Federal Pharmacy Law Practice Exam

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• Which is the correct schedule classification for cough preparations that contain hydrocodone?
• How do drug manufacturers typically identify affected drugs during a recall?
• What must a pharmacist do if they suspect a prescription is for an off-label use?
• What information must be included in a patient's medication profile?
• What vital information is included in the package insert concerning adverse reactions?
• What is the maximum number of refills for a Schedule V controlled substance prescription?
• What are the penalties for knowingly violating federal narcotic laws?
• Which of the following classifications of drugs has no accepted medical use in the United States?
• What does the Prescription Drug Marketing Act of 1988 prohibit?
• What information must be recorded in a pharmacy's controlled substances record keeping system?
• What is the maximum number of refills allowed for Schedule IV drugs within a six-month period?
• Under the FDA Act of 1988, what is expected to be reported to the FDA?
• In a three-file prescription filing system, how are prescriptions categorized?
• What does a pharmacy need to do with their inventory records for controlled substances?
• What can happen to a pharmacist's license after a drug-related crime conviction?
• What is the primary therapeutic use for Methadone?
• What form is required for the ordering of Schedule II drugs?
• If the expiration date on a bottle of Naproxen is 8/08, when does the drug expire?
• Which drug is known by the brand name Tranxene and classified as Schedule IV?
• What does the last two digits of an NDC number indicate?
• What schedule is assigned to anabolic steroids such as testosterone?
• Which of the following medications is marketed under the brand name Restoril?
• Which Schedule IV drug is recognized with the brand name Klonopin?
• What are the consequences for pharmacists who fail to report suspicious activities related to controlled substances?
• What is required for an emergency refill of a controlled substance?
• Pentazocine, branded as Talwin, is a controlled substance in which schedule?
• Which of the following must be included in package inserts?
• What schedule is Dextroamphetamine classified under?
• Hycotuss is categorized as what type of schedule drug?
• Which category of drugs has less potential for abuse than Schedule II, III, and IV drugs?
• What type of medication is represented by diazepam, which is a Schedule IV substance?
• What is included in the review process of a new drug application by the FDA?
• Where can you find a list of manufacturer addresses and phone numbers related to drugs?
• Under what conditions can a pharmacist change the dosage form of a prescribed controlled substance?
• Hycodan is classified under which schedule?
• In a valid DEA number, what must the first letter be?
• What is the purpose of the Orphan Drug Act of 1983?
• Under federal law, what is the limit on the number of refills for a Schedule II prescription?
• Which form is utilized to report lost or stolen drugs?
• What is the key purpose of the Comprehensive Drug Abuse Prevention and Control Act of 1970?
• What is the main purpose of the Health Insurance Portability and Accountability Act (HIPAA)?
• Which DEA form is used to report lost or stolen controlled substances?
• Which of the following is classified under Schedule III?
• How many hours of continuing education are required every two years for pharmacists?
• Flurazepam is classified as which schedule?
• Which medication is identified as Schedule II and is a strong opioid pain reliever?
• What does the Drug Price Competition and Patent-Term Restoration Act facilitate?
• What information is typically included in Material Safety Data Sheets regarding hazardous materials?
• What documentation is necessary for conducting an inventory of controlled substances?
• What defines the expiration date of a controlled substance?
• What does the term "legend drugs" refer to as defined by Federal law?
• What is the brand name of the drug that has triazolam as its generic name and is classified under Schedule IV?
• Which of the following medications is classified as a Schedule IV substance?
• How do prescription drugs differ from over-the-counter (OTC) drugs?
• Which of the following is required for a pharmacy to dispense controlled substances?
• What role do state boards of pharmacy play in relation to federal pharmacy law?
• What is a primary responsibility of pharmacists regarding controlled substances?
• What is required for a valid patient-prescriber relationship for the prescribing of controlled substances?
• Which medication is known by the trade name Dilaudid?
• Which schedule of drugs under the CSA has the highest abuse potential?
• What is the focus of a Class III recall?
• What characterizes Schedule IV drugs in comparison to Schedule II and III drugs?
• What does the Orange Book primarily provide?
• Which category does Empirin # 3 fall under?
• Which medication is in Schedule II and contains hydrocodone?
• Which publication contains detailed monographs and chemical characteristics of drugs?
• Which of the following is identified as Schedule II?
• Which aspect is NOT typically regulated by state boards of pharmacy?
• Which class of drugs has the highest potential for abuse?
• Which resource provides annual packet insert information for physicians?
• What does the green copy of the DEA 222 form indicate?
• What type of medication is exempt from the Poison Prevention Packaging Act (PPPA)?
• How long must pharmacies maintain records of controlled substance inventories according to the DEA?
• What is the minimum age for a person to work as a pharmacy technician in most states?
• Which chapter of the USP outlines requirements for sterile compounding?
• What classification includes both morphine and amphetamines?
• How does the FDA classify a new drug application (NDA)?
• Which act shifted responsibility for drug advertisements to the FTC?
