Federal Requirements Test

Question 1: Which federal agency is responsible for regulating the manufacturing and distribution of prescription and over-the-counter drugs in the United States?

Question 2: What is required on all controlled substance prescriptions by federal law?

Question 3: The federal law that requires pharmacists to offer counseling to Medicaid patients is known as:

Question 4: Which federal agency enforces regulations related to the proper labeling and packaging of medications?

Question 5: Which federal law requires pharmacies to maintain patient medication profiles to help prevent drug interactions?

Question 6: A prescription with the statement 'Caution: Federal Law prohibits dispensing without a prescription' is most likely for a medication classified as a:

Question 7: Which federal act established criteria for approval and marketing of prescription drugs in the United States?

Question 8: Which of the following is required for the transfer of a Schedule II controlled substance prescription between pharmacies at the patient’s request under federal law?

Question 9: The federal agency responsible for enforcing the Comprehensive Drug Abuse Prevention and Control Act is the:

Question 10: Which federal law requires manufacturers to prove the safety and efficacy of dietary supplements?

Question 11: Which federal law established the Drug Enforcement Administration (DEA) to regulate controlled substances in the United States?

Question 12: What federal regulation mandates the handling and disposal procedures for hazardous waste, including pharmaceutical waste?

Question 13: Under federal law, what schedule are medications like morphine and oxycodone classified as?

Question 14: Which federal law requires that pharmacies provide patient counseling for new prescriptions?

Question 15: Physicians prescribing controlled substances must include their ____ on all prescriptions.

Question 16: Which federal act established the guidelines for the privacy and security of protected health information (PHI)?

Question 17: What entity is responsible for the registration and regulation of all pharmacy technicians at the federal level?

Question 18: Under federal law, who is authorized to sign a controlled substance prescription?

Question 19: The federal act that set requirements for storage, handling, and recordkeeping of prescription drugs is known as the ____.

Question 20: What is required to be labeled clearly on all prescription containers under federal law?

Question 21: Which federal agency oversees the regulation of biological products in the United States?

Question 22: What type of drug recall involves a situation where the use of or exposure to a violative product is not likely to cause adverse health consequences?

Question 23: What federal law requires pharmacists to offer vaccine administration services?

Question 24: Which federal agency oversees the regulation of prescription drug advertising and promotion in the United States?

Question 25: Under federal law, which class of medical devices presents the highest risk to patients and requires premarket approval by the FDA?

Question 26: The federal program that provides prescription drug coverage for Medicare beneficiaries is known as ____.

Question 27: Which federal law established a system to report adverse events related to dietary supplements to the FDA?

Question 28: Prescription drug samples provided to healthcare professionals by pharmaceutical representatives must comply with the regulations outlined in the ____.

Question 29: Which federal agency manages the Electronic Prescriptions for Controlled Substances (EPCS) program in the United States?

Question 30: An investigational new drug (IND) application is required by the FDA before ____.

Question 31: Which federal law requires that tamper-evident packaging be used for over-the-counter (OTC) medications?

Question 32: The federal legislation intended to reduce the diversion and abuse of pseudoephedrine products is known as the ____.

Question 33: What is the federal agency responsible for monitoring and regulating tobacco products in the U.S.?

Question 34: Which federal act established the requirement for drug manufacturers to ensure quality in drug production through compliance with current Good Manufacturing Practices (cGMP)?

Question 35: The federal agency responsible for implementing and enforcing the Drug Abuse Prevention and Control Act to regulate controlled substances is the ____.

Question 36: According to the federal law, which schedule of drugs has the lowest potential for abuse among controlled substances?

Question 37: What federal law requires drug manufacturers to provide drug information to healthcare providers and maintain proper records of distribution?

Question 38: Which federal agency regulates the quality and safety of blood and blood products in the U.S.?

Question 39: The federal law that established the prescription drug marketing policies, including drug samples and promotional activities, is the ____.

Question 40: What federal program provides funding for drug purchases in health centers and certain hospitals serving underserved populations?

Question 41: Which federal agency is responsible for enforcing regulations related to the safety and effectiveness of medical devices?

Question 42: Under federal law, how often must controlled substance inventory be conducted in a pharmacy?

Question 43: What federal law requires that controlled substance prescriptions include the prescriber's DEA registration number?

Question 44: The federal regulation that sets standards for pharmacy practice, including prescription dispensing, is known as the ____.

Question 45: Under federal law, how many refills are allowed for a prescription of a Schedule III or IV controlled substance?

Question 46: Which federal regulation requires pharmacists to conduct Drug Utilization Reviews (DUR) to ensure safe and appropriate medication therapy?

Question 47: The federal law that requires pharmacists to verify the legitimacy of controlled substance prescriptions before dispensing is known as the ____.

Question 48: Which category of recall involves a situation in which the use of a product is unlikely to cause any adverse health consequences?

Question 49: What federal law established the requirements for the administration, handling, and storage of vaccines?

Question 50: The federal agency responsible for maintaining and enforcing drug classification under the Controlled Substances Act is the ____.

