Podcast
Questions and Answers
What type of law allows Congress to regulate commerce between states, including drug distribution?
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?
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?
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?
Which class of drug recall represents a serious health risk or death?
What does 'stare decisis' ensure in the legal system?
What does 'stare decisis' ensure in the legal system?
Which amendment guarantees a right to a fair trial?
Which amendment guarantees a right to a fair trial?
Which act clarified compounding standards under the Drug Quality and Security Act?
Which act clarified compounding standards under the Drug Quality and Security Act?
What is the primary purpose of Phase IV clinical trials?
What is the primary purpose of Phase IV clinical trials?
What distinguishes Schedule II controlled substances from those in Schedule III?
What distinguishes Schedule II controlled substances from those in Schedule III?
Which of the following is NOT a requirement for a valid controlled substance prescription?
Which of the following is NOT a requirement for a valid controlled substance prescription?
What is the purpose of the Orange Book?
What is the purpose of the Orange Book?
Which act specifically requires illegal drug prescriptions to involve an in-person evaluation?
Which act specifically requires illegal drug prescriptions to involve an in-person evaluation?
What does OBRA '90 require pharmacists to do?
What does OBRA '90 require pharmacists to do?
What is a key characteristic of 503A facilities in compounding standards?
What is a key characteristic of 503A facilities in compounding standards?
Which type of DEA registration would be unnecessary for a pharmacy dispensing controlled substances?
Which type of DEA registration would be unnecessary for a pharmacy dispensing controlled substances?
Which of the following best defines vicarious liability?
Which of the following best defines vicarious liability?
What is required when reporting a theft/loss of controlled substances?
What is required when reporting a theft/loss of controlled substances?
What is one of the main purposes of state-run Prescription Drug Monitoring Programs (PDMP)?
What is one of the main purposes of state-run Prescription Drug Monitoring Programs (PDMP)?
Which of the following terms refers to unjust enrichment due to illegal remuneration?
Which of the following terms refers to unjust enrichment due to illegal remuneration?
Which of the following controlled substances has the highest potential for abuse?
Which of the following controlled substances has the highest potential for abuse?
What does a pharmacist need to include when counseling a patient about drug interactions?
What does a pharmacist need to include when counseling a patient about drug interactions?
What is a primary requirement under OBRA '90 for pharmacists regarding drug therapy?
What is a primary requirement under OBRA '90 for pharmacists regarding drug therapy?
What is the maximum number of refills allowed for Schedule III controlled substances?
What is the maximum number of refills allowed for Schedule III controlled substances?
Which of the following best describes the requirements for a DEA Form 106?
Which of the following best describes the requirements for a DEA Form 106?
What type of substances is included in Schedule I under controlled substances?
What type of substances is included in Schedule I under controlled substances?
Under what condition is vicarious liability applicable to employers?
Under what condition is vicarious liability applicable to employers?
What is the defined frequency for renewing DEA registration for controlled substances?
What is the defined frequency for renewing DEA registration for controlled substances?
What action must be taken when a secure storage of controlled substances is compromised?
What action must be taken when a secure storage of controlled substances is compromised?
What do the compounding standards under 503B facilities specifically enforce?
What do the compounding standards under 503B facilities specifically enforce?
Which type of law primarily derives its authority from the Commerce Clause?
Which type of law primarily derives its authority from the Commerce Clause?
What defines the responsibility of pharmacists in the event of a drug recall?
What defines the responsibility of pharmacists in the event of a drug recall?
Which of the following drug regulations specifically requires proof of drug efficacy?
Which of the following drug regulations specifically requires proof of drug efficacy?
In the context of legal trials, which of the following correctly differentiates civil from criminal trials?
In the context of legal trials, which of the following correctly differentiates civil from criminal trials?
What guarantees legal consistency through reliance on prior judicial decisions?
What guarantees legal consistency through reliance on prior judicial decisions?
Which class of drug recall indicates an unlikely risk of harm to health?
Which class of drug recall indicates an unlikely risk of harm to health?
Which resource evaluates the therapeutic equivalency of generic drugs?
Which resource evaluates the therapeutic equivalency of generic drugs?
What is a key characteristic of the Federal Food, Drug, and Cosmetic Act (FDCA)?
What is a key characteristic of the Federal Food, Drug, and Cosmetic Act (FDCA)?
