Waxman - Study guides, Class notes & Summaries

Pharmacy Law - MPJE NYS Exam Questions And Answers Which of the following brand name products may not be substituted under New York's "negative formulary"? - Phenergan IR tablets, suppositories, solution for injection, oral suspension - ANS SUPPOSITORIES (along with ER formulations, they need to determine bioequivalence. Therapeutic equivalents that may be substituted must be... - ANS Bioequivalent and approved ANDA What are some enforcement tools utilized by the FDA? - ANS ...

Which of the following brand name products may not be substituted under New York's "negative formulary"? - Phenergan IR tablets, suppositories, solution for injection, oral suspension correct answers SUPPOSITORIES (along with ER formulations, they need to determine bioequivalence. Therapeutic equivalents that may be substituted must be... correct answers Bioequivalent and approved ANDA What are some enforcement tools utilized by the FDA? correct answers 1) Seizure of drugs 2) Criminal ...

Ohio MPJE 2024 Questions and Answers Graded A+ Federal Food, Drug, and Cosmetic Act of 1938 The "Pillar of Pharmacy Law"; gave authority to FDA to oversee safety of food, drugs, and cosmetics Adulteration Contains any poisonous or deleterious substance which may render it injurious to users when used as directed Misbranded Drug that's labeling or packaging is false or misleading; contains incorrect drug, pt name, prescriber name, or directions Durham-Humphrey Amendment of 19...

Which FDCA amendment exempted certain drugs from the "adequate directions for use" labeling requirement if they bear "Rx only" on their labels? a. Durham Humphrey b. Kefauver-Harris c. Prescription Drug Marketing d. Waxman-Hatch - Answer a. Durham Humphrey The FDCA defines a "new drug" as a previously approved drug entity with a new: a. route of administration. b. indication for use. c. combination of ingredients. d. a and b e. a, b and c. - Answer e. route of administrat...

Pure Food and Drug Act of 1906Answer - prohibited the adulteration and misbranding of foods and drugs in interstate commerce Food, Drug, and Cosmetic Act of 1938Answer - Core of today's drug laws. No new drug can be marketed/sold until proven safe and approved by FDA. Labels must contain adequate directions for use and warnings about their habit-forming properties Durham-Humphrey Amendment of 1951Answer - Established two classes of medications: Rx and OTC. Authorized oral prescriptions...

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 after Durham-Humphrey Amendment -Not required to have directions for ...

PA MPJE 2024 QUESTIONS AND ANSWERS GRADED A+ Generic drug companies can submit what two abbreviated drug applications? ANDA or 505(b)(2) application What is the key difference between an ANDA and 505(b)(2) application? Drugs submitted under ANDA must be bioequivalent and have same route of administration, strength, and formulation Drugs submitted under 505(b)(2) can have different strength or formulation What Act approved in March of 2020 includes OTC monograph reform? The CARES Ac...

Which of the following DEA numbers could be Dr. Jack Smith's? A. BS5892143 B. DS5892143 C. JS5892143 D. BJ5892143 - ️️BS5892143 Why? The first letter if a DEA number must be an A,B or F. The second letter of a DEA number must be the first letter of the individual's last name ADD Which of the following acts was responsible for implementing the NDC number used for each drug A. Drug Listing Act 1972 B. Hatch-Waxman Act of 1984 C. Federal Privacy Act of 1974 D. Prescripti...

PETE 321 Final Exam Questions & Answers 2024/2025 Effects on sonic transit time - ANSWERS-gas in drilling mud -large boreholes -slow formations -fluid invasion T/F Wettability of the rock grains does not affect resistivity measurements. - ANSWERSFalse T/F With an increase in porosity, the formation resistivity factor decreases. - ANSWERSTrue T/F At a fixed porosity, an increase in the tortuosity of pores in rock increases the formation resistivity factor. - ANSWERSTrue T/F Ar...

1. How are drugs sorted into therapeutic groups and classes? A. first by the conditions that they are used to treat. and then by their mechanisms of action B. first by their mechanisms of action. and then by their therapeutic effects C. first by their side effects. and then by their therapeutic effects D. first by their toxicity. and then by their effectiveness 2. Bone marrow transplants... A. require that the patient first undergo chemotherapy or radiation to kill the diseased...