Question 51: In the U.S., which federal agency is responsible for the regulation of food, drugs, and cosmetics?

Question 52: Under the Federal Food, Drug, and Cosmetic Act, who is primarily responsible for ensuring prescription drug advertising is not false or misleading?

Question 53: Which federal law requires pharmacies to offer consultation to Medicaid patients regarding their medications?

Question 54: What is required on a prescription for a Schedule II controlled substance by federal law?

Question 55: The federal legislation that established procedures for the approval and marketing of new drugs in the U.S. is known as the ____.

Question 56: What is the federal agency responsible for enforcing regulations to ensure proper labeling and packaging of medications?

Question 57: Which federal law requires pharmacies to maintain patient medication profiles for thorough medication therapy management?

Question 58: A prescription labeled 'Federal Law prohibits transfer' is likely for a medication classified as a ____.

Question 59: The federal agency responsible for enforcing controlled substance regulations is the ____.

Question 60: Which federal law requires manufacturers to establish the safety and efficacy of dietary supplements before marketing them?

Question 61: Which federal agency manages the Orange Book, a publication listing approved drug products and therapeutic equivalence evaluations?

Question 62: The federal legislation that established the National Drug Code (NDC) to identify drug products is known as the ____.

Question 63: Under federal law, who is authorized to write prescriptions for controlled substances?

Question 64: What is the federal program that sets reimbursement rates for prescription drugs covered under Medicare Part B?

Question 65: Which federal law requires prescription drug manufacturers to provide rebates to Medicaid programs?

Question 66: The federal act that governs the electronic transmission of prescription information to pharmacies is known as the ____.

Question 67: What federal agency is responsible for regulating clinical trials of investigational drugs?

Question 68: Under federal law, patient profiles maintained by pharmacies must include the patient's ____.

Question 69: The federal law mandating the placement of prescription drug orders by health care providers electronically is known as the ____.

Question 70: Which federal program provides discounted pricing on prescription drugs for specific health care organizations serving vulnerable populations?

Question 71: Which federal agency enforces the regulations related to the compounding of medications by pharmacies?

Question 72: Under federal regulations, what is required on a prescription label for a controlled substance?

Question 73: The federal law that established the regulations for healthcare providers to report adverse events related to drugs and biologics is known as the ____.

Question 74: Which federal act requires pharmacists to verify patient identification when dispensing controlled substances?

Question 75: The federal program that administers drug plans for federal employees is known as ____.

Question 76: What entity is responsible for the oversight of the approval process for new drugs under the Prescription Drug User Fee Act (PDUFA)?

Question 77: Under federal law, what is required for a drug to be considered an orphan drug eligible for certain incentives?

Question 78: Which federal agency requires the submission of adverse event reports for vaccines administered in the U.S.?

Question 79: The federal law that requires patient consent for the use and disclosure of protected health information is known as ____.

Question 80: What federal law provides incentives for the development of drugs and treatments for rare diseases?

Question 81: Under federal law, what is required to be included in the prescription for a medication to be dispensed?

Question 82: The federal legislation that enacted a standardized system for electronic prescribing of controlled substances is known as the ____.

Question 83: Which federal agency oversees the approval of biosimilar medications in the United States?

Question 84: The federal law that established the FDA's authority to regulate the manufacturing, marketing, and distribution of tobacco products is called the ____.

Question 85: What federal law established the regulation for the disposal of controlled substances by pharmacies?

Question 86: The federal program that provides prescription drugs at reduced cost to eligible individuals is known as ____.

Question 87: What is required by federal law on the label of all over-the-counter (OTC) drugs?

Question 88: Which federal agency is responsible for the regulation of drug information provided by pharmaceutical companies to consumers?

Question 89: Under federal law, how often must Schedule II controlled substance inventory be conducted in a pharmacy?

Question 90: The federal law that requires tamper-evident packaging for OTC medications to prevent product adulteration is called the ____.

Question 91: Which federal agency enforces regulations related to the billing and reimbursement of prescription medications through insurance programs?

Question 92: Under federal law, who is required to maintain accurate records of controlled substance transactions for reporting purposes?

Question 93: The federal law that established the database for monitoring controlled substance prescriptions to prevent abuse is known as the ____.

Question 94: Which federal law governs the submission of adverse event reports for dietary supplements?

Question 95: What is required under federal law when transferring a prescription for a Schedule III controlled substance between pharmacies?

Question 96: The federal agency responsible for the licensing and oversight of biological products in the U.S. is the ____.

Question 97: What federal law established labeling requirements for drugs to include detailed information about indications, dosage, and administration?

Question 98: Under federal regulations, how often must pharmacy compounding documentation be retained?

Question 99: The federal law that imposes controls on the distribution, dispensing, and use of over-the-counter medications containing pseudoephedrine is known as the ____.

Question 100: Which federal agency is responsible for regulating the safety and effectiveness of medical devices used in health care facilities?