What is the primary requirement for a drug to be classified as an interchangeable biologic?
What is the primary requirement for a drug to be classified as an interchangeable biologic?
Which type of drug recall involves the potential for serious adverse health effects or death?
Which type of drug recall involves the potential for serious adverse health effects or death?
What distinguishes a 503B outsourcing facility from a 503A compounding pharmacy?
What distinguishes a 503B outsourcing facility from a 503A compounding pharmacy?
What is the primary function of the Federal Trade Commission (FTC) in relation to pharmaceuticals?
What is the primary function of the Federal Trade Commission (FTC) in relation to pharmaceuticals?
Which of the following accurately describes the burden of proof in a criminal trial?
Which of the following accurately describes the burden of proof in a criminal trial?
Which of the following best outlines the responsibilities of pharmacists during a drug recall?
Which of the following best outlines the responsibilities of pharmacists during a drug recall?
Which best defines the concept of 'stare decisis' in the legal system?
Which best defines the concept of 'stare decisis' in the legal system?
What standard must be met for drug approval regarding efficacy?
What standard must be met for drug approval regarding efficacy?
What is the main focus of Phase IV clinical trials?
What is the main focus of Phase IV clinical trials?
What is the maximum number of refills allowed for a Schedule III controlled substance prescription within six months?
What is the maximum number of refills allowed for a Schedule III controlled substance prescription within six months?
Which of the following is true regarding online pharmacies?
Which of the following is true regarding online pharmacies?
What is the minimum retention period for maintaining records related to controlled substances?
What is the minimum retention period for maintaining records related to controlled substances?
When is a pharmacy required to submit a DEA Form 106?
When is a pharmacy required to submit a DEA Form 106?
Which of the following best describes how a pharmacy can distribute controlled substances without registering as a distributor?
Which of the following best describes how a pharmacy can distribute controlled substances without registering as a distributor?
What is required for a valid prescription of controlled substances?
What is required for a valid prescription of controlled substances?
What determines the classification of a substance as Schedule I under the Controlled Substance Act?
What determines the classification of a substance as Schedule I under the Controlled Substance Act?
What is the role of pharmacy boards in relation to licenses?
What is the role of pharmacy boards in relation to licenses?
Which of the following best describes the difference between manufacturing and compounding in pharmacy?
Which of the following best describes the difference between manufacturing and compounding in pharmacy?
In the context of pharmacy liability, which of the following is true regarding negligence?
In the context of pharmacy liability, which of the following is true regarding negligence?
Which regulatory body is primarily responsible for monitoring long-term safety and effectiveness of drugs?
Which regulatory body is primarily responsible for monitoring long-term safety and effectiveness of drugs?
Which principle ensures that courts follow precedents set in previous cases?
Which principle ensures that courts follow precedents set in previous cases?
What distinguishes an interchangeable biologic drug from standard generics?
What distinguishes an interchangeable biologic drug from standard generics?
What role does the The Food and Drug Administration (FDA) play in drug recalls?
What role does the The Food and Drug Administration (FDA) play in drug recalls?
Which phase of the drug approval process involves extensive clinical monitoring and assessment of safety after marketing?
Which phase of the drug approval process involves extensive clinical monitoring and assessment of safety after marketing?
What is the legal standard of evidence required in civil cases?
What is the legal standard of evidence required in civil cases?
What does the Supremacy Clause ensure in the context of state and federal laws?
What does the Supremacy Clause ensure in the context of state and federal laws?
What is the primary difference between 503A and 503B facilities in compounding?
What is the primary difference between 503A and 503B facilities in compounding?
What distinguishes the Kefauver-Harris Amendment from previous drug legislation?
What distinguishes the Kefauver-Harris Amendment from previous drug legislation?
Which of the following accurately characterizes the responsibilities of pharmacies during drug recalls?
Which of the following accurately characterizes the responsibilities of pharmacies during drug recalls?
Which statement correctly describes the Drug Quality and Security Act (DQSA) of 2013?
Which statement correctly describes the Drug Quality and Security Act (DQSA) of 2013?
What role does the Orange Book serve in relation to generic drugs?
What role does the Orange Book serve in relation to generic drugs?
Which controlled substance schedule includes drugs with the least potential for abuse?
Which controlled substance schedule includes drugs with the least potential for abuse?
