What are cgmps - Study guides, Class notes & Summaries

Which of the following is an example of a patient condition anticipated to manifest with a severe systemic inflammatory response? A. Anorexia nervosa with body mass index (BMI) of 15 B. Major depression with compromised dietary intake and 5% loss of body weight C. Homebound older adult with restricted access to food and 10% loss of body weight D. Thermal burn injury of second and third degrees covering 15% body surface area - ANSWER-D. The burn injury is significant and will be associated wi...

Indiana MPJE Exam Practice Questions and Answers | Latest Upsdated 2023-2024. 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 Food, Drug, and Cosmetic Act (FDCA) of 1938 - Correct answer-Required proof of safety o...

Laws vs. Regulations - Answer laws - enacted through a federal or state legislative process regulations - (or rules) provide specific details to help implement the law, and are issued by state regulatory agencies (e.g. state board of pharmacy) FDA Drug Approval Process - Answer 1) pre-clinical testing (animals) 2) manufacturer files an investigational new drug (INDA) application with the FDA 3) INDA approval --> begin Phase 1 study, Phase 2, then Phase 3 4) file a new drug application...

MPJE – Michigan Exam Questions With Correct Answers Misbranding - answerDrugs which are sold, dispensed or distributed in violation of labeling requirements of FDCA Adulterated or Misbranded?: False/misleading labeling - answerMisbranded Adulterated or Misbranded?: Packaging fails to identify name & address of manufacturer, packager of distributor, and quantity of drug - answerMisbranded Adulterated or Misbranded?: Any word or statement required on label is not prominent, conspicuous...

Texas MPJE Exam 2022 Questions and Answers (Graded A+) Texas pharmacist can administer all vaccines - True requires written protocol with MD What age can pharmacist administer influenza - 7 Can C2 prescriptions be refilled? - no therefore no emergency refills What is the min age for vaccines other than the flu? except? - 14 unless the child is referred by a physician can only be given at pharmacy or location provided in protocol (LTCF) How many hours for nuclear training - 7...

Indiana MPJE Final Exam Practice Questions With Correct Answers | Latest Upsdated 2023-2024. Drug Price Competition (DPC) and Patent Term Restoration Act (PTRA) of 1984 - Correct answer-Created 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 - Correct answer-Established procedures, requirements, and minimum standar...

Texas MPJE Exam 2022 Questions and Answers A Grade Texas pharmacist can administer all vaccines - True requires written protocol with MD What age can pharmacist administer influenza - 7 Can C2 prescriptions be refilled? - no therefore no emergency refills What is the min age for vaccines other than the flu? except? - 14 unless the child is referred by a physician can only be given at pharmacy or location provided in protocol (LTCF) How many hours for nuclear training - 700 ho...

MPJE – Michigan Questions and Answers with Certified Solutions Misbranding Drugs which are sold, dispensed or distributed in violation of labeling requirements of FDCA Adulterated or Misbranded?: False/misleading labeling Misbranded Adulterated or Misbranded?: Packaging fails to identify name & address of manufacturer, packager of distributor, and quantity of drug Misbranded Adulterated or Misbranded?: Any word or statement required on label is not prominent, conspicuous and readable Misb...

Food Drug and Cosmetic Act of 1938 - answer-Followed deaths by sulfanalimide elixier; required new drugs to be SAFE; established FDA as primary federal law dealing with food, drug, costmetic, and medical device safety Durham-Humphrey Act of 1951 - answer-Established Rx and OTC drug class; authorized verbal prescriptions and prescription refills Kefauver-Harris Amendment of 1962 - answer-Required new drugs to be SAFE and EFFECTIVE; increased safety requirements for drugs and established GMP...

HACCP Final Exam QUESTION AND CORRECT ANSWER 2023/2024 What does HAACP stand for? - CORRECT ANSWER-Hazard Analysis Critical Control Points What is HACCP? - CORRECT ANSWER-Systematic approach to the identification, evaluation, and control of food safety hazards HACCP's method is based on _______ rather than inspection - CORRECT ANSWERPrevention HACCP is focused solely on _____ not product quality - CORRECT ANSWER-Hazards Where was HACCP originated? - CORRECT ANSWER-Food for Manned Sp...