Question 101: Which federal agency is responsible for regulating the approval and oversight of prescription drug advertising in the U.S.?

Question 102: Under federal law, who is required to register with the DEA to handle controlled substances?

Question 103: The federal law that established the Drug Supply Chain Security Act (DSCSA) to enhance drug supply chain security is known as the ____.

Question 104: Which federal regulation requires pharmacies to provide patient counseling for new prescriptions to ensure safe and effective use of medications?

Question 105: The federal program that provides discounted prices for prescription drugs to eligible health centers and hospitals is known as ____.

Question 106: What is required by federal law on the label of all prescription containers to ensure proper medication dispensing?

Question 107: Under federal law, what is required for a medication to be classified as an over-the-counter (OTC) product?

Question 108: The federal agency responsible for overseeing drug innovation, development, and approval to ensure patient safety is the ____.

Question 109: Which federal law prohibits the dispensing of controlled substances without a valid prescription from a healthcare provider?

Question 110: The federal regulation that governs the confidentiality of patient information and healthcare transactions is known as ____.

Question 111: Under federal law, what is required for the dispensing of controlled substances by a pharmacist?

Question 112: The federal legislation that regulates the manufacturing and distribution of medicinal products through compliance with GMP is known as the ____.

Question 113: Which federal agency is responsible for monitoring and regulating the trade of prescription drugs across state lines to prevent diversion and abuse?

Question 114: The federal law that requires the maintenance of records for the dispensing of controlled substances by pharmacies is known as the ____.

Question 115: What is required on all medication containers dispensed by pharmacies under federal law to ensure safe and effective use?

Question 116: Under federal regulations, what is required to be included in a drug monograph for over-the-counter products?

Question 117: The federal program that provides funding for health centers and clinics to support the dispensing of affordable medications is known as ____.

Question 118: What federal law requires the labeling of food allergens in packaged foods to protect consumers with allergies?

Question 119: Under federal law, what is required to be included on a prescription label for a patient?

Question 120: The federal regulation that establishes accurate labeling of medication containers to ensure proper dispensing is known as the ____.

Question 121: Which federal agency oversees the approval and regulation of generic drugs in the U.S.?

Question 122: Under federal law, who is responsible for ensuring the accuracy and legality of prescription drug orders?

Question 123: The federal law that requires manufacturers and distributors to report drug shortages to the FDA is known as the ____.

Question 124: What is required on a prescription label for a controlled substance under federal law to prevent misuse?

Question 125: The federal legislation that established the guidelines for the effective use of antibiotics in animals and humans is called the ____.

Question 126: What federal agency is responsible for monitoring and regulating the safety and efficacy of medical devices used in patient care?

Question 127: Under federal law, what is required for the manufacturing and labeling of dietary supplements?

Question 128: The federal program that provides financial assistance for low-income individuals to access prescription medications is known as ____.

Question 129: Which federal law mandates the reporting of adverse events related to vaccines to the Vaccine Adverse Event Reporting System (VAERS)?

Question 130: The federal agency responsible for addressing health disparities and providing healthcare services to underserved communities is the ____.

Question 131: Which federal agency is responsible for regulating the safety and effectiveness of biological products, including vaccines?

Question 132: Under federal law, who is authorized to prescribe controlled substances for patients?

Question 133: The federal law that requires drug manufacturers to submit post-marketing adverse event reports to the FDA is known as the ____.

Question 134: What is required on a prescription label for a non-prescription medication under federal law?

Question 135: The federal legislation that established good practices for the manufacturing, packaging, and labeling of drugs is called the ____.

Question 136: What federal agency regulates the safety and efficacy of medical devices used in clinical settings?

Question 137: Under federal law, what is necessary for a medication to be classified as a legend drug?

Question 138: The federal program that provides prescription drug coverage for military personnel and veterans is known as ____.

Question 139: Which federal law requires drug manufacturers to maintain records of drug distribution and provide samples to healthcare providers?

Question 140: The federal regulation that ensures the privacy and security of health information under HIPAA is known as the ____.

Question 141: Which federal agency regulates the labeling and packaging of dietary supplements to ensure accurate information for consumers?

Question 142: Under federal law, who is responsible for providing accurate and safe compounding of medications in the pharmacy?

Question 143: The federal law that requires pharmacists to conduct drug utilization reviews (DUR) for Medicaid patients is known as the ____.

Question 144: What is required on a controlled substance prescription label by federal law to prevent unauthorized refills?

Question 145: The federal legislation that established the guidelines for the marketing and distribution of over-the-counter drugs is called the ____.

Question 146: What federal agency oversees the regulation and monitoring of drug and device recalls in the U.S.?

Question 147: Under federal law, what is required for a pharmacy to dispense opioid medications?

Question 148: The federal program that provides prescription drug coverage to the elderly and disabled through Medicare is known as ____.

Question 149: Which federal law requires drug manufacturers to provide rebates to Medicaid programs for certain medications?

Question 150: The federal regulation that ensures pharmacies maintain medication profiles for patients to prevent drug interactions is known as the ____.