Florida MPJE Questions and Answers
100% Pass
Food, Drug, and Cosmetic Act of 1938 ✔✔Due to sulfanilamide elixir deaths
New drugs must be SAFE before marketing
Established the FDA
Durham-Humphrey Amendment of 1951 ✔✔Created OTC vs. Legend drugs
Verbal prescriptions
Prescription refills
Kefauver-Harris Amendment of 1962 ✔✔"Drug Efficacy Amendment"
New drugs must be SAFE and EFFICACIOUS
,Established GMPs
FDA oversees prescription drug advertising
Prescription Drug Marketing Act of 1987 ✔✔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 ✔✔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? ✔✔traditional pharmacy that compounds for specific patients
pursuant to prescriptions (no cGMP required)
****Follow USP 797***
What are requirements for outsourcing facilities? ✔✔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) ✔✔"Track and Trace Amendment"
FDA Form 3911 ✔✔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? ✔✔Wholesale distribution license
What is adulteration? ✔✔- filthy, putrid, decomposed substance
- prepped or stored in unsanitary conditions
- does not meet gmp's
- includes unapproved color additive
100% Pass
Food, Drug, and Cosmetic Act of 1938 ✔✔Due to sulfanilamide elixir deaths
New drugs must be SAFE before marketing
Established the FDA
Durham-Humphrey Amendment of 1951 ✔✔Created OTC vs. Legend drugs
Verbal prescriptions
Prescription refills
Kefauver-Harris Amendment of 1962 ✔✔"Drug Efficacy Amendment"
New drugs must be SAFE and EFFICACIOUS
,Established GMPs
FDA oversees prescription drug advertising
Prescription Drug Marketing Act of 1987 ✔✔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 ✔✔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? ✔✔traditional pharmacy that compounds for specific patients
pursuant to prescriptions (no cGMP required)
****Follow USP 797***
What are requirements for outsourcing facilities? ✔✔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) ✔✔"Track and Trace Amendment"
FDA Form 3911 ✔✔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? ✔✔Wholesale distribution license
What is adulteration? ✔✔- filthy, putrid, decomposed substance
- prepped or stored in unsanitary conditions
- does not meet gmp's
- includes unapproved color additive
