Texas MPJE 2025 EXAM WITH VERIFIED
|\ |\ |\ |\ |\ |\
SOLUTIONS
Food, Drug, and Cosmetic Act of 1938 - CORRECT ANSWERS
|\ |\ |\ |\ |\ |\ |\ |\ |\ |\
✔✔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 ANSWERS |\ |\ |\ |\ |\ |\ |\
✔✔Established 2 drug classes - prescription (legend) and OTC.
|\ |\ |\ |\ |\ |\ |\ |\ |\
Authorized verbal scripts and refills.
|\ |\ |\ |\
Kefauver-Harris Amendments of 1962 - CORRECT ANSWERS |\ |\ |\ |\ |\ |\ |\
✔✔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 ANSWERS
|\ |\ |\ |\ |\ |\ |\ |\ |\
✔✔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 ANSWERS ✔✔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 ANSWERS
|\ |\ |\ |\ |\ |\ |\ |\ |\ |\
✔✔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 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.
|\ |\ |\ |\ |\ |\
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 ANSWERS ✔✔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 ANSWERS
|\ |\ |\ |\ |\ |\ |\ |\ |\
✔✔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: |\ |\
1. Standardized numerical identifier (SNI) which comprises the
|\ |\ |\ |\ |\ |\ |\ |\
NDC + unique serial number
|\ |\ |\ |\
2. Lot number
|\ |\
3. Expiration date
|\ |\
Pharmacy must investigate: |\ |\
-Suspect products |\
-Illegitimate products |\
*Verify the product identifier of 3 products or 10% (whichever is
|\ |\ |\ |\ |\ |\ |\ |\ |\ |\ |\
greater)
If illegitimate, notify FDA w/ FDA Form 3911 and trading partners
|\ |\ |\ |\ |\ |\ |\ |\ |\ |\ |\
within 24 hours. |\ |\
Distributing - CORRECT ANSWERS ✔✔Providing a drug to anyone
|\ |\ |\ |\ |\ |\ |\ |\ |\
other than the consumer/patient.
|\ |\ |\
Must have wholesale distribution license and pass DSCSA
|\ |\ |\ |\ |\ |\ |\ |\
transaction data. |\
Exceptions:
|\ |\ |\ |\ |\ |\
SOLUTIONS
Food, Drug, and Cosmetic Act of 1938 - CORRECT ANSWERS
|\ |\ |\ |\ |\ |\ |\ |\ |\ |\
✔✔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 ANSWERS |\ |\ |\ |\ |\ |\ |\
✔✔Established 2 drug classes - prescription (legend) and OTC.
|\ |\ |\ |\ |\ |\ |\ |\ |\
Authorized verbal scripts and refills.
|\ |\ |\ |\
Kefauver-Harris Amendments of 1962 - CORRECT ANSWERS |\ |\ |\ |\ |\ |\ |\
✔✔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 ANSWERS
|\ |\ |\ |\ |\ |\ |\ |\ |\
✔✔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 ANSWERS ✔✔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 ANSWERS
|\ |\ |\ |\ |\ |\ |\ |\ |\ |\
✔✔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 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.
|\ |\ |\ |\ |\ |\
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 ANSWERS ✔✔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 ANSWERS
|\ |\ |\ |\ |\ |\ |\ |\ |\
✔✔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: |\ |\
1. Standardized numerical identifier (SNI) which comprises the
|\ |\ |\ |\ |\ |\ |\ |\
NDC + unique serial number
|\ |\ |\ |\
2. Lot number
|\ |\
3. Expiration date
|\ |\
Pharmacy must investigate: |\ |\
-Suspect products |\
-Illegitimate products |\
*Verify the product identifier of 3 products or 10% (whichever is
|\ |\ |\ |\ |\ |\ |\ |\ |\ |\ |\
greater)
If illegitimate, notify FDA w/ FDA Form 3911 and trading partners
|\ |\ |\ |\ |\ |\ |\ |\ |\ |\ |\
within 24 hours. |\ |\
Distributing - CORRECT ANSWERS ✔✔Providing a drug to anyone
|\ |\ |\ |\ |\ |\ |\ |\ |\
other than the consumer/patient.
|\ |\ |\
Must have wholesale distribution license and pass DSCSA
|\ |\ |\ |\ |\ |\ |\ |\
transaction data. |\
Exceptions:
