Uniform MPJE (UMPJE) Practice Exam

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• DEA Form 106 is filled out in triplicate. How are the copies distributed?
• For nonliquid SLCP products, packaging must be blister packs with how many dosage units per blister?
• For Category 2 CSPs that are Aseptically Prepared w/ No sterility testing results + sterile components, what is the BUD at freezer?
• What are SLCPs?
• Which statement regarding ketamine's scheduling is true?
• Who regulates prescription drug advertising?
• Which statement about MedGuides in inpatient settings is true?
• Which DEA form must be used to document destruction of controlled substances, including breakage?
• What labeling warning is included on acetophenetidin?
• Is a patient permitted to request a blanket waiver of safety caps under PPPA?
• DEA Form 224a renewal is required every how many years?
• DEA Form 363 is the new registration application for which program?
• Which act authorizes the FDA to regulate the development, manufacturing, and distribution of medications and outlines labeling requirements?
• When federal and state laws conflict, which law applies?
• PHI may be used under TPO for which purposes? (select best answer)
• Once completed, where must C-II forms be stored? For how long?
• Which items must be reported to the DEA if theft or significant loss occurs?
• DEA Form 106 is used to report losses of federally scheduled II-V controlled substances.
• Biologics are defined by which statute?
• What must be filed with the DEA as a follow-up within 45 days after the initial report?
• Which USP chapter addresses working with hazardous drugs?
• How often must a complete inventory of all controlled substances be conducted?
• Failure to dispense a medication with a required PPI results in what labeling issue?
• FDA Form 3911 is used for what purpose?
• Which statement best describes DEA prescriber identification requirements?
• For Category 2 CSPs that are Aseptically Prepared with No sterility testing results and at least one nonsterile component, what is the BUD at controlled room temperature?
• Which statement is true regarding C-II partial fills?
• Which act defines pharmacy practice standards and requirements for controlled substance management and dispensing?
• Records of the 3Ts information must be kept for how long?
• OTC pediatric aspirin (1 1/4 grain size) can be sold in at most how many tablets?
• Which statement best defines misbranding?
• Which category has a 12-hour maximum duration at controlled room temperature?
• Nonaqueous Oral Liquid Formulation BUD?
• What warning must a dietary supplement carry?
• Which statement about the NDC label components is true?
• Which of the following statements best defines adulteration?
• For C-II partial filling for anyone, partial fills may be dispensed up to how many days from the first fill?
• Category 2 BUD: Terminal Sterilized w/ No sterility testing results; durations: 14 days RT; 28 days fridge; 45 days freezer. Which is correct?
• How long must records of privacy practice acknowledgments be kept?
• Aspartame labeling must indicate phenylalanine content for phenylketonurics. Which statement correctly reflects this requirement?
• Which are considered Official Compendia?
• For Category 3 CSPs that are Aseptically prepared + Sterility tested + Passed all applicable tests for Category 3 CSPs, what is the BUD at controlled room temperature?
• Which Class Recall corresponds to Wholesale Level?
• Which medication is exempt from the Poison Prevention Packaging Act?
• DEA Form 225 is used for new registration for which type of entity?
• What does the second letter of the TE code stand for?
• Which statement is true regarding CSOS for ordering C-II substances?
• Aqueous Non-Preserved Formulation BUD refrigerated duration?
• How long must records relating to controlled substances be kept?
• What must a record of partial fills include?
• Which act established requirements for packaging certain pharmaceutical items?
• How long must the SLCP logbook be kept?
• Which of the following is an example of a Schedule I controlled substance?
• Which statement must appear on the label for Schedule II-V medications according to federal requirements?
• For OTC NSAIDs, which term must be highlighted on labeling?
• What inventory requirement must be completed before a pharmacy begins business?
• The FDA Purple Book provides information regarding which category of products?
• Are blank Rx pads considered controlled substance documents that must be reported if stolen or lost?
• C-III and C-IV prescriptions may have up to how many refills, provided they are filled within 6 months from the date issued?
