BCPS Regulatory Practice Test

These questions are part of the practice quiz. Start practicing

• Which acts or guidelines provide incentives and regulation for pediatric drug development?
• What is the role of the importer in the FDA’s regulation of drug imports?
• What policy defines recommended action for safe and effective use of medicines in pediatric populations and rare diseases?
• Which item is a component of the NDA package?
• What does the Prescription Drug Marketing Act (PDMA) regulate?
• REMS requires that a drug must be dispensed with one of the following. Which is a valid REMS dispensing requirement?
• Which act prohibited the importation of unsafe or adulterated drugs at key points of entry?
• What is the significance of the 2-year retention requirement for controlled substances?
• What distinguishes an authorized generic drug from the listed drug?
• The NDA code described as new indication for a currently marketed drug or switch from Rx to OTC is best described as
• Which activity is associated with NQF's mission?
• Under HIPAA, the Security Rule requires covered entities to implement which types of safeguards?
• Which statement about biosimilars is accurate?
• IDS must adhere to which of the following standards and regulatory bodies?
• USP <797> relates to sterile compounding; USP <800> relates to handling what in pharmacy?
• What does GLP stand for?
• Which FDA center is responsible for regulating prescription and nonprescription drugs?
• Define minimal risk.
• Which statement correctly describes the focus of GMP, GLP, and GCP?
• One exclusivity provision included in the FDA Modernization Act of 1997 targeted which drugs?
• What is the primary purpose of IRB approval?
• Which agency issues Form 483 after an inspection?
• Which of the following is NOT listed as a duty of an IDS pharmacist?
• Which federal agency oversees vaccine development and licensing, including regulatory oversight of biologics?
• Which of the following is a JC accountability measure for children with asthma inpatients?
• Which REMS program is an example other than isotretinoin?
• Which act regulates tobacco products?
• NDA stands for?
• Which scenario qualifies for IRB exemption when using existing data that are publicly available or de-identified?
• IRB approval is required for which types of studies?
• Which recall class indicates a probability of serious health consequences or death?
• IRB review frequency?
• What is a primary function of AHRQ?
• Which element is typically included in an informed consent document?
• What is the main purpose of the FD&C Act’s adulteration and misbranding provisions?
• Abstracts of clinical study protocols should include which element?
• What does CER stand for in health services research?
• What is an important difference between controlled substances recordkeeping versus non-controlled substances?
• Phase II trials are best described as controlled clinical studies conducted in no more than several hundred subjects to evaluate effectiveness for a specific indication and to determine short-term adverse effects and risks.
• Which two acts are commonly associated with pediatric labeling and safety communication updates?
• Which best defines a clinical trial?
• Which organization has a policy on IRB and investigational use of drugs that supports pharmacists in managing control and distribution of drugs used in research?
• Which of the following statements about IRB composition is true?
• What is the difference between GMP for manufacturing and GLP for preclinical studies?
• Which area among the eight focus areas emphasizes the use of technology to support health care delivery?
• Which law requires serialization and track-and-trace of prescription drugs to enhance drug supply chain security?
• Which act regulates nutritional supplements and vitamins?
• What does Form 483 represent at the end of an FDA inspection?
• Which act created clinicaltrials.gov to provide easy access to information on federal and private trials?
• Kickbacks prohibition to influence referrals for federally funded services is established by which statute?
• Which regulatory path governs manufacturing and labeling of biologic drugs overseen by FDA’s CBER?
• How many measures and domains are in HEDIS?
• Which act provides penalties for submitting false claims to federal health care programs and enables whistleblower suits?
• Which of the following best describes the regulatory goal of ensuring drug establishments and products are registered and listed?
• IND is submitted at what point in development?
• What is the composition of an IRB?
• What is the purpose of the FDA’s Orange Book?
• SCIP measures include timing of antibiotic prophylaxis. Which option correctly states this timing?
