval, is part of the labeling. Provided by the manufacturer. Page 4 of 95 4 What is a Class I recall? - ANSWER -use will likely result in serious adverse health consequences or death. What is a class II recall? - ANSWER -use may cause temporary or medically reversible adverse health consequences. What is a class III recall? - ANSWER -use is not likely to c ause adverse health consequences. In a recall, what is the withdrawal process? - ANSWER -Mfr must contact seller. Seller is responsible for contacting the consumer. Either the manufacturer or the FDA can initiate a recall. Pharmacists are responsible for knowing which drugs have been recall ed. What are current good manufacturing practices? - ANSWER -cGMP are a set or regulations that estabilishes minimum requirements for the methods, facilities, or controls used in the manufacture, processesing, packing, or holding of a drug product. Helsp e nsure drugs are safe and meet the quality and purity requirements - if they don't, drugs are adulterated . What is the new drug development process? - ANSWER -Pre-clinical testing in animals. File IND (investigational new drug). Clinical trials. Phase I = h ealthy volunteers, looks at safety. Phase II = limited trials in patients with the disease, looks at efficacy. Phase III = large -scale clinical trials. File NDA (new drug application). Followed by Phase IV: post -marketing trials. What is the pure food and drug act of 1906? - ANSWER -prohibits the adulteration and misbranding of foods and drugs. Labels not required to list ingredients. Misbranding provisions of the law didn't prevent false or misleading efficacy claims; only prevented false statements as to the drugs identity. Did not provide authority to ban unsafe drugs. Did not regulate cosmetics or medical devices. What is the food, drug and cosmetic act of 1938? - ANSWER -required that new drugs cannot be marketed until proven SAFE for use under the cond itions described on the label. Labels must know contain adequate directions for use. Warnings included about medications that may be habit forming.
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