Misbranding - Study guides, Class notes & Summaries

1906 - Federal Food and Drug Act - correct answer This act prohibits the sale of adulterated or mislabeled food, drinksand drugs 1914 - Harrison Narcotic Act - correct answer This act limits the transport of opium. In order to purchase opium, a prescription is required. 1938 - Food Drug and Cosmetic Act - correct answer This act made the food and Drug Act more comprehensive to include cosmetics. The act also defines misbranding or adulteration of drugs to be illegal, This act require...

Alabama MPJE Latest Update (2024/2025) Already Graded A Pure Food and Drug Act (1906) aka Wiley Law Prohibits adulteration and misbranding Food, Drug and Cosmetic Act (1938) -New drug could not be marketed unless safe -Required manufacturer label to have directions for use and warnings about habit forming drugs Durham-Humphrey Amendment (1951) -Established prescription and OTC drug categories -Allowed for oral prescriptions -Allowed for refills Manufacturer label on Rx drugs afte...

What legistation was created for the provisions for the fast track review of some NDA submissions to expedite approval of new drugs used to treat life-threatening conditions? - Food and Drug A dministration (FDA) Modernization Act 1997 What legistation encouraged manufacturers to conduct research for new uses of drugs and to submit SNDAs for these uses? - FDA modernization act 1997 What act reduced the cose of orphan drugs? - Orphan drug act 1983 What act prohibited the adulteration or misbrandi...

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...

MPJE Part 4 (FDA, Laws, Adultering/Misbranding)

Multistate Pharmacy Jurisprudence(MPJE) Exam Review 2023 (FEDERAL LAW) Questions and Answers. 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 Act of 1970 Correct Answer: PPPA Controlled Substance of...

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...

EXCEPT: a. DOs B. PAs c. NPs d. Optometrists e. veterinarians MN: d. Optometrists (Mid level practitioners: CRNA, NP, Optometrists, PA, RPh, Midwives) A patient has three refills remaining on her Rx for Lorazepam issued 1 month ago. The prescribing physician died. The pharmacist must: a. honor all 3 refills within the next 5 months b. only honor up to 2 refills within the next 5 months c. only honor 1 refill within the next 5 months d. dispense not more than a 3 days' supply to the...

(T/F) There are a limited number that the FDA requires the pharmacist to provide a patient package insert with the prescription Correct Answer-True What are examples of drugs that require a patient package insert when prescribed? Correct Answer-Oral contraceptives Estrogen-containing drugs Progestational drugs Estrogen-progestogen oral contraceptives DES, IUD What kind of FDCA violation is it when a drug that requires a patient package insert does not come with one? Correct Ans...

NH MPJE Questions and Answers 100% Correct| Scored A+ 30 days ____ after the expiration date stated on the label of a drug stock container, becomes an adulterated drug Within 15 days Must notify the Board in writing of any changes in name, address or employment Within 15 days Prior to closing, must notify Board and regional office of DEA in writing of the intended closing of a pharmacy Within 30 days Any theft or loss of controlled substances must be reported on DEA for...