What is a primary characteristic of 503B outsourcing facilities under compounding regulations?
What is a primary characteristic of 503B outsourcing facilities under compounding regulations?
How does the Controlled Substances Act (CSA) categorize drugs?
How does the Controlled Substances Act (CSA) categorize drugs?
What is required for a prescription to be valid in the context of controlled substances?
What is required for a prescription to be valid in the context of controlled substances?
What is the minimum duration for maintaining inventory and dispensing records for controlled substances?
What is the minimum duration for maintaining inventory and dispensing records for controlled substances?
What is the legal status of marijuana under federal law?
What is the legal status of marijuana under federal law?
What distinguishes drugs classified under Schedule I from those in Schedule II?
What distinguishes drugs classified under Schedule I from those in Schedule II?
What provision does the Durham-Humphrey Amendment (1951) establish?
What provision does the Durham-Humphrey Amendment (1951) establish?
Which act requires that physicians exercise caution in promoting off-label drug use?
Which act requires that physicians exercise caution in promoting off-label drug use?
What is a significant requirement introduced by the FDAAA regarding drugs with significant risks?
What is a significant requirement introduced by the FDAAA regarding drugs with significant risks?
What is the key implication of the Supremacy Clause in the context of drug regulation?
What is the key implication of the Supremacy Clause in the context of drug regulation?
What is one consequence if a pharmacy exceeds the distribution limit of 5% for its controlled substance inventory?
What is one consequence if a pharmacy exceeds the distribution limit of 5% for its controlled substance inventory?
Which entity primarily regulates prescription drug advertising to ensure fair balance?
Which entity primarily regulates prescription drug advertising to ensure fair balance?
What essential component of the HIPAA mandates is vital for protecting patient information?
What essential component of the HIPAA mandates is vital for protecting patient information?
What is a required component that must be included with a prescription for controlled substances?
What is a required component that must be included with a prescription for controlled substances?
What is the primary focus of Risk Evaluation and Mitigation Strategies (REMS)?
What is the primary focus of Risk Evaluation and Mitigation Strategies (REMS)?
What differentiates civil trials from criminal trials?
What differentiates civil trials from criminal trials?
What does it mean that a pharmacist shares responsibility for ensuring valid prescriptions?
What does it mean that a pharmacist shares responsibility for ensuring valid prescriptions?
What is the consequence for pharmacies when they lack the full quantity of a prescribed controlled substance?
What is the consequence for pharmacies when they lack the full quantity of a prescribed controlled substance?
Under what circumstances can the loss of controlled substances be reported using DEA Form 106?
Under what circumstances can the loss of controlled substances be reported using DEA Form 106?
What is the required review process for prospective medication dispensing?
What is the required review process for prospective medication dispensing?
What defines the actions of the pharmacy boards in relation to state pharmacies?
What defines the actions of the pharmacy boards in relation to state pharmacies?
What does the term 'monopolization' refer to in the context of regulatory laws?
What does the term 'monopolization' refer to in the context of regulatory laws?
What are the implications of civil liability for pharmacists in malpractice cases?
What are the implications of civil liability for pharmacists in malpractice cases?
What is the maximum duration for the FDA's standard review process for a New Drug Application (NDA)?
What is the maximum duration for the FDA's standard review process for a New Drug Application (NDA)?
Which of the following best describes the purpose of a Fast Track Designation?
Which of the following best describes the purpose of a Fast Track Designation?
In the context of drug approvals, bioequivalence for ANDA approval refers to the drugs being compared in terms of which of the following?
In the context of drug approvals, bioequivalence for ANDA approval refers to the drugs being compared in terms of which of the following?
What is one of the primary objectives of Phase IV clinical trials?
What is one of the primary objectives of Phase IV clinical trials?
Which of the following statements about Priority Review is accurate?
Which of the following statements about Priority Review is accurate?
What is the primary purpose of the Abbreviated New Drug Application (ANDA)?
What is the primary purpose of the Abbreviated New Drug Application (ANDA)?
During which phase of clinical trials is the primary focus on evaluating optimal dosing and short-term side effects?
During which phase of clinical trials is the primary focus on evaluating optimal dosing and short-term side effects?
Which application is necessary to begin clinical trials on a new drug?
Which application is necessary to begin clinical trials on a new drug?