• What is a common characteristic shared by Schedule III and IV drugs?
• What is a "hard copy" prescription?
• What kind of information does Drug Facts and Comparisons include?
• What must a doctor have to prescribe medications?
• What classification of drugs does DEA form 363 pertain to?
• What is required for a healthcare provider to legally prescribe controlled substances?
• How are drugs organized in the American Drug Index?
• Which class of drugs requires a package insert to be distributed with it?
• Which entity is responsible for regulating the prescribing and dispensing of controlled substances?
• Which drug listed is not classified under Schedule I?
• In the context of off-label drug use, what is primarily the responsibility of the prescriber?
• What is the correct format for a valid DEA number?
• What is the generic name of the Schedule IV drug known as Halcion?
• What schedule is heroin classified under?
• What is a primary purpose of child-resistant packaging?
• Which schedule of drugs is classified as having no accepted medicinal use?
• Phentermine, known as Fastin, is categorized under which controlled substance schedule?
• What is meant by an "investigational drug"?
• What is the significance of the Orange Book?
• What rating indicates that a drug product can be therapeutically substituted?
• Which compound is considered a Schedule III medication when combined with codeine?
• What is the purpose of the Drug Listing Act?
• What is required for a manufacturer or distributor of controlled substances?
• What schedule does Percocet belong to?
• Which of the following drugs can no one order?
• What is the primary purpose of the DEA's scheduling system?
• For how long must the blue copy of the DEA 222 form be kept by the purchaser?
• Which drug is known by the brand name Valium and is classified as Schedule IV?
• What does the 1988 Food and Drug Administration Act establish?
• What requirement does the Poison Prevention Packaging Act impose?
• The second set of numbers in an NDC number refers to which aspect?
• What type of drugs are required to be stored in a locked cabinet in a pharmacy?
• Which schedule is cocaine classified under?
• What is the designated schedule for Percodan?
• What type of drugs are primarily affected by childproof packaging requirements?
• Which of the following medications is primarily used for managing anxiety and is classified as Schedule IV?
• What action should be taken if a controlled substance is lost or stolen?
• Which substance is used to treat severe pain and is classified under Schedule II?
• What type of drugs is subject to the Drug Product Safety and Effectiveness provisions of the FDA?
• Which act primarily regulates the advertising and labeling of prescription drugs?
• What is the maximum number of refills allowed for CIII-CV prescriptions within a six-month period?
• What is the function of a commercial invoice in pharmacy operations?
• How many files are used in a two-file prescription filing system for CDS prescriptions?
• What is the main purpose of the Drug Approval Procedure?
• Which filing system involves keeping one file for CDS-CII only?
• Which drug falls under Schedule II and is often preferred for its opioid analgesic properties?
• Which act addresses drug pricing and affordability issues?
• What type of information regarding injectable drugs can be found in the Handbook on Injectable Drugs?
• What labeling requirement was established by the Durham-Humphrey Amendment of 1951?
• What does the first set of numbers in an NDC number identify?
• Which class of drugs does not require regular inventory checks as per federal regulations?
• Where would one typically find a list of drug package inserts?
• What is the primary purpose of the Handbook of Injectable Drugs?
• Antidiarrheal medications containing opioids, such as Lomotil, fall into which controlled substance schedule?
• Which publication is updated monthly and contains a comprehensive listing of drugs?
• What is a key provision of the Health Insurance Portability and Accountability Act (HIPAA) of 1996?
• Mescaline is categorized under which schedule?
• Amphetamines are classified under which schedule?
• Who has the authority to initiate the ordering of an investigational drug?
• What is the purpose of the DEA 222 form?
• Peyote is categorized under which schedule?
• For general pharmacy rules and regulations, which law is considered the most responsible to follow?
• What must be done to dispose of expired or unused medications properly?
• What schedule is characterized by the combination of ibuprofen + hydrocodone?
• Which of the following must OTC drug labeling include?
• What is the classification of marijuana?
• Which schedule of controlled substances has the highest potential for abuse?
• In an NDC number, what do the first five digits represent?
• Which act established the requirements for child-resistant packaging?
• What is the role of the National Association of Boards of Pharmacy (NABP)?
• Which substance is regulated under the Combat Methamphetamine Epidemic Act (CMEA) of 2006?
• What is required to purchase opium under the Harrison Narcotic Act of 1914?
• Phenobarbital, known as Solfoton, belongs to which classification of controlled substances?
• What does the term "off-label" use refer to?
• Which of the following is a limitation set by the CMEA for purchasing pseudophedrine products?
• What labeling requirement must be included on all prescription medications?
• Under what circumstances can a prescriber issue multiple prescriptions for a Schedule II drug?
• What information is included in a Drug Enforcement Administration (DEA) number?
• What must be included in prescription labels according to the Food, Drug, and Cosmetic Act?
• Morphine falls under which controlled substance schedule?
• What is a compound prescription?
• What characterizes a Class II recall?
• Pentazocine is a Schedule IV controlled substance, but what is its combination with naloxone called?
