Federal MPJE Practice Exam

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• Under the FDCA, what is required for a drug to be considered “safe and effective”?
• What is the purpose of the Drug Enforcement Administration (DEA) Form 222?
• What is an example of a Schedule I controlled substance?
• What specific documentation is required when a pharmacist dispenses a controlled substance?
• What is the consequence if a controlled substance is found to be misbranded?
• Why is the regulation of dietary supplements considered less stringent compared to drugs?
• What is the proper interpretation of the FDA equivalency rating AB in relation to a generic medication?
• What does good manufacturing practices (GMP) ensure?
• Which DEA form must be submitted to report the theft or significant loss of controlled substances?
• Re-importation of medications is only legal if performed by which entity?
• Which law prohibits the distribution of food and drugs that are misbranded or adulterated?
• What Act requires health care facilities to report death or injuries caused by or suspected to have been caused by a medical device?
• What defines a “controlled substance” under federal law?
• What system is used to classify controlled substances?
• What is an Abbreviated New Drug Application (ANDA)?
• To comply with Centers for Medicare and Medicaid Services (CMS) requirements, how often must a pharmacist conduct a Drug Regimen Review for long-term care patients?
• Which type of records may a pharmacy keep at a central location other than their registered location with the DEA?
• What is one potential consequence of improper drug disposal?
• What role does clinical pharmacology play in drug approval?
• A patient wants to refill a prescription but was not satisfied with the pharmacy that filled and dispensed the prescription the first time. The patient demands the prescription be returned so they can take it to a different pharmacy to obtain refills. The pharmacist should:
• What would be the correct last digit of the DEA number BS5927683 if it were accurate?
• What does the term “adverse drug reaction” mean?
• Retail containers of 81 mg aspirin must have special warnings for use in children and cannot contain more than:
• What is the main focus of the FDCA?
• Which government agency is responsible for regulating controlled substances?
• Which best describes the practice of transferring large quantities of compounded medications between pharmacies?
• Which organization has the authority to classify drugs into schedules?
• What DEA form is required to purchase or transfer Schedule II controlled substances?
• What is a requirement for labeling over-the-counter (OTC) medications?
• What are the requirements for maintaining a prescription drug log?
• Which agency is primarily responsible for enforcing the FDCA?
• What must be maintained for recordkeeping compliance under the Prescription Drug Marketing Act?
• What is a key requirement of the Occupational Safety and Health Administration (OSHA) in pharmacies?
• Under what conditions may the FDA require a Medication Guide for certain prescriptions?
• In a drug utilization review (DUR), which of the following aspects is NOT reviewed?
• In the event of a breach of unsecured protected health information (PHI) affecting approximately 900 patients, who must be notified?
• What is the maximum quantity of a Schedule V controlled substance that can be sold without a prescription?
• What system is used as an electronic substitute for DEA Form 222 when ordering Schedule II controlled substances?
• What does “pharmacy compounding” mean?
• What type of information is primarily included in the Patient Package Insert (PPI) for medications?
• What must be demonstrated in order for a drug to qualify for the abbreviated NDA process?
• What entity is responsible for providing education on the safe use of medications, including monitoring for adverse effects?
• Which legislation mandated tamper-evident packaging for certain OTC products?
• A pharmacist receives an urgent notification from a manufacturing company for a recall of a specific medication because it may cause serious adverse health issues or death. What type of drug recall is this?
• Which of the following is a feature of patent exclusivity?
• In the context of CSA, what does "scheduling" refer to?
• What does OSHA require pharmacies to do regarding employee training?
• What is a common requirement for non-child-resistant containers?
• When must prescription drug samples be provided to patients?
• What is the purpose of the Drug Approval Process?
• Registering with the FDA as an outsourcing facility allows a pharmacy to do what?
• What is the main goal of the Controlled Substance Act (CSA)?
• A patient requests a copy of her prescription records from a community pharmacy. Within what time period must the pharmacy provide this information?
• What medication requires Risk Evaluation and Mitigation Strategy (REMS) monitoring?
• Which DEA registration form is used for pharmacies to register with the DEA to possess and dispense controlled substances?
• Durable Medical Equipment (DME) must meet which of the following standards?
• Which of the following prescriptions would likely be outside the scope of practice for a dentist?
• Which of the following entities is required to register with the DEA?
• What is the primary goal of the Good Manufacturing Practice (GMP)?
• What does "patent exclusivity" indicate in the pharmaceutical industry?
• Under the iPledge Risk Evaluation and Mitigation Strategy (REMS) for isotretinoin, what is the maximum number of refills authorized on a prescription?
• What Act established the requirement that patients must be offered counseling on all dispensed medications?
• How are dietary supplements primarily regulated by the FDA?
• Which aspect does pharmacovigilance NOT focus on?
• Which of the following defines the importance of the Adverse Event Reporting System (AERS)?
• A drug manufacturer finds that bottles labeled "loratadine 10mg tablets" actually contain 5mg tablets. What is true of this product?
• Which of the following is NOT a component of good manufacturing practices (GMP)?
