Legend drugs - Study guides, Class notes & Summaries

What is the 1938 Federal Food, Drug and Cosmetic Act? (Ans- Misbranding and mislabeling What is the 1951 Durham-Humphrey Amendment? (Ans- Distinction between legend drugs and otc drugs What is the 1970 Poison Prevention Packaging Act? (Ans- Made sure all manufacturers and pharmacies to place medications with childproof caps and packaging What is the 1983 Orphan Drug Act? (Ans- Encourages companies to develop drugs for rare diseases by providing research assistance, grants and co...

Federal MPJE (2024/2025) Exam Questions and Answers 100% Solved What did the FDCA of 1938 accomplish? Food, Drug, and Cosmetic Act Drugs must be safe prior to marketing Established the FDA - Food, Drug, Cosmetic, Medical device safety Durham-Humphrey Amendment of 1951 Created a distinction between "OTC" and "Legend Drugs/Prescription". Authorized verbal prescriptions/refills Required Legend Drugs to carry the statement: "Caution: Federal law prohibits dispensing without a presc...

HOSA Pharmacology (2023 Update) Questions And Answers Revised Grade A+. Absorption Correct Ans:- Process by which a drug enters the circulatory system (blood). Intravenous (IV) & Intra-Arterial Correct Ans:- Administration/Dosage routs that do not require absorption. Absorption, Distribution, Metabolism, & Elimination... The Pharmacokinetic Process Correct Ans:- ADME Addiction Correct Ans:- Dependence characterized by a perceived need to take a drug to attain the psychological & physical...

MPJE Maryland Exam (Latest 2023/ 2024 Update) Questions and Verified Answers | 100% Correct| Grade A Q: How long to retain CE credit records? Answer: 4 years Q: What actions can board take against registration? Answer: Suspend, deny, or revoke Q: What tasks can a technician perform? Answer: Fill script from stock bottle; reconstitute medication;initiate and receive refill authorization requests; prepare/package bulk prescriptions;load automated dispensing sys...

(Updated) EXCPT Pharmacy Technician Exam Study Guide with complete solutions |Latest 2024/2025 1. Pure Food and Drug Act (1906) Prohibits interstate commerce of misbranded and adulterated drugs and foods. 2. Misbranded a drug product is misbranded if its labeling is inaccurate, incomplete, or misleading 3. Adulterated a drug product that fails to meet quality, strength, or purity standards 4. Federal Food, Drug, and CosRequires drug manufacturers to provide the FDA with evidence of saf...

Administrative Procedure Act - correct answer federal law enacted in 1946, "notice and comment rulemaking" 1906: The Pure Food and Drug Act (PFDA) - correct answer interstate commerce labeling 1912 Pure Food and Drug Act - correct answer revised in 1912, stated that a drug was misbranded if its label contained a "false and fraudulent" statement regarding "curative or therapeutic effect." 1938 FD&C Act - correct answer • extended control to cosmetics and therapeutic de...

1906 Pure Food and Drug Act - Answer Prohibits the sale and transport of adulterated or mislabeled food, drinks and drugs. Prohibits the mislabeling and misbranding of products. 1938 Food, Drug and Cosmetic Act (FDCA) - Answer This act requires that manufacture prove a new drug is safe for human consumption. Toxicological studies - done on animals. Clinical trials - done on humans. Gave rise to the Food and Drug Administration. Manufacturer must submit New Drug Application (NDA) to...

North Dakota ND MPJE Questions and Answers 100% Pass How many members serve on the Board of Pharmacy? 7: 5 pharmacists, 1 registered technician, 1 public member How many are public members? (not pharmacist, no financial interest in the field, not spouse of RPh or someone who has financial interest in the field) 1 Which of the following can prescribe legend drugs: O.D. (Optometrist)- Nurse Practitioner - Clinical Nurse Specialist - Physician's Assistant - Midwife - Nurse Midw...

Penn Foster Pharmacology Proctor Exam(Answered 100% Correctly) Indications reasons for giving a drug contraindications reasons to not give a drug legend drugs drugs that have the ability to cause serious harm if misused, must be regulated by the FDA as prescription drugs. Contain a caution statement "caution federal law restricts the use of this drug to use/by/or on the order of a licensed veterinarian." veterinarian client relationship vet takes responsibility for making decisio...

Schedule I Legend drugs requires rx schedule IA Drugs on CPP, must be on duplicate prescription Schedule II Professional Service Area- BTC - NPA Schedule III Professional Products Area- Drugs can be sold to anyone OTC area of licensed pharmacy Schedule IV Prescription by pharmacist, drugs that can be prescribed by a pharmacist Unscheduled Non pharmacy sale, drugs may be sold by non pharmacist to anyone The Health Professions Act-Through the Act, the Ministry of Health (MOA) delegates Auth...