Download PrepIQ NWCA Basic Pharmacy Law Ultimate Exam and more Exams Technology in PDF only on Docsity!
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Question 1. Which federal act first required that new drugs be proven safe before marketing? A) Pure Food and Drug Act of 1906 B) Food, Drug, and Cosmetic Act of 1938 C) Durham-Humphrey Amendment of 1951 D) Kefauver-Harris Amendment of 1962 Answer: B Explanation: The 1938 FD&C Act mandated safety testing and the submission of a New Drug Application (NDA) before a drug could be marketed. Question 2. Under the Durham-Humphrey Amendment, which term designates a prescription-only medication? A) OTC B) Legend drug C) Schedule I D) Generic drug Answer: B Explanation: “Legend” drugs require a prescription; the amendment clarified the distinction between prescription (legend) and over-the-counter (OTC) drugs. Question 3. The DEA number checksum formula is used to: A) Verify the pharmacist’s license number B) Confirm the prescriber’s DEA registration is valid C) Determine the schedule of a controlled substance D) Calculate the quantity of a drug that can be dispensed
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Answer: B Explanation: The checksum algorithm (2nd-4th digits × 2 + 3rd-5th digits) verifies that a prescriber’s DEA number is correctly formatted. Question 4. Which schedule of controlled substances has the highest potential for abuse and no accepted medical use in the United States? A) Schedule I B) Schedule II C) Schedule III D) Schedule V Answer: A Explanation: Schedule I substances (e.g., heroin, LSD) are considered to have no accepted medical use and a high potential for abuse. Question 5. A pharmacy must complete a biennial inventory of controlled substances by: A) The 15th of the month following the anniversary of the first registration B) The last day of the calendar year C) The 30th day after each receipt of a Schedule II drug D) The 31st of December every two years Answer: D Explanation: Federal regulations require a complete inventory of Schedule II-V substances to be performed by December 31 of every even-numbered year. Question 6. Which form is used by a pharmacy to report the theft or loss of a controlled substance? A) DEA Form 41
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Question 9. Which of the following is NOT a required element on a valid prescription? A) Patient’s date of birth B) Prescriber’s signature C) Date of issuance D) Drug name, strength, and dosage form Answer: A Explanation: While many states require DOB, the federal minimum elements are patient name, prescriber signature, date, drug name, strength, and directions; DOB is not universally required. Question 10. A technician may perform which of the following tasks without pharmacist supervision? A) Final verification of a prescription B) Counseling a patient on medication use C) Entering prescription data into the computer system D) Adjusting a medication dosage Answer: C Explanation: Data entry is within the scope of a pharmacy technician; final verification and counseling are pharmacist responsibilities. Question 11. The Drug Supply Chain Security Act (DSCSA) primarily addresses: A) Pricing of generic drugs B) Tracking and tracing prescription drugs across the supply chain C) Compounding standards for sterile preparations D) Requirements for pharmacy technicians’ licensure Answer: B
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Explanation: DSCSA mandates a system for tracking prescription drugs from manufacturers to dispensers to enhance drug safety. Question 12. Which class of recall indicates a reasonable probability that use of the product will cause serious adverse health consequences or death? A) Class I B) Class II C) Class III D) Class IV Answer: A Explanation: Class I recalls are the most serious, involving products that could cause severe health risks or death. Question 13. A Schedule III medication may be refilled: A) Up to 5 times within 6 months after the original fill B) Unlimited times as long as the prescription is valid C) Only once per month D) Never; it requires a new prescription each time Answer: A Explanation: Schedule III substances may be refilled up to five times within six months of the original prescription date. Question 14. Which federal agency is responsible for approving new drug applications (NDAs)? A) DEA B) FDA C) CMS D) CDC
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D) Never refilled; a new prescription is required for each dispense Answer: D Explanation: Schedule II substances cannot be refilled; a new prescription is required for each dispense. Question 18. Which of the following is an example of “tall-man lettering” used to prevent LASA errors? A) LIPITOR vs. LIPITOL B) Warfarin vs. Warfarin C) METOPROLOL vs. METO-PROLOL D) CycloSERINE vs. cycloSPORINE Answer: D Explanation: Tall-man lettering emphasizes differing parts of drug names (e.g., SERINE vs. SPORINE) to reduce look-alike/sound-alike errors. Question 19. The FDA’s “Recall” classification system is based on: A) The cost of the product B) The manufacturer’s location C) The degree of health risk to the consumer D) The number of units sold Answer: C Explanation: Recalls are classified (I, II, III) according to the potential health risk posed by the product. Question 20. A pharmacy technician is prohibited from: A) Counting tablets under pharmacist supervision B) Delivering medication to a patient’s home without pharmacist verification
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C) Preparing a compound sterile preparation D) Both B and C Answer: D Explanation: Technicians may not independently deliver medications or prepare sterile compounding; both actions require pharmacist oversight. Question 21. Which act established the requirement for drug manufacturers to submit an NDA before marketing a new drug? A) Pure Food and Drug Act B) Food, Drug, and Cosmetic Act C) Kefauver-Harris Amendment D) Durham-Humphrey Amendment Answer: C Explanation: The 1962 Kefauver-Harris Amendment added the efficacy requirement and solidified the NDA process. Question 22. The DEA’s electronic ordering system for Schedule II substances is called: A) CSOS (Controlled Substance Ordering System) B) eRx C) NDC D) REMS Answer: A Explanation: CSOS is the DEA’s electronic platform for ordering Schedule II controlled substances. Question 23. Which of the following is a permissible reason for a pharmacist to refuse to fill a prescription?
