Pharmacy law and regulation are fundamental to ensuring public safety, maintaining ethical standards, and defining the scope of practice for pharmacists. For PharmD students, a comprehensive understanding of these principles is essential for navigating the complex legal landscape of the profession and upholding patient well-being. This quiz covers key federal and state laws, regulatory bodies, and ethical considerations that govern pharmacy practice.
- What is the primary purpose of pharmacy law and regulation?
- To maximize pharmaceutical company profits.
- To restrict public access to medications.
- To protect public health and safety by ensuring the safe and effective use of medications.
- To promote international drug trade.
- The Pure Food and Drug Act of 1906 primarily aimed to prevent what in food and drug products?
- High pricing.
- Misbranding and adulteration.
- Lack of patent protection.
- Limited supply.
- The Federal Food, Drug, and Cosmetic Act (FD&C Act) of 1938 was enacted largely in response to which tragic event?
- The Civil War.
- The sulfanilamide elixir tragedy.
- World War II.
- The thalidomide disaster.
- Which amendment to the FD&C Act legally established the distinction between prescription (Rx) and over-the-counter (OTC) drugs?
- Kefauver-Harris Amendment of 1962.
- Durham-Humphrey Amendment of 1951.
- Prescription Drug Marketing Act of 1987.
- FDA Modernization Act of 1997.
- The Kefauver-Harris Amendment of 1962 mandated that drug manufacturers prove what for their products before marketing?
- Affordability.
- Aesthetic appeal.
- Efficacy and safety.
- Ease of manufacturing.
- What federal act regulates the manufacture, distribution, and dispensing of controlled substances?
- Health Insurance Portability and Accountability Act (HIPAA).
- Poison Prevention Packaging Act.
- Controlled Substances Act (CSA).
- Omnibus Budget Reconciliation Act of 1990 (OBRA ’90).
- Under the Controlled Substances Act, substances are categorized into “schedules” based on what?
- Their cost.
- Their route of administration.
- Their potential for abuse and accepted medical use.
- Their chemical structure.
- What is the primary function of a State Board of Pharmacy?
- To set drug prices.
- To regulate the practice of pharmacy within its state, including licensing and discipline.
- To conduct pharmaceutical research.
- To manufacture medications.
- The Poison Prevention Packaging Act (PPPA) of 1970 primarily requires what for certain household substances and medications?
- Tamper-evident packaging.
- Child-resistant packaging.
- Environmentally friendly packaging.
- Large print labeling.
- What information is legally required on a prescription label?
- The patient’s entire medical history.
- The specific mechanism of action of the drug.
- Patient’s name, drug name, dosage instructions, pharmacy information, and warnings.
- The full chemical synthesis pathway.
- What is the key distinction between “label” and “labeling” in pharmacy law?
- “Label” refers to the entire package, while “labeling” is just the drug name.
- “Label” is information on the immediate container, while “labeling” includes all written material accompanying the drug.
- There is no legal distinction; the terms are interchangeable.
- “Label” refers to OTC drugs, “labeling” to Rx drugs.
- The Omnibus Budget Reconciliation Act of 1990 (OBRA ’90) mandated what for pharmacists providing services to Medicaid patients?
- Free drug samples.
- Only generic drug dispensing.
- Prospective drug utilization review (DUR) and patient counseling.
- Monthly patient follow-up visits.
- What is “misbranding” in pharmaceutical law?
- Selling a drug below its market value.
- Labeling a drug falsely or in a misleading way.
- Manufacturing a drug without a patent.
- Developing a new drug.
- What is “adulteration” in pharmaceutical law?
- Selling a drug after its expiration date.
- Manufacturing a drug without a license.
- Impairing a drug’s purity, quality, or strength by adding inferior or harmful substances.
- Marketing a drug for an off-label use.
- Which ethical principle emphasizes the pharmacist’s duty to “do good” for the patient?
- Non-maleficence.
- Justice.
- Beneficence.
- Autonomy.
- What is “non-maleficence” in pharmacy ethics?
- The duty to be fair in distributing resources.
- The duty to respect patient choices.
- The duty to “do no harm.”
- The duty to provide all possible information.
- Which form is typically used by pharmacies to order Schedule II controlled substances?
- DEA Form 106.
- DEA Form 222.
- DEA Form 41.
- DEA Form 224.
- What does “CSOS” refer to in the context of controlled substance ordering?
- Controlled Substance Online System.
- Controlled Substance Ordering System (an electronic equivalent to DEA Form 222).
- Centralized Supply Order System.
- Compound and Ship Order System.
- The Prescription Drug Marketing Act (PDMA) of 1987 primarily aimed to prevent what?
- High drug prices.
- The diversion of prescription drugs from legitimate channels.
- Generic drug competition.
- Patient counseling errors.
- Pharmacists have a legal and ethical responsibility to maintain patient privacy, as largely codified by which federal act?
- Affordable Care Act (ACA).
- Food Quality Protection Act (FQPA).
- Health Insurance Portability and Accountability Act (HIPAA).
- Americans with Disabilities Act (ADA).
- What is “drug utilization review (DUR)”?
- A process to assess the appropriateness of drug therapy.
- A method for drug manufacturing.
- A marketing strategy for new drugs.
- A system for tracking drug sales.
- What does “DEA Form 222” primarily involve for controlled substances?
- Reporting drug loss.
- Ordering Schedule II substances.
- Registering a pharmacy.
- Destroying controlled substances.
- The requirement for “child-resistant packaging” is enforced by which federal act?
- Fair Packaging and Labeling Act.
- Poison Prevention Packaging Act.
- Controlled Substances Act.
- Drug Enforcement Administration (DEA) regulations.
- In the context of pharmacy law, what does “transferring a prescription” typically refer to?
- Moving a patient’s medical records to a new pharmacy.
- Copying a prescription for a patient’s personal use.
- Moving an active prescription from one pharmacy to another for refills.
- Sending a prescription directly to a wholesaler.
- What is the primary role of a pharmacy intern as defined by law?
- To operate the pharmacy independently.
- To perform specific duties under the direct supervision of a licensed pharmacist.
- To prescribe medications.
- To manage the financial aspects of the pharmacy.
- What is the main ethical principle guiding patient “autonomy” in pharmacy practice?
- The patient must always agree with the pharmacist.
- The patient’s right to make decisions about their own healthcare.
- The pharmacist must make all decisions for the patient.
- The patient has no right to refuse treatment.
- What did the “Orphan Drug Act of 1983” incentivize?
- Development of drugs for rare diseases.
- Mass production of common drugs.
- Export of drugs to other countries.
- Generic drug development.
- The “Drug Price Competition and Patent Term Restoration Act of 1984” (Hatch-Waxman Act) primarily facilitated what?
- Increased prices for brand-name drugs.
- Easier approval process for generic drugs.
- Elimination of all drug patents.
- Restriction of new drug development.
- What does the “Florida Board of Pharmacy” primarily regulate?
- Federal drug laws.
- The practice of pharmacy within the state of Florida.
- International drug distribution.
- Research and development of new drugs.
- What is a “pharmacy permit” legally required for?
- Individual pharmacist licensure.
- Entities to legally sell, purchase, and dispense drugs.
- Patient medical insurance.
- Pharmacy marketing campaigns.
- What type of prescriptions require heightened security features and specific ordering procedures under federal law?
- All antibiotic prescriptions.
- Schedule II controlled substance prescriptions.
- Over-the-counter medication orders.
- Vitamin prescriptions.
- The “FDA Modernization Act of 1997” introduced significant changes, including focusing on:
- Restricting patient access to drug information.
- Streamlining drug approval processes and encouraging pediatric drug studies.
- Increasing the cost of generic drugs.
- Eliminating all drug advertising.
- What is the primary ethical principle related to “justice” in pharmacy practice?
- Treating all patients equally regardless of need.
- Fair and equitable distribution of healthcare resources.
- Prioritizing personal gain.
- Ignoring underserved populations.
- What does “DEA Form 106” relate to?
- Ordering Schedule I controlled substances.
- Reporting the theft or significant loss of controlled substances.
- Renewing a pharmacy license.
- Applying for a DEA registration.
- The “FDA Amendment Act of 2007” granted the FDA enhanced authority to do what post-marketing?
- Approve new drug indications without clinical trials.
- Require post-marketing studies and risk evaluation and mitigation strategies (REMS).
- Restrict drug advertising.
- Dictate drug pricing.
- What is a “reverse distributor” in the context of pharmacy law?
- A company that purchases drugs directly from patients.
- A company that manages the return and disposal of controlled substances and other pharmaceutical waste.
- A wholesaler that only sells generic drugs.
- A pharmacy that only dispenses compounded medications.
- What does “HIPAA” primarily aim to protect?
- Drug manufacturing secrets.
- Patient health information.
- Pharmacist salaries.
- Pharmacy building security.
- Which of the following is typically NOT a responsibility that may be performed by a pharmacy technician under the direct supervision of a pharmacist?
- Receiving prescriptions.
- Counseling patients on new medications.
- Preparing prescriptions.
- Inventory management.
- The “Legal Glossary” provided in the course materials would be most useful for understanding:
- Chemical formulas of drugs.
- Terms and definitions related to pharmacy law.
- Historical events in pharmacy.
- Compounding techniques.
- What is the significance of the “Pharmacist’s Code of Ethics”?
- It is a legally binding document that outlines all pharmacy laws.
- It provides a framework for moral principles and professional conduct.
- It dictates drug pricing.
- It regulates drug advertising.
- The “FDA (Food and Drug Administration)” is the primary federal agency responsible for:
- Regulating food, drugs, medical devices, and cosmetics.
- Licensing pharmacists.
- Setting state-specific pharmacy laws.
- Managing pharmacy benefit programs.
- What does “e-prescribing” involve in modern pharmacy practice?
- Hand-written prescriptions delivered by mail.
- Prescriptions transmitted electronically from prescriber to pharmacy.
- Prescriptions called in by phone.
- Prescriptions that are faxed from a provider’s office.
- What is the ultimate goal of ethical principles in pharmacy practice?
- To avoid legal penalties.
- To guide pharmacists in making morally sound decisions that promote patient well-being.
- To increase pharmacy revenue.
- To simplify daily tasks.
- Which of the following ethical considerations is paramount when a pharmacist receives a prescription they suspect is fraudulent?
- Maximizing dispensing speed.
- Disregarding the suspicion to avoid conflict.
- Investigating the prescription and protecting public safety.
- Prioritizing patient privacy over legal obligations.
- What did “Drugstore Memories: American Pharmacists Recall Life Behind the Counter” likely illustrate regarding early pharmacy regulation?
- Strict and comprehensive federal oversight.
- A largely unregulated environment with significant variations in practice.
- International standardization of drug products.
- Universal pharmacist licensure.
- What does the ethical principle of “veracity” in pharmacy mean?
- Always being kind.
- Being truthful and honest with patients.
- Always agreeing with the patient.
- Avoiding all difficult conversations.
- The “DEA (Drug Enforcement Administration)” is primarily responsible for enforcing laws related to what?
- Food safety.
- Controlled substances.
- Cosmetic purity.
- Medical device efficacy.
- When a pharmacist “transfers” a controlled substance prescription, specific federal regulations apply regarding what?
- The patient’s reason for the transfer.
- The type of pharmacy performing the transfer.
- The number of times it can be transferred and information required.
- The drug’s original manufacturing date.
- What does “FDA Regualations 4.040 Student Honor Code and Student Conduct Code” specifically address?
- Professional licensure for pharmacists.
- The use of AI text generators in academic assessments.
- Patient privacy laws.
- Drug manufacturing guidelines.
- The overall evolution of pharmacy law in the U.S. demonstrates a trend towards:
- Decreased federal oversight.
- Increasing patient protection and drug safety.
- Greater reliance on informal ethical guidelines.
- Simplified regulations for drug development.
I am a Registered Pharmacist under the Pharmacy Act, 1948, and the founder of PharmacyFreak.com. I hold a Bachelor of Pharmacy degree from Rungta College of Pharmaceutical Science and Research. With a strong academic foundation and practical knowledge, I am committed to providing accurate, easy-to-understand content to support pharmacy students and professionals. My aim is to make complex pharmaceutical concepts accessible and useful for real-world application.
Mail- Sachin@pharmacyfreak.com