• Through which form are C-I and C-II controlled substances ordered?
• What does the Ipecac Syrup labeling say about use when unconscious or ingestion of certain poisons?
• What is the import limit for SLCPs?
• Which of the following are examples of controlled substance documents that must be reported if stolen or lost?
• Where must SLCPs be kept?
• Under Schedule III, what is the maximum morphine content per 100 mL or per 100 g?
• DEA Form 223 is used for what?
• What water activity threshold defines an aqueous dosage form?
• Which statement about AB ratings is true?
• Which items are included as controlled substance documents that may be stolen or lost?
• Which event is not included in DEA Form 106?
• FDA Form 3500b is used for voluntary adverse event reporting by which group?
• Which Schedule V product has a dosage limit of ≤2.5 mg diphenoxylate and ≥25 mcg atropine per dosage unit?
• Within what timeframe must theft or significant loss be reported to the DEA?
• Labeling for products containing FD&C Yellow #5 and/or #6 must include which statement?
• Which statement about Schedule V controlled substances and OTC availability is accurate?
• DEA Form 224 is used for new registration applications for which type of entity?
• What does the first letter of the TE code stand for?
• Who must complete the DEA Form 222?
• For Category 3 CSPs that are Aspetically prepared + Sterility tested + Passed all applicable tests, what is the BUD at refrigerator temperature?
• Which of the following is a Schedule III controlled substance?
• Which statement correctly differentiates DEA Forms 224 and 224a?
• Potassium salt preparations (≥100 mg per tablet) must include a warning about which risk?
• Which of the following is true about dietary supplements per the source?
• Which statement describes Schedule III controlled substances?
• Compared to Category 2 CSPs, Category 3 CSPs generally have longer BUDs at the same storage temperature.
• For personal use, how many dosage units of controlled substances may be carried across the border in total?
• For OTC acetaminophen products intended for adults, which warning must be included?
• DEA Form 510 is the new application for which type of business?
• Nonaqueous 'Other' Formulation BUD?
• Which of the following is a Schedule II controlled substance?
• The sulfite labeling applies to all preparations except epinephrine injections. True or False?
• What does the FDA Orange Book AB rating mean?
• Which statement describes Schedule IV controlled substances?
• Mineral Oil labeling specifies administration timing. Which statement is correct?
• Under DSCSA, what information must pharmacies obtain when purchasing a drug? (three items)
• Which statement best describes the purpose of the Controlled Substances Act of 1970 in pharmacy practice?
• Which statement correctly describes a drug under FDA definitions?
• When is a MedGuide required for outpatient prescriptions?
• When selling an SLCP, which action is required?
• Which statement accurately describes Schedule V controlled substances?
• Which of the following is NOT part of DSCSA requirements for purchasing a drug?
• The Orphan Drug Act was enacted in which year?
• What does pharmaceutically equivalent mean in FDA's therapeutically equivalent criteria?
• Which statement best describes Class II Recall (Retail/Pharmacy Level)?
• Ipecac Syrup labeling includes packaging restrictions. Which statement is correct?
• Which statement about Schedule I controlled substances is true?
• What does the FDA Purple Book provide?
• Instead of an NDA, what is submitted for a biologic drug?
• Which of the following is considered a controlled substance document that must be reported if stolen or lost?
• Which USP chapter covers standards for compounding non-sterile drugs?
• Which statement describes Class I Recall (Consumer Level)?
• How many days before a registration expiry can a 224a renewal be submitted?
• Which statement about reporting theft/significant loss is true?
• What does an FDA Orange Book 'A' rating mean?
• Which statement accurately describes the final verification step for a manually checked DEA number?
• What is the federal 30-day sale limit for SLCPs?
• Which standard governs working with hazardous drugs?
• If patients self-import drugs from Canada, what is required?
• For all orders of scheduled III-V products, what must be kept?
• For Category 2 CSPs that are Aseptically Prepared with Passed sterility testing, what is the beyond-use date (BUD) at controlled room temperature?
