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Texas MPJE Exam
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Graded Answers |Latest
Updated 2026
,Food, Drug, and Cosmetic Act of 1938
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
Established 2 drug classes - prescription (legend) and OTC. Authorized verbal
scripts and refills.
Kefauver-Harris Amendments of 1962
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
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
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
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)
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
, 503A
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)
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.
Texas MPJE Exam
Questions Verified and
Provided with A+
Graded Answers |Latest
Updated 2026
,Food, Drug, and Cosmetic Act of 1938
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
Established 2 drug classes - prescription (legend) and OTC. Authorized verbal
scripts and refills.
Kefauver-Harris Amendments of 1962
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
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
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
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)
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
, 503A
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)
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.
