Misbranded drug - Study guides, Class notes & Summaries

Indiana MPJE Exam Review Questions 2022/2023 | Consisting Of 111 Questions With Verified Answers From Experts Which federal act discusses adulteration and misbranding of drugs? Food Drug and Cosmetic Act T/F Adulteration/Misbranding can occur with both a drug and a device. True T/F A drug must be contaminated to be considered adulterated. F - if held under unsanitary conditions where it MAYA have been contaminated A container that contains a drug is made of poisonous or harmful material...

Pure Food and Drug Act - correct answer 1906 - Forbade the manufacture or sale of mislabeled or adulterated food or drugs, it gave the government broad powers to ensure the safety and efficacy of drugs in order to abolish the "patent" drug trade. Still in existence as the FDA. The Food Drug and Comestic Act of 1938 - correct answer Established the Food and Drug Administration (FDA). Primarily regulates drug development, manufacturing, and marketing- focus on quality. Only safe and properl...

PTCE Exam Questions and Answers 100% Pass Pure Food and Drug Act - Answer- Prevents the manufacturing, sale/transportation of misbranded or adulturated drugs, poisoned or contaminated drugs Adultered drugs - Answer- Any drug that is not pure misbranded drug - Answer- Not labeled correctly FDCA (Federal Food, Drug, and Cosmetic act) - Answer- drugs must comply with standards of safety and efficacy, more modern act than Pure Food and Drug Act. Oversees safety of food, drugs and cosmetics F...

TX MPJE LATEST UPDATE GRADED A+ 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 and est...

NJ MPJE EXAM | QUESTIONS & ANSWERS (VERIFIED) | LATEST UPDATE | GRADED A+ Neither _____ nor _____ are required by an *ANDA*. Correct Answer: -pre-clinical animal studies -clinical studies *bioequivalence only Prescription drug advertising is regulated by the _____, while OTC drug advertising is regulated by the _____. Correct Answer: -FDA -FTC (Federal Trade Commission) Any false or misleading statements in a drug advertisement could be considered _____. Correct Answer: -misbrand...

Which division has primary jurisdiction over a vascular graft with an antibiotic based on primary mode of action? A. CDER B. CBER C. CDRH D. OCP - correct answer C. CDRH In this combination of a device and a drug, the primary mode of action is that of the vascular graft (device). The antibiotic is supportive in this case. A company wants to modify its legally marketed device such that the modification does not affect the intended use or alter the fundamental scientific technology o...

TEA process - 21 CFR 330-14 add established ingredient to existing OTC monograph Request for Designation (RFD) - ask FDA if it is a drug, biological, device, combo HDE humanitarian device excempt - no effectiveness data required misbranded device - not cleared through 510k process (but needs one) adultered device - does not have PMA but needs one design input for device - requirements that must be met IDE (Investigational Device Exemption) - report within 5 working days: emergencies, use ...

Indiana MPJE Questions and Answers Already Passed Adulteration Something wrong with the preparation, strength, or purity of a product - making the product less pure Expired products - adulteration or misbranding? Adulteration Contaminated drug packaging - adulteration or misbranding? Adulteration Not meeting current good manufacturing practices (cGMP) - adulteration or misbranding? Adulteration Using an unsafe coloring agent - adulteration or misbranding? Adulteration Not meeting USP standa...

CSA correct answers Controlled Substances Act (enforced by the DEA) Poison Prevention Packaging Act correct answers Sets child-resistant drug packaging requirements, under US Consumer Product Safety Commission HIPAA correct answers set by the department of health and human services CMEA correct answers Control Methamphetamine Epidemic Act (CMEA)- pseudoephedrine containing product requirements Hatch-Waxman Act correct answers included the ANDA approval process for generic drugs in...

KS MPJE Review Latest Update Graded A+ Pure Food and Drug Act of 1906 Focused on Purity and Quality Prohibited the interstate transfer of adulterated or misbranded drugs Recognized USP/NF Standards Food, Drug, and Cosmetic Act of 1938 Focused on Safety New drug cannot be marketed until proven safe (drugs prior to 1938 were exempt) Power given to Congress via authority over interstate commerce Durham-Humphrey Amendment of 1951 Established 2 classes of drugs: Rx and OTC Established provisions fo...