• What is the main purpose of Risk Evaluation and Mitigation Strategies (REMS)?
• Which piece of information is NOT required on a manufacturer's container of an OTC medication?
• What is the goal of drug formulation as part of clinical pharmacology?
• What is the primary purpose of the Controlled Substances Act (CSA)?
• What information is required in the transaction report transmitted from a manufacturer to a pharmacy when a pharmacy purchases bulk bottles of a medication?
• What was the first law requiring drugs to be proven safe before being marketed?
• What indicates a “serious adverse event”?
• What does the Controlled Substance Act aim to achieve apart from controlling distribution?
• What is the purpose of a DEA Form 41?
• Define “exempt narcotics” as per federal regulations.
• What is a common reason for a prescription to be deemed invalid?
• What defines a “medical device” under federal law?
• Which of the following provides information about the risks relative to benefits of a drug?
• A prescription for lorazepam can be refilled a maximum of how many times within a six-month period?
• When a patient calls a retail pharmacy requesting that their prescription for a Schedule II controlled substance be mailed to their home, how should the pharmacist respond?
• What is required for a manufacturer to sell a medical device?
• Which of the following is NOT a reason for a pharmacist to provide patient medication counseling?
• What term best describes a pharmacy that compounds ibuprofen suppositories for sale to other pharmacies?
• Schedule II controlled substances CANNOT be transferred in which of the following scenarios?
• Which agency is responsible for overseeing the approval and regulation of drugs in the United States?
• Anabolic steroids are classified under which controlled substance schedule under federal law?
• Which method is valid for ordering Schedule III medications from a supplier?
• What is a key outcome expected from a Drug Utilization Review (DUR)?
• Which of the following methods is appropriate for filing paper prescription records in a pharmacy, according to federal law?
• What is a Class I drug recall typically associated with?
• How often must a pharmacy renew its DEA registration?
• Which Act regulates prescription drug sample sales and their recordkeeping requirements?
• A water-containing oral formulation that is compounded from commercially available drug products has a maximum beyond-use-date (BUD) of how many days when refrigerated?
• Explain the significance of the Orphan Drug Act.
• Who can issue a prescription for controlled substances?
• Under federal law, how are controlled substances classified?
• Federal investigations into thefts and robberies may occur per the Controlled Substances Registrant Protection Act if which condition is met?
• Where can a pharmacist find information to determine if generic warfarin tablets are bioequivalent to brand name Coumadin tablets?
• How long is a DEA registration for possession of controlled substances valid?
• What constitutes a legitimate medical purpose for prescribing controlled substances?
• Which statement best describes the FDA's role in drug recalls?
• An example of a misbranded manufacturer's container of a drug would be if:
• What constitutes a “valid prescription” for controlled substances?
• What are the dispensing restrictions for Schedule III and IV controlled substances?
• What does the term “counterfeit drugs” refer to?
• What must be done if a prescription for a controlled substance is lost or stolen?
• A physician writes a prescription for ibuprofen 800mg tablets for a patient with rheumatoid arthritis and requests easy-open containers for all future prescriptions. What is TRUE regarding this request?
• When a hospital pharmacist contacts a patient's outpatient pharmacy to obtain medication information, what is true regarding HIPAA?
• Which of the following drugs has a REMS program due to a high frequency of birth defects?
• In what situation would it be illegal for a pharmacy to compound drugs?
• What are “investigational new drugs” (IND)?
• What must be included in a proper investigational brochure?
• Which law requires drugs to be proven effective and safe before being marketed?
• What is the first application required to be submitted to the FDA before a drug can be tested on humans?
• In which case would it be permissible to provide controlled substance information without patient consent?
• Which of the following is a Schedule II controlled substance?
• What does “off-label” use refer to?
• What set of regulations specifies the required minimum manufacturing standards for pharmaceutical products in the US?
• Which of the following is/are NOT required to be packaged in a child-resistant container?
• Which statement is true about DEA Form 222?
• What class of drugs typically requires a prescription due to their potential for abuse and side effects?
• Which best describes a “narcotic” according to federal definitions?
• What is the primary purpose of the Federal Food, Drug, and Cosmetic Act (FDCA)?
• Which organization enforces regulations for the handling of controlled substances?
• What statement is required on an OTC package of acetaminophen tablets under the Federal Hazardous Substances Act?
• OTC drug advertising is primarily regulated by which agency?
• Which term best describes the rights given to the pharmaceutical company for marketing a drug?
• Which of the following is NOT required on the manufacturer's drug container label for an oral drug product?
• What is the purpose of Risk Evaluation and Mitigation Strategies (REMS)?
• Which schedule of controlled substances requires the highest level of security and record-keeping?
• Which of the following statements is true about narrow therapeutic index (NTI) drugs?
• How can patients safely dispose of unused medications?
• How does "patent exclusivity" benefit pharmaceutical companies?
• How many doses of controlled substances can a pharmacy transfer to another pharmacy without registering as a distributor?
• How are combination products regulated under federal law?
• Which of the following products is NOT required to be in tamper-evident packaging for retail sale?