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Question 26. A pharmacy must report a significant loss of a controlled substance to the DEA within: A) 24 hours B) 48 hours C 30 days D) 5 days Answer: D Explanation: DEA regulations require reporting of significant loss, theft, or diversion within five business days. Question 27. The “legend” on a prescription drug label is required to be printed in: A) Bold, capital letters B) Red ink only C) A contrasting color to the background D) No specific format; just the word “legend” Answer: C Explanation: FDA regulations require the legend to be printed in a contrasting color to ensure visibility, but no specific font or color is mandated. Question 28. Which of the following best describes the purpose of the Poison Prevention Packaging Act? A) To reduce the cost of medication packaging B) To prevent accidental ingestion by children C) To improve the aesthetic design of medication bottles D) To standardize dosage labeling Answer: B
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Explanation: The act mandates child-resistant packaging to reduce accidental poisonings by children. Question 29. Which of the following is a correct statement regarding the DEA Form 222? A) It is used to register a pharmacy for controlled substances. B) It authorizes a pharmacy to order Schedule II substances. C) It reports a theft of controlled substances. D) It documents the disposal of expired drugs. Answer: B Explanation: DEA Form 222 is the “Order Form” used by registrants to order Schedule II controlled substances. Question 30. Under the Controlled Substances Act, a “significant loss” is defined as: A) Any loss of a Schedule V drug B) A loss of more than 5% of the total inventory in a year C) A loss that could affect the drug’s market price D) Any loss that exceeds the minimum threshold set by the DEA for that schedule Answer: D Explanation: DEA defines significant loss based on specific quantitative thresholds per schedule; exceeding those triggers reporting. Question 31. Which of the following activities is explicitly prohibited for a pharmacy technician under most state boards of pharmacy? A) Measuring bulk powders for compounding B) Performing final drug utilization review
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A) Fill the prescription as written to avoid conflict B) Contact the prescriber for clarification before dispensing C) Reduce the dosage without notifying anyone D) Ignore the issue if the patient pays cash Answer: B Explanation: The pharmacist must verify the prescription’s safety with the prescriber before dispensing an unsafe dosage. Question 35. Under the FD&C Act, a drug label must include which of the following? A) The manufacturer’s profit margin B) The drug’s expiration date C) The prescriber’s DEA number D) The pharmacy’s square footage Answer: B Explanation: Labels must display the “expiration date” to inform patients of product stability. Question 36. Which of the following statements about “OTC” (over-the-counter) drugs is true? A) They never require child-resistant packaging. B) They are exempt from all FDA labeling requirements. C) They can be sold without a prescription but must meet safety standards. D) They are automatically considered Schedule V substances. Answer: C Explanation: OTC drugs can be sold without a prescription but must still meet FDA safety, efficacy, and labeling standards.
