Texas Mpje 2025 Exam With Verified Solutions

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: