Florida MPJE 2023 (100% verified with complete answers)
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Course
Florida MPJE
Institution
Florida MPJE
Food, Drug, and Cosmetic Act of 1938 correct answers Due to sulfanilamide elixir deaths
New drugs must be SAFE before marketing
Established the FDA
Durham-Humphrey Amendment of 1951 correct answers Created OTC vs. Legend drugs
Verbal prescriptions
Prescription refills
Kefauver-Har...
Florida MPJE 2023 (100% verified with complete answers)
Food, Drug, and Cosmetic Act of 1938 correct answers Due to sulfanilamide elixir deaths
New drugs must be SAFE before marketing
Established the FDA
Durham-Humphrey Amendment of 1951 correct answers Created OTC vs. Legend drugs
Verbal prescriptions
Prescription refills
Kefauver-Harris Amendment of 1962 correct answers "Drug Efficacy Amendment"
New drugs must be SAFE and EFFICACIOUS
Established GMPs
FDA oversees prescription drug advertising
Prescription Drug Marketing Act of 1987 correct answers Prevents re-importation of a drug into US
Prohibited hospital and healthcare entities from reselling their pharmaceuticals
Bans sale, trade, or purchase of prescription drug samples
Storage, handling, and record-keeping requirements for prescription drug samples
Prohibits re-sale of prescription drugs purchased from hospitals or healthcare facilities
Drug Compounding Quality Act correct answers Maintains traditional compounding regulations but establishes new section to FDCA that allows facilities that are compounding sterile pharmaceuticals to register with FDA as outsourcing facility (503B)
These facilities are exempt from new drug provisions, adequate directions for use, and drug track/trace provisions
What is a 503A pharmacy? correct answers traditional pharmacy that compounds for specific patients pursuant to prescriptions (no cGMP required)
****Follow USP 797***
What are requirements for outsourcing facilities? correct answers Have a licensed pharmacist Register as an outsourcing facility
Report to the Secretary of HHS on registering and every 6 months
Be inspected by the FDA
Report serious adverse events within 15 days
Label products with identifying statement as compounded products
Only compound drugs that have a clinical need a and/or on shortage
Drug Supply Chain Security Act (DSCSA) correct answers "Track and Trace Amendment"
FDA Form 3911 correct answers Track and trace form to report illegitimate products to the FDA
***Must also notify trading partners within 24 hours***
What license must pharmacies that are "distributing" have? correct answers Wholesale distribution license
What is adulteration? correct answers - filthy, putrid, decomposed substance
- prepped or stored in unsanitary conditions
- does not meet gmp's
- includes unapproved color additive
-contains drug recognized in or not official compendia, but its strength, purity, or quality is lower
than the official standards
- container can leach into product
- substituted active ingredient
What is misbranding? correct answers Label is defaced or misleading
Labeling is missing any of the required information
What information must be on a prescription drug's manufacturer's labeling? correct answers Name and address of manufacturer
Brand and/or generic of drug Net quantity (units, weight, etc.)
Weight of active ingredients per dose
Federal "Rx Only" for legend drugs
Route of administration (unless taken orally)
Any special storage requirements
Expiration date
Adequate info/directions for use
What information must be on a OTC drug's manufacturer's labeling? correct answers Principal display panel with statement of identity of the product
Name and address of manufacturer
Net quantity
Cautions and warnings for the user
Adequate directions for safe and effective use
Drug Facts panel
What is required on the Drug Facts Panel on OTC drugs? correct answers Active ingredients
Purpose
Warnings
Directions
Any other necessary information
Inactive ingredients (alphabetical order)
Questions? (Optional) w/ telephone number
FD&C Yellow No. 5 (tartrazine) warning statement correct answers "precautions" for allergic reactions in susceptible persons
Aspartame warning statement correct answers "Phenylketonurics: Contains phenylalanine ___ mg per dosage unit"
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