• What is the significance of marking CDS-CIII prescriptions with a red "C"?
• Which of the following has the highest potential for abuse?
• Which of the following is classified as Schedule III?
• To whom should drug recalls and adverse drug reactions be reported?
• Which of the following substances is NOT classified as a controlled substance?
• Who was established by the Comprehensive Drug Abuse Prevention and Control Act of 1970?
• What is the form used when ordering CII drugs?
• Which schedule includes substances that have a high potential for abuse and have no accepted medical use in the U.S.?
• Which act made significant changes to include cosmetics in regulatory oversight?
• What schedule is codeine classified in?
• Which of the following drugs is classified as Schedule I?
• What does the acronym CSA stand for in the context of pharmacy law?
• When federal and state record keeping requirements differ, which law should be adhered to?
• How often must a controlled substance inventory be conducted according to regulations?
• Which of the following drugs is marketed as Talwin?
• Which act requires safeguards regarding the approval of new drugs?
• What does Mosby's Complete Drug Reference primarily list?
• Who has the authority to schedule drugs into different categories?
• What schedule does ASA + codeine correspond to?
• Which entity oversees the Drug Approval Procedure in the United States?
• What type of medication requires a Risk Evaluation and Mitigation Strategy (REMS)?
• Cough syrups containing hydrocodone, such as Tussionex, fall under which schedule?
• Methylphenidate is also known as which of the following?
• What does the term "box warning" refer to?
• What information is required on a prescription for controlled substances?
• In what situation can a pharmacy provide an emergency supply of medication without a physician’s prescription?
• What is required on a prescription label for a controlled substance?
• What is the federal regulation governing records of controlled substances?
• What is the significance of the Drug Approval Process?
• What do the last two digits of an NDC number indicate?
• Can a pharmacist accept a controlled substance prescription over the phone for a Schedule II drug?
• What is the primary federal agency responsible for enforcing the Food, Drug, and Cosmetic Act?
• What type of information can be found in the Drug Topics Red Book?
• What does the Food, Drug, and Cosmetic Act require for prescription drugs?
• What do the middle four digits of an NDC number indicate?
• What is a characteristic of Schedule II drugs regarding their packaging?
• How many times may a prescription for alprazolam be refilled?
• Which of the following substances is classified as a Schedule II drug?
• Which Schedule III drug is commonly used for pain relief and is often combined with acetaminophen?
• What must a pharmacist do if they suspect a prescription for a controlled substance is fraudulent?
• Which of the following is a requirement of the Omnibus Budget Reconciliation Act (OBRA) of 1990?
• What must be included in the labeling of over-the-counter medications?
• Which medication is classified as Schedule II and is known as Duragesic?
• Which of the following drugs is NOT classified as Schedule II?
• What does the Omnibus Budget Reconciliation Act require pharmacists to provide to patients?
• What schedule is diethylpropion classified under?
• What is necessary for a pharmacy to operate a controlled substance treatment program?
• Under the CSA, what form is required for the ordering of Schedule I and II controlled substances?
• What does "dispensing" a medication involve?
• What is the Schedule IV classification of the drug clorazepate?
• Which federal act requires proper labeling on prescription drug containers?
• Opium is categorized as what schedule?
• Which information is required on a prescription for a controlled substance?
• How many times can Schedule III drugs be refilled within a six-month period?
• What schedule does Soma with codeine fall under?
• Which of the following is true regarding Schedule I drugs?
• Which of the following benzodiazepines is listed as a Schedule IV controlled substance?
• What is the brand name for the combination drug Hydrocodone w/ acetaminophen?
• Which aspect is critical when handling drug recalls in a pharmacy?
• What does the term "labeling" refer to in the context of medications?
• Vicoprofen is best described as what schedule of medication?
• What is the role of the Prescription Monitoring Program (PMP)?
• What is the maximum number of refills allowed for a Schedule III or IV controlled substance prescription?
• What does the Federal Food and Drug Act of 1906 prohibit?
• Which drug is prescribed for nausea and is classified as Schedule III?
• Which Schedule IV controlled substance is known for inducing sleep and is often used in treating insomnia?
• What is the intent of a Class I recall?
• Fentanyl is commonly referred to by which brand name?
• Schedule II drugs may NOT be what?
• What document is required as proof of receipt when ordering a CIII medication?
• Under federal law, how often must a pharmacy conduct an inventory of controlled substances?
• Which class of drug recall must be communicated to the customer level?
• What is the purpose of the Drug Enforcement Administration (DEA)?
• Which of the following medications is classified as a Schedule IV controlled substance?
• Can pharmacists refuse to fill a controlled substance prescription?
• What must be reported using the DEA 106 form?
• What is the brand name for the Schedule IV substance alprazolam?
• Which of the following medications has the highest potential for abuse among Schedule IV substances?
• Diethylpropion is classified under which controlled substance schedule?
• Which agency is primarily responsible for the regulation of controlled substances?
• What is the main purpose of the USPDI?
• What is the common brand name for Oxycodone?