ETOX 138 Final Questions

ETOX 138 Final Questions - ETX 138 Final Preparation Sheet...

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ETX 138 Final Preparation Sheet EXAM QUESTIONS FOR ETX 138 FINAL 2010 The final is worth 30% of the course grade. The final is worth 180 points. No notes or books can be consulted during the exam. Overall you will be required to answer 6 essay/short answer-type questions for the final. Each question will be worth 30 points. You will be required to answer 4 questions on lecture material. You will also be required to answer one question regarding the student presentations (question 8). You will also be required to answer one analytical question. There will two types of analytical questions; they are described below in questions 9 and 10. Information from the student presentations and the analytical question may include questions regarding material presented before the midterm. Be sure to spell out acronyms. Five of the next seven questions (1-7) will be on the final. You will be given a choice to answer 4 of them. 1. The next several questions relate to the FDA, FDC Act of 1938, and related laws (30 points). a. Describe (what happened, when it happened, chemical(s) involved) the incident which lead to enactment of the FDC Act of 1938. (5 points) b. List the five requirements of the original FDC Act of 1938. (5 points). c. For three categories of products describe how FDA regulates them and identify an example that falls within each category (15 points). d. Explain how tolerances are established for non cancer effects? Describe an example. (5 points) Answer: The enactment of Federal Food, Drug and Cosmetic Act (FDCA) was influenced by an improperly prepared drug Elixir of Sulanilamide, which contained a poisonous solvent diethylene glycol that killed 107 persons, many of whom were children. Chemicals involved were sulfanilamide, diethylene glycol, water, elixir flavor, raspberry extract, saccharin solution, and amaranth. Five requirements of the FDC Act are: new drugs must be shown safe before marketing, safe tolerances must be set for unavoidable poisonous substances, cosmetics and therapeutic devices need to be controlled, standards must be set for foods regarding identity and quality, factory must be inspected. First category is food labeling. FDA regulates that all material facts must be revealed in foods. For example, in 1996 FDA required all products containing Olestra be labeled because it inhibits the absorption of certain vitamins. Second category is food additives. FDA regulates additives by using best science available to see if there is a reasonable certainty of no harm when used. For example, Yellow 5 color additive must be labeled so consumers sensitive to the dye can avoid it. Third category is drugs. FDA regulates drugs by: evaluating products, creating manufacturing standards and labeling all prescription drugs. For example, Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) must revise labels to provide more specific information about potential cardiovascular risks and intestinal bleeding. Tolerances for non-cancer effects are based on: acceptable daily intake, No Adverse Effect
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ETOX 138 Final Questions - ETX 138 Final Preparation Sheet...

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