• Which concept is best captured by the statement: The critical path dimension for assessing safety emphasizes showing the product is safe for each stage of development?
• CDER regulates which categories?
• Which items are typically found in a study notebook?
• Under the Patient Protection and Affordable Care Act, what pathway was established for follow-on biologics?
• The purpose of the "minimum necessary" standard under HIPAA is to...
• Which FDA center oversees the regulation of biologic products?
• Which element is included in JC accountability measures for pediatric asthma care?
• Which code designation indicates Therapeutic Equivalence?
• In the product development pathway, what sequence is typical from lab to market?
• Which type of safeguards does the HIPAA Security Rule require for electronic protected health information (ePHI) in covered entities?
• Which REMS program is specifically used for thalidomide to prevent birth defects?
• HITECH stands for which of the following?
• What is the purpose of a BLA?
• The HITECH Act is associated with which objective?
• Which statement correctly describes the roles of 503A and 503B in compounding under the FDCA?
• Which term describes a drug produced by the brand manufacturer's company and marketed at generic prices during and after the 180-day exclusivity period that is identical to the brand product in active and inactive ingredients?
• Which two statutes govern physician referrals and compensation to avoid improper financial incentives in healthcare?
• ANDA submitted to CDER must demonstrate
• In bioequivalence, which parameter is commonly compared?
• When relying on an IRB approval from another institution, which document is typically required?
• Which activity is associated with the tracer method used in regulatory surveys?
• Which is a criterion for granting a waiver of informed consent?
• In which legislative act was Comparative Effectiveness Research introduced?
• How do NDA and BLA differ in the scope of products they regulate?
• Premarket Approval (PMA) is used for medical devices to demonstrate safety and efficacy for which risk category?
• What is informed consent?
• What is the purpose of PREA (Pediatric Research Equity Act) in drug development?
• What is the primary reference for established brand-name products and their therapeutic equivalence?
• Which recall class indicates a remote risk of adverse health effects?
• After a Form 483 is issued and noncompliance is not corrected, what is a typical regulatory action by FDA?
• FDA recall classifications are based on patient risk. Which statement correctly describes Class I, Class II, and Class III recalls?
• Which act officially established the FDA as an agency in DHHS?
• Under which act was a regulatory pathway for biosimilars or follow-on biologicals established?
• IND stands for Investigational New Drug and is submitted at what point?
• What is the purpose of postmarketing safety communications?
• The term Pharm Eq represents which regulatory concept?
• What is the primary purpose of an ANDA?
• How long are records related to controlled substances typically required to be kept?
• Which act prohibited interstate commerce of adulterated or misbranded drugs?
• Which statement accurately describes an Accountable Care Organization (ACO)?
• Which is a core component of REMS programs?
• The Anti-Kickback Statute (AKS) is intended to protect the integrity of which programs by prohibiting payments to influence referrals?
• Which CFR parts govern drug labeling content and labeling claims?
• What is a primary purpose of the Targeted Solutions Tool in quality improvement?
• Follow-on biologics/biosimilars are defined as which type of drugs?
• Which FDA program collects reports on adverse events and safety concerns regarding drugs and biologics?
• Which accountability mechanism helps to uncover and remedy healthcare fraud to protect public funds?
• Among the eight focus areas identified for quality improvement, which emphasizes care delivery coordination?
• Which FDA center regulates medical devices?
• ED50 is defined as what?
• During an IND trial, which two groups must receive Serious, suspected adverse events (SAEs) within specified timelines?
• What is the purpose of current Good Manufacturing Practice (cGMP) regulations?
• What constitutes a human subject in research?
• Which action may allow use or disclosure of PHI in research without patient authorization?
• Under OBRA '90, what are pharmacists required to provide for Medicaid patients?
• Which regulatory framework governs the conduct of clinical trials, including IRB oversight and informed consent?
• What is the regulatory pathway for approval of generic drugs based on bioequivalence to a reference product?
