Misbranded vs adulterated - Study guides, Class notes & Summaries

Kansas Multistate Pharmacy Jurisprudence Examination Review Rated 100% Correct ATF-1447 *** Form for hospital pharmacies needing to purchase large quantities of tax-free grain alcohol Form 41 *** Form to request permission to destroy damaged, outdated, or unwanted controlled substances Form 106 *** Form to report substantial theft or loss of controlled stubstances Form 222 *** Form used to order C-II controlled substances Form 222 *** Form used to send C-II controlled substances to ...

PSB 411 Law Exam 1 Review Chapter 1 Law: a framework through which people in a society resolve their disputes and problems in a way that does not involve force and consistently yields results that are acceptable to most of society Government regulates medicinal drugs very heavily because of the potential risks to users Orphan Drugs: sufficiently safe and effective to be marketed by the number of patients who need them is so small that it is not commercially feasible for manufacturer...

Multistate Pharmacy Jurisprudence Exam (MPJE) Review (FEDERAL LAW) Multistate Pharmacy Jurisprudence Exam (MPJE) Review (FEDERAL LAW) Food and Drug Administration Correct Answer: a federal agency in the Department of Health and Human Services established to regulate the release of new foods and health-related products (P)FDA Correct Answer: Pure Food and Drug Act of 1906 Federal Food, Drug, and Cosmetic Act of 1938 (6/25/38) Correct Answer: FDCA Poison Prevention Packaging Ac...

Supremacy Clause - correct answer -If a conflict exists between federal and state law, federal law prevails Preemption Doctrine - correct answer -(Based on supremacy clause) Federal law preempts state law, even when the laws conflict Orphan drugs - correct answer -Drugs that treat a condition with a relatively small number of sufferers Natural Monopoly - correct answer -Occurs when the fixed costs of providing a good are high relative to the variable cost; so the average cost declines o...

What is the Food and Drug Act of 1906? - ANSWER Prohibited adulterated or misbranded food and drugs Established the FDA What is the Food, Drug, and Cosmetic Act of 1938? - ANSWER Drugs must be proven safe to the FDA prior to marketing Established the FDA as law of land referring food, drugs, cosmetics Granted authority to FDA for factory inspections and warnings of habit-forming drugs What are the Durham-Humphrey Amendments of 1951? - ANSWER Established two types of drugs: OTC and...

Where to find federal laws and regulations - Correct answer-United 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) - Correct answer-The Indiana Code (IC) Indiana Administrative Code (IAC) Pure Food and Drug Act of 1906 - Correct answer-Prevented the manufacture, sale, or transportation of adulterated or misbranded or poisonous or deleterious foods, drugs, medicines, and liquors...