Texas MPJE 2025 Exam Questions
and Answers 100% Pass
Food, Drug, and Cosmetic Act of 1938 - CORRECT ANSWER-After
Sulfanilamide deaths in 1937, passed legislation requiring drugs to be proven safe
prior to marketing. Also established the FDA.
Durham-Humphrey Amendments of 1951 - CORRECT ANSWER-Established 2
drug classes - prescription (legend) and OTC. Authorized verbal scripts and refills.
Kefauver-Harris Amendments of 1962 - CORRECT ANSWER-Focused on safety
AND efficacy (established effectiveness as a standard). Established Good
Manufacturing Practices (GMP). Transferred jurisdiction of Rx advertising from
FTC to FDA.
Prescription Drug Marketing Act of 1987 - CORRECT ANSWER-Prohibits the
re-importation of a drug into the US by anyone except the manufacturer.
Prohibits the sale, trade, or purchase of samples.
,Mandates storage, handling, and recordkeeping requirements of samples.
Prohibits resale of prescription drugs purchased by hospitals or healthcare facilities
(there are exceptions).
Drug Sample Rules - CORRECT ANSWER-Most pharmacies prohibited from
selling, purchasing, trading, or possessing samples.
EXCEPTIONS: Pharmacies owned by charitable organizations or by a city, state,
or county government and that are part of a healthcare entity providing care to
indigent or low-income patients at no or reduced cost, and must be given at no
charge to patients.
Drug Quality and Security Act of 2013 - CORRECT ANSWER-Addressed large-
scale compounding by pharmacies, and establishment of a framework for a
uniform track-and-trace system for prescription drugs throughout the supply
chain.
Drug Compounding Quality Act (DCQA) - CORRECT ANSWER-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)
COPYRIGHT ©️ 2025 ALL RIGHTS RESERVED
,These facilities are exempt from new drug provisions, adequate directions for use,
and drug track/trace provisions.
Must:
-RPH overseeing
-Register & report drugs sold every 6 months
-Inspections & pay for them
-Report serious AE w/in 15days
-Label as compounded drug
May not compound meds w/ bulk drug substance, unless:
-They're on list of meds w/ clinical need
-They're on shortage list
Passed in response to fungal meningitis outbreak in 2012 due to contaminated
injectable steroids
, 503A - CORRECT ANSWER-Pharmacy that compounds pursuant to a
prescription.
States with an MOU with the FDA can ship interstate, but not >50% of total
scripts.
If no MOU, no more than 5% allowed.
Drug Supply Chain Security Act (DSCSA) - CORRECT ANSWER-FDA to create
and implement national track-and-trace system for pharmaceuticals.
Transaction data required (maintain for 6 years):
-Transaction Info (includes product identifier)
-Transaction History
-Transaction Statement
Pharmacies can only receive drugs with product identifiers containing 3 elements:
COPYRIGHT ©️ 2025 ALL RIGHTS RESERVED
and Answers 100% Pass
Food, Drug, and Cosmetic Act of 1938 - CORRECT ANSWER-After
Sulfanilamide deaths in 1937, passed legislation requiring drugs to be proven safe
prior to marketing. Also established the FDA.
Durham-Humphrey Amendments of 1951 - CORRECT ANSWER-Established 2
drug classes - prescription (legend) and OTC. Authorized verbal scripts and refills.
Kefauver-Harris Amendments of 1962 - CORRECT ANSWER-Focused on safety
AND efficacy (established effectiveness as a standard). Established Good
Manufacturing Practices (GMP). Transferred jurisdiction of Rx advertising from
FTC to FDA.
Prescription Drug Marketing Act of 1987 - CORRECT ANSWER-Prohibits the
re-importation of a drug into the US by anyone except the manufacturer.
Prohibits the sale, trade, or purchase of samples.
,Mandates storage, handling, and recordkeeping requirements of samples.
Prohibits resale of prescription drugs purchased by hospitals or healthcare facilities
(there are exceptions).
Drug Sample Rules - CORRECT ANSWER-Most pharmacies prohibited from
selling, purchasing, trading, or possessing samples.
EXCEPTIONS: Pharmacies owned by charitable organizations or by a city, state,
or county government and that are part of a healthcare entity providing care to
indigent or low-income patients at no or reduced cost, and must be given at no
charge to patients.
Drug Quality and Security Act of 2013 - CORRECT ANSWER-Addressed large-
scale compounding by pharmacies, and establishment of a framework for a
uniform track-and-trace system for prescription drugs throughout the supply
chain.
Drug Compounding Quality Act (DCQA) - CORRECT ANSWER-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)
COPYRIGHT ©️ 2025 ALL RIGHTS RESERVED
,These facilities are exempt from new drug provisions, adequate directions for use,
and drug track/trace provisions.
Must:
-RPH overseeing
-Register & report drugs sold every 6 months
-Inspections & pay for them
-Report serious AE w/in 15days
-Label as compounded drug
May not compound meds w/ bulk drug substance, unless:
-They're on list of meds w/ clinical need
-They're on shortage list
Passed in response to fungal meningitis outbreak in 2012 due to contaminated
injectable steroids
, 503A - CORRECT ANSWER-Pharmacy that compounds pursuant to a
prescription.
States with an MOU with the FDA can ship interstate, but not >50% of total
scripts.
If no MOU, no more than 5% allowed.
Drug Supply Chain Security Act (DSCSA) - CORRECT ANSWER-FDA to create
and implement national track-and-trace system for pharmaceuticals.
Transaction data required (maintain for 6 years):
-Transaction Info (includes product identifier)
-Transaction History
-Transaction Statement
Pharmacies can only receive drugs with product identifiers containing 3 elements:
COPYRIGHT ©️ 2025 ALL RIGHTS RESERVED
