Misbranded vs adulterated - Study guides, Class notes & Summaries

MPJE Section 1 Questions and Answers 2023 Food, Drug, and Cosmetic Act of 1938 Followed deaths caused by sulfanilamide elixir 1937 Requires new drugs to be proven safe prior to marketing Established FDA Primary federal Law dealing with food, drug, cosmetic and medical device safety today (has lots of amendments) Durham-Humphre Amendments of 1951 2 classes of drugs: RX OTC Authorized verbal prescriptions and prescription refills Study tip: RX vs OTC Expect...

Regulations - Answer-interpret laws and describe how they will be enforced guidance document - Answer-used to convey FDA's current thinking or enforcement priorities - not legally binding Sherley Amendment - Answer-prohibited labeling medicines with false therapeutic claims intended to defraud the purchaser Pure Food and Drug Act of 1906 - Answer-prohibited misbranded and adulterated foods, drinks and drugs from entering interstate commerce FD&C Act - Answer-1938 - repealed 1906 law ...

FDA is under? - Answer-Department of health and human services (DHHS) FDA regulates what types of products? - Answer-Food, dietary supplements, cosmetics, vet products, drugs, med devices, biologics, tobacco, vaping Statute vs regulation vs Guidance - Answer-Statute is a law passed by congress, regulation is a rule issued by a federal agency, guidance is the FDA's current thinking on its regulations Biologics control act - Answer-1901 law regulating vaccines, serums and antibodies F...

Indiana MPJE Exam Questions With Correct Answers Latest Updated 2024 (GRADED) 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 ...

TX MPJE Summary Notes Latest Updates Food Drug and Cosmetic Act of 1938 - 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 - Established Rx and OTC drug class; authorized verbal prescriptions and prescription refills Kefauver-Harris Amendment of 1962 - Required new drugs to be SAFE and EFFECTIVE; increased safety requirements for drugs ...

Mpje Solved Questions and answers Actual test Latest DEAform 224 renew every? - new pharmacy registration to dispense controlled substances (application for new registration) - pharmacy registration is renewed every 3 years (renewal registration form DEA form 224a - chain=224b) - registration kept onsite - issued by attorney gen. 3 exceptions for registration for dispensing controlled substances - employees, contract carrier, ultimate user who has to obtain a registration as a chemical...

RAC Exam New Edition 2023 Solved Correctly drug - Any article intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease in man. medical device - An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent or similar or relate article, including any component, part or accessory intended for the use in diagnosis of disease or other conditions, or in the cure, mitigation, treatment or prevention of disease on man or other animals inte...

MPJE Texas Questions and Answers Already Solved 2023 Which pharmacy must provide one-time notice to patients informing them that Central Processing is being used to fill their prescriptions? SATA -Class A -Class C -Class D -Class E - Ans: -Class A -Class E Which provider pharmacy may establish a satellite pharmacy in a location that is not the same as the pharmacy? SATA -Class A -Class C -Class E -Class D - Ans: -Class A -Class C Durham-Humphrey Amendment of 1951 - -Establ...

Indiana MPJE Exam Questions With 100% Correct Answers | Latest Upsdated 2023-2024. 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 adultera...

NY MPJE Exam Already passed questions and answers 2023 What is the technician to pharmacist ratio? - 2:1 What can a technician do? - Receive Rx (not orally), type info in computers, get drugs from stock, retrieve rx files, count rx/label rx, hand to patient, and OFFER COUNSELING TO PATIENT ON REFILLS What can technicians NOT do? - no telephone rx orders, no clinical interpretation of rx, no compounding, no signing records, no counseling Requirements for pharmacist to be a supervisor?...