What is a key component included in a New Drug Application (NDA)?
What is a key component included in a New Drug Application (NDA)?
What is the primary objective of Phase III clinical trials?
What is the primary objective of Phase III clinical trials?
What change can be requested through a Supplemental New Drug Application (sNDA)?
What change can be requested through a Supplemental New Drug Application (sNDA)?
Which is NOT a characteristic requirement of the Preclinical Studies phase?
Which is NOT a characteristic requirement of the Preclinical Studies phase?
What is the minimum number of participants typical for Phase I clinical trials?
What is the minimum number of participants typical for Phase I clinical trials?
What is a key aspect of the Kefauver-Harris Amendment regarding drug regulation?
What is a key aspect of the Kefauver-Harris Amendment regarding drug regulation?
Which federal law primarily assures safety and labeling of food and drugs in interstate commerce?
Which federal law primarily assures safety and labeling of food and drugs in interstate commerce?
Which of the following represents the primary role of the Durham-Humphrey Amendment?
Which of the following represents the primary role of the Durham-Humphrey Amendment?
What is the focus of the FDA Amendments Act of 2007?
What is the focus of the FDA Amendments Act of 2007?
What type of drug recall is classified as a Class I recall?
What type of drug recall is classified as a Class I recall?
Under the Supremacy Clause, what is the status of a federal law conflicting with state law?
Under the Supremacy Clause, what is the status of a federal law conflicting with state law?
Which law initially required pre-market testing for drug safety?
Which law initially required pre-market testing for drug safety?
What constitutes adulteration of a drug?
What constitutes adulteration of a drug?
What is the monthly pseudoephedrine sales limit for a single purchaser?
What is the monthly pseudoephedrine sales limit for a single purchaser?
Which prescription element is mandatory for Schedule II drugs?
Which prescription element is mandatory for Schedule II drugs?
Phase II clinical testing primarily evaluates which aspect?
Phase II clinical testing primarily evaluates which aspect?
Which agency is responsible for overseeing drug recalls?
Which agency is responsible for overseeing drug recalls?
Under the Controlled Substances Act, what characterizes a Schedule IV drug?
Under the Controlled Substances Act, what characterizes a Schedule IV drug?
Which law established a difference between OTC and prescription drugs?
Which law established a difference between OTC and prescription drugs?
DEA Form 106 must be filed for which situation?
DEA Form 106 must be filed for which situation?
What is one of the main focuses of OBRA '90?
What is one of the main focuses of OBRA '90?
What is the primary goal of REMS programs?
What is the primary goal of REMS programs?
What is the required frequency for conducting a biennial inventory of controlled substances in a pharmacy?
What is the required frequency for conducting a biennial inventory of controlled substances in a pharmacy?
Which class of drug recall involves reasonable probability that the use of the product will cause serious health consequences or death?
Which class of drug recall involves reasonable probability that the use of the product will cause serious health consequences or death?
Which organization is primarily responsible for overseeing the marketing of prescription drugs?
Which organization is primarily responsible for overseeing the marketing of prescription drugs?
What is a primary role of Phase IV clinical trials?
What is a primary role of Phase IV clinical trials?
Which document is essential for a pharmacy to order Schedule I and II controlled substances?
Which document is essential for a pharmacy to order Schedule I and II controlled substances?
What key feature differentiates 503B compounding facilities from 503A ones?
What key feature differentiates 503B compounding facilities from 503A ones?
What does the Orange Book provide regarding pharmaceuticals?
What does the Orange Book provide regarding pharmaceuticals?
Under HIPAA, which of the following actions can occur without patient consent?
Under HIPAA, which of the following actions can occur without patient consent?
What is the purpose of a PDMP?
What is the purpose of a PDMP?
What is the primary requirement before a drug can be marketed in the U.S.?
What is the primary requirement before a drug can be marketed in the U.S.?
Which of the following is NOT a responsibility of pharmacies under OBRA '90?
Which of the following is NOT a responsibility of pharmacies under OBRA '90?
Which of the following correctly states the limitation on refills for Schedule III-IV prescriptions?
Which of the following correctly states the limitation on refills for Schedule III-IV prescriptions?
What type of information does HIPAA protect?
What type of information does HIPAA protect?
What does the Anti-Kickback Statute primarily prohibit?
What does the Anti-Kickback Statute primarily prohibit?
Which of the following actions would NOT commonly result in disciplinary measures by a state board of pharmacy?
Which of the following actions would NOT commonly result in disciplinary measures by a state board of pharmacy?
Under the Controlled Substances Act (CSA), what is the main purpose of classifying drugs into schedules?
Under the Controlled Substances Act (CSA), what is the main purpose of classifying drugs into schedules?
What distinguishes a Schedule I drug from other schedules?
What distinguishes a Schedule I drug from other schedules?
What is a primary responsibility of state boards of pharmacy?
What is a primary responsibility of state boards of pharmacy?
Which law specifically addresses physician self-referrals?
Which law specifically addresses physician self-referrals?
What is the maximum number of refills allowed for a Schedule IV medication within a 6-month period?
What is the maximum number of refills allowed for a Schedule IV medication within a 6-month period?
What is required for an Abbreviated New Drug Application (ANDA)?
What is required for an Abbreviated New Drug Application (ANDA)?
Which DEA form is necessary for ordering Schedule I and II controlled substances?
Which DEA form is necessary for ordering Schedule I and II controlled substances?
What defines negligence per se in pharmacy practice?
What defines negligence per se in pharmacy practice?
What is the key purpose of REMS programs?
What is the key purpose of REMS programs?
What is the maximum amount of pseudoephedrine that can be purchased in one day?
What is the maximum amount of pseudoephedrine that can be purchased in one day?
Which organization is crucial for facilitating cooperation among state boards of pharmacy?
Which organization is crucial for facilitating cooperation among state boards of pharmacy?
What must appear on a controlled substance prescription?
What must appear on a controlled substance prescription?
Which DEA form is used to order controlled substances?
Which DEA form is used to order controlled substances?
Which element of malpractice directly links the pharmacist’s actions to patient harm?
Which element of malpractice directly links the pharmacist’s actions to patient harm?
What element of malpractice involves proving that harm would not have occurred without the pharmacist’s actions?
What element of malpractice involves proving that harm would not have occurred without the pharmacist’s actions?
How does a PDMP reduce controlled substance misuse?
How does a PDMP reduce controlled substance misuse?
Which law introduced the requirement for tamper-resistant Medicaid prescription pads?
Which law introduced the requirement for tamper-resistant Medicaid prescription pads?
What is the federal limit on refills for Schedule III and IV prescriptions?
What is the federal limit on refills for Schedule III and IV prescriptions?
What does the Anti-Kickback Statute prohibit?
What does the Anti-Kickback Statute prohibit?
Which type of DEA warrant requires probable cause?
Which type of DEA warrant requires probable cause?
Which of the following would constitute negligence per se?
Which of the following would constitute negligence per se?
How long must Schedule II controlled substance prescriptions be retained under federal law?
How long must Schedule II controlled substance prescriptions be retained under federal law?
Which type of Pharmacy practice acts are designed to?
Which type of Pharmacy practice acts are designed to?
What entity primarily coordinates between state boards of pharmacy?
What entity primarily coordinates between state boards of pharmacy?
Which legislation mandates pharmacists to provide counseling to patients?
Which legislation mandates pharmacists to provide counseling to patients?
Which of the following is NOT true regarding a breach under HIPAA?
Which of the following is NOT true regarding a breach under HIPAA?
What is the maximum number of days allowed to complete a partial fill for a Schedule II drug according to regulations?
What is the maximum number of days allowed to complete a partial fill for a Schedule II drug according to regulations?
Which of the following describes the primary focus of a retrospective Drug Utilization Review (DUR)?
Which of the following describes the primary focus of a retrospective Drug Utilization Review (DUR)?
Which law regulates the distribution and handling of prescription drugs by specifying practices for compounding facilities?
Which law regulates the distribution and handling of prescription drugs by specifying practices for compounding facilities?
What is the primary requirement for drugs that are subject to REMS programs?
What is the primary requirement for drugs that are subject to REMS programs?
What type of facility produces sterile drugs and is specifically regulated under 503B?
What type of facility produces sterile drugs and is specifically regulated under 503B?
What is the maximum monthly limit for purchasing pseudoephedrine?
What is the maximum monthly limit for purchasing pseudoephedrine?
How often are pharmacies required to conduct controlled substance inventories?
How often are pharmacies required to conduct controlled substance inventories?
Which phase of clinical trials focuses on the safety of a drug?
Which phase of clinical trials focuses on the safety of a drug?
Which law prohibits financial arrangements that incentivize referrals in healthcare?
Which law prohibits financial arrangements that incentivize referrals in healthcare?
Which agency oversees the regulation of 503A compounding pharmacies?
Which agency oversees the regulation of 503A compounding pharmacies?
What is a requirement for a prescription for controlled substances?
What is a requirement for a prescription for controlled substances?
Flashcards
Stare Decisis
Stare Decisis
The legal principle requiring courts to follow previous decisions in similar cases.
Supremacy Clause
Supremacy Clause
Federal law overrides conflicting state laws unless state law is stricter.
Civil Trial Burden of Proof
Civil Trial Burden of Proof
The standard of proof in civil cases, requiring a "preponderance of evidence".
Criminal Trial Burden of Proof
Criminal Trial Burden of Proof
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Adulteration
Adulteration
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Misbranding
Misbranding
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Drug Recall Class I
Drug Recall Class I
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Drug Recall Class III
Drug Recall Class III
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New Drug Approval Phases
New Drug Approval Phases
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503A Compounding
503A Compounding
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503B Compounding
503B Compounding
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HIPAA
HIPAA
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Controlled Substances Schedule I
Controlled Substances Schedule I
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DEA Registration
DEA Registration
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Prescription Requirements: Controlled Substances
Prescription Requirements: Controlled Substances
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PDMP
PDMP
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DEA Form 106
DEA Form 106
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OBRA '90
OBRA '90
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Anti-Kickback Statute
Anti-Kickback Statute
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Medicare
Medicare
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Negligence Per Se
Negligence Per Se
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State Board of Pharmacy
State Board of Pharmacy
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What's the difference between 503A and 503B compounding?
What's the difference between 503A and 503B compounding?
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Hazardous Drug Compounding
Hazardous Drug Compounding
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Prescription Requirements
Prescription Requirements
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FDCA (1938)
FDCA (1938)
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Durham-Humphrey Amendment
Durham-Humphrey Amendment
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Kefauver-Harris Amendment
Kefauver-Harris Amendment
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FDAAA (2007)
FDAAA (2007)
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DQSA (2013)
DQSA (2013)
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First Amendment
First Amendment
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Fourth Amendment
Fourth Amendment
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Fifth Amendment
Fifth Amendment
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Sixth Amendment
Sixth Amendment
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Eighth Amendment
Eighth Amendment
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What are the four main sources of law?
What are the four main sources of law?
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What is stare decisis?
What is stare decisis?
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What is the Supremacy Clause?
What is the Supremacy Clause?
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What is the burden of proof in a civil trial?
What is the burden of proof in a civil trial?
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What is the burden of proof in a criminal trial?
What is the burden of proof in a criminal trial?
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What is the purpose of the FDA?
What is the purpose of the FDA?
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What's a generic drug?
What's a generic drug?
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What is the difference between a prescription and an OTC drug?
What is the difference between a prescription and an OTC drug?
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What is an IND?
What is an IND?
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What are the different phases of clinical trials?
What are the different phases of clinical trials?
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DEA Inspection
DEA Inspection
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Pharmacy Inventory Records
Pharmacy Inventory Records
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Refills for Controlled Substances
Refills for Controlled Substances
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Pharmacist's Role in Controlled Substances
Pharmacist's Role in Controlled Substances
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Off-Label Prescribing
Off-Label Prescribing
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Federal Law vs. State Law
Federal Law vs. State Law
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Commerce Clause
Commerce Clause
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Preponderance of Evidence
Preponderance of Evidence
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Beyond a Reasonable Doubt
Beyond a Reasonable Doubt
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Risk Evaluation and Mitigation Strategies (REMS)
Risk Evaluation and Mitigation Strategies (REMS)
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Prospective DUR
Prospective DUR
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Retrospective DUR
Retrospective DUR
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OTC Drugs
OTC Drugs
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Legend Drugs
Legend Drugs
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Drug Adulteration
Drug Adulteration
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Drug Misbranding
Drug Misbranding
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Phase IV Trials
Phase IV Trials
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Orange Book
Orange Book
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Purple Book
Purple Book
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NDA Approval
NDA Approval
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Bioequivalence
Bioequivalence
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Priority Review
Priority Review
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Fast Track Designation
Fast Track Designation
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NDA (New Drug Application)
NDA (New Drug Application)
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ANDA (Abbreviated New Drug Application)
ANDA (Abbreviated New Drug Application)
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sNDA (Supplemental New Drug Application)
sNDA (Supplemental New Drug Application)
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IND (Investigational New Drug Application)
IND (Investigational New Drug Application)
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Phase I Clinical Trial
Phase I Clinical Trial
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Phase II Clinical Trial
Phase II Clinical Trial
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Phase III Clinical Trial
Phase III Clinical Trial
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Phase IV Clinical Trial
Phase IV Clinical Trial
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Statutory Law
Statutory Law
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Administrative Law
Administrative Law
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Burden of Proof (Criminal)
Burden of Proof (Criminal)
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Pure Food and Drug Act (1906)
Pure Food and Drug Act (1906)
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Kefauver-Harris Amendment (1962)
Kefauver-Harris Amendment (1962)
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FDA Amendments Act (2007)
FDA Amendments Act (2007)
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Who notifies the FDA about a recall?
Who notifies the FDA about a recall?
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Which entity regulates prescription drug advertising?
Which entity regulates prescription drug advertising?
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Off-label drug use
Off-label drug use
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What's required before marketing a drug?
What's required before marketing a drug?
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Schedule II Controlled Substances
Schedule II Controlled Substances
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DEA Warrant
DEA Warrant
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Methadone for Opioid Use Disorder
Methadone for Opioid Use Disorder
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Tamper-Resistant Prescription Pads
Tamper-Resistant Prescription Pads
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Pharmacy Practice Acts
Pharmacy Practice Acts
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Malpractice
Malpractice
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REMS Program
REMS Program
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NABP's Role
NABP's Role
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HIPAA Breach Reporting
HIPAA Breach Reporting
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OBRA '90 Counseling
OBRA '90 Counseling
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Schedule II Narcotics
Schedule II Narcotics
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Partial Fill for Schedule II
Partial Fill for Schedule II
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Controlled Substance Prescription Requirements
Controlled Substance Prescription Requirements
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Medicaid Funding
Medicaid Funding
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Medicare Eligibility
Medicare Eligibility
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Stark Law
Stark Law
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USP Purpose for Compounding
USP Purpose for Compounding
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503B Outsourcing Facilities
503B Outsourcing Facilities
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AIW (Administrative Inspection Warrant)
AIW (Administrative Inspection Warrant)
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Biodegradable Pads
Biodegradable Pads
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Tamper-Resistant Pads
Tamper-Resistant Pads
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Digital-Only Prescriptions
Digital-Only Prescriptions
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FDA-Approved Pads
FDA-Approved Pads
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What does the Anti-Kickback Statute prohibit?
What does the Anti-Kickback Statute prohibit?
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What does the Stark Law regulate?
What does the Stark Law regulate?
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Primary Role of State Boards of Pharmacy
Primary Role of State Boards of Pharmacy
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Disciplinary Actions by State Boards of Pharmacy
Disciplinary Actions by State Boards of Pharmacy
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Enforcing Pharmacy Practice Acts
Enforcing Pharmacy Practice Acts
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Conflicting Federal and State Pharmacy Laws
Conflicting Federal and State Pharmacy Laws
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Elements of Malpractice
Elements of Malpractice
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Vicarious Liability
Vicarious Liability
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FTC
FTC
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What is the distinction between OTC and prescription drugs?
What is the distinction between OTC and prescription drugs?
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What is the purpose of Phase II clinical trials?
What is the purpose of Phase II clinical trials?
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What agency oversees drug recalls?
What agency oversees drug recalls?
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What is the purpose of REMS programs?
What is the purpose of REMS programs?
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What is the legal standard for Schedule IV drugs?
What is the legal standard for Schedule IV drugs?
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What are the key elements of a Schedule II prescription?
What are the key elements of a Schedule II prescription?
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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.
- Key Applications:
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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Description
Test your knowledge on the different sources of law, including constitutional, statutory, administrative, and case law. Understand key principles like stare decisis, the Supremacy Clause, and the differences between civil and criminal trials. Explore important amendments and their implications in the legal system.
