Texas MPJE 2025|2026 Latest Update
With Complete 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:
, -2 entities that are affiliated/under common ownership
-Providing product to another dispenser on a patient specific basis
-Distributing under emergency medical reasons
-Distributing minimal quantities to licensed MD for office use
Adulteration CORRECT ANSWERS -Filthy, putrid, or decomposed
-Prepared or held under unsanitary conditions and may have been contaminated
-Manufacturing does not conform to cGMP
-Delay, deny, or limit an inspection/refusing to permit entry or inspection
-Container composed of poisonous or deleterious substance that may contaminate the
drug
-Unsafe color additive
-It is in an official compendium, and strength differs from or its quality or purity falls
below compendium standard, unless clearly stated
-Not in a compendium, and strength differs from or quality falls below what is on the
label
-Mixed or packed with any substance that reduces its strength or quality, or has been
substituted in whole or part
If the strength differs from what is represented on the label, is it misbranded or
adulterated? CORRECT ANSWERS Both
Misbranded in manufacturing CORRECT ANSWERS -Labeling is false or misleading
-Drug that could deteriorate unless packaged accordingly
-Container made to be misleading
-Imitation of another drug
-Dangerous when used in manner on label
-Violates PPPA
Rx drug and manufacturer label does not have:
-Name and address of manufacturer
-Brand/generic name
-Net qty
-Wt of AI per unit
-Federal legend "RX ONLY"
-Unless oral, specific route of admin
-Storage instructions
-Control/lot number
-Expiration
-Info for use
OTC drug and manufacturer label does not have:
-Principal display panel (including statement of identity)
-Name and address of manufacturer
-Net qty of contents
-Cautions and warnings
With Complete 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:
, -2 entities that are affiliated/under common ownership
-Providing product to another dispenser on a patient specific basis
-Distributing under emergency medical reasons
-Distributing minimal quantities to licensed MD for office use
Adulteration CORRECT ANSWERS -Filthy, putrid, or decomposed
-Prepared or held under unsanitary conditions and may have been contaminated
-Manufacturing does not conform to cGMP
-Delay, deny, or limit an inspection/refusing to permit entry or inspection
-Container composed of poisonous or deleterious substance that may contaminate the
drug
-Unsafe color additive
-It is in an official compendium, and strength differs from or its quality or purity falls
below compendium standard, unless clearly stated
-Not in a compendium, and strength differs from or quality falls below what is on the
label
-Mixed or packed with any substance that reduces its strength or quality, or has been
substituted in whole or part
If the strength differs from what is represented on the label, is it misbranded or
adulterated? CORRECT ANSWERS Both
Misbranded in manufacturing CORRECT ANSWERS -Labeling is false or misleading
-Drug that could deteriorate unless packaged accordingly
-Container made to be misleading
-Imitation of another drug
-Dangerous when used in manner on label
-Violates PPPA
Rx drug and manufacturer label does not have:
-Name and address of manufacturer
-Brand/generic name
-Net qty
-Wt of AI per unit
-Federal legend "RX ONLY"
-Unless oral, specific route of admin
-Storage instructions
-Control/lot number
-Expiration
-Info for use
OTC drug and manufacturer label does not have:
-Principal display panel (including statement of identity)
-Name and address of manufacturer
-Net qty of contents
-Cautions and warnings