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Question 37. The “National Drug Code” (NDC) is used to: A) Identify the pharmacy’s DEA registration number B) Uniquely identify a specific drug product and package size C) Classify drugs into schedules D) Determine the price of a medication Answer: B Explanation: The NDC is a unique 10-digit identifier for drug products, indicating manufacturer, product, and package. Question 38. Which of the following actions would be considered a breach of patient confidentiality under HIPAA? A) Discussing a patient’s medication with the patient’s spouse when the patient is present B) Sharing a patient’s prescription history with another pharmacist for a transfer request C) Posting a patient’s name and diagnosis on a public bulletin board D) Using a patient’s initials on a medication label Answer: C Explanation: Publicly posting identifiable health information violates HIPAA’s privacy rule. Question 39. A pharmacy must retain records of controlled substance inventories for: A) 6 months B) 1 year C) 2 years D) 5 years Answer: C
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C) A drug that is only available in over-the-counter form D) A drug that is exempt from FDA approval Answer: A Explanation: Generic drugs contain the same active ingredient, strength, dosage form, and route as the brand-name product. Question 43. Under the Controlled Substances Act, a pharmacy must secure Schedule II-V drugs in: A) A locked cabinet or safe that meets DEA specifications B) An open shelf accessible to all staff C) A refrigerated unit without a lock D) A drawer in the pharmacist’s office Answer: A Explanation: DEA regulations require that controlled substances be stored in a securely locked container meeting specific standards. Question 44. Which of the following is NOT a requirement for a pharmacy technician’s registration in most states? A) Completion of a state-approved training program B) Passing a national certification exam C) Submission of a background check D) Holding a Doctor of Pharmacy (Pharm.D.) degree Answer: D Explanation: A Pharm.D. is required for pharmacists, not technicians. Question 45. The “Drug Enforcement Administration” (DEA) falls under which U.S. department? A) Department of Health and Human Services
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B) Department of Justice C) Department of Agriculture D) Department of Commerce Answer: B Explanation: The DEA is a federal law enforcement agency within the U.S. Department of Justice. Question 46. Which of the following is a permissible reason for a pharmacist to dispense a medication without a prescription in an emergency? A) The patient is a minor needing a vaccine B) The patient has a documented allergy to the medication C) The patient presents with a life-threatening condition requiring immediate administration of a medication that the pharmacist can legally dispense (e.g., epinephrine) D) The patient requests a medication for recreational use Answer: C Explanation: In emergencies, pharmacists may dispense certain medications (e.g., epinephrine auto-injectors) under standing orders or emergency protocols. Question 47. Which of the following best describes the purpose of “look-alike/sound-alike” (LASA) drug precautions? A) To reduce manufacturing costs B) To prevent medication errors caused by similar drug names or appearances C) To increase the market share of generic drugs D) To standardize packaging colors across all medications Answer: B
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D) Pharmacy technician licensure standards Answer: C Explanation: The 1976 amendments gave the FDA authority to regulate medical devices, separate from drug regulations. Question 51. A pharmacist receives a prescription that lacks the prescriber’s DEA number for a Schedule III drug. The correct action is to: A) Fill the prescription anyway because the DEA number is optional for Schedule III B) Contact the prescriber to obtain the DEA number before dispensing C) Refuse to fill the prescription and discard it D) Fill the prescription but note the missing DEA number in the record Answer: B Explanation: Schedule III prescriptions must include the prescriber’s DEA number; the pharmacist must verify before dispensing. Question 52. Which of the following is true regarding “compounding” under federal law? A) All compounded sterile preparations are exempt from FDA oversight. B) Compounded drugs are subject to the same labeling requirements as FDA-approved drugs. C) Compounding can be performed without a pharmacist’s presence. D) The FDA does not regulate any aspect of compounding. Answer: B Explanation: Compounded medications must meet labeling requirements, including drug name, strength, and beyond-use date, though they are exempt from NDA approval.
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Question 53. The “Controlled Substance Ordering System” (CSOS) allows pharmacies to: A. Order Schedule I substances for research purposes only B. Submit electronic orders for Schedule II-V drugs without paper forms C. Track over-the-counter medication sales D. Register new pharmacists with the DEA Answer: B Explanation: CSOS is the DEA’s electronic platform for ordering Schedule II-V controlled substances. Question 54. Which of the following best describes the “Pharmacy Benefit Manager” (PBM) role? A. Regulates controlled substance schedules B. Negotiates drug prices and manages formularies for insurers C. Issues DEA registration numbers D. Conducts FDA drug approvals Answer: B Explanation: PBMs handle drug pricing, formulary management, and claim processing for health plans. Question 55. Under the “Pure Food and Drug Act” of 1906, which of the following was prohibited? A. Advertising prescription drugs on television B. Misbranding or adulterating foods and drugs C. Importing foreign pharmaceuticals D. Compounding sterile preparations without a license Answer: B