• What is the main purpose of the Poison Prevention Packaging Act of 1970?
• LTCF patient status is the same as a group home or assisted living facility patient.
• How long must prescription records for Medicare Part D prescriptions be kept?
• When a SLCP is sold, which option correctly lists the items that must be included in the purchase log?
• Which characteristic describes Schedule II controlled substances?
• Under Category 2, which statement accurately describes the storage conditions for the BUDs?
• What emergency-use instruction is included on Ipecac Syrup labeling?
• Salicylates (aspirin) labeling includes a warning regarding which risk in children?
• Which form must be followed up with within 45 days after an initial theft report?
• By what timeframe must C-III and C-IV prescriptions be filled after the date of issue?
• Typically, the letter M on a DEA number pertains to which type of provider?
• What is the immediate action when there is a theft or significant loss?
• For Category 2 w/ Passed sterility testing, what is the BUD at freezer?
• Buprenorphine is listed as which Schedule?
• What is the BUD for Nonaqueous 'Other' Formulation?
• How often must CLIA Waivers be renewed?
• Under PPPA, which entity is prohibited from requesting a blanket waiver?
• Which category requires Terminally sterilized + Sterility tested + Passed all applicable tests?
• What items may NEVER be changed on a C-II prescription?
• What formatting requirement is specified for OTC Acetaminophen labeling?
• What act distinguished a drug vs. a supplement?
• Which medications require a patient package insert (PPI)?
• For Category 3 CSPs that are Terminally sterilized + Sterility tested + Passed all applicable tests for Category 3 CSPs, what is the BUD at room temperature?
• Which statement correctly describes biologics?
• For Category 2 CSPs that are Aseptically Prepared with No sterility testing results and sterile components, what is the BUD at controlled room temperature?
• What is the FDA Orange Book?
• In an institutional setting, how can the PPI be provided to a patient?
• Labeling for products containing NSAIDs or APAP must include a warning about alcohol consumption. How many drinks per day trigger the warning?
• What additional action must be taken within 24 hours after reporting illegitimate products with FDA Form 3911?
• Aqueous Preserved Formulation BUD refrigerated or controlled room temperature?
• Which form is used to order C-I and C-II substances?
• The DEA 106 form is used for what purpose?
• Isoproterenol Inhalation Preparations labeling warns about what adverse effect with repeated, excessive use?
• If renewal is more than one month past expiry, what must be done?
• The initial notification to the DEA must be made within what timeframe?
• What does an FDA Orange Book 'B' rating mean?
• The electronic CSOS system is used to order which schedules?
• For C-II partial fills for LTCF or hospice patients, partial fills may be dispensed up to how many days from the first fill?
• Which pharmacopoeias may recognize drugs under FDA definitions?
• For Category 2 w/ No sterility testing results + sterile components, what is the BUD at refrigerator?
• For Schedule III substances that are mixed with at least one active, non-narcotic ingredient, which is the maximum codeine content?
• Which of the following is an example of a biologic?
• Under Category 2 BUDs for USP 797, which statement is accurate?
• FDA Form 3500 is used for what purpose?
• Which population threshold defines a rare disease for orphan drug status?
• The 45-day follow-up requirement applies after the initial report of theft or loss of which items?
• Medicare Part D prescriptions must be sent how?
• The reporting requirement applies to theft or significant loss of which items?
• Sulfites labeling includes which of the following statements?
• Which USP chapter covers standards for sterile compounding?
• DEA Form 225 is used for new registration applications for which of the following?
• DEA Form 41 is used to document destruction of controlled substances.
• The FDA classifies drugs as therapeutically equivalent if they meet which criteria?
• Which statement about TE codes is incorrect?
• What are the three components of an NDC label?
• Category 1 BUD: 12 hours at controlled room temperature; 24 hours refrigerated. Which option correctly states these durations?
• Which of the following is NOT listed as an example of a controlled substance document?