• Which regulation part primarily governs Institutional Review Board operations?
• Which statement best defines PHI?
• In what year did meaningful use incentives begin?
• What program mitigates known serious safety risks for certain drugs and requires prescriber/patient enrollment, such as isotretinoin?
• Which federal act restricts the distribution of prescription drug samples and requires samples be dispensed from licensed, registered sources?
• Under IRB exemptions, which activity qualifies for exemption when it involves educational tests, surveys, interviews, or observation?
• Which type of research is exempt from IRB due to being conducted in established or commonly accepted educational settings with normal educational practices?
• What items comprise the drug information portion of the study notebook?
• Which framework requires documentation of equipment calibration and validation in manufacturing?
• Which amendments included the FDA regulating advertising of prescription drugs?
• Which form is used to authorize sharing protected health information under HIPAA in research?
• Which elements should be described in informed consent?
• Which statement about an Investigational New Drug application is correct?
• Which is a JC pneumonia accountability measure?
• Which statement best describes an expedited IRB review?
• How does a biosimilar product obtain market approval under the BPCIA pathway?
• Which of the following best describes the ongoing monitoring of drug safety after approval?
• MedWatch is an FDA program primarily concerned with what aspect?
• DEA Form 222 is used to order which substances?
• Which act authorized Risk Evaluation Mitigation Strategies (REMS) as part of its provisions?
• Which act created the biosimilar pathway and outlines regulatory approval for biosimilars?
• Under the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA), which organization did the Department of Health and Human Services contract with to establish a portfolio of quality and efficiency?
• Which statement describes a key feature of an ACO?
• CMS identified 20 high-priority conditions accounting for over 95% of costs. What activity is emphasized for these conditions?
• In biologics regulation, which designation corresponds to biosimilars seeking licensure as biosimilar products?
• In regulatory coding, Ther Equiv (Code A) refers to which concept?
• What is the primary purpose of the Investigational Drugs Service (IDS)?
• FDA can approve after 12 years of data exclusivity for the manufacturing of a new biologic agent. This describes which concept?
• LD50 is defined as what?
• What does ANDA stand for?
• What should an informed consent document describe?
• Phase IV drug trial refers to
• Which statute provides the legal framework for the FDA's regulation of biologics and vaccines?
• Which type of products does the Biologics Price Competition and Innovation Act primarily regulate?
• Which USP chapters are most relevant to sterile compounding and to handling hazardous drugs in pharmacy?
• According to the IOM definition, health services research examines which dimensions to increase knowledge about health services?
• Which act grants and tax incentives to develop targeted drugs for patient populations under 200,000?
• Phase III trials are primarily designed to
• Which statement best describes an investigational drug?
• Which law requires child-resistant packaging for many household and drug products?
• What is the purpose of meaningful use under ARRA 2009?
• NCQA accreditation framework includes how many accreditation programs?
• Which act requires drugs, biologics, and medical devices manufacturers to pay fees for product applications, supplements and other services, and is reauthorized every 5 years?
• Which items are commonly submitted to the IRB as part of the documents for a research protocol submission?
• Toxicology studies provide the basis for which classification in humans?
• What does CITI refer to in the context of research ethics training?
• Which organization is responsible for accountability measures such as heart attack, heart failure, and pneumonia in hospitals?
• Which standardization framework guides pharmacovigilance data exchange and signal detection globally?
• Which statement best describes minimal risk in IRB terms?
• Which regulatory path governs the manufacturing and listing of drug establishments and products?
• What is the regulatory approach to the importation of drugs into the United States?
• Which agency enforces the two-year retention requirement for controlled substances?
• The Drug Price Competition and Patent Term Restoration Act of 1984 is commonly known as
• BLA stands for?
• Which statement best describes the use of an IND?
• What does ORYX refer to in JC accreditation?
• What is an Emergency Use Authorization (EUA) and when is it used?