• What does pharmacovigilance involve?
• A drug has an NDC of 16103-0350-11. The 0350 represents:
• What is the primary responsibility of the Drug Enforcement Administration (DEA)?
• Prescription records must be kept for a minimum of how many years based on federal law?
• What is the main purpose of drug recalls?
• What is the primary purpose of the Orange Book?
• Which of the following is considered a mid-level practitioner?
• What is the primary purpose of the Drug Enforcement Administration (DEA)?
• What key aspect of dietary supplements differentiates them from prescription medications?
• What is the significance of the FDA Modernization Act?
• What is the primary purpose of the FDA?
• Which agency is responsible for enforcing the federal Controlled Substances Act (CSA)?
• When must a Patient Package Insert (PPI) be given to a nursing home patient prescribed an estrogen-containing product?
• What is the expiration date of a bottle of metformin labeled 3/19?
• Drugs classified as Schedule I are characterized by which of the following?
• Is there any barriers preventing an independent community pharmacy from offering refill reminders by mail?
• When a pharmacy submits a DEA Form 222 to purchase Schedule II controlled substances, who retains the original copy?
• Which of the following would NOT be considered a potential part of a Risk Evaluation and Mitigation Strategy (REMS) program?
• What must pharmacies do in relation to action plans for chemical safety?
• Which of these is a valid DEA Registration number for a mid-level practitioner?
• What is the purpose of conducting a medication therapy management review?
• Which FDA expedited review program is intended for drugs that treat serious conditions and fill an unmet medical need?
• Which schedule contains drugs with a lower potential for abuse and is accepted for medical use?
• Which act or amendment created the separation of drugs into two different categories, prescription (legend) and OTC?
• What is required of pharmacies under the Poison Prevention Packaging Act?
• During a Drug Utilization Review, what type of information is primarily evaluated?
• What information can be determined from the National Drug Code (NDC) number on a medication bottle?
• Which type of information is NOT required on prescription labels according to regulations?
• Provide an example of a Schedule II controlled substance.
• What does an NDC number allow one to identify about a drug?
• An example of an adulterated drug is:
• What defines a "dangerous drug" under federal regulations?
• What does the FDA's relaxed regulation of dietary supplements imply?
• Which schedule contains drugs deemed the most dangerous with no accepted medical use?
• Who administers the Poison Prevention Packaging Act (PPPA)?
• What must an outpatient prescription include to be considered legally valid?
• Under what circumstance can a pharmacy technician accept a prescription drug order?
• Who is authorized to sign a DEA 222 Form at a community pharmacy?
• What Act set the requirements for child-resistant closures for prescription drugs, non-prescription drugs, and hazardous household products?
• If a manufacturer wants to change the way an existing drug is produced, what application must they submit to the FDA?
• What impact does patent exclusivity have on generic drugs?
• What factor is most important in determining whether a substance is classified as a narcotic?
• In which phase of drug development does the investigation focus on a large population to establish efficacy and side effects?
• What are the penalties for trafficking in controlled substances?
• What are the recordkeeping requirements for Schedule II controlled substances?
• Which of the following schedules includes substances with a high potential for abuse and severe dependence but has recognized medical use?
• How does the FDA monitor post-marketing drug safety?
• What types of patients are included in a Phase I clinical trial for drug development?
• For which type of drug recall is there a possibility of temporary or medically reversible adverse effects, but serious adverse effects are remote?
• Which law requires new drugs to be proven safe and effective before approval?
• What is a “New Drug Application” (NDA)?
• What phase of clinical trials focuses on long-term effects of a drug?
• What is the role of the Pharmacy Technician Certification Board (PTCB)?
• Each numbered line on a DEA Form 222 may contain how many items?
• What is required for the electronic prescription of controlled substances?
• What does CSOS stand for in the context of controlled substances ordering?
• Which phase of a clinical trial is primarily used to assess the efficacy of a drug?
• DEA registration is NOT required for which of the following situations?
• A pharmacist may call a prescriber and receive verbal permission to change all of the following on a Schedule II prescription EXCEPT:
• What purpose does a "Drug Utilization Review" (DUR) serve?
• What is the responsibility of pharmacies regarding the Drug Enforcement Administration?
• What is a primary purpose of the REMS program?
• What information is typically not required on a medication label?
• Acetaminophen with codeine (Tylenol #3) is classified under which controlled substance schedule?
• For which class of drugs is a new prescription generally required more frequently due to high abuse potential?
• Which of the following best defines “controlled substances”?
• Which statement is true regarding the handling of prescription drug samples?
• What must be included in the labeling of prescription medications for certain high-risk drugs?
• A warning stating "Caution: Federal law prohibits the transfer of this drug to any person other than the patient" is required on labels for which prescriptions?
• What are the labeling requirements for prescription medications?
• What is the purpose of the Proof of Concept studies in the drug development process?
• What constitutes “labeling” under the FDCA?
• Which of the following is required information on a prescription label?
• What is a “corresponding responsibility” in the context of prescribing controlled substances?
• Which organization outlines standards and requirements for preparing sterile compounded drugs?