Texas MPJE 2025 EXAM WITH VERIFIED SOLUTIONS

Texas MPJE 2025 EXAM WITH VERIFIED
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SOLUTIONS

Food, Drug, and Cosmetic Act of 1938 - CORRECT ANSWERS
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✔✔After Sulfanilamide deaths in 1937, passed legislation
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requiring drugs to be proven safe prior to marketing. Also
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established the FDA. |\ |\




Durham-Humphrey Amendments of 1951 - CORRECT ANSWERS |\ |\ |\ |\ |\ |\ |\


✔✔Established 2 drug classes - prescription (legend) and OTC.
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Authorized verbal scripts and refills.
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Kefauver-Harris Amendments of 1962 - CORRECT ANSWERS |\ |\ |\ |\ |\ |\ |\


✔✔Focused on safety AND efficacy (established effectiveness as
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a standard). Established Good Manufacturing Practices (GMP).
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Transferred jurisdiction of Rx advertising from FTC to FDA.
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Prescription Drug Marketing Act of 1987 - CORRECT ANSWERS
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✔✔Prohibits the re-importation of a drug into the US by anyone
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except the manufacturer.
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Prohibits the sale, trade, or purchase of samples.
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Mandates storage, handling, and recordkeeping requirements of
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samples.

,Prohibits resale of prescription drugs purchased by hospitals or
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healthcare facilities (there are exceptions). |\ |\ |\ |\




Drug Sample Rules - CORRECT ANSWERS ✔✔Most pharmacies
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prohibited from selling, purchasing, trading, or possessing
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samples. |\




EXCEPTIONS: Pharmacies owned by charitable organizations or by
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a city, state, or county government and that are part of a
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healthcare entity providing care to indigent or low-income
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patients at no or reduced cost, and must be given at no charge
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to patients.
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Drug Quality and Security Act of 2013 - CORRECT ANSWERS
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✔✔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.
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Drug Compounding Quality Act (DCQA) - CORRECT ANSWERS
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✔✔Maintains traditional compounding regulations but establishes
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new section to FDCA that allows facilities that are compounding
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sterile pharmaceuticals to register with FDA as outsourcing
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facility (503B) |\




These facilities are exempt from new drug provisions, adequate
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directions for use, and drug track/trace provisions.
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Must:
-RPH overseeing
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,-Register & report drugs sold every 6 months
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-Inspections & pay for them |\ |\ |\ |\




-Report serious AE w/in 15days |\ |\ |\ |\




-Label as compounded drug
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May not compound meds w/ bulk drug substance, unless:
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-They're on list of meds w/ clinical need
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-They're on shortage list |\ |\ |\




Passed in response to fungal meningitis outbreak in 2012 due to
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contaminated injectable steroids |\ |\




503A - CORRECT ANSWERS ✔✔Pharmacy that compounds
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pursuant to a prescription. |\ |\ |\




States with an MOU with the FDA can ship interstate, but not
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>50% of total scripts.|\ |\ |\




If no MOU, no more than 5% allowed.
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Drug Supply Chain Security Act (DSCSA) - CORRECT ANSWERS
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✔✔FDA to create and implement national track-and-trace system
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for pharmaceuticals.
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Transaction data required (maintain for 6 years): |\ |\ |\ |\ |\ |\




-Transaction Info (includes product identifier) |\ |\ |\ |\

, -Transaction History |\




-Transaction Statement |\




Pharmacies can only receive drugs with product identifiers
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containing 3 elements: |\ |\




1. Standardized numerical identifier (SNI) which comprises the
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NDC + unique serial number
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2. Lot number
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3. Expiration date
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Pharmacy must investigate: |\ |\




-Suspect products |\




-Illegitimate products |\




*Verify the product identifier of 3 products or 10% (whichever is
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greater)


If illegitimate, notify FDA w/ FDA Form 3911 and trading partners
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within 24 hours. |\ |\




Distributing - CORRECT ANSWERS ✔✔Providing a drug to anyone
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other than the consumer/patient.
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Must have wholesale distribution license and pass DSCSA
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transaction data. |\




Exceptions: