Sources of Law - Constitutional and Statutory Law
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Questions and Answers

What type of law allows Congress to regulate commerce between states, including drug distribution?

  • Case Law
  • Constitutional Law (correct)
  • Statutory Law
  • Administrative Law

    • What is the burden of proof in a criminal trial?

  • Clear and convincing evidence
  • Preponderance of evidence
  • Beyond a reasonable doubt (correct)
  • Probable cause

    • Which drug regulation act introduced requirements to prove drug safety and included adequate directions for use?

  • Durham-Humphrey Amendment (1951)
  • Pure Food and Drug Act (1906)
  • Kefauver-Harris Amendment (1962)
  • FDCA (1938) (correct)

    • Which class of drug recall represents a serious health risk or death?

    <p>Class I</p> Signup and view all the answers

    What does 'stare decisis' ensure in the legal system?

    <p>Precedent is followed for consistency</p> Signup and view all the answers

    Which amendment guarantees a right to a fair trial?

    <p>Sixth Amendment</p> Signup and view all the answers

    Which act clarified compounding standards under the Drug Quality and Security Act?

    <p>DQSA (2013)</p> Signup and view all the answers

    What is the primary purpose of Phase IV clinical trials?

    <p>Monitor long-term safety of a drug</p> Signup and view all the answers

    What distinguishes Schedule II controlled substances from those in Schedule III?

    <p>Schedule II substances are deemed to have a high abuse potential</p> Signup and view all the answers

    Which of the following is NOT a requirement for a valid controlled substance prescription?

    <p>Patient's insurance information</p> Signup and view all the answers

    What is the purpose of the Orange Book?

    <p>Assess equivalency of generic medications</p> Signup and view all the answers

    Which act specifically requires illegal drug prescriptions to involve an in-person evaluation?

    <p>Ryan Haight Act</p> Signup and view all the answers

    What does OBRA '90 require pharmacists to do?

    <p>Offer counseling and maintain patient records</p> Signup and view all the answers

    What is a key characteristic of 503A facilities in compounding standards?

    <p>Patient-specific prescriptions with stricter limits</p> Signup and view all the answers

    Which type of DEA registration would be unnecessary for a pharmacy dispensing controlled substances?

    <p>Research registration</p> Signup and view all the answers

    Which of the following best defines vicarious liability?

    <p>An employer is liable for their employees’ actions during employment</p> Signup and view all the answers

    What is required when reporting a theft/loss of controlled substances?

    <p>Complete DEA Form 106 within one business day</p> Signup and view all the answers

    What is one of the main purposes of state-run Prescription Drug Monitoring Programs (PDMP)?

    <p>Track prescribing and dispensing to prevent diversion</p> Signup and view all the answers

    Which of the following terms refers to unjust enrichment due to illegal remuneration?

    <p>Anti-Kickback Statute</p> Signup and view all the answers

    Which of the following controlled substances has the highest potential for abuse?

    <p>Fentanyl</p> Signup and view all the answers

    What does a pharmacist need to include when counseling a patient about drug interactions?

    <p>Specific risks and contraindications</p> Signup and view all the answers

    What is a primary requirement under OBRA '90 for pharmacists regarding drug therapy?

    <p>Offering counseling and maintaining records</p> Signup and view all the answers

    What is the maximum number of refills allowed for Schedule III controlled substances?

    <p>Five refills in six months</p> Signup and view all the answers

    Which of the following best describes the requirements for a DEA Form 106?

    <p>Theft reporting documentation</p> Signup and view all the answers

    What type of substances is included in Schedule I under controlled substances?

    <p>No accepted medical use and high abuse potential</p> Signup and view all the answers

    Under what condition is vicarious liability applicable to employers?

    <p>Employees must have acted within their scope of employment</p> Signup and view all the answers

    What is the defined frequency for renewing DEA registration for controlled substances?

    <p>Every three years</p> Signup and view all the answers

    What action must be taken when a secure storage of controlled substances is compromised?

    <p>Report using DEA Form 106</p> Signup and view all the answers

    What do the compounding standards under 503B facilities specifically enforce?

    <p>Stricter requirements than 503A</p> Signup and view all the answers

    Which type of law primarily derives its authority from the Commerce Clause?

    <p>Constitutional Law</p> Signup and view all the answers

    What defines the responsibility of pharmacists in the event of a drug recall?

    <p>Notify distributors and inform patients when necessary</p> Signup and view all the answers

    Which of the following drug regulations specifically requires proof of drug efficacy?

    <p>Kefauver-Harris Amendment</p> Signup and view all the answers

    In the context of legal trials, which of the following correctly differentiates civil from criminal trials?

    <p>Criminal trials have a higher burden of proof than civil trials.</p> Signup and view all the answers

    What guarantees legal consistency through reliance on prior judicial decisions?

    <p>Stare Decisis</p> Signup and view all the answers

    Which class of drug recall indicates an unlikely risk of harm to health?

    <p>Class III</p> Signup and view all the answers

    Which resource evaluates the therapeutic equivalency of generic drugs?

    <p>Orange Book</p> Signup and view all the answers

    What is a key characteristic of the Federal Food, Drug, and Cosmetic Act (FDCA)?

    <p>It mandates that all drugs prove safety before approval.</p> Signup and view all the answers

    What is the primary requirement for a drug to be classified as an interchangeable biologic?

    <p>It must demonstrate high similarity with no meaningful clinical differences.</p> Signup and view all the answers

    Which type of drug recall involves the potential for serious adverse health effects or death?

    <p>Class I recall</p> Signup and view all the answers

    What distinguishes a 503B outsourcing facility from a 503A compounding pharmacy?

    <p>It must adhere to sterility and quality standards for large-scale compounding.</p> Signup and view all the answers

    What is the primary function of the Federal Trade Commission (FTC) in relation to pharmaceuticals?

    <p>To regulate drug advertising and marketing practices.</p> Signup and view all the answers

    Which of the following accurately describes the burden of proof in a criminal trial?

    <p>Beyond a reasonable doubt.</p> Signup and view all the answers

    Which of the following best outlines the responsibilities of pharmacists during a drug recall?

    <p>Pharmacists must inform patients if they have dispensed the drug.</p> Signup and view all the answers

    Which best defines the concept of 'stare decisis' in the legal system?

    <p>The requirement to follow precedent established in previous cases.</p> Signup and view all the answers

    What standard must be met for drug approval regarding efficacy?

    <p>Both safety and efficacy must be demonstrated.</p> Signup and view all the answers

    What is the main focus of Phase IV clinical trials?

    <p>To monitor long-term safety and effectiveness.</p> Signup and view all the answers

    What is the maximum number of refills allowed for a Schedule III controlled substance prescription within six months?

    <p>Five refills</p> Signup and view all the answers

    Which of the following is true regarding online pharmacies?

    <p>They must verify valid prescriptions through in-person evaluations.</p> Signup and view all the answers

    What is the minimum retention period for maintaining records related to controlled substances?

    <p>Two years</p> Signup and view all the answers

    When is a pharmacy required to submit a DEA Form 106?

    <p>When reporting the theft or loss of controlled substances.</p> Signup and view all the answers

    Which of the following best describes how a pharmacy can distribute controlled substances without registering as a distributor?

    <p>Distribute less than 5% of its total inventory.</p> Signup and view all the answers

    What is required for a valid prescription of controlled substances?

    <p>It should include the patient's ultimate user status.</p> Signup and view all the answers

    What determines the classification of a substance as Schedule I under the Controlled Substance Act?

    <p>It has no accepted medical uses and a high potential for abuse.</p> Signup and view all the answers

    What is the role of pharmacy boards in relation to licenses?

    <p>They issue licenses and enforce state laws.</p> Signup and view all the answers

    Which of the following best describes the difference between manufacturing and compounding in pharmacy?

    <p>Manufacturing involves large-scale production; compounding is tailored for individual patients.</p> Signup and view all the answers

    In the context of pharmacy liability, which of the following is true regarding negligence?

    <p>Legal mandates can establish what constitutes negligence.</p> Signup and view all the answers

    Which regulatory body is primarily responsible for monitoring long-term safety and effectiveness of drugs?

    <p>Food and Drug Administration (FDA)</p> Signup and view all the answers

    Which principle ensures that courts follow precedents set in previous cases?

    <p>Stare decisis</p> Signup and view all the answers

    What distinguishes an interchangeable biologic drug from standard generics?

    <p>Higher standards for bioequivalence</p> Signup and view all the answers

    What role does the The Food and Drug Administration (FDA) play in drug recalls?

    <p>Oversees the response to safety concerns</p> Signup and view all the answers

    Which phase of the drug approval process involves extensive clinical monitoring and assessment of safety after marketing?

    <p>Phase IV</p> Signup and view all the answers

    What is the legal standard of evidence required in civil cases?

    <p>Preponderance of the evidence</p> Signup and view all the answers

    What does the Supremacy Clause ensure in the context of state and federal laws?

    <p>Federal laws take precedence over conflicting state laws</p> Signup and view all the answers

    What is the primary difference between 503A and 503B facilities in compounding?

    <p>503B can compound for office use</p> Signup and view all the answers

    What distinguishes the Kefauver-Harris Amendment from previous drug legislation?

    <p>It required drugs to prove their efficacy in addition to safety.</p> Signup and view all the answers

    Which of the following accurately characterizes the responsibilities of pharmacies during drug recalls?

    <p>Pharmacies must promptly notify patients if affected drugs have been dispensed.</p> Signup and view all the answers

    Which statement correctly describes the Drug Quality and Security Act (DQSA) of 2013?

    <p>It established tracking systems for enhancing drug supply chain security.</p> Signup and view all the answers

    What role does the Orange Book serve in relation to generic drugs?

    <p>It assesses therapeutic equivalency and identifies substitutable drugs.</p> Signup and view all the answers

    Which controlled substance schedule includes drugs with the least potential for abuse?

    <p>Schedule V</p> Signup and view all the answers

    What is a primary characteristic of 503B outsourcing facilities under compounding regulations?

    <p>They can compound large batches of drugs under stricter GMP standards.</p> Signup and view all the answers

    How does the Controlled Substances Act (CSA) categorize drugs?

    <p>By their potential for abuse and accepted medical use.</p> Signup and view all the answers

    What is required for a prescription to be valid in the context of controlled substances?

    <p>It requires the prescriber's DEA number among other details.</p> Signup and view all the answers

    What is the minimum duration for maintaining inventory and dispensing records for controlled substances?

    <p>Two years</p> Signup and view all the answers

    What is the legal status of marijuana under federal law?

    <p>Classified as a Schedule I substance</p> Signup and view all the answers

    What distinguishes drugs classified under Schedule I from those in Schedule II?

    <p>Schedule I drugs carry the highest abuse potential and lack accepted medical use.</p> Signup and view all the answers

    What provision does the Durham-Humphrey Amendment (1951) establish?

    <p>Distinction between prescription-only and over-the-counter drugs</p> Signup and view all the answers

    Which act requires that physicians exercise caution in promoting off-label drug use?

    <p>Federal Food, Drug, and Cosmetic Act</p> Signup and view all the answers

    What is a significant requirement introduced by the FDAAA regarding drugs with significant risks?

    <p>They require establishment of Risk Evaluation and Mitigation Strategies (REMS).</p> Signup and view all the answers

    What is the key implication of the Supremacy Clause in the context of drug regulation?

    <p>Federal law supersedes conflicting state law</p> Signup and view all the answers

    What is one consequence if a pharmacy exceeds the distribution limit of 5% for its controlled substance inventory?

    <p>It must register as a distributor</p> Signup and view all the answers

    Which entity primarily regulates prescription drug advertising to ensure fair balance?

    <p>Food and Drug Administration (FDA)</p> Signup and view all the answers

    What essential component of the HIPAA mandates is vital for protecting patient information?

    <p>Preserves patient privacy by controlling use and disclosure of PHI.</p> Signup and view all the answers

    What is a required component that must be included with a prescription for controlled substances?

    <p>Directions for use</p> Signup and view all the answers

    What is the primary focus of Risk Evaluation and Mitigation Strategies (REMS)?

    <p>Ensure safe drug use</p> Signup and view all the answers

    What differentiates civil trials from criminal trials?

    <p>Civil trials typically have a lower burden of proof</p> Signup and view all the answers

    What does it mean that a pharmacist shares responsibility for ensuring valid prescriptions?

    <p>They can be held liable for fraudulent prescriptions</p> Signup and view all the answers

    What is the consequence for pharmacies when they lack the full quantity of a prescribed controlled substance?

    <p>They can partially fill the prescription under certain conditions</p> Signup and view all the answers

    Under what circumstances can the loss of controlled substances be reported using DEA Form 106?

    <p>If the pharmacy experiences a significant loss</p> Signup and view all the answers

    What is the required review process for prospective medication dispensing?

    <p>Pre-dispensing review</p> Signup and view all the answers

    What defines the actions of the pharmacy boards in relation to state pharmacies?

    <p>They enforce laws and investigate complaints</p> Signup and view all the answers

    What does the term 'monopolization' refer to in the context of regulatory laws?

    <p>The attempt to dominate a market or sector by a single player</p> Signup and view all the answers

    What are the implications of civil liability for pharmacists in malpractice cases?

    <p>Pharmacists may be liable for negligence if standards are not met</p> Signup and view all the answers

    What is the maximum duration for the FDA's standard review process for a New Drug Application (NDA)?

    <p>10 months</p> Signup and view all the answers

    Which of the following best describes the purpose of a Fast Track Designation?

    <p>To allow for rolling review during drug development</p> Signup and view all the answers

    In the context of drug approvals, bioequivalence for ANDA approval refers to the drugs being compared in terms of which of the following?

    <p>Rate and extent of absorption into the bloodstream</p> Signup and view all the answers

    What is one of the primary objectives of Phase IV clinical trials?

    <p>To monitor long-term safety and effectiveness</p> Signup and view all the answers

    Which of the following statements about Priority Review is accurate?

    <p>It is granted to drugs that address unmet medical needs</p> Signup and view all the answers

    What is the primary purpose of the Abbreviated New Drug Application (ANDA)?

    <p>To demonstrate bioequivalence to a reference listed drug.</p> Signup and view all the answers

    During which phase of clinical trials is the primary focus on evaluating optimal dosing and short-term side effects?

    <p>Phase II</p> Signup and view all the answers

    Which application is necessary to begin clinical trials on a new drug?

    <p>IND</p> Signup and view all the answers

    What is a key component included in a New Drug Application (NDA)?

    <p>Extensive data from preclinical and clinical trials.</p> Signup and view all the answers

    What is the primary objective of Phase III clinical trials?

    <p>Confirm efficacy and monitor adverse reactions on a large scale.</p> Signup and view all the answers

    What change can be requested through a Supplemental New Drug Application (sNDA)?

    <p>Change in the drug's labeling or packaging.</p> Signup and view all the answers

    Which is NOT a characteristic requirement of the Preclinical Studies phase?

    <p>Evaluation of drug interactions in clinical settings.</p> Signup and view all the answers

    What is the minimum number of participants typical for Phase I clinical trials?

    <p>20–80 participants</p> Signup and view all the answers

    What is a key aspect of the Kefauver-Harris Amendment regarding drug regulation?

    <p>It requires a demonstration of drug efficacy.</p> Signup and view all the answers

    Which federal law primarily assures safety and labeling of food and drugs in interstate commerce?

    <p>Pure Food and Drug Act of 1906</p> Signup and view all the answers

    Which of the following represents the primary role of the Durham-Humphrey Amendment?

    <p>It categorizes drugs into over-the-counter and prescription.</p> Signup and view all the answers

    What is the focus of the FDA Amendments Act of 2007?

    <p>Implementation of risk evaluation and mitigation strategies (REMS).</p> Signup and view all the answers

    What type of drug recall is classified as a Class I recall?

    <p>Drugs with a potential for serious health effects.</p> Signup and view all the answers

    Under the Supremacy Clause, what is the status of a federal law conflicting with state law?

    <p>State law is rendered void by federal law.</p> Signup and view all the answers

    Which law initially required pre-market testing for drug safety?

    <p>Food, Drug, and Cosmetic Act (FDCA) of 1938</p> Signup and view all the answers

    What constitutes adulteration of a drug?

    <p>Failure to meet quality standards.</p> Signup and view all the answers

    What is the monthly pseudoephedrine sales limit for a single purchaser?

    <p>3.6 grams</p> Signup and view all the answers

    Which prescription element is mandatory for Schedule II drugs?

    <p>Prescriber DEA number</p> Signup and view all the answers

    Phase II clinical testing primarily evaluates which aspect?

    <p>Efficacy and safety in a small group of patients</p> Signup and view all the answers

    Which agency is responsible for overseeing drug recalls?

    <p>FDA</p> Signup and view all the answers

    Under the Controlled Substances Act, what characterizes a Schedule IV drug?

    <p>Low abuse potential with accepted medical use</p> Signup and view all the answers

    Which law established a difference between OTC and prescription drugs?

    <p>Durham-Humphrey Amendment</p> Signup and view all the answers

    DEA Form 106 must be filed for which situation?

    <p>Reporting theft or loss of controlled substances</p> Signup and view all the answers

    What is one of the main focuses of OBRA '90?

    <p>Counseling mandates</p> Signup and view all the answers

    What is the primary goal of REMS programs?

    <p>Ensure safe use of high-risk drugs</p> Signup and view all the answers

    What is the required frequency for conducting a biennial inventory of controlled substances in a pharmacy?

    <p>Every 2 years</p> Signup and view all the answers

    Which class of drug recall involves reasonable probability that the use of the product will cause serious health consequences or death?

    <p>Class I</p> Signup and view all the answers

    Which organization is primarily responsible for overseeing the marketing of prescription drugs?

    <p>FDA</p> Signup and view all the answers

    What is a primary role of Phase IV clinical trials?

    <p>Monitoring post-marketing safety</p> Signup and view all the answers

    Which document is essential for a pharmacy to order Schedule I and II controlled substances?

    <p>DEA Form 222</p> Signup and view all the answers

    What key feature differentiates 503B compounding facilities from 503A ones?

    <p>Subject to FDA oversight and GMP requirements</p> Signup and view all the answers

    What does the Orange Book provide regarding pharmaceuticals?

    <p>Information on therapeutic equivalence</p> Signup and view all the answers

    Under HIPAA, which of the following actions can occur without patient consent?

    <p>Disclosure for treatment, payment, or healthcare operations</p> Signup and view all the answers

    What is the purpose of a PDMP?

    <p>To monitor prescription drug abuse</p> Signup and view all the answers

    What is the primary requirement before a drug can be marketed in the U.S.?

    <p>Premarket approval by the FDA</p> Signup and view all the answers

    Which of the following is NOT a responsibility of pharmacies under OBRA '90?

    <p>Conducting drug recalls</p> Signup and view all the answers

    Which of the following correctly states the limitation on refills for Schedule III-IV prescriptions?

    <p>Up to 5 refills within 6 months</p> Signup and view all the answers

    What type of information does HIPAA protect?

    <p>Protected Health Information (PHI)</p> Signup and view all the answers

    What does the Anti-Kickback Statute primarily prohibit?

    <p>Financial incentives for federal healthcare referrals</p> Signup and view all the answers

    Which of the following actions would NOT commonly result in disciplinary measures by a state board of pharmacy?

    <p>Revoking a pharmacist's license for errors in patient counseling</p> Signup and view all the answers

    Under the Controlled Substances Act (CSA), what is the main purpose of classifying drugs into schedules?

    <p>To schedule drugs based on abuse potential and medical use</p> Signup and view all the answers

    What distinguishes a Schedule I drug from other schedules?

    <p>High abuse potential with no accepted medical use</p> Signup and view all the answers

    What is a primary responsibility of state boards of pharmacy?

    <p>Licensing and regulating pharmacy practice</p> Signup and view all the answers

    Which law specifically addresses physician self-referrals?

    <p>Stark Law</p> Signup and view all the answers

    What is the maximum number of refills allowed for a Schedule IV medication within a 6-month period?

    <p>5 refills</p> Signup and view all the answers

    What is required for an Abbreviated New Drug Application (ANDA)?

    <p>Proof of bioequivalence to a reference listed drug (RLD)</p> Signup and view all the answers

    Which DEA form is necessary for ordering Schedule I and II controlled substances?

    <p>Form 222</p> Signup and view all the answers

    What defines negligence per se in pharmacy practice?

    <p>Violation of a statute designed to protect patient safety</p> Signup and view all the answers

    What is the key purpose of REMS programs?

    <p>Ensure the safe use of high-risk drugs</p> Signup and view all the answers

    What is the maximum amount of pseudoephedrine that can be purchased in one day?

    <p>5 grams</p> Signup and view all the answers

    Which organization is crucial for facilitating cooperation among state boards of pharmacy?

    <p>NABP</p> Signup and view all the answers

    What must appear on a controlled substance prescription?

    <p>Prescriber DEA number</p> Signup and view all the answers

    Which DEA form is used to order controlled substances?

    <p>DEA Form 222</p> Signup and view all the answers

    Which element of malpractice directly links the pharmacist’s actions to patient harm?

    <p>Causation</p> Signup and view all the answers

    What element of malpractice involves proving that harm would not have occurred without the pharmacist’s actions?

    <p>Causation</p> Signup and view all the answers

    How does a PDMP reduce controlled substance misuse?

    <p>Tracks controlled substance prescribing and dispensing</p> Signup and view all the answers

    Which law introduced the requirement for tamper-resistant Medicaid prescription pads?

    <p>OBRA ’90</p> Signup and view all the answers

    What is the federal limit on refills for Schedule III and IV prescriptions?

    <p>5 refills in 6 months</p> Signup and view all the answers

    What does the Anti-Kickback Statute prohibit?

    <p>Offering or receiving payment for healthcare referrals</p> Signup and view all the answers

    Which type of DEA warrant requires probable cause?

    <p>Search warrant</p> Signup and view all the answers

    Which of the following would constitute negligence per se?

    <p>Dispensing medication without a valid prescription</p> Signup and view all the answers

    How long must Schedule II controlled substance prescriptions be retained under federal law?

    <p>2 years</p> Signup and view all the answers

    Which type of Pharmacy practice acts are designed to?

    <p>Define the scope of pharmacy practice within the state</p> Signup and view all the answers

    What entity primarily coordinates between state boards of pharmacy?

    <p>NABP</p> Signup and view all the answers

    Which legislation mandates pharmacists to provide counseling to patients?

    <p>OBRA ’90</p> Signup and view all the answers

    Which of the following is NOT true regarding a breach under HIPAA?

    <p>Involves only specific individuals</p> Signup and view all the answers

    What is the maximum number of days allowed to complete a partial fill for a Schedule II drug according to regulations?

    <p>30 days</p> Signup and view all the answers

    Which of the following describes the primary focus of a retrospective Drug Utilization Review (DUR)?

    <p>Evaluating prescribing trends for compliance</p> Signup and view all the answers

    Which law regulates the distribution and handling of prescription drugs by specifying practices for compounding facilities?

    <p>Drug Quality and Security Act</p> Signup and view all the answers

    What is the primary requirement for drugs that are subject to REMS programs?

    <p>Include risk evaluation and mitigation strategies</p> Signup and view all the answers

    What type of facility produces sterile drugs and is specifically regulated under 503B?

    <p>Outsourcing facilities</p> Signup and view all the answers

    What is the maximum monthly limit for purchasing pseudoephedrine?

    <p>9.0 grams</p> Signup and view all the answers

    How often are pharmacies required to conduct controlled substance inventories?

    <p>Every 2 years</p> Signup and view all the answers

    Which phase of clinical trials focuses on the safety of a drug?

    <p>Phase I</p> Signup and view all the answers

    Which law prohibits financial arrangements that incentivize referrals in healthcare?

    <p>Stark Law</p> Signup and view all the answers

    Which agency oversees the regulation of 503A compounding pharmacies?

    <p>State boards of pharmacy</p> Signup and view all the answers

    What is a requirement for a prescription for controlled substances?

    <p>Drug strength and quantity</p> Signup and view all the answers

    Study Notes

    Sources of Law

    • Constitutional Law: Highest authority; outlines federal/state power distribution (e.g., Interstate Commerce Clause); federal authority primarily from Commerce Clause.
    • Statutory Law: Laws created by legislative bodies (e.g., FDCA, CSA).
    • Administrative Law: Rules from regulatory agencies (e.g., FDA, DEA).
    • Case Law (Common Law): Based on judicial opinions; stare decisis ensures consistency; influenced by prior rulings e.g., Controlled Substances Act (CSA).

    Stare Decisis

    • Ensures consistent legal decisions by adhering to prior rulings; courts follow precedents.

    Supremacy Clause

    • Article VI: Federal law prevails over conflicting state laws unless state law more stringent; example: federal marijuana laws (CSA) preempt state legalization unless states have stricter laws.

    Civil vs. Criminal Trials (Burden of Proof)

    • Civil: Preponderance of evidence (e.g., malpractice cases); dispute between individuals.
    • Criminal: Beyond a reasonable doubt (e.g., drug diversion cases); violation of statutes.

    Key Amendments and Purpose

    • First Amendment: Freedom of speech (relevant to advertising).
    • Fourth Amendment: Protection against unlawful searches.
    • Fifth Amendment: Due process, protection against self-incrimination.
    • Sixth Amendment: Right to a fair trial.
    • Eighth Amendment: Protection from cruel punishment.
    • Fourteenth Amendment: Equal protection clause.

    Major Drug Laws

    • Pure Food and Drug Act (1906): Prevented misbranding and adulteration; did not include pre-market safety or efficacy.
    • FDCA (1938): Required drug safety proof before marketing; defined adequate labeling; addressed cosmetics and medical devices.
    • Durham-Humphrey Amendment (1951): Distinguished Rx and OTC drugs; introduced “legend drugs”: “Caution: Federal law prohibits dispensing without a prescription.”
    • Kefauver-Harris Amendment (1962): Required drug efficacy proof in addition to safety; strengthened FDA control over drug trials and adverse event reporting.
    • FDA Amendments Act (FDAAA) (2007): Introduced REMS for drug safety; strengthened post-marketing surveillance (Phase IV trials).
    • DQSA (2013): Addressed compounding standards; improved drug supply chain security; introduced national tracking systems.
    • Prescription Drug Marketing Act (1987): Regulated drug samples and prevented reimportation of drugs.
    • Controlled Substances Act (CSA): Introduced controlled substance scheduling (Schedules I–V) based on abuse potential and medical use.

    Adulteration, Misbranding, and Recalls

    • Adulteration: Concerns drug quality, safety (e.g., contamination during manufacturing or storage).
    • Misbranding: Inaccurate labeling (e.g., missing dosage instructions or warnings).
    • Drug Recalls:
      • Class I: Risk of death.
      • Class II: Reversible risks.
      • Class III: Unlikely to harm.
    • Responsibility for Recalls:
      • Manufacturers: Notify distributors and FDA.
      • Wholesalers: Notify pharmacies.
      • Pharmacists: Notify patients if affected drugs have been dispensed.

    FDA Regulation and Drug Approval

    • New Drug Approval Process:
      • Key Applications:
        • NDA (New Drug Application): Submitted for a new drug entity; includes preclinical and clinical trial data, manufacturing details, labeling, and marketing plans.
        • ANDA (Abbreviated New Drug Application): Used for generic drugs; demonstrates bioequivalence to a reference listed drug (RLD); no need to duplicate clinical trials.
        • sNDA (Supplemental New Drug Application): Filed for changes to an approved drug (e.g., new indications, labeling updates, manufacturing changes).
        • IND (Investigational New Drug Application): Submitted before clinical trials; ensures safety of participants, includes preclinical data, proposed clinical protocols, and manufacturing information.
      • Phases of Clinical Trials:
        • Preclinical Studies: Conducted in labs and animals to assess safety, mechanism of action, pharmacokinetics, and pharmacodynamics.
        • Phase I: Safety and Dosage; assesses drug safety and pharmacokinetics in healthy volunteers.
        • Phase II: Efficacy and Safety; evaluates drug efficacy and further assesses safety in patients, often includes placebo-controlled trials.
        • Phase III: Large-Scale Trials; confirms efficacy and monitors adverse reactions in a large population, compares new drug to existing treatments.
        • Phase IV (Post-Marketing Surveillance): Monitors long-term safety and effectiveness after FDA approval; may involve REMS.
      • FDA Review of NDA: FDA has 10 months for standard review, 6 months for priority review; reviews clinical trial results, labeling, and manufacturing.
      • Key Definitions:
        • Bioequivalence: For ANDA, generic drugs must show same absorption rate/extent as RLD; measured by pharmacokinetic parameters (Cmax, AUC).
        • Priority Review: Expedites FDA review for drugs addressing unmet medical needs.
        • Fast Track Designation: Expedites drug development for serious medical conditions, allows rolling review.

    FDA References

    • Orange Book: Evaluates therapeutic equivalence of generic drugs.
    • Purple Book: Evaluates biosimilarity and interchangeability of biologics.

    Compounding Standards

    • 503A: Patient-specific prescriptions; exempt from certain FDA regulations.
    • 503B: Outsourcing facilities regulated under stricter GMP standards.
    • USP Chapters: Non-sterile, sterile compounding, and hazardous drug handling.
    • USP standards are mandatory to comply with for all hazardous drugs

    Hazardous Drugs (NIOSH)

    • NIOSH is an agency overseeing safety standards in work environments.
    • Must comply with USP standards for handling hazardous drugs.
    • PPE, risk assessments, and proper disposal required.

    HIPAA and OBRA

    • HIPAA: Protects PHI; allows use/disclosure for Treatment, Payment, or Healthcare Operations (TPO).
    • OBRA ’90: Mandates DUR and patient counseling for Medicaid patients.

    Controlled Substances

    • Controlled Substance Schedules: Categorized based on abuse potential and medical use.
    • DEA Registration: Required for manufacturing, distribution, or dispensing controlled substances.
    • Security Requirements: Secure storage, theft/loss reported within one business day.

    PDMP and Prescription Requirements

    • PDMP: Monitors prescribing and dispensing of controlled substances.
    • Prescription Requirements: Includes patient name, prescriber info, DEA number, drug details, directions, date of issuance.
    • Max Refills: Schedule II: No refills; Schedule III–V: Up to five refills.
    • Ryan Haight Act: Regulates internet pharmacies requiring in-person evaluation
    • Prescriber DEA numbers required on Schedule II prescriptions but not on III -V.

    DEA Forms and Filing

    • DEA Forms: Form 222, Form 41, Form 106.
    • Recordkeeping Requirements: Controlled substance records retained for at least two years; biennial inventories needed.

    DEA Inspections and Restrictions

    • Inspection Warrants: Administrative(AIW) warrants do not require probable cause. Search warrants do.
    • Opioid Use Disorder: Methadone only through certified OTPs.
    • Sudafed Limits: Daily: 3.6 grams; Monthly: 9 grams.

    Medicare/Medicaid and Anti-Kickback Statutes

    • Medicare: Federal program for 65+ or disabled.
    • Medicaid: Joint federal-state program for low-income.
    • Anti-Kickback Statute: Prohibits payments for patient referrals.
    • Stark Law: Prevents self-referral for designated health services.

    Pharmacy Boards and Regulations

    • State Board: Licenses, investigates complaints, and enforces laws.
    • NABP: Facilitates state board cooperation.

    Malpractice and Liability

    • Malpractice Elements: Duty, breach, causation, damages.
    • Negligence Per Se: Negligence established by violating a statute.
    • Vicarious Liability: Employers liable for employee actions.

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