Indiana MPJE review Exam Questions And Answers With Latest Solutions

Indiana MPJE review Exam Questions And Answers With Latest Solutions Where to find federal laws and regulations - answerUnited States Code (USC) The Code of Federal Regulations (CFR) Majority can be found in Title 21 of both Where to find Indiana laws and regulations (Rules in Indiana) - answerThe Indiana Code (IC) Indiana Administrative Code (IAC) Pure Food and Drug Act of 1906 - answerPrevented the manufacture, sale, or transportation of adulterated or misbranded or poisonous or deleterious foods, drugs, medicines, and liquors Food, Drug, and Cosmetic Act (FDCA) of 1938 - answerRequired proof of safety of a drug Required labels to provide adequate directions for use Did not require coverage for pre-1938 drugs already on the market Durham-Humphrey Amendment of 1951 - answerAmended 1938 Act Established legend and non-legend drugs Prohibited refills of prescriptions without consent from prescriber Outlined minimal information required on the prescription label Allowed pharmacists to accept oral order from prescribers Kefauver-Harris Amendments of 1962 - answerAmended 1938 Act Required drugs to be safe and effective Established CGMPs Provided for testing in humans Federal Comprehensive Drug Abuse Prevention and Control Act of 1970 - answerCreated the DEA Created a closed system to control the manufacture, distribution, prescribing, and dispensing of all controls Poison Prevention Packaging Act of 1970 - answerGives Consumer Product Safety Commission the authority to require special packaging of "hazardous substances"- pretty much all oral drugs Medical Device Amendments of 1976 - answerCalled for all devices to be divided into classes (3), with varying amounts of control required in each one Orphan Drug Act of 1983 - answerProvided financial incentives to attract industry's interest in creating drugs for rare diseases Drug Price Competition (DPC) and Patent Term Restoration Act (PTRA) of 1984 - answerCreated abbreviated new drug application for generic drugs Allowed the marketing of a generic drug without conducting clinical studies but still required CGMPs and proof of bioequivalence Prescription Drug Marketing Act (PDMA) of 1987 - answerEstablished procedures, requirements, and minimum standards for the distribution of prescription drugs and samples Has 6 parts: Prohibits reimportation of rx's into US unless for emergency use by the FDA Bans the actual or offer to sell, purchase, or trade a rx drug that was purchased by a hospital or facility (hospitals can sell to other entities though) Prohibits selling drug samples and selling/counterfieting coupons; requires drs to ask for drug samples in writing, prohibits pharmacies from having drug samples, establishes record keeping and regulations for samples Details how records should be kept and how to respond to record requests How to apply for a whistleblower award Requirements for wholesale distributors that all states must license The Omnibus Reconciliation Act of 1990 (OBRA 90) - answerRequired that states develop stands for a reasonable effort to maintain patient profiles for all Medicaid patients and prospective DUR and an offer to counsel for all Medicaid patients Prescription Drug User Fee Act of 1992 - answerAllowed the FDA to collect fees from drug manufacturers to fund the new drug approval process Dietary Supplement Health and Education Act (DSHEA) of 1994 - answerAllows manufacturers to make certain statements about dietary supplements relating to a structure or function in the body if the statement includes specific things: Claims a benefit related to a classical nutrient deficiency disease and discloses the prevalence of such disease in US Describes the role of a nutrient or dietary ingredient intended to affect the structure or function in humans Characterizes the documented mechanism by which a nutrient or dietary ingredient acts to maintain such structure/function Describes general well-being from consumption of a nutrient or dietary ingredient Manufacturer must have evidence that the claim is truthful and not misleading Cannot make claims about a disease or a dysfunction Health Insurance Portability and Accountability Act (HIPAA) of 1996 - answerFederal standards for protecting privacy and security of patients' protected health information Food and Drug Administration Modernization Act (FDAMA) of 1997 - answerAmended 1938 Act Added Rx only to labels Clarified guidelines on compounding Eliminated warning about habit forming drugs on label Drug Addict Treatment Act of 2000 (DATA 2000) - answerAllows office-based detox treatment by allowing practitioner to administer/dispense/prescribe any CIII-V narcotic approved by the FDA for detox (buprenorphine/suboxone) Prescriber can be a physician, nurse practitioner, or PA and have appropriate XDEA number Practitioners cannot treat more than 30 pts in the first year of becoming DATA waived, then can submit a notification of need and intent to treat up to 100 pts Physicians that have been approved for 100 pts can apply to treat a max of 275 Anabolic Steroids Act of 2004 - answerPlaced anabolic steroids into a Schedule III substance Patient Safety and Quality Improvement Act (PSQIA) of 2005 - answerEstablished a voluntary reporting system designed to enhance the data available to assess and resolve patient safety and health care quality issues Food and Drug Administration Amendment Act (FDAAA) of 2007 - answerAdded REMS Biologics Price Competition and Innovation Act of 2010 - answerCreated an abbreviated approval pathway for biological products that are biosimilar to FDA approved biologics FDA Safety and Innovation Act of 2012 - answerRenewed FDA authorization for *accelerated approval of urgently needed drugs*; established new accelerated process, "breakthrough therapy," in addition to "priority review," "accelerated approval" and *"fast- track" procedures*. Drug Quality and Security Act (DQSA) of 2013 - answerDistinguishes between compounders who are engaged in traditional practice and those who practice outside that scope The latter can voluntarily register with FDA as an outsourcing facility and is subjected to similar FDA oversight as traditional manufacturers Comprehensive Addiction and Recovery Act (CARA) of 2016 - answerImproved access to overdose treatment, allowed pharmacists can dispense naloxone, expanded prescribing of buprenorphine to NPs and PA Major Adulteration elements relevant to drugs - answerWhole or in part filthy, putrid, or decomposed Prepared, packed, or held under unsanitary conditions where it MAY have been contaminated or rendered injurious to health Methods or controls used in its manufacturing, processing, packing, or holding don't conform to current GMP Container is composed of poisonous or deleterious substance Is an unsafe coloring agent or contains an unsafe color additive Doesn't meet the official standards listed in the official compendium (USP, NF, HPUS) Strength doesn't match or quality or purity falls BELOW label claims Has been mixed to reduce its quality or strength Has been substituted wholly or in part Major Misbranding Elements Relevant to Drugs - answerLabeling is false or misleading in any way Label doesn't have the name and place of business of the manufacturer, packer, or distributor Label doesn't have accurate quantity listed Required information isn't prominently plac