• Which act created the Drug Enforcement Administration and regulates controlled substances?
• Under the FD&C Act, which statement best defines drugs?
• Which regulation governs electronic records and signatures for the pharmaceutical industry?
• Which compliance framework helps ensure patient privacy and security in healthcare organizations?
• Which amendments differentiated prescription and nonprescription drugs?
• IND stands for?
• The HITECH Act is best described as legislation that primarily aimed to do which of the following?
• The IRB's role includes which of the following?
• Which agency instituted the incentive program to promote meaningful use of electronic health records?
• The False Claims Act provides penalties and enables whistleblower suits for incorrect claims to which kind of programs?
• In IRB waiver considerations, the research must present no more than what level of risk?
• Which item is a HEDIS domain?
• Postmarketing surveillance involves which of the following?
• What federal act/regulation prohibits false or misleading prescription drug advertising and statements?
• Under HIPAA, which concept requires that the minimum necessary information be used or disclosed?
• AHRQ is an agency within which department?
• Which act required labeling of selected dangerous and addictive substances and identified USP and NF as official standards?
• Which statement accurately describes generic drug equivalence?
• Which is a NDA review designation?
• ANDA stands for which of the following?
• Which CFR parts govern IRB oversight and IND requirements for clinical trials?
• Which pathway would a sponsor use to obtain approval for a new biologic product?
• Under SCIP guidelines, which statement about hair removal is accurate?
• NCQA is best described as which of the following?
• What is the major purpose of risk management activities in pharmacy operations?
• The law that expanded HIPAA protections and promoted electronic health records and e-prescribing is called?
• Which item is included as a NDA component?
• Which descriptor best identifies a new molecular entity in NDA coding?
• Which act required evidence of safety before marketing and placed drug advertising under the FTC?
• Which is a core requirement of meaningful use?
• Which entry would be found under procurement details in the study notebook?
• What is the main purpose of the HIPAA Privacy Rule in pharmacy practice?
• Which activity is a duty of the IDS pharmacist?
• In the heart attack accountability measures, what is the required timing for fibrinolytic therapy?
• Which center within the FDA is primarily responsible for regulating biologics?
• Which entity enforces the HIPAA Privacy Rule in practice?
• Which amendments required efficacy as well as safety, informed consent for research subjects, FDA advertising regulation of Rx drugs, and GMP?
• NOT a requirement for pharmaceutical equivalents?
• Which is a JC heart attack accountability measure?
• What does IDS stand for in regulatory practice?
• Which activity is associated with the National Quality Forum (NQF)?
• Which statement best describes the FDA Office of the Commissioner?
• An ANDA is submitted to which FDA center?
• An at-risk launch occurs when which event takes place?
• Medical devices are regulated by which FDA center, and some devices require Premarket Approval (PMA) to show safety and efficacy?
• Which act reauthorized the Prescription Drug User Fee Act (PDUFA)?
• Which act provides the FDA authority to regulate the import of drugs into the United States?
• What does HEDIS stand for?
• Which statement best describes Current Good Manufacturing Practice (cGMP)?
• Which act established annual licensing for biologics manufacturing and authorized inspections for purity and potency?
• In clinical trial operations, what is the main purpose of an IRB?
• Which act authorized DHHS to create programs to improve health care quality, safety and efficiency through HIT and EHRs?
• Phase 1 drug trials typically involve how many healthy volunteers?
• How does FDA regulate advertising and labeling of OTC products differently from prescription drugs?
• Which act authorized the Hygienic Laboratory to conduct inspections for purity and potency of biologics?
• Which is a JC heart failure accountability measure?
• In an investigational drug study, what is the pharmacist's role?
• Which labeling framework provides updates on pregnancy and lactation labeling in the U.S.?
• The Critical Path Initiative focuses on which objective?
• What does an NDA do?
• A generic drug must be identical to the innovator drug in which characteristics?
• Which act identified USP and NF as official standards?